Targeted business development acquisitions, improvements in R&D and operating performance, and a strengthened post-demerger balance sheet are creating new capacity and flexibility for GSK to invest in growth and innovation for patients and shareholders.
By Andrew Humphreys • firstname.lastname@example.org
980 Great West Road
Brentford, Middlesex TW8 9GS, United Kingdom
+44 (0)20 8047 50000 • gsk.com
|2021||2020||1H 2022||1H 2021|
|All figures are in millions of dollars except EPS and were translated using the Federal Reserve Board’s average rate of exchange in 2021: £1.3764.|
All sales are in millions of dollars and were translated using the Federal Reserve Board’s average rate of exchange in 2021: £1.3764.
- Triumeq $2,590
- Shingrix $2,369
- Tivicay $1,901
- Advair/Seretide $1,868
- Trelegy Ellipta $1,675
- Nucala $1,572
- Breo/Relvar Ellipta $1,543
- Xevudy $1,319
- Benlysta $1,203
- Dovato $1,083
- Ventolin $988
- Fluarix, FluLaval $935
- Bexsero $895
- Infanrix, Pediarix $747
- Rotarix $745
- Boostrix $717
- Juluca $712
- Anoro Ellipta $694
- Lamictal $658
- Flovent/Flixotide $611
- Augmentin $586 $
- Zejula $544
1H 2022 sales
- Xevudy $2,440
- Shingrix $1,967
- Triumeq $1,174
- Trelegy Ellipta $1,111
- Tivicay $917
- Nucala $911
- Breo/Relvar Ellipta $804
- Dovato $794
- Advair/Seretide $776
- Benlysta $705
- Ventolin $516
- Bexsero $451
- Infanrix, Pediarix $406
- Juluca $392
- Boostrix $391
- Flovent/Flixotide $372
- Augmentin $356
- Lamictal $340
- Rotarix $326
- Zejula $300
- Anoro Ellipta
Outcomes Creativity Index Score: 13
- Manny Awards — N/A
- Cannes Lions — N/A
- Clio Health — N/A
- Creative Floor Awards — 8
- London International Awards – N/A
- MM+M Awards — 5
- One Show — N/A
GSK separated during 2022 to create two new leading companies, both with the opportunity to impact human health at scale and deliver compelling performance for shareholders. The demerger represents the most significant corporate change for GSK during the past 20 years, according to management. Both new companies have clear targets for growth and the ability to positively impact the health and lives of billions of people. Meanwhile, the pharma giant announced the decision to change its name to GSK from GlaxoSmithKline in the company’s April 27, 2022, earnings release, and officially made the change on May 16.
New GSK is uniting science, talent, and technology to “get ahead of disease together.” Following the demerger, GSK is concentrating purely on biopharmaceuticals, prioritizing investment towards the development of innovative vaccines and specialty medicines, maximizing the increasing opportunities to prevent and treat disease. Step-change in growth includes anticipated sales growth of more than 5 percent and adjusted operating profit growth of more than 10 percent on a compound basis 2021-26; research and development concentrated on the science of the immune system, human genetics and advanced technologies; positively impacting the health of more than 2.5 billion people over 10 years; and maintaining a leading environmental, social and governance (ESG) performance.
Haleon will be a worldwide leader 100 percent focused on consumer health. Management said Haleon will have a clear purpose to deliver better everyday health with humanity, and a focused strategy to deliver sustainable above-market growth and attractive returns to shareholders. Strong prospects for growth include an exceptional portfolio of category-leading brands with an attractive global footprint and competitive capabilities; a compelling strategy to outperform in a growing, £150 billion-plus sector that is “more relevant than ever;” 4-6 percent annual organic sales growth in the medium term, sustainable moderate margin expansion and high cash conversion; and an attractive growth profile with the capacity to invest and deliver shareholder returns.
The July 18, 2022, arrival of the Haleon Group marks a new world leader in consumer healthcare with a clear strategy to outperform and run a responsible business, company executives said. According to management, the balance sheet has been strengthened for GSK, through dividend of more than £7 billion from Haleon. American Depositary Shares representing shares of Haleon plc commenced “regular-way” trading on the New York Stock Exchange on July 22.
Financial & product performance
Total turnover for GSK during 2022’s first half reached £14.12 billion ($19.43 billion), representing a year-over-year increase of 28 percent at AER and 25 percent at CER, reflecting strong performance in all three product groups. Commercial Operations turnover, excluding pandemic sales, rose 15 percent at AER and 12 percent at CER.
Specialty Medicines sales for GSK amounted to £5.84 billion ($8.04 billion), up 69 percent at AER and 63 percent at CER compared to first-half 2021, driven by consistent growth in all therapy areas. Specialty Medicines, excluding sales of the COVID-19 treatment Xevudy, reached £4.07 billion ($5.6 billion), rising 18 percent at AER and 14 percent at CER. HIV sales were reported at £2.59 billion ($3.56 billion) with growth of 14 percent at AER and 10 percent at CER.
Oncology sales for first-half 2022 were £281 million ($387 million), up 23 percent at AER, 19 percent at CER.
Immuno-inflammation, Respiratory and Other sales increased 26 percent at AER and 21 percent at CER to £1.2 billion ($1.65 billion).
Vaccines turnover for GSK during the January–June 2022 period amounted to £3.38 billion ($4.66 billion), up 21 percent at AER, 17 percent at CER. Excluding unrepeated 2021 pandemic adjuvant sales, vaccine sales grew 33 percent at AER and 30 percent at CER. This performance reflects a favorable comparator to first-half 2021, which was adversely impacted by COVID-19 related disruptions in several markets, and the strong commercial execution of the shingles vaccination Shingrix, particularly in the United States and Europe.
GSK’s General Medicines sales in the first half of 2022 totaled £4.9 billion ($6.74 billion), up 3 percent at AER and 2 percent at CER, with the impact of generic competition in United States, Europe, and Japan offset by Trelegy growth in respiratory and the post-pandemic rebound of the antibiotic market since H2 2021 in Other General Medicines. General Medicines includes £76 million ($105 million) of turnover between GSK and Haleon recorded in continuing operations with an offsetting amount accounted for in discontinued operations.
Total operating profit for GSK during the 2022 first half was reported at £3.37 billion ($4.64 billion) versus £2.49 billion ($3.42 billion) during H1 2021. GSK said this included the £0.9 billion upfront income received from the settlement with Gilead Sciences and increased profits on turnover growth of 25 percent at CER, partly offset by higher re-measurement charges for contingent consideration liabilities.
Adjusted operating profit was recorded at £3.95 billion ($5.44 billion), marking 33 percent growth at AER and 26 percent at CER over first-half 2021 on a turnover increase of 25 percent at CER. The Adjusted operating margin of 28.0 percent was 1 percentage point higher at AER and stable at CER compared to the reported January-June 2021 period. Management said this primarily reflected the impact from low-margin COVID-19 solutions sales (Xevudy), which reduced adjusted operating profit growth by 2 percent at AER, 1 percent at CER and reduced the adjusted operating margin by 3.3 percentage points at AER and at CER. This was offset by operating leverage from strong sales growth, beneficial mix, and higher royalty income according to GSK.
Total EPS (adjusted to reflect GSK’s share consolidation on July 18, 2022) from continuing operations was 54.8p (75 cents) during H1 2022 versus 50.3p (69 cents) during the one-year-earlier period. This growth primarily reflected the £0.9 billion upfront income received from the Gilead settlement and increased profits on turnover growth of 25 percent at CER, partly offset by higher re-measurement charges for contingent consideration liabilities as well as an unfavorable comparison due to a credit of £325 million to taxation in Q2 2021.
Following completion of the Consumer Healthcare business demerger on July 18, GSK plc Ordinary shares were consolidated in order to maintain share price comparability before and after the demerger. GSK plc shareholders received 4 new ordinary shares for every 5 existing ordinary shares. GSK reported that earnings per share, diluted EPS, adjusted EPS and dividends per share have been retrospectively adjusted to reflect the share consolidation in all the periods presented.
Adjusted EPS was 67.0p (92 cents) versus 49.3p (68 cents) in H1 2021, an increase of 36 percent at AER and 27 percent at CER, on a 26 percent CER rise in adjusted operating profit. The results included higher COVID-19 solutions sales at low margin with the reduction to growth from COVID-19 solutions being 2 percent at AER and 2 percent at CER. Leverage from growth in sales of Specialty Medicines, beneficial mix, higher royalty income and a lower effective tax rate was partly offset by higher supply chain, freight and distribution costs, lower associate income and higher non-controlling interests.
Cash generated from operations attributable to continuing operations for the first six months of 2022 was £3.94 billion ($5.42 billion) compared to the H1 2021 amount of £1.76 billion ($2.42 billion). The growth primarily reflected a significant increase in operating profit including the upfront income from the Gilead settlement, favorable exchange and favorable timing of collections and profit share payments for Xevudy sales, partly offset by increased contingent consideration payments reflecting the Gilead deal and a higher seasonal increase in inventory.
GSK CEO Emma Walmsley stated, “This is GSK’s first set of results as a newly focused biopharma company, and we have delivered an excellent second-quarter performance, with strong growth in Specialty Medicines, including HIV, and a record quarter for our shingles vaccine Shingrix. With this momentum in sales and operating profit growth, we have raised our full-year guidance and are confident in delivering the long-term growth outlooks we set out for shareholders last year. We continue to strengthen our pipeline, notably with very positive high-level results from our late-stage RSV vaccine candidate, together with targeted business development acquisitions of Sierra Oncology and Affinivax. These improvements in R&D and operating performance, together with a strengthened post-demerger balance sheet, create new capacity and flexibility for GSK to invest in growth and innovation for patients and shareholders.”
According to GSK management, “With the momentum from the business performance to date (through Q2 2022), GSK now expects 2022 sales to increase between 6 to 8 percent and adjusted operating profit to increase between 13 to 15 percent, excluding any contributions from COVID-19 solutions. Adjusted earnings per share is expected to grow around 1 percent lower than operating profit. We have delivered first-half performance ahead of our full-year guidance, slightly better than expected, informed by strong business delivery and the dynamics of prior year comparators.”
According to company management, “Predominantly reflecting a more challenging H2 2021 sales comparator as well as an expected increase in R&D spend, we expect lower reported growth in the second half. Key external factors that will influence the second half of 2022 include the continued risk from COVID-19 dynamics and possible developments in the current uncertain global economic environment.”
GSK is collaborating with companies and research groups around the globe to work on promising COVID-19 vaccine candidates through the use of GSK’s innovative vaccine adjuvant technology. GSK said the use of an adjuvant is of particular significance in a pandemic situation since it may reduce the amount of vaccine protein required per dose, enabling more vaccine doses to be produced and therefore contributing to protecting more people.
According to management, GSK’s response to COVID-19 has been one of the broadest in the industry, with potential treatments in addition to the company’s vaccine candidates in development with partner organizations. GSK has been working with Sanofi, Medicago, and SK bioscience to develop adjuvanted, protein-based vaccines.
GSK and Sanofi revealed positive data in June 2022 from the companies’ vaccine study, which assessed an adjuvanted bivalent D614 and Beta (B.1.351) vaccine candidate. Sanofi-GSK’s vaccine is the first candidate to show efficacy in a placebo-controlled study in an environment of high Omicron variant circulation. The vaccine candidate demonstrated a favorable safety and tolerability profile.
Additionally reported in June, Sanofi unveiled positive data from two trials conducted with the company’s new next-generation COVID-19 booster vaccine candidate modeled on the Beta variant antigen and including GSK’s pandemic adjuvant. Taken together, management said these data strongly indicate the potential of Sanofi-GSK’s next-generation Beta-based booster to be a relevant response to public health needs.
GSK Vaccines President Roger Connor stated, “These positive data show efficacy of our protein-based, bivalent adjuvanted vaccine candidate in an environment of high Omicron variant circulation. Our vaccine candidate has the potential to make an important contribution to public health as the pandemic evolves further. We are looking forward to the discussions with regulatory authorities with the aim of making our vaccine candidate available later this year.”
GSK said these efforts are supported by federal funds from the Biomedical Advanced Research and Development Authority, part of the office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services in collaboration with the U.S. Department of Defense Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense under Contract # W15QKN-16-9-1002 and by the National Institute of Allergy and Infectious Diseases.
Health Canada during February 2022 granted approval for the Medicago COVID-19 vaccine Covifenz (plant-based virus-like particles [VLP], recombinant, adjuvanted). Covifenz is indicated for active immunization to prevent coronavirus disease 2019 caused by severe acute respiratory syndrome coronavirus 2 (SARS‑CoV‑2) in individuals 18 to 64 years of age.
“This first approval is an important milestone in our approach of pairing GSK’s well-established pandemic adjuvant with promising antigens to develop protein-based, refrigerator-stable COVID-19 vaccines to help protect people against COVID-19 disease,” Connor noted. “We look forward to working with Medicago to make the vaccine available in Canada and to progress further regulatory submissions.”
SK bioscience and GSK announced during April 2022 the filing of a biologics license application for SKYCovione, a recombinant protein-based COVID-19 vaccine candidate adjuvanted with GSK’s pandemic adjuvant, to the Korean Ministry of Food and Drug Safety (KMFDS) following positive Phase III data. The self-assembled nanoparticle vaccine candidate targets the receptor binding domain of the SARS-CoV-2 Spike protein for the parental SARS-Cov-2.
SKYCovione is jointly developed with the Institute for Protein Design (IPD) at the University of Washington School of Medicine with combination of GSK’s pandemic adjuvant. The development of the vaccine has been supported by funding from the Coalition for Epidemic Preparedness Innovations (CEPI).
GSK is exploring treatments for COVID-19 patients, collaborating with Vir Biotechnology to evaluate monoclonal antibodies that could be used as therapeutic or preventive options for COVID-19.
GSK and Vir Biotechnology announced in January 2022 a U.S. government deal to purchase additional supply of sotrovimab, authorized for the early treatment of COVID-19. The 600,000 additional doses were supplied to the U.S. government for distribution in first-quarter 2022, allowing additional access to sotrovimab nationwide. The agreement brought the total amount of doses secured through binding agreements to 1.7 million worldwide as of January 2022. The deal included the option for the U.S. government to buy further additional doses during Q2 2022.
The investigational single-dose intravenous (IV) infusion SARS-CoV-2 monoclonal antibody sotrovimab was granted Emergency Use Authorization (EUA) by the FDA during May 2021. Under the EUA, sotrovimab can be used for treating mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death.
GSK and Vir anticipated manufacturing 2 million doses worldwide in the 2022 first half and additional doses during the second half of the year.
The European Commission (EC) issued a marketing authorization to Xevudy (sotrovimab) for the early treatment of COVID-19 in December 2021. Sotrovimab is approved in the EU for treating adults and adolescents (aged 12 years and over and weighing at least 40 kg) with COVID-19 who do not require supplemental oxygen and who are at increased risk of progressing to severe COVID-19. Sotrovimab, which incorporates Xencor’s Xtend technology, has been designed to achieve high concentration in the lungs to ensure optimal penetration into airway tissues affected by SARS-CoV-2 and to have an extended half-life.
GSK is additionally working with mRNA specialist CureVac to jointly develop next-generation, optimized mRNA vaccines for COVID-19 with the potential to address multiple emerging variants within one vaccine.
Deals, Collaborations & Partnerships
GSK completed the acquisition of Affinivax during mid-August 2022. A clinical-stage biopharmaceutical company based in Cambridge, Mass., Affinivax has pioneered the development of a novel class of vaccines, the most advanced of which are next-generation pneumococcal vaccines.
Management stated that the acquisition of Affinivax aligns with GSK’s strategy of building a strong portfolio of specialty medicines and vaccines. The acquisition includes the next-generation 24-valent pneumococcal vaccine candidate AFX3772, which is based on the highly innovative Multiple Antigen Presenting System (MAPS) platform technology. A 30-plus valent pneumococcal candidate vaccine is additionally in preclinical development.
The MAPS technology supports higher valency than conventional conjugation technologies, potentially allowing for broader coverage against prevalent pneumococcal serotypes and generating higher antibody responses against many individual serotypes than existing pneumococcal vaccines.
In adult Phase I/II studies, AFX3772 was well tolerated in participants and showed good immune responses versus the current standard of care. The FDA during July 2021 granted Breakthrough Therapy designation for AFX3772 to prevent S. pneumoniae invasive disease and pneumonia in adults 50 years and older. As of August 2022, preparations for the beginning of the Phase III program were under way. Phase II trials began in June 2022 to evaluate the use of the vaccine in the pediatric population.
GSK obtained 100 percent of the outstanding shares of Affinivax. An upfront payment of $2.1 billion was paid upon closing and two potential milestone payments of $0.6 billion are to be paid upon the achievement of certain pediatric clinical development milestones. GSK accounted for the transaction as a business combination.
According to GSK Chief Scientific Officer Tony Wood, “Affinivax’s exciting pneumococcal vaccine candidates, the potentially disruptive MAPs technology and their fantastic scientific talent, further strengthen our pipeline of novel vaccines and presence in the Boston area.”
The acquisition of Sierra Oncology was completed on July 1, 2022. The California-based biopharmaceutical company has concentrated on targeted therapies for treating rare forms of cancer.
With the acquisition came the late-stage potential new medicine momelotinib, which has a unique dual mechanism of action that may address the critical unmet medical needs of myelofibrosis patients with anemia. According to management, momelotinib complements GSK’s Blenrep (belantamab mafodotin). The transaction builds on GSK’s expertise in hematology and aligns with the company’s strategy of building a strong portfolio of specialty medicines and vaccines.
Sierra Oncology submitted a New Drug Application for momelotinib to the FDA in June 2022, and GSK anticipated a regulatory filing in Europe during second-half 2022. If cleared for marketing, momelotinib will contribute to GSK’s growing specialty medicines business, with a U.S. launch anticipated during 2023.
GSK acquired all outstanding shares of Sierra Oncology for $55 per share in cash, representing a total equity value of $1.9 billion (£1.6 billion at current exchange rates). The per-share price represented a premium of 39 percent to Sierra Oncology’s closing stock price on April 12, 2022, and 63 percent to Sierra’s volume-weighted average price (VWAP) during the previous 30 trading days before the acquisition closed.
GSK inked an exclusive license deal in September 2022 for tebipenem pivoxil hydrobromide (tebipenem HBr). The late-stage antibiotic is being developed by Spero Therapeutics as the first oral carbapenem antibiotic to potentially treat complicated urinary tract infections (cUTI), including pyelonephritis, resulting from certain bacteria. Spero will begin a new Phase III clinical study during 2023.
The exclusive license enables GSK to commercialize tebipenem HBr in all regions except for Japan and certain other Asian countries. Spero Therapeutics received $66 million upfront, with the potential for future milestone payments and tiered royalties. GSK will purchase $9 million in shares of Spero common stock.
ViiV Healthcare, the worldwide specialist HIV company majority owned by GSK, with Pfizer and Shionogi as shareholders, and the Medicines Patent Pool (MPP) signed a new voluntary licensing pact in July 2022. The agreement pertains to patents relating to cabotegravir long-acting (LA) for HIV pre-exposure prophylaxis (PrEP) to help enable access in least developed, low-income, lower middle
-income and Sub-Saharan African countries.
Certain generic manufacturers will have the opportunity to develop, manufacture, and supply generic versions of cabotegravir LA for PrEP, the first long-acting HIV prevention product, in 90 countries, subject to required regulatory approvals being obtained. This agreement is anticipated to help to enable at-scale access to generic cabotegravir LA for PrEP. This announcement was made seven months after the first regulatory approval of cabotegravir LA for PrEP in the world, by the FDA, under the trade name Apretude.
A framework contract was signed during July 2022 by GSK with the European Commission’s (EC) Health Emergency Preparedness and Response Authority (HERA) for the reservation of future production and supply of 85 million doses of the company’s pandemic influenza vaccine Adjupanrix [pandemic influenza vaccine (split virion, inactivated, adjuvanted)].
This is one of the first contracts signed by HERA since being established during September 2021. HERA’s core mission is to prevent, detect, and rapidly respond to health emergencies by working closely with other EC and national health agencies, industry and international partners to improve Europe’s readiness for health emergencies.
GSK and the University of Oxford launched the Oxford-GSK Institute during December 2021 to harness advanced technology and unravel mechanisms of disease. According to GSK, the major new collaboration aims to deepen understanding of complex diseases such as Alzheimer’s and Parkinson’s, and increase drug discovery and development success rates. The institute is based at Oxford’s Nuffield Department of Medicine.
With a £30 million investment from GSK, the institute is intended to pioneer further improvements in how new medicines are discovered and developed. The institute will assess and integrate new approaches in genetics, proteomics and digital pathology to understand detailed patterns of disease that vary amongst individuals. The initial research focus will be on neurological diseases, including Alzheimer’s and Parkinson’s disease.
Product Approvals & pipeline updates
ViiV’s Apretude (cabotegravir extended-release injectable suspension) was the recipient of FDA approval in December 2021 as the first long-acting injectable option for HIV prevention. The medicine was approved for use in adults and adolescents weighing at least 35 kg who are at risk of sexually acquiring HIV, including men who have sex with men as well as women and transgender women who have sex with men. Apretude is given as few as six times annually and has demonstrated superior efficacy to a daily oral PrEP option (FTC/TDF tablets) in reducing the risk of HIV acquisition.
Apretude represents the first long-acting injectable pre-exposure prophylaxis (PrEP) option proven superior to daily oral FTC/TDF in reducing HIV acquisition. The product is indicated for HIV PrEP in adults and adolescents at risk of sexually acquiring HIV, weighing at least 35 kg, who have a negative HIV-1 test prior to initiation. The integrase strand transfer inhibitor (INSTI) is administered as a single 600 mg (3-ml) intramuscular (IM) injection of cabotegravir in the buttocks by a healthcare provider every two months after two initiation injections administered one month apart and an optional oral lead-in to assess tolerability.
Triumeq PD won U.S. marketing clearance in late March 2022 as the first dispersible single-tablet regimen containing dolutegravir, a once-daily treatment for children living with HIV. The NDA was approved for a dispersible tablet formulation of the fixed-dose combo of abacavir, dolutegravir and lamivudine for treating pediatric patients weighing 10 kgs to <25 kgs with human immunodeficiency virus type 1 (HIV-1). Also, a supplemental New Drug Application (sNDA) was approved for Triumeq tablet, lowering the minimum weight that a child with HIV-1 can be prescribed this medicine to 25 kgs from 40 kgs.
GSK announced a settlement between ViiV and Gilead in February 2022, resolving global litigation relating to Biktarvy and ViiV’s dolutegravir patents and entry into a patent license deal. Gilead made an upfront payment of $1.25 billion to ViiV during first-quarter 2022. Gilead is also responsible for paying a 3 percent royalty on future U.S. sales of the blockbuster medicine Biktarvy, a triple-combination HIV product containing the HIV integrase inhibitor bictegravir, tenofovir alafenamide and emtricitabine.
ViiV, GSK and Shionogi alleged that Biktarvy infringed certain of their patents relating to dolutegravir. As a result of the settlement deal, patent infringement cases in the United States, UK, France, Ireland, Germany, Japan, Korea, Australia, and Canada were discontinued.
A label update for Cabenuva (cabotegravir and rilpivirine) was cleared by U.S. regulators in March 2022, making the oral lead-in with cabotegravir and rilpivirine tablets optional. Oral cabotegravir and rilpivirine can be taken for a month to evaluate tolerability to the medicines before initiating cabotegravir and rilpivirine injections, a regimen jointly developed as part of a collaboration with Janssen, but this oral lead-in is now optional after clinical study data showed similar safety and efficacy profiles for both initiation methods (with or without the oral lead-in).
Cabenuva is the first complete long-acting HIV treatment regimen and is marketed in the United States as a once-monthly
or every-two-month treatment for HIV-1 in virologically suppressed adults. The medicine contains ViiV’s cabotegravir extended-release injectable suspension in a single-dose vial and rilpivirine extended-release injectable suspension in a single-dose vial, a product of Janssen Sciences Ireland Unlimited Company, one of the Janssen Pharmaceutical Companies of Johnson & Johnson.
During January 2022, the FDA approved Cabenuva for every-
two-month dosing for treating HIV-1 in virologically suppressed adults (HIV-1 RNA less than 50 copies per milliliter [c/ml]) on a stable regimen, with no history of treatment failure, and with no known or suspected resistance to either cabotegravir or rilpivirine.
Priorix (Measles, Mumps and Rubella Vaccine, Live) was the recipient of FDA approval during June 2022 for active immunization for the prevention of measles, mumps and rubella (MMR) in individuals 12 months of age and older. The vaccine is licensed in more than 100 countries, including all European countries, Canada, Australia, and New Zealand, with more than 800 million doses distributed.
The oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) daprodustat is undergoing regulatory review for the potential treatment of anemia due to chronic kidney disease (CKD) in adult patients on dialysis and not on dialysis. The U.S. FDA’s Cardiovascular and Renal Drugs Advisory Committee was scheduled to review the New Drug Application (NDA) on Oct. 26, 2022.
The daprodustat NDA is based on positive results from the ASCEND Phase III study program, which included five pivotal trials evaluating the efficacy and safety of daprodustat for treating anemia across the spectrum of CKD. Results from the key cardiovascular outcomes trials were published in the New England Journal of Medicine during November 2021 and included non-dialysis (ASCEND-ND) and dialysis (ASCEND-D) CKD patients. These studies showed that daprodustat improved and/or maintained hemoglobin (Hb) within the target level (10-11.5 g/dL), and the primary safety analysis of the intention-to-treat (ITT) populations demonstrated that daprodustat achieved non-inferiority of MACE (major adverse cardiovascular events) versus the standard of care, an erythropoietin stimulating agent (ESA), across non-dialysis and dialysis patient settings.
Daprodustat tablet was approved under the brand name Duvroq during June 2020 by Japan’s Ministry of Health, Labour and Welfare for patients with renal anemia. The European Medicines Agency during March 2022 validated the marketing authorization application for daprodustat, which is undergoing regulatory review. Other regulatory filings were anticipated to continue throughout 2022.
According to GSK, daprodustat was developed based upon the unique Nobel Prize-winning science that showed how cells sense and adapt to oxygen availability.
GSK unveiled long-term data from the Phase III PRIMA (ENGOT-OV26/GOG-3012) trial demonstrating Zejula (niraparib) maintained a sustained and clinically meaningful progression-free survival (PFS) benefit as a maintenance therapy in patients with first-line ovarian cancer following a response to platinum-based chemotherapy. Importantly, this benefit was sustained across all biomarker subgroups according to GSK, including BRCAm, HRd and HRp.
Zejula represents the only once-daily oral monotherapy maintenance treatment approved in the United States and the European Union for patients with first-line platinum-responsive advanced ovarian cancer regardless of biomarker status.
The poly (ADP-ribose) polymerase (PARP) inhibitor niraparib is being investigated in multiple pivotal studies. GSK said the company is building a robust niraparib clinical development program by evaluating activity across multiple tumor types and by assessing several potential combinations of niraparib with other therapeutics. The development program includes several combination studies.
The FDA’s Oncologic Drugs Advisory Committee (ODAC) was scheduled to discuss overall survival (OS) data from the ENGOT-OV16/NOVA Phase III study for Zejula on November 22, 2022. NOVA is a randomized, double-blind, placebo-controlled Phase III study of Zejula for the maintenance treatment of women with platinum-
sensitive recurrent ovarian cancer.
The FDA accepted the NDA in August 2022 for momelotinib, a potential new medicine with a proposed differentiated mechanism of action that may address the significant unmet medical needs of myelofibrosis patients with anemia. The FDA has set a Prescription Drug User Fee Act action date of June 16, 2023. The NDA is based on the results from key Phase III studies, including the pivotal MOMENTUM trial, which met every primary and key secondary endpoint, including Total Symptom Score (TSS), Transfusion Independence (TI) rate and Splenic Response Rate (SRR).
Momelotinib was not approved in any market as of September 2022. Momelotinib has inhibitory ability along three key signaling pathways: Janus kinase (JAK) 1, and JAK2 and activin A receptor, type I (ACVR1). According to research, inhibition of JAK1 and JAK2 may improve constitutional symptoms and splenomegaly. Also, direct inhibition of ACVR1 leads to a decrease in circulating hepcidin, which is elevated in myelofibrosis and contributes to anemia.
Promising Phase IIb interim data were presented by GSK during June 2022 for bepirovirsen, a potential new treatment for chronic hepatitis B. Interim analysis from the B-Clear Phase IIb study demonstrates bepirovirsen’s potential to suppress both the surface antigen and the virus of hepatitis B, resulting in the possibility of functional cure.
The investigational antisense oligonucleotide (ASO) bepirovirsen (product code GSK3228836) is designed to specifically recognize the RNA that the hepatitis B virus uses to replicate itself in infected liver cells (hepatocytes) and make the viral antigens (proteins) which facilitate chronicity of the disease by helping to avoid clearance by the immune system.
Previously known as ISIS 505358 or IONIS-HBVRX, the potential new drug candidate was discovered by and jointly developed with Ionis Pharmaceuticals. Bepirovirsen is one of the ASO HBV program assets in-licensed by GSK from Ionis during August 2019.
GSK said a Phase III monotherapy study for bepirovirsen is anticipated to begin during first-half 2023. The company is exploring potential combination treatments to reduce the global burden of chronic hepatitis B. The clinical trials include a Phase IIb study of bepirovirsen in sequential combination with pegylated interferon treatment and a Phase II trial of bepirovirsen in combination with the company’s chronic hepatitis B targeted immunotherapy.
The World Health Organization (WHO) during September 2022 awarded prequalification to GSK’s groundbreaking malaria vaccine Mosquirix (also known as RTS,S/AS01). The company said this is the first prequalification for a malaria vaccine and is a significant step in rolling out the vaccine in countries with moderate-to -high malaria transmission.
Positive headline results were reported by the company during June 2022 from a pre-specified efficacy interim analysis of the AReSVi 006 Phase III study. The interim analysis was reviewed by an Independent Data Monitoring Committee, and the primary endpoint was exceeded with no unexpected safety concerns observed, according to GSK. The AReSVi 006 study is testing GSK’s respiratory syncytial virus (RSV) vaccine candidate for adults aged 60 years and older.
This marks the first RSV vaccine candidate to demonstrate statistically significant and clinically meaningful efficacy in adults aged 60 years and older. According to GSK, the magnitude of effect observed was consistent across RSV A and B strains, key secondary endpoints and in those aged 70 years and older. As a result, anticipated regulatory filings were expected during first-half 2022.
GSK announced that, further to the voluntary pause shared on February 18, 2022, the company decided to halt enrollment and vaccination in studies assessing the potential RSV maternal vaccine candidate in pregnant women (NCT04605159, NCT04980391, NCT05229068). This decision does not impact the AReSVi 006 study.
Approval in Japan was granted in late May 2022 for Vocabria (cabotegravir injection and tablets), used in combination with Janssen’s Rekambys (rilpivirine long-acting injectable suspension) and Edurant (rilpivirine tablets), as the first complete long-acting treatment for HIV. The approval was granted by Japan’s Ministry of Health, Labour and Welfare (MHLW). Cabotegravir injection used in combination with rilpivirine long-acting is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults who are virologically suppressed, on a stable regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine. The long-acting treatment allows people living with HIV to reduce the days they receive treatment from 365 to 12 or 6 per year after initiation.
The integrase strand transfer inhibitor (INSTI) cabotegravir is developed by ViiV Healthcare for treating HIV-1 in virologically suppressed adults. Cabotegravir is approved as a long-acting formulation in combination with injectable rilpivirine.
MHLW during June 2022 accepted the regulatory filing of Shingrix (Zoster Vaccine Recombinant, Adjuvanted) to prevent shingles in at-risk adults aged 18 years and older. Administered intramuscularly in two doses, the non-live, recombinant sub-unit adjuvanted vaccine was originally approved in Japan during March 2018 for adults aged 50 years and older.
The European Commission and the United Kingdom approved Shingrix on August 25, 2020, to prevent shingles and post-herpetic neuralgia (PHN) in adults aged 18 or older at increased risk of shingles. The FDA approved the vaccine on July 26, 2021, to prevent shingles in adults aged 18 years or older at increased risk of shingles due to immunodeficiency or immunosuppression caused by known disease or therapy. The extended indication for preventing shingles and PHN in adults aged 18 years or older at increased risk of developing shingles has additionally been approved in Australia.
Shingrix is recommended in the United States by the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices as the preferred vaccine for the prevention of shingles and related complications for immunocompetent adults aged 50 years and older.
In China, a two-dose schedule for GSK’s HPV vaccine Cervarix [Human Papillomavirus bivalent (types 16, 18) Vaccine, Recombinant)] was approved by the National Medical Products Administration (NMPA) for girls aged 9 to 14 years. With this marketing clearance, Cervarix is the first imported two-dose HPV vaccine for this age group in mainland China. The NMPA authorization of the two-dose regimen adds China to two-dose approvals in 100 countries, including the EU, Asia, Africa, and Latin America. GSK said the three-dose schedule remains on the label for girls and women aged 15–45 years in China.
China’s NMPA approved Benlysta (belimumab) during February 2022 for adults with active lupus nephritis. Benlysta is the first biologic approved in China for both systemic lupus erythematosus and lupus nephritis. The B-lymphocyte stimulator (BLyS) specific inhibitor Benlysta is a human monoclonal antibody that binds to soluble BLyS. By binding BLyS, belimumab inhibits the survival of B cells and reduces the differentiation of B cells into immunoglobulin-producing plasma cells.
During the second half of 2022, Phase III data readouts were anticipated for the pentavalent (MenABCWY) meningitis vaccine candidate, otilimab in rheumatoid arthritis, Jemperli in first-line endometrial cancer, and Blenrep in third-line multiple myeloma.
An investment of £1 billion over 10 years was announced by GSK during June 2022 to accelerate research and development dedicated to infectious diseases that disproportionately impact lower-income countries. This research will concentrate on new and disruptive vaccines and medicines to prevent and treat malaria, tuberculosis, HIV (through ViiV Healthcare), neglected tropical diseases, and anti-microbial resistance, which continue to have a devastating toll on the most vulnerable, accounting for more than 60 percent of the disease burden in many lower-income countries.
GSK Global Health R&D hubs are advancing more than 30 potential new vaccines and medicines, targeting 13 high-burden infectious diseases. The company will maintain donations of albendazole until the elimination of lymphatic filariasis, and will double production of GSK’s adjuvant for use in the RTS,S malaria vaccine. The new commitments support management’s ambition to positively impact the health of more than 2.5 billion people during the next 10 years.federal reserve pandemic coronavirus covid-19 disease control emergency use authorization vaccine treatment testing fda clinical trials preclinical antibodies therapy monoclonal antibodies rna transmission recovery africa japan canada european europe uk france germany eu china world health organization
Escobar: Russia-China Partnership Defangs US Empire
Escobar: Russia-China Partnership Defangs US Empire
Authored by Pepe Escobar,
China’s State Council has released a crucial policy paper…
China’s State Council has released a crucial policy paper titled 'A Global Community of Shared Future: China’s Proposals and Actions' that should be read as a detailed, comprehensive road map for a peaceful, multipolar future.
That is if the hegemon - of course faithful to its configuration as War Inc. - does not drag the world into the abyss of a hybrid-turned-hot war with incandescent consequences.
In sync with the ever-evolving Russia-China strategic partnership, the white paper notes how “President Xi Jinping first raised the vision of a global community of shared future when addressing the Moscow State Institute of International Relations in 2013.”
That was ten years ago, when the New Silk Roads – or Belt and Road Initiative (BRI) - was launched: that became the overarching foreign policy concept of the Xi era. The Belt and Road Forum next month in Beijing will celebrate the 10th anniversary of BRI, and relaunch a series of BRI projects.
“Community of Shared Future” is a concept virtually ignored across the collective West – and in several cases lost in translation across the East. The white paper’s ambition is to introduce “the theoretical base, practice and development of a global community of shared future.”
The five key points include building partnerships “in which countries treat each other as equals”; a fair and just security environment; “inclusive development”; inter-civilization exchanges; and “an ecosystem that puts Mother Nature and green development first," as Xi detailed at the 2015 UN General Assembly.
The white paper forcefully debunks the “Thucydides Trap” fallacy: “There is no iron law that dictates that a rising power will inevitably seek hegemony. This assumption represents typical hegemonic thinking and is grounded in memories of catastrophic wars between hegemonic powers in the past.”
While criticizing the “zero-sum game” to which “certain countries” still cling to, China completely aligns with the Global South/global majority, as in “the common interests of all peoples around the world. When the world thrives, China thrives, and vice versa.”
Well, that’s not exactly the “rules-based international order” in play.
It’s All About Harmony
When it comes to building a new system of international relations, China prioritizes “extensive consultation” among equals and “the principle of sovereign equality” that “runs through the UN Charter.” History and realpolitik, though, dictate that some countries are more equal than others.
This white paper comes from the political leadership of a civilization-state. Thus it naturally promotes the “increase of inter-civilization exchanges to promote harmony” while elegantly remarking how a “fine traditional culture epitomizes the essence of the Chinese civilization.”
Here we see a delicate blend of Taoism and Confucianism, where harmony – praised as “the core concept of Chinese culture” - is extrapolated to the concept of “harmony within diversity”: and that is exactly the basis for embracing cultural diversity.
In terms of promoting a dialogue of civilizations, these paragraphs are particularly relevant:
“The concept of a global community of shared future reflects the common interests of all civilizations – peace, development, unity, coexistence, and win-win cooperation. A Russian proverb holds, 'Together we can weather the storm.'
"The Swiss-German writer Hermann Hesse proposed, 'Serve not war and destruction, but peace and reconciliation.' A German proverb reads, 'An individual’s effort is addition; a team’s effort is multiplication.' An African proverb states, 'One single pillar is not sufficient to build a house.' An Arabian proverb asserts, 'If you want to walk fast, walk alone; if you want to walk far, walk together.'
"Mexican poet Alfonso Reyes wrote, 'The only way to be profitably national is to be generously universal.' An Indonesian proverb says, 'Sugarcane and lemongrass grow in dense clumps.' A Mongolian proverb concludes, 'Neighbors are connected at heart and share a common destiny.' All the above narratives manifest the profound cultural and intellectual essence of the world.”
BRI Caravan Rolls On
Chinese diplomacy has been very vocal on the need to develop a “new type of economic globalization” and engage in “peaceful development” and true multilateralism.
And that brings us inevitably to the BRI, which the white paper defines as “a vivid example of building a global community of shared future, and a global public good and cooperation platform provided by China to the world.”
Of course, for the hegemon and its collective West vassals, BRI is nothing but a massive debt trap mechanism unleashed by “autocrat China”.
The white paper notes, factually, how “more than three-quarters of countries in the world and over 30 international organizations” had joined the BRI, and refers to the sprawling, ever-expanding connectivity framework of six corridors, six routes, an array of ports, pipelines and cyberspace connectivity, among others via the New Eurasian Land Bridge, the China-Europe Railway Express (a “steel camel fleet”) and the New Land-Sea Trade Corridor crisscrossing Eurasia.
A serious problem may involve China’s Global Development Initiative, whose fundamental aim, according to Beijing, is “to accelerate the implementation of the UN’s 2030 Agenda for Sustainable Development.”
Well, this agenda has been designed by the self-described Davos elites and conceptualized way back in 1992 by Rockefeller protégé Maurice Strong. Its inbuilt wet dream is to enforce the Great Reset – complete with a nonsensical zero-carbon green agenda.
Better Listen to Medvedev’s Warning
The hegemon is already preparing the next stages of its hybrid war against China – even as it remains buried deep down into a de facto proxy hot war against Russia in Ukraine.
Russian strategic policy, in essence, completely aligns with the Chinese white paper, proposing a Greater Eurasian Partnership, a concerted drive towards multipolarity, and the primacy of the Global South/global majority in forging a new system of international relations.
But the Straussian neocon psychos in charge of the hegemon’s foreign policy keep raising the stakes. So it’s no wonder that after the recent attack on the HQ of the Black Sea Fleet in Sevastopol, a new National Security Council report leads to an ominous warning by Security Council Deputy Chairman Dmitry Medvedev:
“NATO has turned into an openly fascist bloc similar to Hitler’s Axis, only bigger (...) It looks like Russia is being left with little choice other than a direct conflict with NATO (...) The result would be much heavier losses for humanity than in 1945."
The Russian Ministry of Defense, meanwhile, has revealed that Ukraine has suffered a staggering 83,000 battlefield deaths since the start of the - failed - counteroffensive four months ago.
And Defense Minister Shoigu all but gave away the game in terms of the long-term strategy, when he said, “the consistent implementation of measures and activity plans until 2025 will allow us to achieve our goals."
So the SMO will not be rounded up before 2025 – incidentally, much later than the next US presidential election. After all, Moscow’s ultimate aim is de-NATOization.
Faced with a cosmic NATO humiliation on the battlefield, the Biden combo has no way out: even if it declared a unilateral ceasefire to re-weaponize Kiev’s forces for a new counteroffensive in the spring/summer of 2024, the war would keep rumbling on all the way to the presidential election.
There’s absolutely no way some sharp intellect in the Beltway would read the Chinese white paper and be “infected” by the concept of harmony. Under the yoke of Straussian neocon psychos, there are zero prospects for a détente with Russia – not to mention Russia-China.
Both the Chinese and Russian leaderships know quite well how the Ray McGovern-defined MICIMATT (military-industrial-congressional-intelligence-media-academia-think tank complex) works.
The kinetic aspect of MICIMATT is all about protection of the global interests of big US banks, investment/hedge funds and multinational corporations. It’s not a coincidence that MICIMATT monster Lockheed-Martin is mostly owned by Vanguard, BlackRock and State Street. NATO is essentially a mafia protection racket controlled by the US and the UK that has nothing to do with “defending” Europe from the “Russian threat."
The actual MICIMATT and its NATO extension’s wet dream is to weaken and dismember Russia to control its immense natural resources.
War Against the New 'Axis of Evil'
NATO’s incoming graphic humiliation in Ukraine is now compounded with the inexorable rise of BRICS 11 – which embodies a lethal threat to the hegemon’s geoeconomics. There’s next to nothing the MICIMATT can do about that short of nuclear war – except turbo-charging multiple instances of Hybrid War, color revolutions and assorted divide-and-rule schemes. What’s at stake is no less than a complete implosion of neoliberalism.
The Russia-China strategic partnership of true sovereigns has been coordinating full-time.
Strategic patience is the norm. The white paper reveals the magnanimous facet of the number one economy in the world by PPP: that’s China’s response to the infantile notion of “de-risking”.
China is “de-risking” geopolitically when it comes to not falling for serial provocations by the Hegemon, while Russia exercises Taoist-style control to not risk a kinetic war.
Still, what Medvedev just said carries the implication that the hegemon on desperation row could even be tempted to launch WWIII against, in fact, a new “axis of evil” of three BRICS nations – Russia, China and Iran.
Secretary of the [Russian] National Security Council Nikolai Patrushev could not have been more crystal clear:
“In its attempts to maintain its dominance, the West itself destroyed the tools that worked better for it than the military machine. These are freedom of movement of goods and services, transport and logistics corridors, a unified system of payments, global division of labor and value chains. As a result, Westerners are shutting themselves off from the rest of the world at a rapid pace.”
If only they could join the community of shared future – hopefully on a later, non-nuclear, date.
“More Deceit”: Gaetz Rages Over McCarthy-Ukraine Side Deal To Pass Stopgap
"More Deceit": Gaetz Rages Over McCarthy-Ukraine Side Deal To Pass Stopgap
Update (2155ET): Following the Senate’s passage of the Continuing…
Update (2155ET): Following the Senate's passage of the Continuing Resolution, Rep. Matt Gaetz took to Twitter, where he was enraged over a side deal made between Speaker Kevin McCarthy and the Democrats for Ukraine funding, which Gaetz says he "didn't tell House Republicans" about until after the vote.
Gaetz was responding to Punchbowl News' Jake Sherman, who related a message from House Democratic leadership.
"When the House returns, we expect Speaker McCarthy to advance a bill to the House Floor for an up-or-down vote that supports Ukraine, consistent with his commitment to making sure that Vladimir Putin, Russia and authoritarianism are defeated. We must stand with the Ukrainian people until victory is won."
Nine Senate Republicans voted against the bill; Marsha Blackburn (R-Tenn.), Mike Braun (R-Ind.), Ted Cruz (R-Texas), Bill Hagerty (R-Tenn.), Mike Lee (R-Utah), Roger Marshall (R-Kan.), Rand Paul (R-Ky.), Eric Schmitt (R-Mo.) and J.D Vance (R-Ohio).
* * *
Update (2109ET): The Senate has voted 88-9 to pass the House's Continuing Resolution stopgap funding bill, which stripped out funds for Ukraine, includes $16 billion for disaster relief, and will keep the US government running for another 45 days.
Among the Senate "Yea" votes was Michael Bennet (D-CO), who was absolutely flipping his lid over the lack of Ukraine funding earlier in the day.
The bill, which passed the House earlier in the day by a bipartisan vote of 335-91, was passed with just three hours to go before a shutdown.
Just before the vote, Sen. Majority Leader Chuck Schumer (D-NY) vowed to keep fighting for more US taxpayer dollars for Ukraine, saying that he and Senate Minority Leader Mitch McConnell (R-KY) have "agreed to continue fighting for more economic and security aid for Ukraine."
"We support Ukraine’s efforts to defend its sovereignty against Putin’s aggression," said Schumer - to which McConnell said he's "confident" that the Senate can pass more "urgent assistance to Ukraine later this year. But let's be clear," that the "alternative," a shutdown, "would not just pause our progress on these important priorities, it would actually set them back."
Schumer: “McConnell and I have agreed to continue fighting for more economic and security aid for Ukraine.”— Greg Price (@greg_price11) October 1, 2023
* * *
Update (1755ET): After an afternoon of theatrics from Rep. Jamal Bowman (D-NY), it appears that the stopgap legislation to keep the government running through November 17 will now pass at the 11th hour.
According to the Wall Street Journal, the bill to keep the government funded past 12:01 Sunday includes $16 billion in disaster relief, but does not include Ukraine funds.
The House voted 335-91 for the funding measure, which includes $16 billion in disaster relief but omits aid for Ukraine. It also excludes border-security measures sought by Republicans. The margin exceeded the two-thirds majority needed to clear the bill through the House, which considered the legislation under special procedures requiring a supermajority of votes. All but one Democrat voted in favor of the measure, while nearly half of Republicans voted against it. -WSJ
While White House officials say President Biden supports the measure, the Senate has reportedly been lax in quickly taking up the measure late Saturday, raising the possibility of further malarkey.
* * *
(Update 1655ET): So let's get this straight. In the home stretch of negotiations over the House's GOP stopgap bill - while Democrats were actively trying to stall the vote so they could actually read it - a widely reported phenomenon, Rep. Jamal Bowman (D-NY) pulls the fire extinguisher.
His excuse is that he wasn't actually trying to stall the the vote, and that he's essentially an idiot...
"Congressman Bowman did not realize he would trigger a building alarm as he was rushing to make an urgent vote. The Congressman regrets any confusion," said a spokesperson.
Yes. Because this happens all the time.
MSNBC breathlessly repeats the Simple Jack defense.
Yasmin Vossoughian, with a straight face, reports on the fire alarm pulling "'Congressman Bowman did not realize he would trigger a building alarm as he was rushing to make an urgent vote, the congressman regrets any confusion,' just to clarify some things on that." pic.twitter.com/8TbAk5ni71— Alex Christy (@alexchristy17) September 30, 2023
House Speaker Kevin McCarthy capitalized on the incident, comparing Bowman to a January 6th insurrectionist.
New: McCarthy compares Bowman to J6ers who were charged with ‘obstruction’ pic.twitter.com/VYEHYMW2Z5— Jack Poso ???????? (@JackPosobiec) September 30, 2023
I'm about to flush the toilet. pic.twitter.com/jCTsXzt2vP— Rep. Mike Collins (@RepMikeCollins) September 30, 2023
As we noted below... Bowman used to be a public school principal before he was elected to Congress, who rallied against standardized testing, at a private school he founded that has a 27% literacy rate, so... maybe?
Then again, he would be no stranger to fire drills, no?
???? Congressman Bowman regularly brags about his years as a teacher and principal. He's from a state that requires TWELVE fire drills per school year.— Ginny Gentles (@ginnygentles) September 30, 2023
The man knows exactly how fire alarms work. https://t.co/d7XWGoe2K7 pic.twitter.com/smWPceXRk1
* * *
House before the House finally approved a 'clean' stopgap funding bill to avert a government shutdown (which has since been sent to the Senate for consideration before the midnight funding deadline), Socialist Rep. Jamaal Bowman (D-NY) was caught pulling the fire alarm in a House office building Saturday in order to try and delay a vote on ta House GOP stopgap spending bill.
???????????? BREAKING: Insurrectionist Democrat Rep. Jamaal Bowman has been CAUGHT ON-CAMERA pulling the Capitol fire alarm seconds before critical vote to keep government open.— Benny Johnson (@bennyjohnson) September 30, 2023
Violation of 1512(c)(2) obstruction of an official proceeding.
ARREST & Prosecute Rep. Bowman IMMEDIATELY! pic.twitter.com/3m883RB88A
The incident in the Cannon Building was caught on camera and confirmed by several witnesses, Politico reports.
"This is the United States Congress, not a New York City high school. To pull the fire alarm to disrupt proceedings when we are trying to draft legislation to AVERT A SHUTDOWN is pathetic…even for members of the socialist squad," Staten Island GOP Rep. Nicole Malliotakis wrote on X, formerly Twitter.
BREAKING: Capitol police release photo of Jamaal Bowman pulling the fire alarm. pic.twitter.com/XpUoEu9lU4— Greg Price (@greg_price11) September 30, 2023
"Rep Jamaal Bowman pulled a fire alarm in Cannon this morning," House Administration Committee Chairman Bryan Steil wrote on X. "An investigation into why it was pulled is underway."
NEWS: Rep. Jamaal Bowman (D-NY) was caught on camera pulling the Cannon fire alarm ahead of this motion to adjourn vote as Dems tried to delay the CR vote, multiple sources tell me.— Olivia Beavers (@Olivia_Beavers) September 30, 2023
We have reached out to him for comment - we haven't viewed footage ourselves.
According to Bowman spox Emma Simon, "Congressman Bowman did not realize he would trigger a building alarm as he was rushing to make an urgent vote. The Congressman regrets any confusion."
In other words, he's claiming to be too stupid to have known what he did - and don't believe your lying eyes!
Needless to say, the memes are already flying.
Meanwhile, the House cleared the 'clean' stopgap bill without funding for Ukraine or the border, by a vote of 335-91. One Democrat and 90 Republicans voted against the measure.
* * *
Update: (1335ET): With a government shutdown just hours away, House Speaker Kevin McCarthy has turned to Democrats for help passing a temporary bill, after House Freedom Caucus members dug their heels in over no funds for Ukraine.
"What I am asking, Republicans and Democrats alike, put your partisanship away," said McCarthy. "Focus on the American public."
McCarthy needs a two-thirds majority to pass their Continuing Resolution (CR), which would require a significant number of Democrats - who have strongly supported more Ukraine aid - to cross the aisle.
The House GOP bill would be a 'clean' Continuing Resolution, which won't include Ukraine funding or border assistance.
"We will put a clean funding stopgap on the floor to keep government open for 45 days for the House and Senate to get their work done," said McCarthy following a meeting. "We will also, knowing what had transpired through the summer, the disasters in Florida, the horrendous fire in Hawaii, and also the disasters in California and Vermont. We will put the supplemental portion that the president asked for in disaster there too."
"Keeping the government open while we continue to do our work to end the wasteful spending and the wokeism and most important, secure our border," McCarthy said.
If the bill does not pass, Republicans plan to bring up several measures to mitigate the effects of a government shutdown, multiple members said.
Those include bills to continue paying service members and extending authorization of the Federal Aviation Administration and National Flood Insurance Program, both of which are also set to expire at midnight unless Congress takes action. Republicans are also examining measures to continue pay for border patrol agents. -The Hill
The Democrats, meanwhile, have been using parliamentary tactics to slow down the vote so they can more carefully read the GOP proposal.
Rep. Matt Gaetz (R-FL), one of the key holdouts in the House, called McCarthy's bipartisan appeal "disappointing," and said that McCarthy's speakership is "on tenuous ground."
When asked what his next move will be, Gaetz said "I guess we'll have to see how the vote goes."
According to Goldman, there's a 90% probability of a shutdown before the Oct. 1 deadline.
That said, there will be three upcoming catalysts in the next few weeks that may result in passage.
1) All members of the US military are due to be paid on Oct. 13, and a missed pay date would have serious political ramifications; there is a good chance the House will vote to reopen before or shortly after that date;
2) A few House Republicans have said they might bring a “motion to vacate” that would remove McCarthy as Speaker unless a majority of the House supports him. Whatever the outcome of such a vote, getting past it could set the stage for a reopening;
3) There are procedural moves (a “discharge petition” is the most frequently discussed) that Democrats can make to pass an extension of spending authority in the House over Speaker McCarthy’s objections. However, this would require support from at least 5 House Republicans (assuming that all Democrats sign on). This will not help avoid a shutdown, but could come into play over the next two weeks, as political pressure to reopen grows (particularly when combined with the first point on military pay).
In light of the above, Goldman doesn't expect this to last more than 2-3 weeks, and that the Oct. 13 military pay date will become a focal point in the timeline.
* * *
Update (2157ET): It looks like the Senate isn't willing to strip Ukraine funds from the continuing resolution. In a Friday night tweet, House Speaker Kevin McCarthy (R-CA) said that the "misguided Senate bill has no path forward and is dead on arrival."
After meeting with House Republicans this evening, it’s clear the misguided Senate bill has no path forward and is dead on arrival.— Kevin McCarthy (@SpeakerMcCarthy) September 30, 2023
The House will continue to work around the clock to keep government open and prioritize the needs of the American people.
Meanwhile, according to Punchbowl News' Jake Sherman and Josh Bresnahan, McCarthy is floating a CR that would last until Nov. 17 at FY2023 funding levels, which would not include border funds or Ukraine funding.
* * *
In an 11th hour Hail Mary in the hopes of averting a government shutdown, House Speaker Kevin McCarthy (R-CA) announced that the only way the House will pass a Continuing Resolution (CR) to fund the government through October is to drop Ukraine funding.
"I think if we had a clean one without Ukraine on it, we could probably be able to move that through," McCarthy told CNN's Manu Raju.
The comment comes hours after McCarthy lost a game of chicken with the House Freedom Caucus, failing to pass a CR which left McCarthy will few options to try and avert a shutdown in less than 36 hours. McCarthy was hoping that the House bill's border security provisions would win over enough holdouts to pass.
Meanwhile, the White House slammed the failed bill over the 'elimination of 12,000 FBI agents,' and 'almost 1,000 ATF agents.'
White House budget director:— Townhall.com (@townhallcom) September 29, 2023
Republicans’ bill “would eliminate 12,000 FBI agents, almost 1,000 ATF agents!” pic.twitter.com/y5ymbTIDYM
Of note, House Republicans on Thursday narrowly passed the annual defense spending bill, but only after they removed $300 million in Ukraine aid from the legislation (which then cleared in a separate vote because a bunch of Democrats then voted).
Speaker Kevin McCarthy, who failed twice last week to advance the bill to the floor, finally locked down enough Republican votes to pass the bill after the House stripped $300 million to arm Ukraine from the text.
The separate bill carved out to allocate those funds for Kyiv passed Thursday in a 311-117 blowout bipartisan vote. Republicans had won a close procedural vote earlier in the day to separate the Ukraine money from the Pentagon bill, a move meant to flip a handful of GOP holdouts. -Politico
Democrats framed the optics as Kremlin-friendly, with House Armed Services ranking Democrat Adam Smith saying "The Russians are good at propaganda... It will be played as America backing off of its commitment for Ukraine."
Republicans responded that by carving Ukraine out of the defense bill, it allows opponents of either measure (Ukraine aid or the defense bill) to voice their opinions on each independently.
"Why don’t we make sure this gets through? I mean, I’m just mystified that this is somehow a problem," said House Rules Chair Tom Cole (R-OK), according to Politico. "We guarantee you something you want is going to pass the House and you’re upset about it."
And now, McCarthy says there's no way to avert a government shutdown unless the House, and the Senate, agree to nix Ukraine aid from the 30-day stopgap.
Fire and Brimstone...
On Friday, White House top economic adviser Lael Brainard said that a shutdown would pose an "unnecessary risk" to what he described as a resilient economy with moderating inflation.
Treasury Secretary Janet Yellen then chimed in, warning that all of Bidenomics could be negatively impacted.
"The failure of House Republicans to act responsibly would hurt American families and cause economic headwinds that could undermine the progress we’re making," Yellen said from Port of Savannah, Georgia, adding "A shutdown would impact many key government functions from loans to farmers and small businesses, to food and workplace safety inspections, to Head Start programs for children.
"And it could delay major infrastructure improvements."
Goldman has predicted that a shutdown will last 2-3 weeks, and that a 'quick reopening looks unlikely as political positions become more deeply entrenched.' Instead, as political pressure to reopen the government builds, pay dates for active-duty military (Oct. 13 and Nov. 1) will become key dates to pay attention to.
In addition, they think a shutdown could subtract 0.2pp from Q4 GDP growth for each week it lasts (adding the same to 1Q2024, assuming it's over by then).
What's more, all data releases from federal agencies would be postponed until after the government reopens.
More via Goldman:
What are the odds the government shuts down?
A shutdown this year has looked likely for several months, and we now think the odds have risen to 90%. The most likely scenario in our view is that funding will lapse after Sep. 30, leading to a shutdown starting Oct. 1. That said, a short-term extension cannot be entirely ruled out. In the event that Congress avoids a shutdown starting Oct. 1, we would still expect a shutdown at some point later in Q4.
While there is likely sufficient support in both chambers of Congress to pass a short-term extension of funding—this is known as a “continuing resolution” (CR)—that is “clean” with no other provisions attached, the majority of that support would come from Democrats. The Senate is considering a CR that includes aid for disaster relief and Ukraine. House Republican leaders are under political pressure to pass a CR that includes Republican policy priorities that can pass with mainly or exclusively Republican support. At the moment, neither chamber looks likely to pass the other chamber's CR.
The outlook seemed bleak ahead of the debt limit deadline earlier this year, but Congress resolved it in time; why shouldn’t we expect a last-minute deal once again?
The smaller economic hit from a shutdown puts less pressure on Republican leaders to override the objections of some in their party to reach a deal. Ahead of the debt limit deadline earlier this year, Republican leaders reached a deal over the objections of some in their party because the potential hit to the economy from an impasse would have been unpredictable and severe, and even lawmakers most strongly opposed to a compromise agreed that the debt limit must be raised. By contrast, the economic hit from a shutdown would be smaller and more predictable, as there have already been two protracted shutdowns over the last decade. While most lawmakers on both sides of the aisle would prefer to avoid a shutdown, both sides appear more willing to take the chance it occurs.
* * *
A Climate Of Fear
A Climate Of Fear
Authored by James Gorrie via The Epoch Times,
The medical, media, and political elites’ focus has shifted from facts…
The medical, media, and political elites’ focus has shifted from facts to fomenting and magnifying fear.
In Franklin D. Roosevelt’s first inaugural address in 1933, the new president told a nation in the depths of the Great Depression that “the only thing we have to fear is fear itself.”
Those words were true and rightfully spoken at that time. Roosevelt knew that fear is a powerful emotion that limits our ability to reason, act wisely, and work together. It’s also an emotion that’s contagious and not easily diminished or dissipated.
The Power of Fear to Fragment Society
Unfortunately, Roosevelt’s words are even more applicable today.
On a personal level, decisions made under the emotional duress of fear are rarely the best ones and often the worst. Fear can bring out the best in us, but can often bring out the worst. That’s more likely to occur the more fragmented a society becomes. Fear among different groups of people creates an us-versus-them context in the minds of individuals, or even an “every-man-for-himself” attitude, which pits one group against another or even each of us against each other.
Now elevate that sense of fear to the level of the national electorate. A people or a nation that's paralyzed with fear makes rash decisions based on their fears of what could happen, not necessarily what the current situation truly is. When that happens, a society can quickly degenerate, where our base instincts determine our behavior in a law-of-the-jungle social environment.
Roosevelt knew this, as do our leaders today. The difference is that today, rather than seeking to dispel fear, our political and media elites create it, expand it, and revel in it. Rather than promote hope and strength of character in us, in a Roosevelt- or even a Reagan-like fashion, they traffic in fear and its fellow traveler social division in order to fragment our society.
It’s the old but effective divide-and-conquer strategy, and sadly, it works far too well. The mechanism for divide and conquer is the constant drumbeat of the Big Lie, which is also a tried and true method for controlling society. It was first practiced and perfected by Joseph Goebbels in Nazi Germany using the mass media, but has been successfully used by the USSR and every other communist and dictatorial regime in the world since the 1930s.
Social Media Is Magnitudes More Powerful Than Legacy Media
The difference today is the massive and pervasive presence of social media. Its reach and social saturation throughout society are magnitudes greater than have ever been possible before. What’s more, our political and media elites create and exaggerate fear without even mentioning the word. “Fear” is driven into our collective psyches under the guise of our government keeping us “safe,” while demonizing anyone who challenges that narrative.
The repetition by the media and the pharmaceutical industry of how to stay safe from COVID-19 always involves more drugs and less freedom. That’s by design. The elites that run society know that once enough of our friends, neighbors, coworkers, and others with whom we interact become more fearful than rational, they’re easily manipulated and divided into confrontational groups.
Does that sound like a conspiracy theory?
Yes, it probably does, but it’s also how the Stasi, the East German security agency, turned virtually every neighbor into an informant. The result was that people were fearful of doing anything that could be construed as being against the communist East German government. In light of what we’ve been through the last three years—and what looks to be on the horizon—the conspiracy theory accusation has lost its sting.
From Conspiracy Theory to Fact
Recall, for example, how those who received the COVID-19 vaccine turned against those who remained unvaccinated. The contrast and social division couldn’t have been clearer or more deliberate. Vaccinated people were characterized by the media and government agency spokespeople as selfless, smarter, and better human beings than those who refused the vaccine.
On the flip side, the “anti-vaxxers,” as they came to be called, were publicly derided by the medical, pharmaceutical, media, and government elites. They were accused of being low-intelligence conspiracy theory nuts who wouldn’t or couldn’t “follow the science,” even when they followed the science from experts such as Robert Malone, one of the inventors of the mRNA technology, and other medical doctors in Europe and Asia, including former Pfizer Vice President Dr. Michael Yeadon, all of whom were de-platformed from mainstream media and social media.
In fact, any “alternative” remedy to the experimental and highly dangerous mRNA vaccines, such as ivermectin, was summarily dismissed, even though nations that used ivermectin had the lowest mortality rates. As noted above, many media personalities and even medical experts with contrary opinions were silenced, shamed, and shunted into professional oblivion, being substituted by compliant replacements. That practice continues to this day, with Russell Brand being the latest example of being de-monetized by YouTube.
In light of vaccine injuries and deaths, and the staggering profits that vaccines have delivered to the pharmaceutical industry, the number of people who believe the mainstream media, the government, and in the vaccines, is much smaller today than three years ago.
Conspiracy theory narratives have become conspiracy facts.
The Endgame of Fear
So, what’s the endgame of promoting and enforcing a climate of fear throughout society?
It’s simple. Fearful people are far more compliant and, therefore, are easily controlled, pacified, monitored, and dehumanized. Next thing you know, we’ll all be eating bugs and liking it.
The antidote to fear, of course, is freedom and access to real and contrary information so that each person can make up his or her own mind. The encouragement, enablement, and empowerment of private individuals to exercise informed judgment about their health and their livelihoods are also part of the solution. A vibrant, thinking, and active society of informed individuals isn't nearly as vulnerable to the polarizing climate of fear our elites are foisting upon us.
In short, to live in fear is to live in bondage.
Exclusive: Former Genentech duo reunites to push Sonoma into the clinic; Ex-Magenta commercial chief heads to Editas
Suella Braverman is wrong about the UN refugee convention being ‘not fit for purpose’ – here’s why
Scoop: Altesa BioSciences raises $35M for antivirals, recruits Moncef Slaoui to board
Volkswagen reveals electrified iconic model, new SUV production
Yet Another Fear-Mongering COVID Surge Turns Into Trickle As Hospital Admissions Wane
Hairy polymer balls help get genetic blueprints inside T-cells for blood cancer therapy
House Passes Rep. Marjorie Greene’s Amendment To Cut Defense Secretary Lloyd Austin’s Salary To $1
Global government bonds experience largest 2023 sell-off
These Are The World’s Least Affordable Housing Markets
Apple finally solves a very urgent iPhone issue
Uncategorized17 hours ago
Bitcoin Payment Service BTCPay Server Now Easier to Integrate with React Apps
Government19 hours ago
Henderson on Illegal Weed
International15 hours ago
Putin Signs Decree To Draft 130K Young Men In Fall Conscription
Uncategorized15 hours ago
Expect new crypto regulations to follow Bitcoin ETFs
Government9 hours ago
Is The US Military Laying The Groundwork To Reinstitute The Draft?
Government11 hours ago
What Is The Top Priority Or Number One Concern Of Most Americans?
Government20 hours ago
October 2023 Monthly
Uncategorized19 hours ago
A U.S. Debt Default Will Impact Your Finances and Investments – Here’s How