Authored by Lorenz Duchamps via The Epoch Times (emphasis ours),
The U.S. pharmaceutical and biotechnology company Moderna Inc. on Friday issued a recall in Europe involving 764,900 doses of its COVID-19 vaccine “Spikevax” after contaminants were discovered in a vial.
“The lot is being recalled due to a foreign body being found in one vial in the lot manufactured at the company’s contract manufacturing site, ROVI,” Moderna and Spain’s ROVI Pharma Industrial Services said in a joint statement.
The drugmaker did not specify what kind of foreign substance was found and had recalled the whole lot out of “an abundance of caution.”
The contamination was traced in just one vial of the batch and investigators do not believe the contamination posed a risk to other vials in the lot.
“Moderna conducted a cumulative search of its global safety database, and no safety concerns were reported in individuals who received the Moderna COVID-19 vaccine from this lot. To date, no safety or efficacy issues have been identified,” according to the statement.
The lots were distributed from Jan. 13 to Jan. 14 in Norway, Poland, Portugal, Spain, and Sweden. To date, more than 900 million doses of the Moderna COVID-19 vaccine have been administered worldwide.
Last year, Moderna had several lots of its COVID-19 vaccines recalled by Japanese authorities after an investigation found stainless steel contaminants in some vials. The recalled batches were manufactured by the same Spanish company, ROVI.
Japan’s biggest drugmaker, Takeda Pharmaceutical, said in a statement the contamination was traced back to the production run by ROVI. The findings were discovered by an investigation carried out by the two companies, not the Japanese health ministry.
Three men in Japan had fallen severely ill in August 2021 after being administered a second dose of the now-recalled COVID-19 vaccine and died shortly after. Takeda said in a statement at the time there is no evidence they are linked to the vaccine, Reuters reported.
“Stainless steel is routinely used in heart valves, joint replacements, and metal sutures and staples. As such, it is not expected that injection of the particles identified in these lots in Japan would result in increased medical risk,” the company said.
The first two deaths reported in the country linked to contaminated Moderna doses were two men, aged 30 and 38. They both died two days after receiving a second dose from a tainted batch of vaccines.
The third case was a 49-year-old man, who also fell ill after receiving his second dose, and died the next day, the health ministry said, noting that his only known health issue was a buckwheat allergy.
From NTD News
Diamond Prices Are Crashing, Forcing Russian Mining Giant To Halt Sales
Diamond Prices Are Crashing, Forcing Russian Mining Giant To Halt Sales
A surge in lab-grown diamonds flooding the market, coupled with a…
A surge in lab-grown diamonds flooding the market, coupled with a decline in luxury spending, has forced Russian mining giant Alrosa PJSC to temporarily suspend rough diamond sales to prevent prices from crashing further.
Bloomberg obtained a memo from Alrosa addressed to its customers, explaining rough diamond sales for September and October have been suspended as the company "strives to reverse the existing trend of diminishing demand."
Diamonds, watches, and other jewelry soared during the pandemic and peaked in the first half of 2022. We have covered the Rolex boom and bust extensively and have turned our attention to crashing diamond prices in 2023:
Besides the luxury spending slowdown due to tapped-out consumers, man-made diamonds have been all the rage because these gems are only a fraction of the cost. The big fear of the natural diamond industry is starting to be realized as consumers accept lab-grown diamonds in rings.
Edahn Golan, an independent diamond industry analyst, told CNN Business consumers are flocking to man-made diamonds because the most popular one-carat round man-made diamond for an engagement ring in March was $2,318. He said that's 73% cheaper than a natural diamond of the same size, cut, and clarity.
The latest data from the Diamond Index via the International Diamond Exchange shows prices have crashed well below pre-Covid levels.
Alrosa competes with De Beers, the biggest producer of diamonds, both of which have been rocked by a rough diamond sales slowdown this year after a massive boom during the pandemic.
Last week, Reuters reported the Group of Seven (G7) nations might be preparing to reshape the global diamond supply chain by placing restrictions on Alrosa.
Mark Velleca takes over at Black Diamond; Verve Therapeutics separates CMO, CSO posts
→ David M. Epstein is out as CEO of cancer player Black Diamond Therapeutics, which is putting chairman Mark Velleca in charge. This is…
→ David M. Epstein is out as CEO of cancer player Black Diamond Therapeutics, which is putting chairman Mark Velleca in charge. This is Velleca’s third CEO post in less than a decade after running G1 Therapeutics (2014-20) and StrideBio (2021-23). Epstein will still be on the board at Black Diamond, a company that hit the scene in 2018 with $20 million from Versant and quickly followed that up with an $85 million Series B in January 2019. Co-founded by Epstein (not to be confused with Seagen’s David R. Epstein) and Elizabeth Buck, Black Diamond made an impressive Nasdaq debut with an IPO that exceeded $200 million in 2020, but layoffs affected 30% of the staff two years later.
→ Verve Therapeutics has made an adjustment to the team as Andrew Bellinger concentrates on his CSO duties and Fred Fiedorek steps in as CMO. “Now is the right time to split the CMO and CSO roles with two, complementary industry leaders,” Verve CEO Sek Kathiresan said in a statement. “Verve’s tremendous progress over the last five years has been made possible by Andrew’s significant contributions in his joint role.”
Fiedorek held a series of executive positions in a 13-year span at Bristol Myers Squibb, culminating in his promotion to SVP and head of cardiovascular and metabolic development. He has previous CMO credits at Intarcia — where he also led global regulatory affairs — and Rhythm Pharmaceuticals. While Verve’s base editor VERVE-101 for heterozygous familial hypercholesterolemia is stuck in neutral with a clinical hold in the US, Kathiresan’s crew inked a gene editing deal with Eli Lilly in June. Bellinger had been effectively juggling the CSO and CMO roles since “they started planning their Phase I studies,” a spokesperson tells Peer Review.
→ Rezo Therapeutics, a UCSF spinout chaired by ex-Biogen and Vir Biotechnology CEO George Scangos, has tapped Nadir Mahmood as CEO. Interim chief and co-founder Nevan Krogan, the director of UCSF’s Quantitative Biosciences Institute, will shift to the role of president. Mahmood became SVP, corporate development at Nkarta in 2018 and would later be promoted to chief financial and business officer for Paul Hastings’ crew before his first CEO job at Rezo, which made its debut in November 2022. SR One, a16z Bio + Health and Norwest Venture Partners helped lead the $78 million Series A, and Rezo’s co-founders also include Kronos Bio chief Norbert Bischofberger and UCSF’s Kevan Shokat.
→ Vir Biotechnology COO Johanna Friedl-Naderer is stepping down on Sept. 29, and an SEC filing says that Vir won’t be looking for a replacement. Friedl-Naderer is a 21-year Biogen veteran who started out as Vir’s CBO, global in March 2022.
→ Shares of Bausch Health $BHC dropped by as much as 9.5% after the announcement that CFO Tom Vadaketh will resign on Oct. 13. In the event that Bausch Health comes up empty in its CFO search, controller and chief accounting officer John Barresi will take over as finance chief.
→ Elahere maker ImmunoGen has recruited Lauren White as CFO. Peer Review regulars will know that White recently left C4 Therapeutics and Kendra Adams took over as finance chief on Sept. 18. Before she took the C4 job, White had a 10-year career with Novartis and was VP & global head of financial planning and analysis with the Novartis Institutes for BioMedical Research from 2017-21. ImmunoGen is hoping its Phase III data for Elahere in the MIRASOL trial will be enough to cross the finish line in the European market.
→ BeiGene isn’t the only one that’s reclaimed the rights to a drug involved in a partnership with Novartis. Pliant Therapeutics and the Swiss pharma giant had teamed up on the NASH asset PLN-1474, but Novartis signaled that it was moving away from the indication before it officially pulled the plug on the alliance in February. As Pliant moves forward with its lead program bexotegrast in idiopathic pulmonary fibrosis and primary sclerosing cholangitis, Minnie Kuo has joined the team as chief development officer. Kuo is a Nektar and Gilead clinical operations vet who spent the last six years at Vir; she was promoted to SVP of translational and clinical development operations in 2021.
→ Pablo Legorreta’s Royalty Pharma has tapped Eric Schneider as chief technology officer. The Moody’s and Barclays alum held several leadership positions in his 11 years at Verisk, where he was recently chief data officer and chief technology officer. Royalty took a dip in the gene therapy pool when it forked over $300 million upfront for a 5.1% royalty on net sales of Ferring’s bladder cancer med Adstiladrin. “We’ve always got questions of: ‘When are you going to ever make a gene therapy investment?’” Royalty CFO Terrance Coyne said at the Morgan Stanley Global Healthcare Conference. “And what we said is: We’re going to be patient there. There’s a lot that we still need to understand. But this opportunity came along. The data is really remarkable.”
→ Paris-based gene therapy developer Coave Therapeutics has named J&J’s Lolita Petit as CSO. Petit just finished a two-year stint as director of gene therapy and delivery at Janssen and led the ocular platform team while she was with Spark from 2018-21. Coave is testing an AAV-based gene therapy for eye diseases like retinitis pigmentosa with PDE6b mutations. Spark’s Luxturna, on the other hand, was approved for a rare retinal disease that goes after mutations in the RPE65 gene.
→ Sticking with the theme of gene therapies for eye diseases, Nanoscope Therapeutics has introduced Samuel Barone as CMO. Barone had the same gig at Gemini Therapeutics before it merged with Disc Medicine last summer, and he’s the ex-SVP, clinical development for Adverum Biotechnologies. In March, Nanoscope unveiled Phase II data for its retinitis pigmentosa gene therapy MCO-010 that didn’t reach statistical significance.
→ In a double whammy, Lonza lost two execs this week. Amid a drop in sales growth, CEO Pierre-Alain Ruffieux said Monday that he is waving goodbye to the CDMO at the end of this month. Chairman Albert Baehny is taking over for Ruffieux in the interim. Ruffieux spent nearly three years with the company, having jumped aboard in November 2020 from Roche. Meanwhile, Catalent also swooped in and nabbed David McErlane as its new biologics lead. McErlane had served as Lonza’s SVP and business unit head for the company’s bioscience business.
→ Little-known in vivo gene editing biotech CorriXR Therapeutics has appointed Deborah Moorad as CEO. The Dentsply Sirona alum has been a chief executive at Lincoln, NE-based Nature Technology Corp, which was purchased by Aldevron, which was then acquired by Danaher. Moorad’s predecessor, co-founder Eric Kmiec, slides into the role of CSO at the ChristianaCare spinout.
→ Atreca president and CEO John Orwin is replacing Frazier managing partner Jamie Topper as chairman of the board at San Diego-based AnaptysBio. Orwin, the new chairman of CARGO Therapeutics, will also be principal financial officer for Atreca after CFO Herb Cross headed for the exit. Topper is giving up his seat on the board after nearly 16 years, eight of those as chairman, and he’ll be an advisor until the first quarter of 2024.
→ Marie-Louise Fjällskog is leaving her role as CMO of Faron Pharmaceuticals, but she will stay with the company as a board member. Longtime J&J vet Birge Berns is succeeding Fjällskog as interim medical chief and will work out of the UK for the Finnish cancer biotech. Fjällskog came to Faron from her CMO post at Sensei Biotherapeutics in January 2022.
→ Ipsen’s acute myeloid leukemia partner Accent Therapeutics is putting an emphasis on three new execs this week: Jason Sager (CMO) is the ex-medical chief at Ikena Oncology — back when it was known as Kyn Therapeutics — and has also worked for Genentech, Novartis and Sanofi; Steven Mennen (VP of preclinical development) is a 10-year Amgen vet who left Fulcrum Therapeutics in April after four years as head of CMC; and Bayer alum Stuart Ince (VP of program leadership) has served as VP of program management with Tango Therapeutics.
→ Chaired by Gossamer Bio CEO Faheem Hasnain, Ann Arbor, MI-based thyroid eye disease biotech Sling Therapeutics has selected Raymond Douglas as CSO. Douglas is familiar with the area from his eight years at the University of Michigan as an ophthalmology professor and director of the school’s thyroid eye center. He’s an oculoplastic surgeon who has a private practice in Beverly Hills and was in charge of the orbital and thyroid eye disease programs at Cedars-Sinai.
→ While we’re thinking of thyroid eye disease, Tourmaline Bio is testing its lead candidate TOUR006 in the same indication and has welcomed Gerhard Hagn as SVP, head of commercial and business development. Hagn had a scrollable list of positions in a 20-year period at Pfizer before he moved to Gilead in 2019 as VP, head of inflammation, global commercial strategy. Starting in 2021, he expanded his role by leading Gilead’s liver franchise as well.
→ Tempest Therapeutics CMO Sam Whiting has taken on the additional role of R&D chief. Peer Review informed you about Whiting’s original appointment back in the fall of 2020, when he succeeded Tom Dubensky as Tempest’s medical leader. The California biotech touted Phase Ib/II data in April that showed seven of 40 patients had a confirmed response to its liver cancer treatment TPST-1120 in a combo with Tecentriq and Avastin, while only three of 29 patients had a confirmed response to Tecentriq and Avastin alone.
→ Daybue maker Acadia Pharmaceuticals has picked up Albert Kildani as SVP, investor relations and corporate communications. At Halozyme, another San Diego biotech, Kildani was the investor relations and corporate communications leader for nearly four years. Daybue made history in March by becoming the first-ever drug to receive an FDA approval for Rett syndrome.
→ John Yee has been named SVP, medical affairs at Apnimed, the sleep apnea biotech that rang in 2023 with a $79.7 million raise that was stapled on to the original $62.5 million Series C in May 2022. The AstraZeneca and Vertex medical affairs vet is coming off a six-month sabbatical after three years as CMO of Sobi North America.
→ The CRO Parexel has rolled out the welcome mat for Gwyn Bebb as SVP and global therapeutic area head, oncology. Bebb joins the Durham, NC-based team from Amgen, where he was clinical research medical director in early- and late-stage oncology drug development. Bebb’s résumé also sports a stint as a professor at the department of medicine at the University of Calgary.
→ ImmunOs Therapeutics, an immuno-oncology player that bagged a $74 million Series B in June 2022, has enlisted Constanze Guenther as SVP, CMC and technical development. Guenther ends her 13-year run at Novartis, where she was global portfolio head, cell therapy and also oversaw the manufacturing of Kymriah in Europe.
→ Amgen sales vet Marc-Andre Goldschmidt has landed at Amsterdam-based Avanzanite Bioscience as country manager of Germany. Goldschmidt was elevated to national sales manager of neurology during his six years at Alexion.
→ After disappointing data for its Dravet syndrome drug STK-001 caused its shares $STOK to sink in July, Stoke Therapeutics has added former Vertex CFO and COO Ian Smith to the board of directors. Smith chairs the board at Solid Bio and is a senior advisor for Bain Capital Life Sciences.
→ Flare Therapeutics president and CFO Daphne Karydas has picked up a pair of board appointments at Mineralys Therapeutics and Compass Pathways. Glenn Sblendorio, the former CEO of Astellas sub Iveric Bio, will join Karydas on the board of directors at Mineralys, the hypertension biotech that made a February debut on the Nasdaq in a once-barren IPO environment. New listings are popping up as market conditions gradually improve, like the ones we’ve seen with Neumora, RayzeBio and others.
→ Ex-Kymab CEO Simon Sturge has clinched a spot on the board of directors at Galapagos that was vacated by Mary Kerr. Sturge chairs the board at MoonLake Immunotherapeutics, the maker of an IL-17 inhibitor for hidradenitis suppurativa that has shown some promise in Phase II.
→ J&J’s bispecific partner Xencor has elected Barbara Klencke to the board of directors. Klencke was the CMO and chief development officer for Sierra Oncology until it was purchased by GSK for $1.9 billion, a deal that’s bearing fruit with the approval of JAK inhibitor Ojjaara, formerly known as momelotinib.nasdaq treatment testing fda preclinical therapy european europe uk germany
“That 70s Show”
The hit TV series "That 70s Show" aired from 1998 to 2006 and focused on six teenage friends living in Wisconsin in the late 70s. The irony was that the…
The hit TV series “That 70s Show” aired from 1998 to 2006 and focused on six teenage friends living in Wisconsin in the late 70s. The irony was that the actors playing the teenagers were not born in the late 70s and had never experienced life during that period. Many alive today cannot fathom a lifestyle devoid of the internet, cable television, mobile phones, and social media. Oh…the horrors.
Yet, today, almost 50 years later, financial commentators, many of whom were not alive at the time, suggest that inflation and yields will repeat “That 70s Show.” Understandably, the increase in inflation and interest rates from their historic lows is cause for concern. As James Bullard noted, “Inflation is a pernicious problem,” which is why the Federal Reserve lept into action.
“When the US Federal Reserve embarked on an aggressive campaign to quash inflation last year, it did so with the goal of avoiding a painful repeat of the 1970s, when inflation spun out of control and economic malaise set in.” – CNN
That concern of “spiraling inflation” remains the key concern of the Federal Reserve in its current monetary policy decisions. It has also pushed many economists to point back at history, using “That 70s Show” period as the yardstick for justifying their concerns about a resurgence of inflation.
“The chair of the Federal Reserve at the time, Arthur Burns, hiked interest rates dramatically between 1972 and 1974. Then, as the economy contracted, he changed course and started cutting rates.
Inflation later roared back, forcing the hand of Paul Volcker, who took over at the Fed in 1979, Richardson said. Volcker brought double-digit inflation to heel — but only by raising borrowing costs high enough to trigger back-to-back recessions in the early 1980s that at one point pushed unemployment above 10%.
‘If they don’t stop inflation now, the historical analogy [indicates] it’s not going to stop, and it’s going to get worse,’ said Richardson, an economics professor at the University of California, Irvine.”
However, such may be an oversimplification to suggest Burns was wrong and Volker was right. The reason is the economy today is vastly different than during “That 70s Show.”
Today Is Very Different Than The 1970s
During the 70s, the Federal Reserve was entrenched in an inflation fight. The end of the Bretton Woods and the failure of wage/price controls combined with an oil embargo sent inflation surging. That surge sent markets crumbling under the weight of rising interest rates. Ongoing oil price shocks, spiking food costs, wages, and budgetary pressures led to stagflation through the end of that decade.
What was most notable was the Fed’s inflation fight. Like today, the Fed is hiking rates to quell inflationary pressures from exogenous factors. In the late 70s, the oil crisis led to inflationary pressures as oil prices fed through a manufacturing-intensive economy. Today, inflation resulted from monetary interventions that created demand against a supply-constrained economy.
Such is a critical point. During “That 70s Show,” the economy was primarily manufacturing-based, providing a high multiplier effect on economic growth. Today, the mix has reversed, with services making up the bulk of economic activity. While services are essential, they have a very low multiplier effect on economic activity.
One of the primary reasons is that services require lower wage growth than manufacturing.
While wages did rise sharply over the last couple of years, such was a function of the economic shutdown, which created a supply/demand gap in the employment matrix. As shown, full-time employment as a percentage of the population fell sharply during the pandemic lockdown. However, with full employment back to pre-pandemic levels, wage growth declines as employers regain control over the labor balance.
Furthermore, the economic composite of wages, interest rates, and economic growth remain highly correlated between “That 70s Show” and today. Such suggests that while inflation rose with the supply/demand imbalance created by the shutdown, the return to normalcy will lower inflation as economic activity slows.
With a correlation of 85%, the inflationary decline will be coincident with economic growth, interest rates, and wages.
Unlike “That 70s Show,” where economic growth and wages were rising steadily, which allowed for higher levels of interest rates and inflation, There is a singular reason why a repeat of that period is quite impossible.
The Debt Burden And Economic Weakness
What is notable about “That 70s Show” is that it was the culmination of events following World War II.
Following World War II, America became the “last man standing.” France, England, Russia, Germany, Poland, Japan, and others were devastated, with little ability to produce for themselves. America found its most substantial economic growth as the “boys of war” returned home to start rebuilding a war-ravaged globe.
But that was just the start of it.
In the late ’50s, America stepped into the abyss as humankind took its first steps into space. The space race, which lasted nearly two decades, led to leaps in innovation and technology that paved the wave for the future of America.
These advances, combined with the industrial and manufacturing backdrop, fostered high levels of economic growth, increased savings rates, and capital investment, which supported higher interest rates.
Furthermore, the Government ran no deficit, and household debt to net worth was about 60%. So, while inflation increased and interest rates rose in tandem, the average household could sustain its living standard. The chart shows the difference between household debt versus incomes in the pre- and post-financialization eras.
With the Government running a deep deficit with debt exceeding $32 trillion, consumer debt at record levels, and economic growth rates fragile, consumers’ ability to withstand higher inflation and interest rates is limited. As noted previously, the “gap” between income and savings to sustain the standard of living is at record levels. The chart shows the gap between the inflation-adjusted cost of living and the spread between incomes and savings. It currently requires more than $6500 of debt annually to fill the “gap.“
It Is Not The Same
While the Fed is currently engaged “in the fight of its life,” trying to quell inflation, The economic differences are vastly different today. Due to the heavy debt burden, the economy requires lower interest rates to sustain even meager economic growth rates of 2%. Such levels were historically seen as “pre-recessionary,” but today, they are something economists hope to maintain.
This is one of the primary reasons why economic growth will continue to run at lower levels. Such suggests we will witness an economy:
- Subject to more frequent recessionary spats,
- Lower equity market returns, and
- A stagflationary environment as wage growth remains suppressed while the cost of living rises.
Changes in structural employment, demographics, and deflationary pressures derived from changes in productivity will magnify these problems.
While many want to suggest that the Federal Reserve is worried about “That 70s Show,” we would be lucky to have the economic strength to support such a concern.
The Fed’s bigger worry should be when the impact of higher rates causes a financial break in a debt-dependent financial system.unemployment economic growth monetary policy fed federal reserve spread lockdown pandemic interest rates unemployment oil japan france germany poland russia
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