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FDA OKs first biosimilar of Roche’s blockbuster AMD drug Lucentis

Samsung Bioepis and Biogen have claimed the first FDA approval for a biosimilar version of Roche and Novartis’
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Samsung Bioepis and Biogen have claimed the first FDA approval for a biosimilar version of Roche and Novartis’ Lucentis (ranibizumab) for leading causes of blindness, raising the prospect of a cheaper treatment option for US patients.

The US green light for Byooviz (formerly SB11) covers the treatment of wet age-related macular degeneration (AMD) and two other eye conditions, and is the first ophthalmology biosimilar to be registered by the FDA.

The approval comes a few weeks after the biosimilar was cleared for marketing in the EU with a broader label, as it also includes diabetic macular oedema (DMO), another of Lucentis’ approved indications.

Lucentis was first approved in the US in 2007 for wet AMD and grew quickly thereafter thanks to a string of additional indications, including DMO, myopic choroidal neovascularisation (mCNV) and macular oedema following retinal vein occlusion (RVO).

Sales reached a peak in 2019, when Roche booked $1.8 billion in sales from the drug while Novartis made $2.1 billion, but fell back to $1.4 billion and $1.9 billion respectively during 2020 as the pandemic reduced patient access to treatment.

The base patent for Lucentis expired in the US last year. However,  Byooviz – which also has mCNV and RVO on its US label – isn’t due to launch there until next year under the terms of a deal with Roche, which has US rights to the Lucentis brand and claims additional patent protection until 2022.

Approximately 11 million people in the US are affected by AMD, according to Samsung Bioepis and Biogen.

Biosimilars are near-copies of complex biologic drugs grown in cells, that have been analysed and tested in trials showing that they have the same safety and efficacy profile as the originator drug.

Because the approval process is more complicated and the products themselves are expensive to produce, biosimilars are not sold at the rock-bottom prices of generics, but still come with a sizeable discount compared with the originators, cutting healthcare costs.

Savings in the US from 2020 to 2024 as a result of biosimilars are projected to exceed $100 billion, according to IQVIA figures.

“Continuing to grow the number of biosimilar approvals is a key part of our efforts to provide greater access to treatment options for patients, increase competition and potentially lower costs,” said the FDA head of therapeutic biologics and biosimilars Sarah Yim.

Other potential Lucentis biosimilars could come from Hospira/Pfizer, Bausch + Lomb or Coherus/Bioeq, all of which have potential biosimilars nearing the end of clinical development.

The availability of Byooviz could also have an impact on Bayer and Regeneron’s Eylea (aflibercept), which still has a few years of patent protection but could be affected by cut-price competition.

Meanwhile, with its much-anticipated Alzheimer’s drug Aduhelm (aducanumab) having a stuttering start on the market and competition growing to spinal muscular atrophy therapy Spinraza (nusinersen), Biogen is increasingly relying on its biosimilars business to help support revenue growth.

The company reported sales of more than $400 million from biosimilars in the first six months of this year.

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Fauci Funded ‘Cruel’ Puppy Experiments Where Sand Flies ‘Eat Them Alive’; Vocal Cords Severed

Fauci Funded ‘Cruel’ Puppy Experiments Where Sand Flies ‘Eat Them Alive’; Vocal Cords Severed

While recent attention has been focused on Dr. Anthony Fauci’s National Institutes of Health funding the genetic manipulation of bat coronaviruses..

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Fauci Funded 'Cruel' Puppy Experiments Where Sand Flies 'Eat Them Alive'; Vocal Cords Severed

While recent attention has been focused on Dr. Anthony Fauci's National Institutes of Health funding the genetic manipulation of bat coronaviruses in the same town as the bat coronavirus pandemic emerged, a bipartisan group of lawmakers have demanded answers over 'sick' experiments on drugged puppies, according to The Hill.

"Our investigators show that Fauci’s NIH division shipped part of a $375,800 grant to a lab in Tunisia to drug beagles and lock their heads in mesh cages filled with hungry sand flies so that the insects could eat them alive," writes nonprofit organization the White Coat Waste Project. "They also locked beagles alone in cages in the desert overnight for nine consecutive nights to use them as bait to attract infectious sand flies."

As The Hill's Christian Spencer writes:

The White Coat Waste Project, the nonprofit organization that first pointed out that U.S. taxpayers were being used to fund the controversial Wuhan Institute of Virology, have now turned its sights on Anthony Fauci on another animal-testing-related matter — infecting dozens of beagles with disease-causing parasites to test an experimental drug on them.

House members, most of whom are Republicans, want Fauci to explain himself in response to allegations brought on by the White Coat Waste Project that involve drugging puppies.

According to the White Coat Waste Project, the Food and Drug Administration does not require drugs to be tested on dogs, so the group is asking why the need for such testing. 

White Coat Waste claims that 44 beagle puppies were used in a Tunisia, North Africa, laboratory, and some of the dogs had their vocal cords removed, allegedly so scientists could work without incessant barking. -The Hill

The concerned lawmakers are led by Rep. Nancy Mace (R-SC), who said in a letter to the NIH that cordectomies are "cruel" and a "reprehensible misuse of taxpayer funds." Mace is joined by reps Cindy Axne (D-Iowa), Cliff Bentz (R-Ore.), Steve Cohen (D-Tenn.), Rick Crawford (R-Ark.), Brian Fitzpatrick (R-Pa.), Scott Franklin (R-Fla.), Andrew Garbarino (R-N.Y.), Carlos Gimenez (R-Fla.), Jimmy Gomez (D-Calif.), Josh Gottheimer (D-N.J.), Fred Keller (R-Pa.), Ted Lieu (D-Calif.), Lisa McClain (R-Mich.), Nicole Malliotakis (R-N.Y.), Brian Mast (R-Fla.), Scott Perry (R-Pa.), Bill Posey (R-Fla.), Mike Quigley (D-Ill.), Lucille Roybal-Allard (D-Calif.), Maria E. Salazar (R-Fla.), Terri Sewell (D-Ala.), Daniel Webster (R-Fla.) and Del. Eleanor Holmes Norton (D-D.C.) via The Hill.

How will Fauci spin this?

Tyler Durden Sat, 10/23/2021 - 15:00

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COVID-19 pandemic shifted patient attitudes about colorectal cancer screening

Key takeaways Credit: American College of Surgeons Key takeaways A survey of adults eligible for colorectal cancer screening patterns found a preference for at-home fecal occult blood testing (FOBT) versus colonoscopy during the COVID-19 pandemic. Survey.

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Key takeaways

Credit: American College of Surgeons

Key takeaways

  • A survey of adults eligible for colorectal cancer screening patterns found a preference for at-home fecal occult blood testing (FOBT) versus colonoscopy during the COVID-19 pandemic.
  • Survey respondents reported less use of colonoscopy during the pandemic compared to pre-pandemic levels, with factors related to both COVID-19 infection concerns and the financial strain of having copays.
  • FOBT shows potential as an alternative to screening colonoscopy to improve access to colorectal cancer screening in the context of COVID-19 safety and economic concerns.

CHICAGO: The impact of the COVID-19 pandemic on patients’ willingness to keep appointments for non-COVID-19 illnesses has been well documented, but a team of researchers at Virginia Commonwealth University report that for people hesitant to come into the hospital or an outpatient center to get a colonoscopy, home-administered fecal occult blood tests (FOBT) may provide a useful workaround tool. About 30 percent more survey respondents completed home-based test during the pandemic than before.

Kristine Kenning, MD, MS, presented findings from a survey of adults age-eligible for screening at the virtual American College of Surgeons (ACS) Clinical Congress 2021. “The key message from our findings is that barriers to screening have increased during the pandemic, and we have to find a way to work with the community to increase those rates,” said Dr. Kenning, chief general surgery resident at Virginia Commonwealth University (VCU) School of Medicine, Richmond. “Our study found that people are compliant with, and willing to do, home-based fecal occult blood testing. This test provides a very important way for us to increase screening for colorectal cancer.”

The American College of Gastroenterology clinical guidelines recommend colonoscopy for colorectal cancer evaluation and following a positive FOBT with a colonoscopy.1 About 148,000 cases of colorectal cancers are newly diagnosed in the United States each year, the American Cancer Society reports, and they account for 53,000 deaths.2

About the survey

The cross-sectional survey involved 765 people age 50 years and older. Dr. Kenning and colleagues found that their respondents reported a higher completion of stool tests pre-COVID than the American Cancer Society reported,2 32 percent vs. 11 percent. During the pandemic, 50 percent of respondents said they completed the FOBT. By contrast, 44 percent of survey respondents who said they had colon screening during the pandemic underwent a colonoscopy. This practice appears to demonstrate substitution of stool-based testing for colonoscopy, Dr. Kenning noted. 

“Our study looked at attitudes toward colorectal cancer screening and how they were impacted during the pandemic, both related to concerns about the pandemic as well as to economic impacts,” senior author Emily B. Rivet, MD, MBA, FACS, said. “What we learned is that fecal occult blood testing was seen by patients as a viable alternative to conventional screening colonoscopy.” Dr. Rivet is an associate professor in the department of surgery, division of colorectal surgery, and an affiliated professor of internal medicine at VCU School of Medicine.

Patient concerns about copays

Notably, a greater percentage of respondents indicated being unemployed during the pandemic than the year prior: 7.4 vs. 2.6 percent. In addition, 41 percent of respondents expressed concerns about copays; 57.6 percent of those respondents said this was a factor for delaying screening. Dr. Kenning noted that she is working with Carrie Miller, PhD, MPH, the principal investigator of the larger survey, on a follow-up assessment of the pandemic-related impact on attitudes toward colorectal cancer screening. Dr. Miller is post-doctoral fellow with VCU’s department of health behavior and policy.

Other screening delays

Copays were not the only deterrent to getting scheduled colorectal screenings during the pandemic, the study found. Almost two-thirds of respondents—65.9 percent—confirmed concerns about COVID-19 exposure when scheduling colonoscopies; and 59 percent of them said this caused them to delay their screening. 

To address those concerns, respondents endorsed that being offered protective equipment (gloves and masks), visits to smaller offices, or weekend screening appointments would increase their likelihood of following through with the colonoscopy; respectively, 30.7 percent for each of the two former factors and 19.7 percent for weekend screening. However, 48.1 percent of respondents said they were willing to do an at-home FOBT as an alternative to colonoscopy, among whom 93 percent indicated they would be willing to undergo a follow-up colonoscopy if the FOBT was positive. 

Lessons learned from the pandemic

“Even pre-pandemic, the rates for colorectal screening in the United States were very far from 100 percent, so I think the lessons that we are learning from this pandemic and working with patients to find alternatives to what the conventional approaches have been in the past are going to be applicable to care moving forward. This approach applies even if we do eventually enter a post-pandemic state, which is, of course, what we are all hoping for,” Dr. Rivet said.

Dr. Kenning said the survey results show that there is still much work to do to improve colorectal screening. “Colorectal cancer screening has decreased significantly during the pandemic and still hasn’t improved to the rate that it was before,” Dr. Kenning said. “Making sure that we’re offering all of the options to patients is very important so that, whatever form of screening they’re comfortable with, they’ll start down that pathway in order to get the screening they need.”

The survey results also underscore the need to tailor colorectal cancer screening to each patient’s concerns and needs, Dr. Rivet said. “It’s important to have a conversation about all of these different alternatives and what the different positives and negatives are,” she said.

Study coauthors are Dr. Miller and Bernard F. Fuemmeler, PhD, MPH, also with the department of health behavior and policy at VCU; and Jaime L. Bohl, MD, FACS, with the department of surgery at VCU.

“FACS” designates that a surgeon is a Fellow of the American College of Surgeons.

The study authors have no relevant financial relationships to disclose. The survey was funded as part of a larger survey led by Dr. Miller on colorectal cancer and funded, in part, through support of an institutional training grant awarded by the National Cancer Institute (T32CA093423).

Citation: Kenning K. et al, COVID-19 Pandemic Impact on Colorectal Cancer Screening. Scientific Forum Presentation. American College of Surgeons Clinical Congress 2021.

______________ 

  1. Shaukat A, Kahi C, Burke CA, Rabeneck L, Sauer BG, Rex DK. ACG Clinical Guidelines: Colorectal Cancer Screening 2021. Amerc J Gastroenterol. 2021;116(3):458-479. doi: 10.14309/ajg.0000000000001122
  2. American Cancer Society. Colorectal Cancer Facts & Figures 2020-2022. Atlanta: American Cancer Society; 2020:22. Available at: https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/colorectal-cancer-facts-and-figures/colorectal-cancer-facts-and-figures-2020-2022.pdf 

# # #

About the American College of Surgeons
The American College of Surgeons is a scientific and educational organization of surgeons that was founded in 1913 to raise the standards of surgical practice and improve the quality of care for all surgical patients. The College is dedicated to the ethical and competent practice of surgery. Its achievements have significantly influenced the course of scientific surgery in America and have established it as an important advocate for all surgical patients. The College has more than 84,000 members and is the largest organization of surgeons in the world. For more information, visit www.facs.org.


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Sweden Suspends Moderna Shot Indefinitely After Vaxxed Patients Develop Crippling Heart Condition

Sweden Suspends Moderna Shot Indefinitely After Vaxxed Patients Develop Crippling Heart Condition

Authored by Jack Davis via The Western Journal (emphasis ours),

New concerns are being raised about side effects from the Moderna vaccine again

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Sweden Suspends Moderna Shot Indefinitely After Vaxxed Patients Develop Crippling Heart Condition

Authored by Jack Davis via The Western Journal (emphasis ours),

New concerns are being raised about side effects from the Moderna vaccine against the coronavirus.

Swedish health officials have now decided that a moratorium on giving the Moderna vaccine to anyone under 31 will be extended indefinitely, the U.K. Daily Mail reported. The pause on the Moderna shots had been scheduled to end on Dec. 1.

Finland, Iceland and Denmark have taken similar steps. Norway is encouraging men under 30 not to get the Moderna shot, but is not mandating it.

For months, the Moderna vaccine has been under scrutiny because of data that shows young men who receive it are at increased risk for myocarditis, an inflammation of the heart muscle, and pericarditis, an inflammation of the sac around the heart.

The Daily Mail reported that one U.S. study that has not yet been peer-reviewed concluded that “young males under [age] 20 are up to six times more likely to develop myocarditis after contracting COVID-19 than those who have been vaccinated.”

The decision comes as the U.S. Food and Drug Administration is putting Moderna’s plans for a shot aimed at the population from age 12 to 17 on hold due to concerns over risks of the ailments, according to The Wall Street Journal.

Although a federal Centers for Disease Control and Prevention panel on Thursday approved boosters for the Moderna and Johnson & Johson vaccines, there were some cautions raised, according to CNBC.

Dr. Tom Shimabukuro said there is an increased risk of myocarditis and pericarditis with either the Moderna or Pfizer vaccine, in particular after the second dose of the vaccines.

According to the Daily Mail, the data indicated the risk was 13 times greater for those getting the Moderna vaccine than for those who got the Pfizer vaccine.

Sweden’s Public Health Agency said the unpublished data linking the Moderna vaccine with the two conditions means there is “an increased risk of side effects such as inflammation of the heart muscle or the pericardium.”

“The risk of being affected is very small.”

That data has not been publicly released.

The FDA had addressed concern about the Pfizer vaccine in its statement giving it full authorization, saying that “the data demonstrate increased risks, particularly within the seven days following the second dose.”

“The observed risk is higher among males under 40 years of age compared to females and older males. The observed risk is highest in males 12 through 17 years of age,” the FDA said.

The agency noted that “some individuals required intensive care support” and that long-term information about the risks is not yet available.

The Western Journal has published this article in the interest of shedding light on stories about the COVID-19 vaccine that are largely unreported by the establishment media. In that same spirit, according to the most recent statistics from the CDC’s Vaccine Adverse Event Reporting System, 7,439 deaths have been reported among those who received a vaccine, or 20 out of every 1,000,000. By contrast, 652,480 deaths from COVID-19 have been reported by the CDC, or 16,101 out of every 1,000,000. In addition, it must be noted that VAERS reports can be filed by anyone and are unverified by the CDC. Thus, as the agency notes, “Reports of adverse events to VAERS following vaccination, including deaths, do not necessarily mean that a vaccine caused a health problem.” The decision of whether to receive a COVID vaccine is a personal one, but it is important to consider context when making that decision. — Ed. note

Tyler Durden Sat, 10/23/2021 - 08:10

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