Miss a day, miss a lot. Subscribe to The Defender's Top News of the Day. It's free.
FDA Advisors Recommend First-Ever RSV Vaccine From Pfizer, Despite Possible Guillain-Barré Risks
The Food and Drug Administration’s independent advisors on Tuesday recommended what would be the world’s first RSV vaccine, a shot from Pfizer for adults ages 60 and older, despite safety concerns after two trial participants developed a rare neurological disorder.
A majority of the FDA committee members backed the vaccine, but they wrestled with separate votes on whether the safety and efficacy data are adequate to support approval by the agency. The FDA is expected to make its decision in May. In the first vote Tuesday, seven FDA committee members said the safety data was adequate for approval, while four said it was not, and one member abstained.
The FDA considers the two Guillain-Barré cases during the trial as possibly linked to the vaccine, said Dr. Nadine Peart Akindele, an agency official. The FDA has asked Pfizer to develop a safety study that will monitor Guillain-Barré risks after approval, which the company has agreed to do.
“It seems to me that one case is a red flag. Two cases are very concerning and it’s concerning to me that Pfizer doesn’t think that there are any safety concerns,” said Dr. Marie Griffin, an FDA advisory committee member and a professor of health policy at Vanderbilt University Medical Center.
A Drug Company Exploited a Safety Requirement to Make Money
The New York Times via Yahoo!News reported:
The pharmaceutical industry is rife with tales of companies dreaming up ways to prolong their monopolies on lucrative drugs. They tinker with chemicals. They tweak dosing. They swap out capsules for tablets. By piling up patents, drug companies delay the day when competitors can introduce similar, cheaper products.
Jazz Pharmaceuticals has figured out a way to push the boundaries even further — a feat that demonstrates the lengths to which drugmakers go to eke out extra profits and that two federal courts have now ruled was improper. Jazz’s most important product is a medication for the sleep disorder narcolepsy. The company patented the drug’s formulation. But Jazz also went further, arming itself with a new weapon to block competition.
Because of the drug’s serious side effects and its history of being abused for date rape, federal regulators required Jazz to come up with a plan to ensure that the drug was safely distributed to patients without falling into unintended hands. Jazz’s program included having a single pharmacy nationwide send the medication directly to patients.
Jazz’s strategy has been criticized by the Federal Trade Commission and knocked down in court. A federal court in Delaware ruled in November that the company had inappropriately used the Orange Book to block the drug from its rival, Avadel Pharmaceuticals. Jazz appealed, and a federal circuit court on Friday upheld the lower court’s ruling.
Drugmaker Eli Lilly Caps the Cost of Insulin at $35 a Month, Bringing Relief for Millions
Eli Lilly will cap the out-of-pocket cost of its insulin at $35 a month, the drugmaker said Wednesday. The move, experts say, could prompt other insulin makers in the U.S. to follow suit.
The change, which Eli Lilly said takes effect immediately, puts the drugmaker in line with a provision in the Inflation Reduction Act, which in January imposed a $35 monthly cap on the out-of-pocket cost of insulin for seniors enrolled in Medicare.
Insulin makers have faced pressure from members of Congress and advocacy groups to lower the cost of the lifesaving medication. Insulin costs in the U.S. are notoriously high compared to the costs in other countries; the Rand Corporation, a public policy think tank, estimated that in 2018, the average list price for one vial of insulin in the U.S. was $98.70.
CDC Warns About the Rise in Almost Untreatable Shigella Bacterial Infections
The Centers for Disease Control and Prevention is warning about a rise in extensively drug-resistant cases of the bacterial infection Shigella, a major cause of inflammatory diarrhea.
The agency calls the new form of the stomach bug, which causes the diarrheal condition known as shigellosis, a “serious public health threat.” Evidence suggests the illness is spreading among gay and bisexual men in particular, apparently through sexual contact, both in the U.S. and abroad.
The CDC held a call Tuesday with the Colorado Department of Public Health and Environment and the U.K. Health Security Agency to alert doctors about the spread of a form of the bacterium that is resistant to all typically recommended antibiotic treatments.
Shigella is considered extensively drug-resistant when it is not susceptible to any of the recommended first-line or alternative antibiotics, including azithromycin, ciprofloxacin, ceftriaxone, trimethoprim-sulfamethoxazole and ampicillin.
Dutch Judges to Decide Whether Humira’s Price and AbbVie’s Profits Are ‘Too High’
In a unique challenge to drug makers, the Dutch Pharmaceutical Accountability Foundation is taking the manufacturer of Humira, AbbVie, to court for alleged excessive profiteering. The Foundation accuses AbbVie of engaging in “unfair, excessive pricing practices” regarding its drug Humira (adalimumab).”
If the Foundation’s challenge is successful, this could establish a precedent on price and profit limits which in turn could become a template for holding pharmaceutical companies accountable for excessive profiteering in other (European Union) jurisdictions.
The court case against AbbVie concerns the fundamental question to what extent pharmaceutical companies like AbbVie are free to set and maintain the prices of the drugs they offer. Effectively, the Foundation is stating that AbbVie engaged in price gouging.
Regardless of the complexities involved in the case and the uncertainty concerning any judicial outcome that may be reached, the Dutch Pharmaceutical Accountability Foundation has thrown down the gauntlet, putting drug companies on notice about their pricing practices.
Biotech Startup Focused on Bat Biology Raises $100 Million
Paratus Sciences, a Massachusetts drug discovery startup leveraging bat biology, has raised $100 million in venture capital funding.
Why it matters: This has been a winning week for bats, long maligned for spreading disease and general creepiness. First, there was the (still unreleased) Department of Energy report that COVID-19 was more likely to have been caused by a lab leak than by zoonotic spillover.
And now this big-money effort to study the flying mammals for the purpose of developing human therapeutics in areas like inflammation.
Investors include Polaris Partners, Arch Venture Partners, ClavystBio, EcoR1 Capital, Leaps by Bayer and Alexandria Venture Investments.
Pfizer in Talks to Buy Cancer Drugmaker Seagen — WSJ
Pfizer Inc. (PFE.N) is in early-stage talks to acquire cancer drugmaker Seagen Inc. (SGEN.O) in what could be a multi-billion dollar deal, the Wall Street Journal reported on Sunday, citing people familiar with the matter.
Seagen had a market capitalization of roughly $30 billion, as of Friday’s close.
Seagen was in advanced talks to be acquired by Merck (MRK.N), in a deal that would have been worth $40 billion or more, the Journal reported last year, but the two sides failed to reach an agreement, according to multiple reports.
Seagen’s shares have fallen nearly 10% since July when the deal talks with Merck were first reported. They rose 12.3% to $182 in premarket trading on Monday.
For Big Pharma, the Clinical Trials Supply Chain Is Critical
Pharmaceutical companies run two types of supply chains. There is the commercial supply chain where drugs that have been approved for use on patients are shipped to distributors, drug stores, and hospitals around the world. Then there is a clinical trials supply chain. Drug companies hold clinical trials to prove the safety and efficacy of their drugs. If national drug agencies approve the drug, that drug can then be sold in that nation.
Until talking to Antonio Tramontano, the senior director of digital strategy in R&D clinical supply at Novartis, I had not realized how critical this supply chain was to pharmaceutical companies. Mr. Tramontano gave me permission to cite him in this article, but he wanted to make it clear that all opinions expressed were his own.
Although patents are good for 20 years after the invention of the drug, according to Mr. Tramontano it takes on average 6 or 7 years for a pharmaceutical company to do enough testing for approval from the U.S. Food and Drug Administration.
The U.S. is the most lucrative market for drugs and thus achieving approval in the U.S. is a critical hurdle. This leaves 13 or 14 years of drug exclusivity. In practice, since competitors are vying to bring similar drugs to market, a pharma company may only have 3 or 4 years in which to drive the bulk of its revenues from a new drug.
The Next Generation of Cancer Vaccines Is Coming; What That Means for Moderna and Other Biotech Stocks
Investor’s Business Daily reported:
Moderna (MRNA), the little-known company that built a big name on COVID vaccines, is shaking Wall Street and Big Pharma with a technology leap that could give medicine its best chance yet to take down cancer. And investors are asking whether personalized cancer vaccines will become the next big thing for biotech stocks, and drive a second act for Moderna stock.
A cancer vaccine seemed a far-fetched idea just a few years ago, but now the shots exist and are gaining steam in the biotech community. Further, the newest vaccines are personalized, meaning they can target a patient’s specific tumor DNA and be much more effective.
Personalized cancer vaccines are likely to “dramatically disrupt the landscape of cancer therapy,” said Dan Costin, director of the White Plains Hospital Center for Cancer Care. He also directs the Cancer Blood Specialists of New York. Four shots are available in the U.S. to prevent viruses that increase the chances of developing cervical or liver cancers. Another two treat bladder and prostate cancers.
Multiple biotech stocks are working in the cancer vaccine space, including BioNTech (BNTX) and Gritstone Bio (GRTS).
Meanwhile, others see risks to treating cancer too early — namely that the cancer can mutate to avoid detection.
