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Pfizer, AstraZeneca and Others Ask U.S. Supreme Court to Bar Iraq Terrorism Funding Claims
More than 20 U.S. and European pharmaceutical and medical device makers have asked the U.S. Supreme Court to bar claims that the companies helped to fund terrorism that killed or injured hundreds of American service members during the war in Iraq.
The companies, part of five corporate families — AstraZeneca (AZN.L), Pfizer (PFE.N), GE Healthcare USA, Johnson & Johnson (JNJ.N) and F. Hoffmann-La Roche — are challenging a ruling by the U.S. Court of Appeals for the District of Columbia Circuit.
The DC Circuit order from last year at the center of the case reinstated a lawsuit alleging that 21 U.S. and European medical equipment and pharmaceutical companies made corrupt payments to the Hezbollah-sponsored militia group Jaysh al-Mahdi in order to obtain medical-supply contracts. The plaintiffs’ complaint said Jaysh al-Mahdi controlled Iraq’s health ministry.
FDA Grants First Full Approval for an Alzheimer’s Drug in 20 Years
The FDA on Thursday granted traditional approval to an Alzheimer’s drug for the first time in more than two decades.
Now, the question becomes how many people will be able to access the drug, which is targeted at patients in the early stages of the debilitating disease.
Medicare has said that it will reimburse the drug’s costs — more than $26,000 annually — only for beneficiaries enrolled in a nationwide registry that tracks patient side effects and outcomes over time. Patient advocacy groups and some clinicians fear this means that few of the hundreds of thousands of Alzheimer’s patients eligible for the treatment will be able to access it.
The agency previously granted Leqembi, developed and manufactured by Eisai and Biogen, accelerated approval before evaluating late-stage clinical trial data earlier this year. The drug moderately slowed trial participants’ cognitive decline compared to a placebo, according to the data, but had potentially serious side effects, including brain swelling and bleeding.
Bernie Sanders Proposes Price Caps on Drugs Developed With Federal Funds
After becoming chairman of the powerful Senate Health, Education, Labor and Pensions Committee earlier this year, Sen. Bernie Sanders, I-Vermont — a longtime opponent of Big Pharma — has become even more ubiquitous in his efforts to reduce drug prices.
His most recent push is to mandate price caps for drugs that were developed with the help of government funding.
In a Senate draft reauthorization of the 2006 Pandemic and All-Hazards Preparedness Act, Sanders proposes that the U.S. price of a product developed with support from the Centers for Disease Control and Prevention or the Biomedical Advanced Research and Development Authority must not exceed the lowest price charged for it in Canada, France, Germany, Italy, Japan or the U.K.
This move would essentially leave the U.S. price of government-developed drugs in the hands of regulators in Europe, who assess therapies by way of cost-benefit analysis. This system keeps prices in check, much more so than in the U.S., where there is no such analysis.
Biotech Firms Target Weight-Loss Drugs Without Wegovy’s Side Effects
Weight-loss drug Wegovy helped Rebecca Vogt achieve a major goal — shedding the weight she had not managed to drop since giving birth. But, after a particularly brutal day in the bathroom suffering from vomiting and diarrhea, she called it quits.
“The nausea is just so awful with this medication,” said Vogt, who had endured daily sickness for months. After stopping taking the weekly injection, Vogt, a 48-year-old customer service representative in Buffalo, New York, said she regained the 27 pounds (12.2 kilograms) she had lost.
Though extreme, Vogt’s experience on Novo Nordisk’s (NOVOb.CO) hugely popular drug is not unique. Some 44% of patients taking the weekly injection experienced nausea and 30% experienced vomiting, according to prescribing information — the guidance for healthcare professionals approved by the U.S. health regulator, the Food and Drug Administration (FDA).
Some U.S. and European biotech companies are hoping to offer an alternative to Vogt and other people suffering side effects. More than a dozen small, privately-owned companies are developing drugs that hold the promise of Wegovy-like weight loss without the downside of nausea, according to U.S. investment bank Stifel (SF.N), which published reports in March and July on the obesity market.
Wegovy Maker Novo Nordisk Sues Florida Pharmacies Over Copycat Drugs
Novo Nordisk (NOVOb.CO) on Thursday accused three Florida pharmacies of illegally selling products claiming to contain semaglutide, the active ingredient in the Danish drugmaker‘s weight loss and diabetes drugs Wegovy, Ozempic and Rybelsus.
In three separate lawsuits in Florida federal court, Novo Nordisk sought orders barring TruLife Pharmacy, Brooksville Pharmaceuticals and WellHealth Inc from selling the products and seeking unspecified monetary damages. The three defendants are compounding pharmacies, which make custom drug preparations for customers.
Novo Nordisk is the only company with approval from the U.S. Food and Drug Administration to sell semaglutide drugs. It said that the pharmacies are selling new drugs without FDA approval and claiming to compete with Novo Nordisk’s approved drugs, violating federal and state law.
FDA Appears to Mostly Follow Its Drug Advisory Committees’ Advice — ‘Pro-Approval Bias’ Suggests Committees Are Used to Identify Barriers to Approval, Expert Argues
The FDA tends to agree with the recommendations of its drug advisory committees most of the time — especially if the committee votes in favor of approving a drug — but it is also convening advisory committees less often than before, a qualitative study showed.
During the years 2010 to 2021, the agency approved 142 of the 147 drugs for which its advisory committees recommended initial approvals and 33 out of the 36 drugs for which committees recommended approval for supplemental indications, reported Aaron S. Kesselheim, MD, JD, MPH, of Brigham and Women’s Hospital and Harvard Medical School in Boston, and colleagues.
Advisory committees were also convened less frequently as time went on, from a high of 50 in 2012 to a low of 18 in 2020 and 2021.
“On its face, the chief question that the FDA poses to advisory committees appears to be, ‘Should we approve this drug?’ What these findings tell us is that the FDA is not really asking that,” noted Genevieve Kanter, Ph.D., of the University of Southern California in Los Angeles in an accompanying editorial. “Instead, the agency is asking, ‘What is preventing this drug from being approved right now?’ or perhaps, ‘What are different ways we can get this drug approved?'”
“Pro-approval bias need not be problematic as long as it reflects the public’s priorities of speedy access to new treatments and high(er) risk tolerance,” she concluded. “If, on the other hand, it reflects the influence of pharma, this bias is deeply concerning,” especially in light of recent developments suggesting political arm twisting, as well as the diminished frequency of advisory committee meetings, among other issues.
Hearing Problems From Tepezza Impacted 16.5% of Participants in New Study
As a growing number of Tepezza hearing loss lawsuits continue to be filed against Horizon Therapeutics, a new study released by the drug maker reports that more than 16% of participants experienced hearing problems after receiving the thyroid eye disease drug.
Researchers from the University of Michigan and Horizon Therapeutics recently published findings from a small study in the medical journal Endocrine Practice, indicating that most patients reported satisfaction with the drug’s treatment of thyroid eye disease symptoms, but acknowledged that many also complained of hearing problems from Tepezza, including hearing loss, tinnitus, autophony and eustachian tube dysfunction.
Many patients require multiple Tepezza infusions to treat the condition, and combined with aggressive marketing and a high cost for treatment, Horizon was able to quickly push the drug to blockbuster status, generating sales that exceed $1 billion per year. However, concerns have quickly emerged that the drug maker failed to adequately research the potential hearing side effects from Tepezza, and withheld important safety information for consumers and the medical community.
