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FDA Approves Pfizer RSV Vaccine for Older Adults
The Food and Drug Administration on Wednesday approved a vaccine made by Pfizer that protects adults ages 60 and older from respiratory syncytial virus, a common pathogen that kills and hospitalizes thousands of seniors every year.
Pfizer, in a statement Wednesday, said it expects to have supply available in the third quarter of this year ahead of the RSV season. The Centers for Disease Control and Prevention’s committee of independent advisors will meet on June 21 to make recommendations on the use of the vaccine.
The approval of Pfizer’s vaccine comes just weeks after the FDA cleared a similar shot targeting RSV that is made by GSK. The FDA’s committee of independent advisors endorsed Pfizer’s vaccine in February. But several members of the panel had voiced safety concerns about the shot.
Two participants in Pfizer’s clinical trial developed Guillain-Barré syndrome after receiving the vaccine. Guillain-Barré is a rare neurological disorder with symptoms ranging from brief weakness to paralysis.
J&J Faces New Trial Over Talc Cancer Claims, Amid Settlement Push
Johnson & Johnson (JNJ.N) on Wednesday faced the first trial in almost two years over claims that asbestos in its baby powder and other talc products causes cancer, as it seeks to settle thousands of similar cases in bankruptcy court.
Emory Hernandez, 24, says he developed mesothelioma, a deadly cancer, in the tissue around his heart as a result of exposure to J&J’s talc products beginning when he was a baby. The company has denied that its talc contains asbestos, which is linked to mesothelioma, or causes cancer.
J&J subsidiary LTL Management in April filed for bankruptcy in Trenton, New Jersey proposing to pay $8.9 billion to settle more than 38,000 lawsuits and prevent new cases from coming forward in the future. It is the company’s second attempt to resolve talc claims in bankruptcy, after a federal appeals court rejected an earlier bid.
Litigation has largely been halted during bankruptcy proceedings, but U.S. Chief Bankruptcy Judge Michael Kaplan, who is overseeing LTL’s Chapter 11, allowed Hernandez’s trial to go ahead because he is only expected to live a short time.
Making Us Thinner Will See Fatter Profits for Pharma as Bloomberg’s Crystal Ball Predicts Obesity Drug Sales Hitting $44 Billion by 2030
Novo Nordisk has lit the tinder of a new megablockbuster market with Saxenda and Wegovy as new, branded anti-obesity drugs are set to haul in $44 billion by this decade’s end.
That’s according to the latest projections in a new report by Bloomberg Intelligence, which found sales of branded anti-obesity drugs could hit $44 billion, when risk-adjusted, in 2030. That would be a major ballooning of a market that was worth just $2.5 billion last year.
The market is set to be dominated by Novo’s Saxenda and, more notably, its newer semaglutide-based drug Wegovy, both GLP-1s, as well as Eli Lilly‘s tirzepatide. Lilly’s drug, which works as a dual GLP-1/GIP (glucose-dependent insulinotropic polypeptide), is currently marketed as Mounjaro in diabetes but will likely soon see a filing for obesity, with a potential launch by late this year or early 2024.
FDA Issues Warning About Compounded Versions of Wegovy, Ozempic
U.S. News & World Report reported:
Patients taking semaglutide for type 2 diabetes or weight loss should be careful about where they’re getting the medication, the U.S. Food and Drug Administration warned Tuesday.
Shortages of the drug, commonly sold as Wegovy and Ozempic, have led to the making of compounded versions of the drugs, which is combining or mixing ingredients to meet patient needs.
Compounders can make a version of a drug if the medication is in shortage and they meet the requirements of the Federal Food, Drug and Cosmetic (FD&C) Act. But the FDA said it has received reports that some patients have had some problems after taking the compounded drugs.
How the Makers of Inhalers Keep Prices so High
Millions of Americans rely on inhalers to help them breathe. These products have existed for more than 65 years, but pharmaceutical manufacturers have used legal and regulatory strategies to keep prices artificially high. Americans will continue to spend billions of dollars unnecessarily on inhalers — unless Congress and the Food and Drug Administration finally intercede on behalf of patients.
“Inhalers” refer to a class of medications sold together with their delivery devices (known as drug-device combinations) that treat asthma and the smoking-related lung condition chronic obstructive pulmonary disease (COPD). Riker Laboratories developed the first modern inhalers in 1955, drawing inspiration from aerosolized hairspray to replace clunky delivery apparatuses then in wide use.
Over the years, the FDA approved dozens of new inhalers. Between 2000 and 2021, manufacturers earned more than $178 billion in revenue on these products in the United States alone. Of the 50 drugs with the highest gross Medicare Part D spending in 2021, seven were brand-name inhalers.
Manufacturers’ prices remain high, and with most products designed to last just one month, prescription costs can run to several thousand dollars per year, driving up premiums in commercial insurance plans and straining Medicare and Medicaid budgets.
Pfizer Says Its Experimental Antibiotic Combo Can Treat Some Superbug Infections
Pfizer Inc (PFE.N) said on Thursday data from late-stage trials showed its experimental combination of antibiotics was effective in treating deadly infections caused by drug-resistant bacteria.
Deaths from antibiotic-resistant bacteria, also known as superbugs, have been on the rise globally, and health regulators have called for the development of newer treatments as resistance to older antibiotics grows.
The late-stage studies compared the experimental combination of the antibiotics aztreonam-avibactam (ATM-AVI) and existing generic drug metronidazole with a combination of two older antibiotics – meropenem and colistin – to treat complicated intra-abdominal infections and types of hospital-acquired pneumonia.
