FTC Challenges Over 100 Brand-Name Meds’ Patents For Inaccuracies
The issue, the Federal Trade Commission says, is improper or inaccurate patent listings made by some of the world's biggest drugmakers. Among other news, the FDA says Accord Healthcare has resumed making the common cancer drug methotrexate amid ongoing cancer drug shortages.
Stat:
FTC Challenges Drugmakers Over Inaccurate, Improper Patent Listings
Making good on a recent threat, the Federal Trade Commission is challenging more than 100 patents on brand-name medicines that were improperly or inaccurately listed by some of the world’s biggest drug companies in a key government registry. (Silverman, 11/7)
In news about cancer —
Reuters:
Accord Resumes Production Of Cancer Drug Methotrexate Amid Supply Shortage
The U.S. Food and Drug Administration (FDA) reported on Tuesday Accord Healthcare has resumed manufacturing of methotrexate, one of the most commonly used cancer drugs, amid ongoing shortages for some cancer drugs in the United States. Methotrexate is an injected drug used to treat cancers ranging from acute lymphoblastic leukemia in children, breast cancer, lung cancer, bone cancers and certain types of head and neck cancers, according to the National Cancer Institute. (11/7)
CBS News:
FDA Moves To Pull Carbadox, Drug Used By Pork Industry, Citing Human Cancer Risk
A common veterinary drug used by American pork farms could soon be pulled from the market, the Food and Drug Administration announced Tuesday, due to concerns that it could pose a cancer risk in humans who eat hot dogs, sausages and other foods made from animals given the drug. The FDA's move comes nearly a decade after the agency first began a renewed probe into safety concerns over the drug, carbadox, which is added to feed given to pigs to combat infections and help fatten them up. (Tin, 11/7)
Reuters:
Bayer Says Judge Gave Roundup Jury Secret Message Before $175 Mln Verdict
Bayer is seeking to overturn a recent $175 million verdict in favor of a man who alleged that the company's Roundup weed killer caused his cancer, saying that the trial judge gave the jury a secret instruction that may have swayed their verdict. (Pierson, 11/7)
Stat:
In The Fight Against Cancer, It’s Boom Times For Radiopharmaceuticals
When Ken Song was getting ready to leave his job as the CEO of a small biotech in 2020, he wasn’t sure what was next. But he knew one thing. “I deliberately said I’m not going to do oncology. Oncology is so crowded. Everybody thinks they have the solution, but the reality is, it’s all noise,” he said. That was until late March 2020, when he received two phone calls from two different investors, both pondering about the same thing: Was it possible to make more effective and widely applicable treatments that drop toxic radiation specifically to cancer cells, decimating them on site? (DeAngelis, 11/8)
In other pharmaceutical developments —
Reuters:
Biogen-Sage Therapeutics Postpartum Depression Pill Priced At $15,900
Sage Therapeutics has priced the oral postpartum depression (PPD) pill it developed with partner Biogen at $15,900 for a full 14-day course of treatment, the company said on Tuesday, months after the drug was approved by the U.S. health regulator. The companies had sought U.S. approval for Zurzuvae to treat clinical depression, a much larger market, and postpartum depression, but the Food and Drug Administration in August approved it only for PPD. (Mandowara, 11/7)
CBS News:
FDA Investigating Reports Of Hospitalizations After Fake Ozempic
At least three Americans have been reported hospitalized after using suspected counterfeits of semaglutide drugs, which include Novo Nordisk's diabetes medication Ozempic, according to records released by the Food and Drug Administration. The hospitalizations are among 42 reports to the FDA's Adverse Event Reporting System that mention use of counterfeit semaglutide from around the world. The agency last updated its database at the end of last month to include reports tallied through the end of September. (Tin, 11/7)
AP:
Drugs Aren't Required To Be Tested In People Who Are Obese. Here's Why That's A Problem
More than 40% of American adults are considered obese, yet the medications many take are rarely tested in bigger bodies. That’s because they are not required to be included in drug studies. And often, they’re explicitly excluded. “Clinical trials and dosing instructions don’t always ensure that drugs will be safe and effective for people with obesity,” said Christina Chow, a drug researcher who’s reported on the challenges of considering obesity in drug development. “There’s no real emphasis for them to be studied at all.” (Aleccia, 11/7)
Reuters:
Bayer Weighs Break-Up Options As Management Job Cuts Loom
Bayer is considering spinning off its consumer health or crop science divisions, it said on Wednesday, as new CEO Bill Anderson gave his initial thoughts on how to revive the diversified German company's battered share price. Management is looking into separating either the non-prescription medicines business or the agriculture business from the rest of the group which includes pharmaceuticals, but not at the same time, Bayer said in a statement. (Burger, 11/8)
KFF Health News:
US To Cover HIV Prevention Drugs For Older Americans To Stem Spread Of The Virus
A proposed federal policy aims to protect older Americans from contracting HIV by offering free preventive medication, the latest effort to catch up to much of Europe and Africa in stemming the spread of the virus. Under the plan from the Biden administration, Medicare would cover patients’ full cost of preexposure prophylaxis drugs, which prevent HIV transmission. The drugs, known by the shorthand “PrEP,” would be free in pill form and — for the first time — as long-acting injectables through the government insurance program designed for those 65 and older. Those 50 and over make up half of all people in the U.S. already living with HIV. (Scaturro, 11/8)
