Good morning, everyone, and welcome to another working week. We hope the weekend respite was relaxing and invigorating, because that oh-so familiar routine of online meetings and deadlines has predictably returned. But what can you do? The world, such as it is, continues to spin. So why not give it a nudge in a better direction with a hot cup of stimulation? Our choice today is peppermint mocha. As always, you are invited to join us. Meanwhile, we have assembled the latest list of interesting items for you to peruse. We hope you have a smashing day and, of course, encourage you to keep in touch. We treasure every new pen pal. …
Johnson & Johnson said it does not intend to make an offer for Horizon Therapeutics, days after the developer of medicines for rare autoimmune and inflammatory diseases revealed it was in talks with the company, Bloomberg News writes. Janssen Global Services, J&J’s pharmaceutical division, did not provide a reason why it is not planning to proceed with an offer in a statement released Saturday. Horizon shares surged over the past week after the company said it is in separate preliminary talks with J&J, Amgen, and Sanofi about a possible sale. Amgen and Sanofi have said that any offer for Horizon would be cash only.
The U.S. Food and Drug Administration is taking a harder line on its program that fast-tracks drug approvals based on preliminary evidence, spurring GSK, Roche, and others to remake plans for their drugs or pull them from the market, The Wall Street Journal notes. In recent weeks, the agency prodded GSK to withdraw a blood-cancer drug after it failed a follow-up trial, and announced that Viatris stopped selling a burn treatment because the company never finished its confirmatory study. Meantime, the FDA told ImmunoGen and ADC Therapeutics, which have been developing cancer drugs, that it would not grant a speedy approval until they had begun follow-up studies.
Reproductive rights advocates are on edge over a lawsuit to revoke the decades-old FDA approval of mifepristone, which, if successful, would end legal access to abortion pills nationwide, The Hill explains. Advocates and legal experts say the suit has no merit, but they fear conservative courts will think otherwise. Abortion pills have become one of the next major fronts in the fight over reproductive health care in the wake of the U.S. Supreme Court decision overturning Roe v. Wade, and the lawsuit is seen by both sides as the start of the battle to come. Mifepristone, a drug that blocks hormones necessary for pregnancy, was approved by the FDA in 2000.
Kansas attorney general Derek Schmidt filed a lawsuit accusing three insulin manufacturers — Eli Lilly, Sanofi, and Novo Nordisk — and some of the largest pharmacy benefit managers of deliberately inflating insulin prices over the past two decades. He alleged the pricing scheme worked this way: The insulin manufacturers gained formulary access from the PBMs for their medicines, artificially and willingly raised their prices, and then secretly paid a significant portion of that price back to the PBMs, including Express Scripts, CVS Caremark, and OptumRx. The PBMs then granted national formulary status based upon the highest price and upon which of the medicines generated the largest profits.
Novartis reported that a prostate treatment that delivers radiation to specifically targeted cancer cells helped patients in a study that the company will use for U.S. regulatory approval, Bloomberg News says. The precision medicine, called Pluvicto, showed an effect on a form of survival without the disease worsening in patients who had already been treated with androgen-receptor pathway inhibitor therapy and whose prostate cancer had spread. The study is the second to show positive effects of the drug in an advanced clinical trial. Pluvicto is already cleared in the U.S. and several other countries for people with some types of prostate cancer who’ve received other therapies first.
Dr Reddy’s Laboratories and Sun Pharma are recalling different products in the U.S. market due to manufacturing issues, The Times of India tells us, as per an enforcement report issued by the U.S. Food and Drug Administration. The U.S. unit of Dr Reddy’s is recalling over 48,000 cartons of a drug used to treat a sneezing, runny, or stuffy nose because of “failed stability specifications.” And the U.S.-based arm of Sun Pharma is recalling 14,064 cartons of a medication to treat erosive esophagitis or heartburn caused by gastroesophageal reflux disease, or GERD. The company is recalling the affected lot, produced at its plant in Mohali, India, due to “discoloration.”