Nutramigen Infant Formula Recalled Over Possible Contamination

The Hill: Nutramigen Powder Baby Formula Recalled For Fear Of Bacterial Contamination
Reckitt/Mead Johnson Nutrition on Sunday recalled some batches of its Nutramigen Hypoallergenic Infant Formula Powder, a product marketed toward infants with milk allergies. The recall affects Nutramigen Powder 12.6 and 19.8 ounce cans sold in the United States. MJN said in an announcement that the recall was due to a “possibility of contamination with Cronobacter sakazakii.” The recall was triggered by a sample outside the United States — according to the company, “all product in question went through extensive testing by MJN and tested negative for the bacteria.” The recalled product was manufactured in June and distributed between June and August. (Bernal, 1/1)

In legal updates —

Bloomberg: McKinsey To Pay $78 Million To Settle Opioid Claims By Insurers
McKinsey & Co. is poised to pay $78 million to health insurers and company benefit plans, in its latest settlement of lawsuits over its role advising opioid makers in their sales of the painkillers. The proposed accord, filed in federal court in San Francisco on Friday, would resolve allegations that the management consulting firm helped fuel the US opioid epidemic by providing sales analysis and marketing advice to manufacturers of the highly addictive painkillers, including Purdue Pharma LP and Johnson & Johnson. (Blumberg, 12/30)

Reuters: Judge Certifies Johnson & Johnson Shareholder Class Action Over Talc Disclosures 
A federal judge said Johnson & Johnson shareholders may pursue as a class action their lawsuit accusing the company of fraudulently concealing how its talc products were contaminated by cancer-causing asbestos. U.S. District Judge Zahid Quraishi in Trenton, New Jersey, on Friday allowed shareholders from Feb. 22, 2013, to Dec. 13, 2018, to pursue their securities fraud claims as a group. (Stempel, 12/29)

The Washington Post: Apple Wins Temporary Reprieve From The Ban On Apple Watch Sales
One day after a ban on the import and sale of its two newest Apple Watches became official, Apple managed to buy itself some time. Shortly after the office of U.S. Trade Representative Katherine Tai confirmed on Tuesday that the United States would not overturn the International Trade Commission ruling calling for the ban, Apple appealed the decision and submitted an emergency filing to the D.C.-based U.S. Court of Appeals for the Federal Circuit, seeking a short pause on the ban’s enforcement. The court on Wednesday granted Apple that temporary reprieve. That means Apple is allowed to resume selling Apple Watch models with blood oxygen tracking features — the Watch Ultra 2 and the Watch Series 9 — direct to consumers. The company confirmed both devices would be available for sale in Apple retail stores Wednesday, and on its website by Thursday at 12 p.m. Pacific time. (Velazco, 12/27)

More pharmaceutical industry developments —

Fierce Biotech: Iovance Cell Therapy Trial Hit With FDA Hold After Patient Death
The FDA has hit Iovance Biotherapeutics’ cell therapy trial with a clinical hold after a patient with non-small cell lung cancer (NSCLC) died in a case that may be related to the study. The federal agency implemented the hold Dec. 22 after a grade 5 adverse event (AE)—the most serious form of AE that signifies a fatality—was reported, according to a Dec. 27 release from Iovance. The patient death is potentially related to the non-myeloablative lymphodepletion pre-conditioning regimen, Iovance added in its statement. (Masson, 12/29)

USA Today: Cytokinetics Heart Drug Trial Has Positive Results, Could Go To FDA
A new drug to treat a rare heart condition may be set to go before the Food and Drug Administration. Pharmaceutical company Cytokinetics announced Wednesday that its drug aficamten produced, "statistically significant and clinically meaningful" results in the phase three trial of the drug. Aficamten is intended to treat hypertrophic cardiomyopathy, a condition that thickens the heart muscle and is present in .2% of the world's population, according to the National Institute of Health. (Powel, 12/28)

NPR: Why GSK's Flovent Asthma Inhaler Is Being Discontinued In 2024
Some asthma patients may start out the new year scrambling for their go-to inhaler – at least that's the concern as Flovent, a popular drug, leaves store shelves starting in January. Earlier this year, drugmaker GSK announced it's discontinuing Flovent in 2024. There is a generic version to take its place, but some doctors worry patients could be left in the lurch as they sort out how to get the new medication covered by insurance. (Lupkin, 12/30)

Fox News: Vibrating Weight Loss Pill Could Provide Alternative To Ozempic And Wegovy, Say Researchers
A vibrating pill has shown promise in early studies as a possible obesity treatment. Developed by engineers at MIT (Massachusetts Institute of Technology), the capsule is intended to be swallowed prior to eating in order to "trick" the brain into thinking the body is full — thereby reducing the amount of calories consumed. The vibrations activate the "stretch receptors" that detect satiety after eating, sending a signal to the brain that the stomach is full even if it’s not. (Rudy,12/31)