Pfizer Inc. is ending work on oral GLP-1 candidate danuglipron for weight loss following the report of a single potentially drug-induced liver injury, a move that appears to open the door for other firms working on oral therapies in the high-dollar obesity space, even as industry watchers seek further details to determine whether similar safety signals could emerge for those competitors.
The I148M mutation in the PNPLA3 gene, which encodes patatin-like phospholipase domain-containing protein 3, is known to confer risk of fatty liver, cirrhosis and hepatic inflammation, which may lead to hepatocellular carcinoma or metabolic dysfunction-associated steatohepatitis (MASH).
Mixed clinical results led shares of Arvinas Inc. (NASDAQ:ARVN) to close March 11 at $8.30, down $9.26, or 52%, after the company and Pfizer Inc. disclosed results from the phase III Veritac-2 study testing vepdegestrant monotherapy vs. fulvestrant in adults with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2-negative advanced or metastatic breast cancer. Enrolled were subjects whose disease progressed after treatment with CDK4/6 inhibitors and endocrine therapy.
As U.S. regulatory uncertainty swirls around the vaccine space and health care in general, Vaxcyte Inc. stands poised for a readout of phase II infant data by the end of this quarter with VAX-24, the 24-valent pneumococcal conjugate vaccine (PCV). The San Carlos, Calif.-based firm will offer top-line safety, tolerability, and immunogenicity data, to be followed by top-line data with the booster dose by the end of this year.
Once high-flying Bluebird Bio Inc. has found a way out of its financial squeeze, as funds managed by global investment firms Carlyle and SK Capital Partners LP, along with a team of biotech executives, will be taking over the company.
A second pentavalent vaccine for preventing meningococcal disease has been approved by the U.S. FDA. GSL plc’s Penmenvy will now go up against Pfizer Inc.’s Penbraya, which had a two-year head start in the market.
Amid a strengthening offensive against direct-to-consumer drug ads, two senators flagged a Super Bowl ad promoting compounded drugs as part of the company’s attack on the U.S. weight-loss industry that it said was built to keep Americans “sick and stuck.”
Due diligence plays a significant role in M&A transactions, but the eventual return on investments don’t always add up to the purchase price. While some companies such as Abbvie Inc. and Bristol Myers Squibb Co. – as shown in part one of this three-part series – have succeeded in acquiring products able to surpass M&A sticker prices, the vast majority of deals analyzed by BioWorld showed that most buyers remain significantly in the red.
In another cautionary tale of kicking all the tires before an acquisition, Pfizer Inc. agreed to a nearly $60 million settlement to resolve a whistleblower’s claims that Biohaven Pharmaceutical Holding Co. Ltd. was paying kickbacks to induce prescriptions of its migraine drug ahead of Pfizer’s $11.6 billion acquisition of the company in October 2022.
In the final days of the Biden administration, the U.S. Department of Health and Human Services’ Centers for Medicare and Medicaid Services (CMS) laid out the latest 15 drugs that are subject to negotiated prices, with Novo Nordisk A/S’ GLP-1 drug Ozempic for type 2 diabetes topping the list, bringing Rybelsus and Wegovy along for the ride because they share the same active ingredient, semaglutide.
