Litigation against companies in the life sciences has far too often covered those who were not injured by the device or drug, but there are signs that this tide is shifting.
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.
Positive data for Veru Inc.’s enobosarm lend more weight to the potential progress of the company’s body-mass preservation program in patients taking Wegovy (semaglutide). The side effect of lean mass loss has dogged those taking GLP-1s. The study results didn’t support the company’s stock on the day of the data release as it had the previous four weeks.
What a difference 60 weeks can make. That’s the lesson Akero Therapeutics Inc. shared with the rollout of what executives called “unprecedented” data from the phase IIb Symmetry trial testing efruxifermin (EFX), its FGF21 receptor agonist, in patients with compensated cirrhosis due to metabolic dysfunction-associated steatohepatitis (MASH). While earlier findings had shown only a trend in improvement at 36 weeks, full 96-week results showed more than doubling of earlier effect size, hitting the primary endpoint and sending shares of Akero (NASDAQ:AKRO) up 97% to close Jan. 27 at $51.71.
Inflammatory diseases specialist AB2 Bio Ltd. has signed a potential $686 million U.S. commercialization deal for its interleukin-18 neutralizing drug tadekinig. The agreement with Japanese pharma company Nippon Shinyaku Co. Ltd. includes an initial payment of $6 million, with a further $30 million due later this year.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Abyssinia, Astrazeneca, Cordance, Moderna, Purdue.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Clarity, X4.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: CG Pharmaceuticals, Eisai, Exuma, Merck, Neuvivo, Novo Nordisk, Page, Rakuten, Vedanta.
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