Gilead Sciences Inc. is acquiring partner Arcellx Inc. at a value of up to $7.8 billion, consisting of $115 per share up front and a potential payment of $5 per share through a contingent value right. Read More
Vanda Pharmaceuticals Inc. gained U.S. FDA approval for Bysanti (milsaperidone), cleared for use in acute bipolar I disorder and schizophrenia and ensuring continuation of the firm’s atypical antipsychotic franchise, with Fanapt (iloperidone) set to start losing patent protection in 2027. It also offered a rare straightforward regulatory win for Vanda, which has tussled with the FDA in recent years. Read More
An “outsized placebo response” is not stopping Gossamer Bio Inc. from seeking a path to potential approval of inhaled tyrosine kinase inhibitor seralutinib in pulmonary arterial hypertension (PAH), but the missed primary endpoint in the phase III Prosera study sent shares of the company (NASDAQ:GOSS) tumbling 80% and left investors skeptical going forward. Read More
Shares in Novo Nordisk A/S took another battering after the company announced its next-generation obesity drug Cagrisema failed to show noninferiority to Eli Lilly and Co. Inc.’s Zepbound in an open-label comparator study. Read More
The ramifications of the U.S. Supreme Court’s decision Feb. 20 that shot down President Donald Trump’s reciprocal tariffs issued under the International Emergency Economic Powers Act are rippling across the world. And Trump’s immediate response to that ruling – a proclamation imposing a temporary 10% import duty on most goods brought into the country beginning Feb. 24 – isn’t helping. Read More
Neurosoft Bioelectronics SA has signed an agreement with Science Corp. to gain access to its full stack of clinical-grade neural recording tools as it looks to advance its brain-computer interface (BCI) system. Read More
Harbour Biomed is spinning out newco Solstice Oncology and is outlicensing its CTLA-4 antibody, porustobart (HBM-4003), to the newco in a cash and equity deal worth more than $1.2 billion. Read More
The U.S. FDA rolled out its anticipated “plausible mechanism” draft guidance, enabling ultrarare disease drug developers to generate evidence of effectiveness and safety to support approval when randomized controlled trials are not possible due to small patient populations. Read More
Swiss pharmaceutical giant Novartis AG is selling off its India-listed business unit, Novartis India Ltd. (NIL), to a private equity-led consortium for about ₹14.46 billion (US$159.3 million) as it seeks to grow with “pure-play innovation.” Read More
Amid an ongoing court challenge to the current composition of the CDC’s Advisory Committee on Immunization Practices (ACIP), the committee’s Feb. 25-27 meeting has been removed from its calendar. Read More
Clinical updates for biopharma and med tech, including data readouts and publications: AC Immune, Agenus, Eli Lilly, Janssen, Johnson & Johnson, Novartis, Partner, PDS, Scandinavian, Takeda. Read More
Biopharma and med-tech happenings, including deals and partnerships, and other news in brief: Beyond Air, Biocomposites, Biopharma-Middle East and Africa, Cigalah, Corcept, Fennec, Immunitybio, Seaport, Teva. Read More
Regulatory snapshots for biopharma and med tech, including global submissions and approvals, and other regulatory decisions and designations: Astrazeneca, Puretech, Roche. Read More
