Regulatory snapshots for biopharma and med tech, including global submissions and approvals, and other regulatory decisions and designations: Astrazeneca, Puretech, Roche.
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.
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.
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.
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.
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.
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.
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.