Five years after the COVID-19 pandemic gripped the world, the U.S. FDA is moving away from annual routine boosters for all children and adults. Instead of that one-size-fits-all regulatory framework by which it has granted broad COVID-19 vaccine marketing authorization for all Americans older than 6 months, the agency said it’s adopting a policy akin to that followed in Europe, which now restricts the vaccines to older adults and those at high risk for severe disease.
Pfizer Inc. is paying $1.25 billion up front and up to $4.8 billion in milestone payments to gain global, ex-China rights to SSGJ-707, a PD-1/VEGF bispecific antibody from 3Sbio Inc. that recently won China clearance for a phase III study in lung cancer as a potential first-line monotherapy. Announced after U.S. market hours May 19, the exclusive agreement for SSGJ-707 spells up to $6.15 billion combined for Shenyang, China-based 3Sbio, along with separate tiered double-digit royalty payments on sales of SSGJ-707, if approved.
The U.S. Department of Health and Human Services (HHS) put biopharma companies on notice May 20: It’s time to commit to reducing prescription drug prices to reflect most-favored-nation (MFN) pricing in accordance with President Donald Trump’s May 12 executive order. HHS said it expects manufacturers to commit to aligning their U.S. prices for all brand products across all markets that don’t currently have generic or biosimilar competition with the lowest price of a set of economic peer countries.
The credibility gap in psychedelic drug development continues to narrow with positive top-line data from a Beckley Psytech Ltd. phase IIa study in depression. The results keep the treatment into a tight race with GH Research plc, which also has an inhalable drug in development.
The morning’s negative stock reaction to Tourmaline Bio Inc.’s phase II news with heart drug pacibekitug had some onlookers scratching their heads, even as analysts congratulated the company on results from the ongoing study – a good-news dataset to which the market gradually caught on as the day progressed.
Mirroring results reported in a phase IIb study, Apnimed Inc.’s first of two pivotal trials testing AD-109 as an oral therapy in obstructive sleep apnea hit primary and secondary endpoints. Should similar findings emerge from a second phase III trial, expected to read out in a couple of months, the privately held firm anticipates a U.S. NDA filing in early 2026.
With a PDUFA date less than four weeks away, Urogen Pharma Inc. has been having a rough ride on the Street since the U.S. FDA released a joint briefing document for the May 21 Oncologic Drugs Advisory Committee meeting on UGN-102 (mitomycin).
Frets about how the new federal administration might affect prospects for vaccines were quelled at least somewhat by the U.S. FDA green light for Novavax Inc.’s COVID-19 vaccine Nuvaxovid, indicated for adults 65 and over and people 12-64 years old with at least one underlying condition that puts them at risk of severe outcomes from infection by the virus.
It’s been a big week for Inozyme Pharma Inc. On the heels of a promising interim readout for phase III-stage enzyme replacement therapy (ERT) candidate INZ-701 in ENPP1 deficiency, the firm agreed to be acquired by Biomarin Pharmaceuticals Inc. in a deal valued at about $270 million, putting the rare disease ERT in the hands of an experienced commercial team.
Therini Bio raised an additional $39 million in its series A financing round, bringing the total for the round to $75 million. The capital will be used to advance its fibrin-targeting immunotherapies for neurodegenerative diseases.
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