Gilead Sciences Inc. tallied a “clear win,” said Barclays analyst Carter Gould, in the phase III interim analysis showing that the Foster City, Calif.-based company’s twice-yearly injectable HIV-1 capsid inhibitor, lenacapavir, yielded 100% efficacy as an HIV blocker for cisgender women. Read More
Ionctura SA closed a €80 million (US$86 million) series B round as it prepares to accelerate development of lead asset roginolisib in the treatment of uveal melanoma. That follows publication of phase Ib data showing roginolisib, an orally available allosteric modulator of the delta isoform of PI3K (phosphatidylinositol-4,5-bisphosphate kinase), is distinguished from other drugs in this class, in being well-tolerated over long periods, with patients having been treated for up to 38 months. Read More
A nearly two-year-old partial clinical hold has been lifted by the U.S. FDA on PTC Therapeutics Inc.’s pivotal phase II study in Huntington’s disease. The agency had paused enrollment in October 2022, saying it wanted more data on PTC-518, an orally bioavailable small-molecule splicing modifier, before enrollment could continue. Read More
Quoted biotech investor Syncona Ltd. is still struggling with the fallout from one of the worst bear markets on record, reporting its net asset value fell from £1.25 billion (US$1.58 billion) to £1.24 billion in its 2023-24 financial results on June 20. That is despite a restructuring toward more mature companies, with 70% of the portfolio now invested in clinical-stage assets. Read More
China’s National Medical Products Administration (NMPA) approved Dizal Pharmaceutical Co. Ltd.’s golidocitinib for treating adults with relapsed or refractory peripheral T-cell lymphoma whose disease has progressed or was refractory to at least one prior systemic therapy. Read More
Alzheon Inc. has raised $100 million in a series E financing round to push its oral drug candidate for early Alzheimer’s disease (AD), ALZ-801 (valiltramiprosate), through a late-stage, Apolloe4 study. Read More
Now that it has some experience with interchangeable biosimilars under its belt, the U.S. FDA is proposing an update to its interchangeability guidance that could eliminate the need for switching studies in some instances. Read More
The African Vaccine Manufacturing Accelerator is up and running, with more than $1 billion already pledged to the effort that’s aimed at supporting the sustainable growth of Africa's manufacturing base and contributing to the African Union's goal of producing 60% of the vaccines required by African countries by 2040. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Aurion, Dizal, Neurona, Sobi. Read More
