Bristol Myers Squibb Co.’s audacious $13.1 billion 2020 takeover of Myokardia Inc. appears to have paid off with U.S. FDA approval of the drug at the heart of the deal, mavacamten. The medicine, a cardiac myosin inhibitor for treating adults with obstructive hypertrophic cardiomyopathy (HCM), will be marketed under the brand name Camzyos. Read More
As many biopharmas rethink plans to go public on less-than-welcoming U.S. markets, Hillevax Inc. forged ahead, pricing an upsized IPO April 28, offering 11.8 million shares at $17 apiece, the midpoint of its previously proposed range, for gross proceeds of about $200 million. That’s the highest amount raised in a U.S. IPO so far in 2022, which saw only nine companies go public on Nasdaq during the first quarter. Read More
A handful of developers are advancing drug prospects in the localized scleroderma (LS) space, with candidate mechanisms that range from cell-based gene therapy to IL-4 or IL-6 antagonism to PDE4 blocking, and with efforts that involve approved as well as experimental compounds. Read More
Australia’s Therapeutic Goods Administration will begin conducting routine risk-based good clinical practices (GCP) inspections for clinical trials of drugs and biologics. The agency outlined in final guidance how it would prioritize inspections, what the process would look like and how it would report and follow up on inspections. Read More
Not satisfied with the findings of a World Trade Organization (WTO) dispute panel, Turkey informed the WTO April 28 that it has initiated arbitration proceedings to review those findings, which involve an EU complaint about measures Turkey employs concerning the production, importation and marketing of prescription drugs. Read More
Biopharmas raising money in public or private financings, including: Abeona, Avivagen, Bausch + Lomb, Breakthrough Properties, Creative Medical Technology, Nkarta. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: AB Science, ABVC, Alzinova, Anaptysbio, Arecor, Beigene, Bioinvent, Delpor, Edesa, Eli Lilly, Galmed, Hibercell, Hightide, Ocuphire, Opiant, Transcenta, Tryp, Turning Point, Vaxxinity, Virios, Zymeworks. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Genocea, Ignyte Acquisition, Immune, Nova Mentis, Peak Bio, Promis Neurosciences, Saniona, Serenity Bioworks, Solid, Statera, Unicyte, Valbiotis, Wuxi Advanced Therapies, Xbiotech, Zymeworks. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Astrazeneca, Beigene, Cara, CNS, Janssen, Jasper, Moderna, Mycovia, Nevakar, SQZ, Timber, Vifor, Xbiotech. Read More
