Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amicus, Ascletis, Cue, Eli Lilly, Immuron, Incyte, Iterum, Kiromic, Regulus, Spine, Veru.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: CSL, Enveric, Gain, Juvenescence, Neximmune, Propanc, Rakovina, Selah, Sound, Vifor, Zealand.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Abbvie, Arcellx, Cognition, Genentech, Glyscend, Inovio, Medicenna, Mind, Myeloid, Rhovac, Sanofi, Scilex, Spine.
With its focus on transformative high-risk, high-reward research to drive biomedical breakthroughs, the new Advanced Research Projects Agency for Health (ARPA-H) may be a good concept, but it shouldn’t come at the expense of increased investment in basic research at the NIH, according to the bipartisan leadership of U.S. House appropriators.
Newly appointed President and CEO Jackie Shea looks to have her work cut out for her, as Inovio Pharmaceuticals Inc. decided to ditch its phase II/III COVID-19 vaccination trial in favor of pursuing a booster strategy with INO-4800. That update, disclosed during Inovio’s first-quarter earnings late May 10 alongside a likely delay in filing for approval of HPV immunotherapy candidate VGX-3100, sent the stock (NASDAQ:INO) falling 27% May 11. Over the past year, shares have fallen more than 70%.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Eisai, Gilead, Kadmon, Moleculin, Neogene, Novo Nordisk, Turning Point, Zai Lab.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Alvotech, Anges, Beckley, Bioasis, Corbus, Dare, Eiger, Entrada, Incannex, Inmune, Lophora, Mycrodose, Neuramedy, Rallybio, Rational.
The in vitro diagnostics industry has turned in an impressive response to the COVID-19 pandemic, but a few problems are bound to surface. The U.S. FDA reported May 10 that the Accula test by San Diego-based Mesa Biotech Inc. has been recalled due to contamination of test materials at the manufacturing site, a problem that could lead to false negative findings with the test.
A congressional investigation into COVID-19 vaccine manufacturing failures at Emergent Biosolutions Inc. unveiled more troubling issues at the company’s Bayview facility in Baltimore, which had been awarded a lucrative U.S. government contract to produce vaccines for Johnson & Johnson.
First results from the U.K. Cov-Boost trial, looking at responses to a fourth dose of an mRNA COVID-19 vaccine, show that antibody levels increase more than after the third dose, confirming the precautionary move to give the most vulnerable a second COVID-19 booster in advance of immune response data being available.
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