Moderna Inc. has received conditional authorization from the U.K.’s Medicines and Healthcare Products Regulatory Agency for its bivalent COVID-19 booster vaccine mRNA-1273.214 (Spikevax bivalent original/omicron). The conditional approval, which covers adults aged 18 years and older, marks a new phase in the ongoing global effort to curb the COVID-19 pandemic, as the new vaccine represents the first commercial product to incorporate omicron-specific epitopes. It contains 25 micrograms each of the spike proteins of the omicron BA.1 variant and the original Wuhan strain of SARS-CoV-2. Read More
As expected, the U.S. House of Representatives passed, on a 220-207 party-line vote, a legislative package Aug. 12 that, for the first time, allows Medicare to directly negotiate some prescription drug prices, while imposing severe penalties and an excise tax on companies that refuse to negotiate or don’t comply with the government price. Read More
News of GSK plc’s decision to decline its option for MAT2A inhibitor IDE-397, the lead compound from a 2020 collaboration with Ideaya Biosciences Inc. sent the latter’s shares (NASDAQ:IDYA) slipping 35% to close Aug. 15 at $10.20. For Ideaya, however, which maintained that it has sufficient capital to see the program through phase II on its own, the move works out just fine. Read More
Opthea Ltd. has secured nondilutive funding to complete phase III development and commence commercialization of its wet age-related macular degeneration (wet AMD) treatment OPT-302, in a $170 million agreement with Launch Therapeutics, an operating company set up earlier this year by the private equity group Carlyle to manage biotech investments. Under the terms of the deal, Launch will now commit $120 million in three instalments at fixed time points, with an option to invest a further $50 million. Read More
Novartis AG’s attempt to repurpose its immunology drug canakinumab as an oncology therapy was always considered a long shot. Now, the chances of success have receded further after another phase III failure in lung cancer. The phase III Canopy-A study, which tested the drug as adjuvant treatment in adults with stages II-IIIA and IIIB completely resected non-small-cell lung cancer failed to meet its primary endpoint of disease-free survival vs. placebo. Read More
Kringle Pharma Inc.’s phase II trial evaluating its recombinant human hepatocyte growth factor ligand, oremepermin alfa, failed to meet both primary and secondary endpoints in a study of its potential to help people with amyotrophic lateral sclerosis (ALS). Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Alx, Astrazeneca, Blueprint, Clene, Gilead, Immunogenx, Novartis, Passage, Plus, Roche, Sanofi, Viridian and Virios. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Mitsubishi Tanabe, Rational Vaccines, Therapeutic Solutions. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Acer, Advanced Acclerator Applications, Astrazeneca, Brainstorm, Cullgen, Daewoong, Daiichi, Genentech, Innocare, Larimar, Menarini, Moderna, Novavax, Novelmed, Privo, Relief, Small, Spectrum, Stemline. Read More
