After a previous phase III failure, Savara Inc. kept at it and found success with molgramostim for the rare lung disease autoimmune pulmonary alveolar proteinosis. A second attempt, the pivotal phase III Impala-2 study of molgramostim, an inhaled form of recombinant granulocyte macrophage colony-stimulating factor for adults, hit its primary endpoint and left participants breathing easier. The results led Savara to say it would complete a BLA submission sometime in the first half of 2025, with filings in Europe and Japan to follow.Read More
A patient death and cases of pneumonitis overshadowed positive signs of efficacy for South San Francisco-based Lyell Immunopharma Inc.’s ROR1 CAR T-cell candidate, LYL-797, which is treating triple-negative breast cancer and non-small-cell lung cancer in a phase I trial. Read More
Radiopharm Theranostics Ltd. announced a AU$70 million (US$46.69 million) institutional placement, and as part of that capital raise, radiopharma company Lantheus Holdings, Inc., has agreed to make an initial equity investment of AU$7.5 million. Read More
In reviving another case involving drug label carveouts, the U.S. Court of Appeals for the Federal Circuit insisted that its June 25 decision in Amarin Pharma Inc. v. Hikma Pharmaceuticals plc will not kill so-called skinny labels that allow generics to come to market when some of the brand’s indications still have patent protection. Read More
Merck Sharp & Dohme Corp. (MSD), known as Merck & Co. Inc. in the U.S. and Canada, terminated its potential $1.86 billion deal with San Diego-based Artiva Biotherapeutics Inc. for novel chimeric antigen receptor-natural killer cell therapies. GC Cell disclosed news of the terminated deal on the Korea Exchange near market close of June 25, saying it was notified by Artiva after the decision was reached by MSD’s internal decision makers. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Ascendis, Astrazeneca, Bioxcel, Douglas, Ethris, Innovent, Lipocine, Merck KGaA, Novo, Soligenix, Tevogen, Wave Life, Werewolf. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Astrazeneca, BenevolentAI, CDR-Life, Harmony, Medicure, Novo Nordisk, Nervgen, Rigel. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Astrazeneca, Botanix, Capricor, Carisma, Dermavant, Excellthera, Ionis, Janssen, Junshi, Otsuka, Roche. Read More
