CDC director Rochelle Walensky’s early morning announcement on Sept. 24 recommending boosters for certain frontline workers was considered wise by some but as undermining her advisers and the process by others. She endorsed the Advisory Committee on Immunization Practices’ recommendation for booster doses of the Pfizer Inc.-Biontech SE COVID-19 vaccine but overruled one of the panel’s Sept. 23 decisions by adding boosters for people ages 18 to 64 who are at increased risk of COVID-19 exposure and transmission due to occupational or institutional setting, based on their individual benefits and risks. Read More
Capricor Therapeutics Inc. CEO Linda Marban said the company’s CAP-1002 for Duchenne muscular dystrophy (DMD) should serve as “adjunctive to any of the therapies out there” – a handful are approved – and bring bonus favorable effects on cardiac function that one analyst called “a one-two punch” against the disease. Read More
Astrazeneca plc and Merck & Co. Inc. have data for a new indication for their blockbuster PARP inhibitor class drug Lynparza (olaparib) in advanced prostate cancer in combination with standard abiraterone therapy. The companies said the Propel phase III study testing Lynparza in combination with abiraterone showed a statistically significant and clinically meaningful improvement in radiographic progression-free survival in first-line metastatic castration-resistant prostate cancer vs. standard abiraterone care. Read More
Paul Peter Tak means business. In one very active year, the entrepreneurial president and CEO of Candel Therapeutics Inc., an oncolytic viral immunotherapy company he said was long run as cost-efficient "semi-academic lab,” has hired on a new chief business officer and CFO, recruited a new research advisory board, and led the company to completion of a $79.1 million IPO. Now, ahead of a weekend presentation of data on one of the company's lead candidates for fast-growing brain tumors, shares (NASDAQ:CADL) that dipped post-IPO are again climbing as the company works to develop a slow-growing class of new medicines. Read More
Imugene Ltd.’s recent win with a patent granted in Japan with its HER-Vaxx immunotherapy, in development for HER2-positive gastric cancer, represented a smallish but significant win in the HER2/neu space, where plenty of other players are busy, with Greenwich Life Sciences Inc. a strong emerging name. Read More
Biopharmas raising money in public or private financings, including: Alpha Cognition, Eurazeo, Kintara, Kurma, Onconova, Pharmather, Underdog, Viridian. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Appili, Ascendis, Ayala, Bellus, Cytovation, Daré, Horizon, Immunocore, Nicox, Novan, Point, TFF, Valneva. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Cytodyn, Geneuro, Moderna, Sellas Life Sciences, Strongbridge, Twist, Ventus, Xeris. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: AB Science, Ascentage, Cantargia, Incyte, Innovent, Lion, Novavax, Psybio, Serum, Wake. Read More
