CDC Director Rochelle Walensky’s early morning decision recommending boosters for certain frontline workers was considered wise by some but as undermining her advisors 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 at increased risk of COVID-19 exposure and transmission due to occupational or institutional setting, based on their individual benefits and risks. American Medical Association president Gerald Harmon had no problem with it, saying he applauded and “fully” supports Walensky’s decision. The World Health Organization reiterated its concern about offering boosters to a wealthy slice of the world population while ignoring everyone else as vaccine supplies begin to dwindle. SVB Leerink analyst Geoffrey Porges told investors the addition fundamentally undermines the integrity of the process and “establishes that the traditional vaccine approval and recommendation process is even more politicized in the current administration than it was in the prior one, and is bound to spark a storm of outrage and protest from the vaccination and public health communities.”

Capricor scores in DMD, seeking partner for CAP-1002 push

Capricor Therapeutics Inc. disclosed positive final data from the phase II Hope-2 study with CAP-1002 in Duchenne muscular dystrophy (DMD). The trial met its primary efficacy endpoint of mid-performance of upper limb v. 1.2 scale, as well as skeletal and cardiac endpoints that suggest clinically relevant slowing of disease progression. CAP-1002 is a cell-based product with a mechanism that is immunomodulatory and anti-fibrotic. It’s been shown to regenerate skeletal along with cardiac muscle cells. The data are being presented at the World Muscle Society Virtual Congress. Capricor said it’s looking for a partner to help push CAP-1002 forward. Shares (NASDAQ:CAPR) were trading midday at $5.53, up 51 cents.

Astrazeneca, Merck eye untreated prostate cancer combination for Lynparza after phase III readout

Astrazeneca plc and Merck & Co. Inc. have data for a new indication for their blockbuster PARP inhibitor class drug Lynparza (olaparaib) 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 versus standard abiraterone care. This patient cohort included men either with or without homologous recombination repair gene mutations, who may have been treated with docetaxel at a previous stage of the disease.

After flicker, investor enthusiasm for Candel burns brighter

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 new biomarker 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.

HER2/neu efforts march forward in competitive field

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. In the crowded field of competitors working with HER2/neu-targeting assets, Roche Holding AG and Puma Biotechnology Inc. are the leaders. Among the other players, Greenwich Life Sciences Inc. is a strong emerging name.

Also in the news

Akeso, Alpha Cognition, Astex, Astrazeneca, Baxter, Capricor, Cytodyn, Everest Medicines, Geneuro, Glycomimetics, Innovent, Kintara, Kyowa Kirin, Merck, Moderna, Novavax, Onconova, Otsuka, Pharmather, Phoxbio, PTC, Quadrucept, RDIF, Regeneron, Reven, Roche, Roche, SAB, Scholar Rock, Sellas Life Sciences, Sensorion, Serum Institute of India, Strongbridge, TG, Twist, Underdog, Ventus, Viridian, Vtv, Xeris