Now that Pfizer Inc.-Biontech SE has submitted initial phase II/III study data to the FDA bolstering the case for an emergency use authorization (EUA) for its COVID-19 vaccine to children ages 5 through 11 years, the competition, including Moderna Inc., Novavax Inc. and Sanofi SA, falls further behind.
Cstone Pharmaceuticals Co. Ltd. released positive data from the phase III trial, Gemstone-302, of sugemalimab plus chemotherapy for the first-line treatment of patients with stage IV squamous and non-squamous non-small cell lung cancer.
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.
What one analyst characterized as “a little bit of an exotic or at least unusual statistical analysis on the phase II primary endpoint” may have dampened enthusiasm somewhat for Evelo Biosciences Inc.’s results in mild and moderate psoriasis with EDP-1815, but the firm is advancing the compound to registration studies.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Astex, Astrazeneca, Capricor, Glycomimetics, Innovent, Kyowa Kirin, Novavax, PTC, Reven, Roche, SAB, Sarepta, Scholar Rock, TG, Vtv.
Reports of increased alcohol use began early in the pandemic and, with many counseling services and physicians’ offices closed or more difficult to access, therapists worried that an increasing number of patients with substance use disorders would be unable to find effective treatment. In that gloomy setting, San Francisco-based Woebot Labs Inc. reported cheering news in the October issue of Drug and Alcohol Dependence.
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.
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.
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.
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