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Amgen’s cancer drug Lumakras (sotorasib), developed to treat KRAS G12C-mutated tumors, has posted disappointing phase 1b study results when combined with other regimens. Read More
The FDA has found a small — but statistically significant — association between Guillain-Barre Syndrome (GBS) and Johnson & Johnson’s (J&J) COVID-19 vaccine, Ad26.COV2.S. Read More
In order to produce a high-quality lay summary, drug sponsors should adopt a four-step process: planning, development, translation and dissemination, the guidance recommends. Read More
In late September, HRSA sent similar letters to six pharmaceutical companies — AstraZeneca, Eli Lilly, Novartis, Novo Nordisk, Sanofi and United Therapeutics. Read More
The FDA’s Antimicrobial Drugs Advisory Committee gave Takeda’s investigational antiviral, maribavir, a unanimous thumbs-up yesterday in two 17-0 votes as a potential treatment for refractory human cytomegalovirus (HCMV) infections in post-transplant patients with or without genotypic resistance. Read More
Pfizer and BioNTech have filed for FDA authorization of their COVID-19 vaccine for inoculating children aged five to 11 years and the agency’s vaccine advisory panel will take up the matter at its previously scheduled meeting on Oct. 26 to consider the request. Read More
The White House continues to offer scant details on who its permanent pick to head the FDA might be, although Acting FDA Commissioner Janet Woodcock legally can only stay in that position through Nov. 15. Read More
The European Commission has published documentation outlining how to prepare, write, translate and disseminate lay summaries of clinical trial results, which are required by EU regulations in order to improve transparency. Read More
Norway and Sweden are advising men younger than age 30 and all people under 18 years old to avoid taking the Moderna COVID-19 vaccine because of its rare association with myocarditis and endocarditis. Read More
The companies are alleged to have paid each other — and other, unnamed companies — to manipulate price, supply and customer allocations between 2013-2015. Read More