The U.S. Food and Drug Administration issued a Complete Response Letter (CRL) to Merck for the company’s supplemental Biologics License Application for Keytruda (pembrolizumab) in high-risk early-stage triple-negative breast cancer.
Swiss drugmaker Novartis signed an initial agreement to provide manufacturing capacity for Pfizer and BioNTech’s Covid-19 vaccine, a move aimed at helping boost production as supplies fall shy of demand.
Findings from a Phase III long-term extension study show a once-daily therapy consisting of relugolix with estradiol and norethindrone acetate leads to clinically meaningful reductions in menstrual pain and non-menstrual pelvic pain over one year in women with endometriosis.
Merck KGaA’s drug development program suffered a setback with the company’s most important experimental medicine as the cancer treatment bintrafusp alfa, being jointly developed by GlaxoSmithKline, failed early in a lead trial.
Eli Lilly and Company and Precision BioSciences Inc. announced a research collaboration and exclusive license agreement to use Precision’s ARCUS genome editing platform to research and develop potential in vivo therapies for a series of genetic disorders.
Johnson & Johnson and the U.S. Department of Health and Human Services expanded an agreement to support the next phase of Covid-19 vaccine candidate research and development, the company said.
Moderna Inc. said an analysis of the early-stage data of the company’s experimental Covid-19 vaccine showed mRNA-1273 induced immune responses in older adults that were similar to younger participants.
U.K.-based Celleron Therapeutics signed a licensing agreement with Swiss pharma giant Roche for the worldwide rights to the cancer drug emactuzumab, a monoclonal antibody directed against colony-stimulating factor 1 (CSF-1R) expressed on macrophages.
Days after reports of Novavax Inc.’s experimental Covid-19 vaccine candidate producing antibodies in healthy patients in a clinical study, the company announced a license agreement with Serum Institute of India Private Limited (SIPL) to develop up to 1 billion doses of the preventative drug in India and other countries.
ARC Therapeutics launched with a $6 million financing led by founding investor Eshelman Ventures LLC.