After nearly two years with an unconfirmed acting director at its helm, the U.S. NIH is one step closer to finally having Senate-confirmed leadership to steer the agency in a time pressed with political agendas, pandemic concerns and the potential for what could be life-altering innovations. The Senate Health, Education, Labor and Pensions (HELP) Committee voted 15-6 Oct. 25 to favorably report Monica Bertagnolli’s nomination to the full Senate for a confirmation vote as the next NIH director. Read More
American pharma giant Bristol Myers Squibb Co. (BMS) will pick up the rights to Lianbio Co. Ltd.’s FDA-approved drug for obstructive hypertrophic cardiomyopath, Camzyos (mavacamten), in six Asian countries by paying $350 million up front and waiving some outstanding payments. Read More
The Congress of the European Society of Medical Oncology (ESMO) held in Madrid from Oct. 20 to 24, 2023, could well add the letter W to its acronym after the four sessions on gynecological cancer that could represent a milestone in the lives of all women who suffer from cervical, ovarian, or endometrial cancer. Read More
More layoffs are coming at Amgen Inc., which said it plans to cut about 350 positions from newly acquired Horizon Therapeutics plc. The announcement marks the company’s third round of cutbacks for 2023, following 300 employees in January and another 450 in March, and comes a few weeks after closing on the $27.8 billion buyout. Read More
Four other companies want to replicate Biomarin Pharmaceuticals Inc.’s recent success as they seek approvals to treat the rare but most prevalent genetic form of dwarfism, achondroplasia. The U.S. FDA approved the sNDA for injectable Voxzogo (vosoritide), fibroblast growth factor receptor 3 (FGFR3) inhibitor from Biomarin on Oct. 20. Read More
Peel Therapeutics believes evolutionary biology holds the key to developing new therapeutics for cancer and inflammation, a relatively unique approach in the world of biotech, but one that is bearing fruit: Its lead molecule is derived from camptothecin, a compound originating from the Chinese Happy Tree that is thought to have evolved as a plant defense mechanism, and it has progressed to a phase I dose escalation study in patients with advanced solid tumors. Read More
Bioxcel Therapeutics Inc. said a third-party audit of data from its Tranquility II phase III study came back clean, potentially positioning the firm to submit the statistically significant results in a supplemental NDA seeking approval of BXCL-501 in treating agitation associated with dementia in probable Alzheimer’s disease. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Alphanavi, Appili, Humanetics, Immutep, Myneo, Sumitomo. Read More
