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 agenda, pandemic concerns and the potential for what could be life-altering innovations. The Senate Health, Education, Labor and Pensions (HELP) Committee today voted 15-6 to favorably report Monica Bertagnolli’s nomination to the full Senate for a confirmation vote as the next NIH director. The no votes came from a handful of Republican senators and HELP Chair Bernie Sanders (I-Vt.), who had indicated late yesterday that he wouldn’t support Bertagnolli’s confirmation because he didn’t think “she is prepared to take on the greed and power of the drug companies and health care industry and fight for the transformative changes the NIH needs at this critical moment.”

ESMO 2023: Latest advances in gynecological cancer 

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. The clinical trials all described new therapeutic scenarios for these patients, preventing relapses and increasing survival. Cervical cancer is in many cases associated with a lesion or mutations caused by human papillomavirus infection. It is usually asymptomatic in the early stages or causes vaginal bleeding and pelvic pain as the disease develops.

BMS pays $350M up front for rights to Lianbio’s heart drug Camzyos in Asia

American pharma giant Bristol Myers Squibb Co. (BMS) will pick up the rights to Lianbio Co. Ltd.’s FDA-approved drug for obstructive hypertrophic cardiomyopathy (HCM), Camzyos (mavacamten), in six Asian countries by paying $350 million up front and waiving some outstanding payments. News of the buyout sent shares of Shanghai- and New Jersey-based Lianbio (NASDAQ:LIAN) soaring 117%, closing at $3.02 on Oct. 24. Mavacamten (MYK-581), sold as Camzyos in the U.S., is a cardiac myosin inhibitor for obstructive HCM, a heart condition characterized by thickening of the heart muscle.

More cuts at Amgen, following close of Horizon buyout

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.

Biomarin has challengers for treating rare, genetic achondroplasia

Five 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 Voxzogo (vosoritide) from Biomarin on Oct. 20. The approval expanded the company’s 2021 NDA, which was for children ages 5 and older, to include children of all ages with open growth plates. There are more than 10,000 children in the U.S. who meet the criteria and about 25% of them have open growth plates. The other companies developing treatments for the rare disease are Abbisko Therapeutics Co. Ltd., Bridgebio Pharma Inc., Tyra Biosciences Inc., Ascendis Pharma A/S and Ribomic Inc.

Peeling back the mysteries of nature: US-Israeli biotech progresses tree toxin in phase I

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.

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