Trump offloading drug price battle to new FDA chief; Dr. Gottlieb’s ideas make a lot of sense






The News: New FDA Commissioner Dr. Scott Gottlieb comes into office immediately confronted by a host of tough challenges: from budget concerns, drug prices, staffing issues and a nationwide opioid… Read more »

Biogen spinoff Bioverativ buys Bristol-Myers’ iPierian spinout True North for $825 million; deal shows how to get several bites at the same assets






The News: Bioverativ Inc. (Waltham MA) announced that it entered into a definitive agreement to acquire True North Therapeutics Inc. (South San Francisco) for up to $825 million, including an… Read more »

CBO clears GOP health bill for Senate; only 23 million to lose coverage this version






The News: A bill to disassemble the Affordable Care Act that passed the House by a razor-thin margin earlier this month would leave 14 million more people uninsured next year than under… Read more »

Puma doubles on FDA panel’s nod for breast-cancer drug; but Swiss giant’s challenger lurks






The News: Puma Biotechnology Inc.’s (Los Angeles) experimental breast cancer drug reduces the risk of disease recurrence and should be approved, an advisory committee to the US Food and Drug… Read more »

Amgen’s osteoporosis med almost a home run in latest trial; fate now murky on heart safety






The News: Amgen Inc. (Thousand Oaks CA) and UCB SA (Brussels) no longer expect their experimental osteoporosis drug to win US approval this year after a higher rate of serious… Read more »

Abbvie’s biosimilar fight over Humira patent highlights differences between EU and US regulatory mindsets






The News: Coherus BioSciences Inc. (Redwood City CA) last week announced that the Patent Trial and Appeal Board (PTAB) of the US Patent and Trademark Office ruled in the company’s… Read more »

Surprise! GOP health bill never left the House






The News: The US House of Representatives will send its healthcare overhaul plan passed earlier this month to the Senate in a couple of weeks after it receives a final… Read more »

GlycoMimetics gets Breakthrough title; stock explodes but what’s next?






The News: GlycoMimetics Inc. (Rockville MD) soared Thursday (May 18, 2017), up 99% to $10.67. The unforeseen blastoff followed Tuesday (May 16, 2017) night’s announcement that the company’s clinical-stage acute… Read more »

Akebia surges on anemia drug deal; is a much bigger breakout looming?






The News: Akebia Therapeutics Inc. (Cambridge MA) leaped 18% Tuesday (May 16, 2017) sparked by news the fledgling dialysis treatment developer and Swiss backer Vifor Pharma Group Ltd. (Glattburg) agreed… Read more »

Senate health plan will either fine-tune Obamacare or set the clock back to 2008






Steve’s Take: Obamacare is a great, albeit imperfect, work-in-progress health program, destined to catch us up with the rest of the world where access to care is a right, not… Read more »