Tag Archives: U.S. Food and Drug Administration

CAR-T Therapy: Personalized medicine with the promise of a cure; payers will decide who gets it

The News: Swiss drug giant Novartis AG has drawn widespread praise and a rising dose of controversy pertaining to its breakthrough CAR-T therapy CTL019. The medicine is under review to… Read more »

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 »

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 »

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 »

Glaxo dodges another Advair punch as second generic attempt crashes; Big Pharma’s plight highlights new world order for competition and innovation

The News: GlaxoSmithKline PLC is likely to escape generic competition to its blockbuster lung drug Advair in the US this year, after a second application for a cut-price equivalent form… Read more »

Senate confirms Gottlieb as FDA chief; former FDA tour, industry ties signal solid choice despite Dems’ jabs

The News: The US Senate voted 57 to 42 on Tuesday (May 9, 2017) to confirm Scott Gottlieb, MD, as Food and Drug Administration (FDA) Commissioner. Gottlieb, who was nominated by… Read more »

Novartis 1Q results remain insomnia cure; investors plead for something, anything to get excited about

The News: Novartis AG shares moved higher Tuesday (April 25, 2017) after the pharmaceuticals group clung to full-year earnings targets and barely beat analysts’ estimates for first-quarter earnings. The Swiss… Read more »