Category Archives: Pharmaceuticals

What’s wrong with Novartis? Actually nothing.

The News: Novartis AG (Basel CHE) has been the subject of widespread and lingering chatter to the effect that its stature among the Big Pharma league players has diminished, and… 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 »

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 »

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 »

Merck’s Keytruda gets chemo-combo approval for lung cancer; science, stars align for multi-billion medicine

The News: Merck & Co. announced Wednesday (May 10, 2017) that the FDA awarded accelerated approval to Keytruda (pembrolizumab), in combination with Eli Lilly & Co.’s chemotherapy regimen Alimta (pemetrexed)… Read more »

Why Aeterna Zentaris got crushed, and is there any positive takeaway?

The News: Aeterna Zentaris Inc. (Nasdaq: AEZS) plunged 73% to $0.89 last week after announcing that the ZoptEC Phase 3 clinical study of Zoptrex (zoptarelin doxorubicin) in women with locally advanced,… Read more »