Tag Archives: U.S. Food and Drug Administration

Amgen, Allergan get nod for Avastin biosim; FDA’s Gottlieb making good on vow to hasten generic approvals, catch the EU.

The News: Amgen Inc. (Thousand Oaks CA) and Allergan PLC (Dublin IRL) said Thursday (September 14, 2017) that the Food and Drug Administration has approved their biosimilar version of Roche… Read more »

Slumbering giant Lilly to cut more jobs, take a $1.2-billion hit to bolster R&D pipeline.

The News: Eli Lilly & Co. (Indianapolis IN) last week said it would lay off about 8% of its employees as the drugmaker, which has suffered setbacks over the past… Read more »

Novartis CEO Jimenez is stepping down; does successor Narasimhan have the right stuff to take the reins in 2018?

The News: Swiss pharmaceuticals titan Novartis AG (Basel) will get a new chief executive in 2018–Dr. Vasant Narasimhan (pdf)–after Joseph Jimenez proclaimed his upcoming retirement effective in February. Jimenez has… Read more »

Novartis gets FDA nod for breakthrough leukemia treatment Kymriah; with a cost of $450,000, who’s going to get it?

The News: Novartis AG (Basel CHE) has obtained approval from the US Food and Drug Administration (FDA) for its Kymriah (tisagenlecleucel or CTL019) to treat children and young adults with… Read more »

Intra-Cellular shares zoom higher; is buying this name a gamble or a rational bet?

The News: Intra-Cellular Therapies Inc. (Nasdaq:ITCI) rocketed 41% over the past week to $15.70 on a positive regulatory update from the US Food and Drug Administration regarding its lumateperone treatment for schizophrenia…. Read more »

Alexion on a roll as Soliris gets label expansion in EU; although flying under the radar, analysts, investors still bullish.

The News: Alexion Pharmaceuticals Inc. (New Haven CT) got another shot in the arm this week with the EU approving its key revenue driver Soliris for an additional indication. EU approval… Read more »

Zynerba sinks twice as cannabis trials flop; strike three looms, so where’s the Ouija board?

The News: Zynerba Pharmaceuticals Inc. (ZYNE) lost more than half its value last week to $7.03 after the drug developer said its synthetic cannabis-based gel for epilepsy failed a mid-stage… Read more »

Endo coming out of the darkness into the light; contrarians, buy this name.

The News: Endo International Plc (Dublin IRL) on Tuesday (August 8, 2017) lowered its full-year revenue forecast, saying it expected lower sales of branded drugs to add to the pricing… Read more »

Teva stock crashes on 2Q earnings disaster; run for the hills, or buy at fire sale price?

The News: Teva Pharmaceutical Industries Ltd., which has been without a permanent CEO for six months, plunged $11.74, or 36% last week, to $20.60–the most in almost two decades. The… Read more »

FDA chief Gottlieb makes good on promise to increase drug price competition; will expedite review of generics

The Food and Drug Administration on Tuesday (June 27, 2017) moved to try to spur more competition in the market for generic drugs, an effort aimed at driving down prices. In… Read more »