Tag Archives: U.S. Food and Drug Administration

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 »

Trump’s Exec Order on drug pricing proves he’s like the leopard; he can’t change his spots

A draft of President Donald Trump’s executive order on drug prices lists several proposals to lessen regulatory hurdles for the pharmaceutical industry, reports The New York Times. Here are four things… Read more »

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 »