Tag Archives: Endpoints

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 »

Kite submits IND for CAR-T multiple myeloma treatment; Novartis keeping wary eye on rival’s latest move in high-stakes race.

The News: Kite Pharma Inc. (Santa Monica CA) said it has submitted to the FDA an Investigational New Drug (IND) application to launch a Phase 1, first-in-human trial of a… Read more »

Public craves coverage of Shkreli’s trial for securities fraud; have we lost our senses entirely?

The News: Martin Shkreli is on trial in Federal District Court in Brooklyn, accused of eight counts of securities and wire fraud from his time running two hedge funds and… 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 »

Merck’s Keytruda aces another cancer trial as results dazzle researchers

The News: Hot on the heels of the final presentation at ASCO’s 4-day conference in Chicago, a small, new study is causing jaws to drop after it found that a… Read more »

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 »

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 »

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 »