Tag Archives: Endpoints

Patients lose, lawyers win, as AbbVie does deal with Amgen to delay Humira biosim.

The News: Amgen Inc. (Thousand Oaks CA) has agreed to delay the US launch of its FDA-approved biosimilar version of AbbVie Inc.’s (North Chicago) Humira (adalimumab) until 2023, under a… Read more »

Zai Lab’s U.S. IPO marks another white-hot Chinese offering that begs the question: why are these Asian offerings so special?

The News: Shang­hai-based biotech Zai Lab Ltd. raised $150 mil­lion from its up­sized IPO last Wednes­day (September 20, 2017), sell­ing 8.3 mil­lion shares at $18 each. After trad­ing began, the… 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 »

Merck’s Frazier leads the way quitting Trump business council after Charlottesville; J&J’s Gorsky’s bail way too late.

The News: One day after J&J chief exec Alex Gorsky pub­licly com­mit­ted to stay­ing on Pres­i­dent Don­ald Trump’s man­u­fac­tur­ing coun­cil, he abruptly re­versed course–just as the sud­den mass departure of ex­ec­u­tives forced… 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 »

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 »