The Wall Street Journal has caught up with the Genervon controversy, recapping a series of events from the last few days that followed the big social media campaign to gain an instant approval for a new ALS drug based on the results of a 12-patient study. FierceBiotech readers will know already that the data were questioned by Steve Perrin, president and chief scientific officer of the ALS Therapy Development Institute, and that the FDA followed up a day later with an extraordinary challenge to Genervon to publish the data on a drug that the biotech has touted as a major advance for patients.
Genervon CEO Winston Ko has repeatedly prodded a desperate ALS patient population and their families to demand that the FDA provide an accelerated approval to allow sales of its controversial drug based on the data from 8 patients in one tiny study.
Thanks to deals signed on Monday alone, another $17 billion is set to change hands in the hyperacquisitive drug business, a single-day record that closes out a bracing quarter for buyouts. But with industry titans paying ever-higher prices for a shrinking number of assets, how long can the good times roll?
The big question of the day is whether the unprecedented bull market we've been seeing generate billions of dollars for biotech is sustainable or has transformed into a fragile bubble ready to pop. And we decided to put that question to our audience of subscribers, looking for a revealing snapshot of what the industry is thinking today.
Biogen Idec's decision to replace a group of 20 R&D staffers in chemistry and neurology wasn't the first internal staffing adjustment at the biotech trendsetter. Biogen Idec axed about 21 staffers last fall in a reorganization of clinical operations, R&D quality and compliance, according to sources close to the terminations. That move back in September/October was the first of two rounds of group firings in a quiet internal reorganization, raising concerns that more such department restructuring lies ahead.
Well over 300 responses have been gathered so far, which is not a bad beginning for our first survey.
A period of intense Big Pharma turmoil has failed to create a new normal that can offer investigators greater confidence that they'll be able to keep their jobs. And the disruption is continuing with a new wave of restructuring every bit as traumatic as the first tsunami of makeovers.
Even after the past two years of deals, AbbVie's decision to pay $21 billion for Pharmacyclics, bagging half interest in the blockbuster cancer drug Imbruvica, managed to get jaws to drop among even the most jaded biotech analysts.
Welcome to FierceBiotech Radio, a podcast in which we'll chat with industry experts, newsmakers and veterans on issues affecting the business of biopharma. The idea is to replicate the off-the-cuff encounters normally confined to insidery confabs, avoiding the dullness of hyperscripted earnings calls and technical webinars.
High-profile investment guru Neil Woodford has rolled out his $300 million investment vehicle in the U.K., looking to attract a host of small investors behind a publicly traded trust that has big plans for investing in a new wave of small biotechs.