Prescribed Reading: A new era in pharma
A weekly guide to the goings-on in the biopharma industry.
Biopharma is a complex, rapidly evolving industry that is highly regulated and closely watched — and that means there is constant news. Here's a closer look at the clinical trials, M&A, cool science and regulations that are driving the industry this week.
In case you missed it
- Mallinckrodt pays up for Questcor monopoly
- Evotec creates new fibrotic disease company
- NIBR's Jay Bradner talks drug discovery
Mergers & analysis
While the J.P. Morgan Healthcare Conference last week ushered in the first few deals of the year, M&A activity has not picked up precipitously since. Eli Lilly inked a deal worth almost $1 billion to pick up migraine treatment developer CoLucid. Though most investors are focused on the company's oncology and diabetes franchises, it is trying to strengthen its presence in neuroscience.
While deals are light right now, expect the coming weeks to show how the rest of 2017 could pan out. It's inauguration day and the first 100 days of the new administration's time in office will hopefully reveal more details about President-elect Donald Trump's position on drug pricing and healthcare in general.
In the mean time, earnings season kicks off next week with Johnson & Johnson leading the pack as usual. The company often acts as a bellwether for the industry as a whole. Check out BioPharma Dive here for a closer look at what to expect from the companies that report full-year earnings next week.
AstraZeneca is angling for a stronger position in immuno-oncology. The British pharma announced earlier this week the redesign of its Phase 3 MYSTIC trial, in an effort to show the strength of its durvalumab combo. AstraZeneca has fallen woefully behind competitors Merck & Co. and Bristol-Myers Squibb.
On that same front, Bristol-Myers announced Thursday night that it would not pursue an accelerated timeline for its combination of Opdivo (nivolumab) and Yervoy (ipilimumab) in the first-line setting of non-small cell lung cancer (NSCLC), an indication that Merck's Keytruda (pembrolizumab) already holds, setting back the company again.
Meanwhile, small biotech Alcobra lost more than half of its value when it announced a late-stage failure for its ADHD medication MDX. The drug failed in a mid-stage study in Fragile X syndrome in 2015.
Robert Califf ended his very short tenure as commissioner of the Food and Drug Administration today, but not before getting in a slew of last-minute guidelines. The FDA dropped guidance on biosimilar interchangeability, as well as naming conventions for the copycat biologics, this week, and topped off Califf's reign with directions for the industry on off-label marketing communications.
Donald Trump has yet to name a replacement for Califf and there has already been plenty of resistance to some of the names that have been floating around as his potential picks.
Meanwhile, Trump's nominee to lead the Department of Health and Human Services (HHS) Rep. Tom Price has stirred up worry about ethical conduct regarding his investment positions. Price has been a strong critic of the Affordable Care Act and people expect him to lead the charge in dismantling President Obama's landmark healthcare law.
On the other hand, current NIH Director Francis Collins has been left in his position . . . at least for now. Collins, who was appointed in 2009 by President Obama, has been campaigning to keep his job at the research organization.
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