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July 06, 2018

Welcome to FierceLifeSci Weekly Digest, your roundup of the biggest and most popular stories from each of our publications.

Featured Story

Mylan plant slapped with 32-page FDA Form 483

When Mylan recently announced 500 layoffs at its plant in West Virginia, it said the cuts were “consistent to discussions it was having with the FDA.” What it didn’t say was those discussions included problems the FDA uncovered during a five-week-long inspection of the massive plant.

Top Stories Of The Week

Novartis dumps Aveo drug as relationship sours

Novartis has walked away from Aveo Pharmaceuticals’ AV-380 three years after paying $15 million (€13 million) upfront for the asset. The action cuts short a relationship that was starting to sour amid the slow progress of the treatment for severe, cancer-related weight loss. 

Jefferies says Gilead is poised for turnaround—and JAK inhibitor could be key

Gilead Sciences is eagerly awaiting phase 3 data for its rheumatoid arthritis drug filgotinib due in the next few weeks that could be an antidote for the biotech’s hepatitis C hangover.

Pfizer raises prices on 100 drugs, its second round of hikes this year: FT

President Trump may think top drugmakers are ready to step up with price cuts, but Pfizer, for one, is going the other way instead. The pharma giant hiked prices on 100 drugs, including one of its biggest sellers, as of July 1, the Financial Times reports.

Amgen, Novartis 'overwhelmed' by early interest in migraine drug Aimovig: expert

Amgen and Novartis’ Aimovig, first in its new class of migraine drugs, hit the scene in May. And patients were ready for it: so much so that its makers are now overwhelmed in trying to meet initial interest, according to one analyst.

The old diabetes drug metformin may find yet another role: reversing lung fibrosis

The drug metformin has been used to control blood sugar in many patients with Type 2 diabetes for more than two decades. Now scientists at the University of Alabama, Birmingham, have amassed evidence that the drug’s ability to target cell metabolism could help repair the lung.

Novo Nordisk trumpets more Januvia-topping data for oral semaglutide

Just eight days after posting a trial win over Merck diabetes stalwart Januvia, Novo Nordisk candidate semaglutide is back with another.

Neuronetics goes public with $93.5M IPO following several VC rounds

Shares of Neuronetics have begun trading on the Nasdaq following a $93.5 million IPO this week, which priced 5.5 million shares of common stock at $17 each, under the ticker symbol STIM. As of Friday morning, shares were up 63% to $27.78.

German CRO Proinnovera establishes U.S. foothold in North Carolina

The German dermatology CRO Proinnovera has opened a new U.S. base of operations through a wholly owned subsidiary based in Wilmington, North Carolina.

First clinical MERS vaccine by Inovio and GeneOne shows promise

Inovio and GeneOne Life Science’s MERS vaccine, which is receiving financial support from the International Vaccine Institute and the Coalition for Epidemic Preparedness Innovations, elicited high levels of antibodies and T-cell responses in a phase 1 study.

Enrollment Showcase

SBMI Now Offering an Online Graduate Program in Bioinformatics

UTHealth SBMI now offers a M.S. track in clinical and translational bioinformatics.

Resources

[Survey] 2018 eClinical Technology Solutions Survey

Take this anonymous 10-minute survey to share your thoughts on leading eClinical technology solutions and earn up to $55 honoraria. Take the survey now!

[Whitepaper] Is the pharma business model ready for precision medicine?

Blue Latitude Health explores the commercial barriers and new stakeholder connections for pharma companies developing precision medicines, and reveals how to grasp novel opportunities in the new era of healthcare.

[Whitepaper] Getting to First-in-Human Clinical Trials: A Make-or-Break Milestone for Small Biopharmas

“Faster and better” has become the mantra for biopharmaceutical companies as they face intense pressure to get therapies to market faster. Quickly proving efficacy in first-in-human (FIH) trials is a make-or-break milestone for these cash-strapped companies whose hopes hinge upon one or two molecules. Read how CDMOs are responding to this pressure.

[Whitepaper] Digitizing the Global Life Sciences Supply Chain: The Critical Role of Digital Transaction Management

Life science companies are experiencing a significant transformation in how they bring new products to market.

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