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September 15, 2017

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

Featured Story

FDA commissioner: We need to talk about drug development costs

New FDA Commissioner Scott Gottlieb wants to target drug development costs as yet another study asks how much it really costs to make a medicine.

Top Stories Of The Week

Alexion plots hundreds of layoffs, HQ move in sweeping corporate revamp

Following a sales fraud investigation that led to major executive changes, Alexion’s new management is rolling out its first corporate overhaul. The rare disease biotech on Tuesday announced a restructuring that includes cutting 20% of its staff and moving its headquarters to the Boston biopharma hub.

Regeneron and Sanofi bag breakthrough status for PD-1 latecomer

With five PD-1/PD-L1 inhibitors already on the market, new entrants are looking increasingly like the "me-too" brigade. But Regeneron and Sanofi have found a niche for their cemiplimab candidate—and snagged FDA breakthrough status to boot.

FDA slams Pfizer unit responsible for EpiPens that failed during fatal emergencies

Mylan last spring recalled tens of thousands of EpiPen injectors that had been manufactured by a Pfizer unit and were potentially faulty. It turns out the recalls came right after an FDA inspection at the Meridian Medical Technologies plant, where the FDA found it had been producing the pens even in the face of mounting evidence many were failing during life-and-death emergencies.

Fire ant venom inspires potential psoriasis treatment

Fire ants may be unwelcome guests at picnics, but their venom could prove useful in treating the common autoimmune disease psoriasis. Researchers at Emory and Case Western have developed two experimental compounds inspired by the fire ant that appear promising in treating the skin disorder, which causes painful thickening and rashes.

ESMO need-to-know: Keytruda misses head and neck; Tagrisso wins; plus Lilly, BMS and more

The European Society for Medical Oncology's annual Congress brought in a record 23,000 people for a research slate that included some truly late-breaking data, plus details from trials such as Keytruda's near miss in head and neck cancer. Here's your need-to-know.

Prevnar 13 among blockbusters industry watchers peg as tribal licensing candidates

Even as many on social media blasted Allergan’s licensing deal with the Saint Regis Mohawk Tribe, some industry watchers think the tactic is bound to spread. In the wake of the potentially game-changing patent transfer, Pfizer’s Prevnar 13 is one medical product that’s been pegged as a possible application for the patent protection strategy.

Insulin overdelivery risk prompts Medtronic to pull infusion sets

Medtronic is recalling specific lots of MiniMed infusion sets after learning of the risk of insulin overdelivery. The global, voluntary recall affects older insulin pump infusion sets that featured a vent membrane susceptible to blockage and consequently to overdelivery of insulin.

Xtandi's new Prosper trial win has Pfizer and Astellas eyeing a bigger market

After Johnson & Johnson’s Zytiga put up impressive prostate cancer data in June, Astellas and Pfizer needed a win for their rival medicine Xtandi. And now they have one. The drug was successful in Prosper, a key trial that could significantly expand Xtandi's market.

Clinical trial matching platform raises $11M backed by Merck’s tech fund

Many health tech firms are developing ways to help clinical trials recruit patients. Antidote, which develops a data-driven online platform to match patients with researchers, just raised $11 million in a financing round led by Merck Global Health Innovation Fund.

Resources

[Webinar] Five ways to make your patient support program a success

Join this webinar to learn how to design, deliver, and measure a successful patient support program. Presented by Nareda Mills, Ashfield's SVP of Patient Services in the US, you’ll discover how to improve adherence and improve patient outcomes using 5 key methods.

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