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January 28, 2019

Today's Rundown

Featured Story

FDA staff return to work, but threat of second shutdown looms

FDA staff are returning to paid work today after the longest government shutdown in U.S. history. But with temporary funding set to lapse Feb. 15 and President Donald Trump skeptical a deal can be reached, the agency may be plunged back into a shutdown in less than three weeks.

Top Stories

EMA staff lower flags at London office as Amsterdam move nears

Staff at the European Medicines Agency have lowered the flags outside their London offices as they prepare to move to Amsterdam. The flag lowering took place as the EMA “symbolically said goodbye” to the city it has called home since its creation in 1995.

Ex-Sanofi executive to head up translational medicine at LEO Pharma

LEO Pharma has hired Thomas Hultsch as its new head of translational medicine. Hultsch will build LEO Pharma’s presence in the U.S. and Europe, which includes overseeing the creation of a new translational medicine unit in Boston.

Alexion’s Soliris follow-up clears trial in aHUS, its second rare disease

Smarting from a patent defeat for cash cow Soliris in Europe, Alexion has dulled the pain with a phase 3 readout that sets up new filings for follow-up Ultomiris.

Preventing flu with an antibody-plus-Tamiflu universal vaccine

The flu virus' ability to rapidly mutate into vaccine-resistant strains has made the search for a universal vaccine all the more challenging. Researchers from the National Institutes of Health have found a new clue to providing broad-based protection against the flu—and it rests partly on Roche’s FDA-approved remedy Tamiflu.

Medtronic to buy EPIX and its RF-based cardiac ablation platform

Medtronic has moved to acquire EPIX Therapeutics and its catheter-based cardiac ablation system with plans to offer it alongside its own products and build out what the company describes as a “comprehensive suite of tools” for treating heart arrhythmias, including atrial fibrillation.

Enrollment Showcase

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Drexel University’s online graduate programs in biomedicine, clinical research, drug discovery, and molecular medicine were developed with working professionals in mind, providing you with the education, practical skills, and competitive edge you need to be successful in your career. Learn more.

Resources

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Share your thoughts on the life sciences industry's progress in improving study execution.

[Whitepaper] The 3DP Revolution: Planning Effective Brand Extension for In-Market Drugs

Get ahead of looming challenges in the market that include both generic products and new branded drugs.

[Infographic] Clinical Development Trends And The Impact On Clinical Trial Technology

New infographic shows trends in clinical development and the impact on randomization and trial supply management technology (RTSM).

[Webinar] Building the Business Case for Transformational RIM

Reduce the effort to create submissions and track registrations with a move to unified RIM. Watch the on-demand webinar.

[eBook] 2018 Weekly Compendium

The Biopharma industry is moving at lightning speed and it can be a challenge to keep pace. Here at Biotech Primer we spend hours each week researching, writing, and editing original content for the Biotech Primer WEEKLY with one goal in mind: to help everyone better understand the latest science and technology driving today’s healthcare industry.

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