Mylan Defeats Allergan's Maneuver to Rent Tribal Sovereign Immunity to Avoid Restasis® Patent Cha…
U.S. Patent Trial and Appeal Board denies St. Regis Mohawk Tribe's motion to terminate Restasis patent challenge. Source: BioSpace
TrueCare Biomedix Cited for Slew of Procedural Problems
The FDA slapped TrueCare Biomedix with a Form 483 for numerous procedural issues and violations observed during a November inspection of its facility in Gujarat, India. Source: Drug Industry Daily
FDA Releases Finalized Q&A Guidance on Choosing Chemical Drug Starting Materials
The FDA finalized a Q&A guidance clarifying the International Council for Harmonization’s November 2012 Q11 guidance on development and manufacture of drug substances — giving recommendations for information that should…
Ex-Horizon Exec Claims Firing Was Retaliation for Whistleblowing at Previous Job
A former Horizon Pharma senior director sued the drugmaker, claiming she was fired for raising concerns about off-label drug promotion at a previous employer. Source: Drug Industry Daily
CHMP Recommends Five Drugs, Including First Medicine for Neonatal Diabetes
The EMA’s Committee for Medicinal Products for Human Use recommended five medicines for European Commission approval and six extended indications at its meeting this month. Source: Drug Industry Daily
EMA Recommends Short Physical Performance Battery for Assessing Frailty
The European Medicines Agency published a reflection paper on assessing the frailty of elderly patients in clinical trials, recommending the Short Physical Performance Battery assessment for its prognostic value and…
Tax Reform Could Lead to Spike in Biopharma M&A Activity
The passing of tax reform led most analysts to predict that 2018 will be a strong year for mergers and acquisitions. Source: BioSpace
Women in Biotech Underrepresented on Boards of Directors Across the Bay Area
The proverbial glass ceiling for women in biotech has some cracks but it may not yet have shattered – particularly in the Bay Area hotbed. Source: BioSpace
3 Resume Tweaks to Help Scientists Get a Job in the Private Sector
According to the National Science Foundation (NSF), approximately 42% of life science professionals with doctorate degrees work in academia. Source: BioSpace
Teva's Shrinking U.S. Footprint
Teva Pharmaceuticals will close its offices in Washington, D.C. and New York City as part of the cost-cutting measures. Source: BioSpace
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