BioSpace News Archive

The U.S. Food and Drug Administration (FDA) has granted Shire’s Biologics License Application (BLA) for lanadelumab (SHP643) priority review.

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) offered a negative opinion on Puma Biotechnology’s application for neratinib for breast cancer.

According to the National Science Foundation (NSF), approximately 42% of life science professionals with doctorate degrees work in academia.

The proverbial glass ceiling for women in biotech has some cracks but it may not yet have shattered – particularly in the Bay Area hotbed.

The passing of tax reform led most analysts to predict that 2018 will be a strong year for mergers and acquisitions.

Life science companies are popular targets for securities fraud litigation.

Teva Pharmaceuticals will close its offices in Washington, D.C. and New York City as part of the cost-cutting measures.

If approved, the drug is expected to become the first and only pharmacologic option in the U.S. indicated for treatment of neonates at risk for developing severe hyperbilirubinemia, or severe jaundice.

Puma Biotechnology announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a negative opinion, recommending the refusal of the Marketing Authorisation Application for neratinib for the extended adjuvant treatment of early stage HER2-positive breast cancer.

Getinge plans to launch advanced patient monitoring system and accompanying hemodynamic monitoring technology in the United States during the first quarter of 2018 for use with critically ill patients