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…
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
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
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…
The passing of tax reform led most analysts to predict that 2018 will be a strong year for mergers and acquisitions. Source: BioSpace
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
According to the National Science Foundation (NSF), approximately 42% of life science professionals with doctorate degrees work in academia. Source: BioSpace
Pfizer Inc. (NYSE:PFE) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted positive opinions recommending that two Pfizer hematology…
Life science companies are popular targets for securities fraud litigation. Source: BioSpace
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. Source: BioSpace