Pfizer Inc. announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted positive opinions recommending that two Pfizer hematology medicines be granted marketing authorizations in the European Union.
A European Medicines Agency panel recommended against approving Puma Biotechnology’s lead breast cancer drug, an outcome the U.S drugmaker signaled in January 2018.
AstraZeneca and Merck announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion, recommending a marketing authorization of Lynparza (olaparib) tablets (300 mg twice daily) for use as a maintenance therapy for patients with platinum-sensitive relapsed high grade, epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete response or partial response to platinum-based chemotherapy.
Shire plc announced the U.S. Food and Drug Administration accepted the Biologics License Application and granted priority review for lanadelumab (SHP643).
Beacon Healthcare Communications named Amy Whitcomb as Director of Multi-Channel Marketing in response to growing client needs for integrated multi-channel marketing solutions to drive brand campaign performance.
Compared to inactive people, recreational soccer players have lower cholesterol, blood pressure and resting heart rates as well as less fat mass, a research review suggests.
Novartis is eying a possible 2019 launch for RTH258 (brolucizumab), an ophthalmology drug for the treatment of neovascular age-related macular degeneration. The Swiss-based company is planning to seek regulatory approval of the drug during 2018.
Shares of Regeneron Pharmaceuticals fell slightly in after-hours trading Wednesday following reports by providing doctors of increased observations of known side effects from the blockbuster drug Eylea.
Kite Pharma, a Gilead company, inked a worldwide collaboration deal with Sangamo Therapeutics to develop oncology therapeutics.
Five months after Janssen ended a multi-billion dollar development deal with Achillion Pharmaceuticals for the hepatitis C treatment combination JNJ-4178, the Connecticut-based company is slashing staff and initiating an operational restructuring plan.