Mylan N.V. (NASDAQ: MYL) today announced the U.S. launch of Rivastigmine Transdermal System, 4.6 mg/24 hrs, 9.5 mg/24 hrs and 13.3 mg/24 hrs, a generic version of Novartis' Exelon® Patch. Read More »

Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S Food and Drug Administration (FDA) has accepted and granted priority review for a new supplemental Biologics License Application (sBLA) seeking approval for KEYTRUDA, Merck’s anti-PD-1 therapy, as a treatment for previously treated patients with advanced hepatocellular carcinoma (HCC). Read More »

Halozyme Therapeutics, Inc. (NASDAQ: HALO) today announced that the U.S Food and Drug Administration (FDA) has accepted a Biologics License Application from Genentech, a member of the Roche Group, for a subcutaneous (SC) formulation of trastuzumab (Herceptin®) in its FDA-approved breast cancer indications.. Read More »

Results from an analysis of Bayer´s XANTUS programme were recently published in the Journal of the American College of Cardiology (JACC)(1). Read More »

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for Venclexta® (venetoclax), in combination with a hypomethylating agent or in combination with low dose cytarabine (LDAC), for treatment of people with previously untreated acute myeloid leukemia (AML) who are ineligible for intensive chemotherapy. Read More »

Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) and Pfizer Inc. (NYSE: PFE) today announced the U.S. Food and Drug Administration (FDA) approved a supplemental New Drug Application (sNDA) for XTANDI® (enzalutamide), following FDA Priority Review designation, based on results from the Phase 3 PROSPER trial. Read More »

AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, in cooperation with Neurocrine Biosciences, Inc. (NASDAQ: NBIX), announced that the U.S. Food and Drug Administration (FDA) approved ORILISSA™ (elagolix), the first and only oral gonadotropin-releasing hormone (GnRH) antagonist specifically developed for women with moderate to severe endometriosis pain. Read More »

Allergan plc (NYSE: AGN), a leading global pharmaceutical company, today announced the U.S. Food and Drug Administration has granted Fast Track designation for AGN-241751, an investigational new treatment for Major Depressive Disorder (MDD). AGN-241751 is a novel, oral, rapid-acting anti-depressant that recently entered Phase 2 development. Read More »

Pharmaceutical Care Management Association (PCMA) President and CEO Mark Merritt released the following statement on S. 2554, the Patient Right to Know Drug Prices Act, scheduled to be marked up tomorrow in the U.S. Senate Committee on Health, Education, Labor and Pensions (HELP): Read More »

Halozyme Therapeutics, Inc. (NASDAQ: HALO), a biotechnology company developing novel oncology and drug-delivery therapies, today announced that Genentech, a member of the Roche Group, has dosed the first patient in a Phase 3 study of a fixed-dose combination of pertuzumab (Perjeta®) and trastuzumab (Herceptin®) for subcutaneous administration using Halozyme's proprietary ENHANZE® drug-delivery technology in combination with chemotherapy. Read More »