MYLAN N.V.: Initiates Voluntary Nationwide Recall of 15 Lots of Valsartan Tablets, USP, Amlodipine and Valsartan Tablets, USP, and Valsartan and Hydrochlorothiazide Tablets, USP

Mylan Initiates Voluntary Nationwide Recall of 15 Lots of Valsartan Tablets, USP, Amlodipine and Valsartan Tablets, USP, and Valsartan and Hydrochlorothiazide Tablets, USP, Due to the Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Found in the Active Pharmaceutical Ingredient Read More »

ARIXA PHARMACEUTICALS: Announces Publication of Seminal Paper Demonstrating First Oral Prodrug of Avibactam

Arixa Pharmaceuticals issued the following announcement on Nov. 12.Arixa Pharmaceuticals™, Inc., a company dedicated to developing oral antibiotics for drug-resistant Gram-negative infections, today announced publication of a paper describing the chemistry of its oral prodrug of avibactam, a previously intravenous (IV)-only beta lactamase inhibitor (BLI). Read More »

ACADIA PHARMACEUTICALS INC.: ACADIA Pharmaceuticals and Neuren Pharmaceuticals Announce Exclusive License Agreement for the North American Development and Commercialization of Trofinetide in Rett Syndrome

ACADIA Pharmaceuticals Inc. (NASDAQ: ACAD) and Neuren Pharmaceuticals Limited (ASX: NEU) announced today that they have entered into an exclusive North American License Agreement for the development and commercialization of trofinetide for Rett syndrome and other indications Read More »

PORTOLA PHARMACEUTICALS: U.S. Centers for Medicare and Medicaid Services (CMS) Grants New Technology Add-On Payment for Portola Pharmaceuticals’ Andexxa

Portola Pharmaceuticals, Inc.® (Nasdaq: PTLA) today announced that the U.S. Centers for Medicare and Medicaid Services (CMS) has granted a New Technology Add-on Payment (NTAP) for Andexxa® [coagulation factor Xa (recombinant), inactivated-zhzo], the first and only antidote approved by the U.S. Food and Drug Administration (FDA) for patients treated with rivaroxaban and apixaban, when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding. Read More »

ALLERGAN INC.: Allergan and Editas Medicine Announce Exercise of Options to Jointly Develop CRISPR Genome Editing Experimental Medicine EDIT-101

Allergan plc (NYSE: AGN), a leading global pharmaceutical company, and Editas Medicine, Inc. (NASDAQ: EDIT), a leading genome editing company, today announced that Allergan's wholly-owned subsidiary, Allergan Pharmaceuticals International Limited (Allergan), has exercised its option to develop and commercialize EDIT-101 globally for the treatment of LCA10 Read More »

HALOZYME THERAPEUTICS, INC: Phase 3 Study Of Subcutaneous Pertuzumab And Trastuzumab Initiated Using Halozyme's ENHANZE® Technology

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 »

ALLERGEN INC: Allergan Receives FDA Fast Track Designation for AGN-241751 for the Treatment of Major Depressive Disorder (MDD)

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 »