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 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 »

Theravance Biopharma, Inc. (NASDAQ: TBPH) ("Theravance Biopharma" or the "Company") announced the sale of its proprietary antibiotic, VIBATIV® (telavancin), to Cumberland Pharmaceuticals, Inc. Read More »

New safes for controlled substances will help combat opioid epidemic, reduce robbery incidents. All 228 CVS Pharmacy locations in Maryland area now using time-delay safe technology. Read More »

Researchers from the University of Central Florida recently received a $400,000 grant from the Juvenile Diabetes Research Foundation, which they will use to create a tube that resists infection and encapsulation and is inserted under the skin for the delivery of insulin via a pump. Read More »

The Pharmaceutical Care Management Association (PCMA) released the following statement on President Trump signing into law S. 2553/ S. 2554, the Know the Lowest Price Act of 2018 and the Patient Right to Know Drug Prices Act. Read More »

For the remainder of 2018, Astellas will not increase any of the company’s drug prices in the United States. Read More »

Upsher-Smith Laboratories, LLC (Upsher-Smith) today announced that it has added another product to its growing generic portfolio, supporting its commitment to expanding and diversifying its product offerings. Read More »

Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) announced today that the U.S. Food and Drug Administration (FDA) has approved GRANIX® (tbo-filgrastim) Injection for a new vial presentation and indication in pediatric patients 1 month and older. Read More »

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, 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 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 »

Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) announced today that the U.S. Food and Drug Administration (FDA) has approved GRANIX® (tbo-filgrastim) Injection for a new vial presentation and indication in pediatric patients 1 month and older. 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 »

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 »

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 »

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 »

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 »

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 »

Seattle Genetics, Inc. (Nasdaq:SGEN) and Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") today announced completion of enrollment for the enfortumab vedotin EV-201 pivotal phase 2 clinical trial cohort of patients with locally advanced or metastatic urothelial cancer who have been previously treated with both platinum chemotherapy and a checkpoint inhibitor (PD-L1 or PD-1). Read More »