Endo International plc has voluntarily opted to withdraw its Opana ER (oxymorphone hydrochloride extended release) product from the market after an FDA request in June, following a thorough review period and collaboration with the agency. Read More »
McKesson Pharmacy Systems recently unveiled two new features — Medication Synchronization and Mobile Delivery — serving its pharmacy management suite, which comprises EnterpriseRx, PharmacyRx and Pharmaserv systems. Read More »
Texas-based Maxor National Pharmacy Services LLC recently unveiled two on-site pharmacy shops for Unity Health Care's Parkside and Upper Cardozo Health Centers, both with physical locations serving the community in Washington, D.C. Read More »
Endo International PLC has finalized the divestiture of Litha Healthcare Group to Acino Pharma AG. Read More »
Arena Pharmaceutical Inc. has completed Phase 1 of its comparative bioavailability study on pharmacokinetic profile of extended release ralinepag in comparison to immediate release. Read More »
Meridian Bioscience Inc. released comments on a recent Food and Drug Administration Safety Notification concerning Magellan Diagnostics. Read More »
Baxter International Inc. and Tel Aviv University through Ramot have entered a new licensing agreement that will be assessing technologies that are being developed at the university and Tel Aviv Sourasky Medical Center. Read More »
KaloBios Pharmaceuticals Inc. of California, specializing in rare and neglected diseases, recently obtained FDA clearance for its oral anti-parasitic medication benznidazole designed to combat Chagas disease, a tropical malady transmitted to humans by insects. Read More »
Progressive women's health care company Agile Therapeutics Inc. of Princeton, New Jersey has resubmitted its Twirla hormonal contraceptive patch to the U.S. Food and Drug Administration for a New Drug Application. Read More »
Pfizer Inc. and Merck released positive data from two Phase 3 studies of ertugliflozin, an investigational oral GGLT-2 inhibitor that seeks to treat Type 2 diabetes patients by improving glycemic control. Read More »
Novo Nordisk is recalling insulin cartridge holders of the NovoPen Echo model, warning that they may crack if they are in the presence of chemicals, such as those found in cleaners. Read More »
Cardiome Pharma Corp. partner SteadyMed Ltd. has submitted a New Drug Application for Trevyent with the U.S. Food and Drug Administration. Read More »
Pediatric-onset hypophosphatasia, an extremely rare metabolic disease affecting bone structure and strength, came into sharper focus recently when Alexion Pharmaceuticals won funding for its Strensiq medication from two sources via a managed access agreement. Read More »
New Haven, Connecticut-based Biohaven Pharmaceutical Holding Company Ltd.’s BHV-5000 compound developed to treat Rett syndrome recently attained orphan drug designation from the U.S. Food and Drug Administration (FDA), its fourth product to achieve the status. Read More »
Two DelMar Pharmaceuticals Inc. executives recently accepted requests to join the National Brain Tumor Society's Research Roundtable, attending its premiere meeting in Washington, D.C. to consider ways research can improve clinical trials for regulatory approval. Read More »
A decade-long study of GSK’s Benlysta — the longest to date — recently culminated with indications of the drug’s safety and efficacy against active systemic lupus erythematosus, when administered with standard care. Read More »
Egalet Corp. of Pennsylvania recently obtained a complete response letter from the U.S. Food and Drug Administration about its Oxaydo tablets in 10 mg and 15 mg dosage strengths. Read More »
DelMar Pharmaceuticals recently presented a poster on dianhydrogalactitol at the Society for Neuro-Oncology's 4th Pediatric Neuro-Oncology Basic and Translational Research Conference, which took place at the Wyndham New Yorker Hotel in New York City in June. Read More »
Pfizer Inc. recently published noninferiority results from its study of Xeljanz, a twice-daily monotherapy to be used in combination with methotrexate in treating patients with moderate to severe rheumatoid arthritis. Read More »
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