A resubmitted Biologics License Application from California-based Portola Pharmaceuticals was recently deemed acceptable for review by the U.S. Food and Drug Administration and assigned an expected action due date of Feb. 2, 2018. Read More »
Having disputed portions of Novartis’ patent for Gilenya (fingolimod), an immunosuppressant used to treat MS, New York City-based Argentum Pharmaceuticals LLC successfully obtained a special petition from the U.S. Patent & Trademark Office (PTO) recently. Read More »
Diplomat Pharmacy Inc. recently announced that it will dispense opioid-overdose antidote naloxone without prescription to residents in Michigan via the company’s retail pharmacy at G-3320 Beecher Road in Flint. Read More »
Ionis Pharmaceuticals Inc. will retain all rights to inotersen and IONIS-FB-LRx. Read More »
The international market for insulin delivery devices remains highly competitive with at least six major producers currently dominating the trade, according to Transparency Market Research, which predicts continued growth over the next eight years. Read More »
The U.S. Food and Drug Administration advises consumers and health care professionals to not use any liquid drug or dietary supplement products manufactured by PharmaTech LLC of Davie, Florida, and labeled by Rugby Laboratories, Major Pharmaceuticals and Leader Brands. Read More »
Sweden’s research-oriented pharmaceutical firm Medivir AB's Investigational New Drug application for an osteoarthritis treatment has been accepted by, and is currently open with, the U.S. Food and Drug Administration. Read More »
Arcadia Biosciences Inc. and Bioceres S.A. have entered a joint venture titled Verdeca, and announced that the company’s safety evaluation for HB4 soybeans received a full review by the U.S. Food and Drug Administration. Read More »
Soligenix Inc., a late-stage biopharmaceutical company that creates rare-disease targeting products, recently announced that its good manufacturing practices-compliant bulk drug substance, RiVax, has received funding from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health. Read More »
Apollo Endosurgery Inc. recently announced an update and clarifications to a letter sent by the U.S. Food and Drug Administration to health care providers about potential risks with liquid-filled intragastric balloons. Read More »
Arcadia Biosciences Inc., an agricultural technology company, recently received FDA approval from the U.S. Food and Drug Administration for the use of its safflower oil in dog diets. Read More »
Regeneron Pharmaceuticals Inc. recently announced that a Phase 3 study evaluating suptavumab (REGN2222), an antibody to respiratory syncytial virus (RSV), failed to meet its primary endpoint. Read More »
Walgreens recently announced the launch of its Center for Health & Wellbeing Research, a website documenting roughly 50 outcomes from studies the company undertook in the past six years. Read More »
Naloxone, a nasal spray developed as an antidote for opioid overdose, will soon become available to Pennsylvania first responders thanks to support and outreach efforts sponsored by Philadelphia-based managed care provider AmeriHealth Caritas. Read More »
Amneal Pharmaceuticals, based in Bridgewater, New Jersey, has voluntarily recalled 13 lots of Lorazepam Oral Concentrate, USP 2mg/mL, Lorazepam Oral Concentrate, USP 2mg/mL — a product for which the accompanying dropper dispenser may be erroneously labeled. Read More »
Achieving U.S. Food and Drug Administration priority review status for its New Drug Application, Gilead Sciences Inc. recently made strides towards realizing an investigational, fixed-dose product combining several drugs to address HIV-1 infection. Read More »
Regional Cancer Care Associates (RCCA) recently announced its attainment of accreditation by URAC, a leading nonprofit health care benchmark group, as a Specialty Pharmacy in Hackensack, New Jersey. Read More »
Award-winning, Arizona-based Avella Specialty Pharmacy recently launched an e-commerce platform to simplify orders for compounded products — featuring user-friendly, secure web access and streamlining ophthalmologists’ online tasks. Read More »
Health care investment firm Ampersand Capital Partners recently divested its former portfolio firm Roadrunner Pharmacy in a deal transferring Roadrunner to Vets First Choice after five years of supported growth in revenue and EBITDA. Read More »
Express Scripts, one of the largest pharmacy benefit managers (PBMs) in the country, has announced the expansion of a pilot program that limits opioid prescriptions to seven days without prior authorization. Read More »
Alerts Sign-up
