Novartis recently announced that the U.S. Food and Drug Administration (FDA) approved Kymriah suspension for intravenous infusion for the treatment of patients up to 25 years of age with B-cell precursor acute lymphoblastic leukemia (ALL) that is refractory or in second or later relapse. Read More »

Merck and researchers from the Clinical Trial Service Unit at the University of Oxford recently announced positive results for the REVEAL Study. Read More »

Coherus BioSciences Inc. of Redwood City, California recently announced initial results from several current clinical pharmacokinetic bioequivalence (PK/BE) studies comparing two products, both developed for the purpose of addressing certain chronic arthritic and skin conditions. Read More »

Endo International plc of Dublin, Ireland recently launched shipping operations for its generic Sabril (vigabatrin for oral solution USP, 500 mg) product via Par Pharmaceutical, following final approval of its Abbreviated New Drug Application (ANDA). Read More »

Orfadin, a drug used to treat a condition causing kidney and liver damage, has now received the FDA’s go-ahead for once-a-day use, cutting its dosing frequency in half. Read More »

Accorda Therapeutics Inc. recently announced that the U.S. Food and Drug Administration (FDA) provided a Refusal to File (RTF) letter regarding the company’s New Drug Application (NDA) for Inbrija, an investigational treatment for symptoms of OFF periods in people with Parkinson’s disease taking a carbidopa/levodopa regimen. Read More »

Novo Nordisk recently announced that the U.S. Food and Drug Administration approved a new indication for Victoza, which should help reduce the risk of major adverse cardiovascular (CV) events, heart attack, stroke and CV death, in adults with type 2 diabetes and established CV disease. Read More »

Abbott recently announced the initiation of a pivotal clinical study based in the United States that will assess the safety and efficacy of a modified version of its Amplatzer device. Read More »

With the goal of treating dyskinesia in certain Parkinson’s disease patients, Adamas Pharmaceuticals of Emeryville, California recently obtained U.S. Food and Drug Administration approval for its Gocovri (amantadine) extended release capsules. Read More »

Express Scripts, a company that provides pharmacy benefit management services, recently announced research showing significant benefits of adherence to diabetes medications. Read More »

BioMarin Pharmaceuticals' Biologics License Application (BLA) for pegvaliase, a PEGylated recombinant phenylalanine ammonia lyase enzyme product, has been accepted for Priority Review by the U.S. Food and Drug Administration. Read More »

Genentech, a member of the Roche Group, recently announced that its drug Actemra received approval from the U.S. Food and Drug Administration (FDA). Read More »

Albertsons Cos. plans on continued care for its customers as flu season approaches, reporting from its Boise, Idaho base that influenza vaccines are now in stock. Read More »

Newly compiled data from the Blue Cross Blue Shield Association indicates that the nation — particularly the state of Massachusetts — has substantially lowered the number of outpatient prescriptions for antibiotics, association sources announced recently from Boston. Read More »

Murray Hill, New Jersey-based surgical product producer and marketer C. R. Bard recently obtained premarket approval (PMA) from the U.S. Food and Drug Administration (FDA) for its Lutonix 035 drug coated balloon PTA catheter (DCB). Read More »

Drug developer Ligand Pharmaceuticals Inc. (LGND) of San Diego, California will receive $2 million plus royalties and other benefits from WuXi Biologics in a new licensing agreement involving an antibody technology, company officials announced recently. Read More »

Soliciting marketing approval for a medication addressing major depressive disorder, Alkermes PLC recently began a rolling submission of a New Drug Application regarding its ALKS 5461 product, expecting completion by the end of 2017. Read More »

Following President Donald Trump’s recent signing of the Food and Drug Administration Reauthorization Act, Biotechnology Innovation Organization officials released a statement of support celebrating the legislation reauthorizing prescription drug user fees. Read More »

The American Society for Parenteral and Enteral Nutrition (ASPEN) and Baxter International Inc. recently announced a comprehensive collaborative program entitled “Smart PN” that will provide healthcare professionals with educational tools for parenteral nutrition (PN) therapy. Read More »

AstraZeneca and Merck & Co. Inc. recently announced that their collaborative PARP inhibitor, Lynparza, received approval from the U.S. Food and Drug Administration (FDA). Read More »