FDA approves reduced dosing of Orfadin for HT-1 sufferers
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 receives Refusal to File letter for Inbrija
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's Victoza approved for new indication by FDA
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 to begin clinical study of Amplatzer device
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 »
Adamas gains FDA approval for Parkinson’s medication
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 »
Research shows benefits of adhering to diabetes medication
Express Scripts, a company that provides pharmacy benefit management services, recently announced research showing significant benefits of adherence to diabetes medications. Read More »
BioMarin's pegvaliase accepted for FDA priority review
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's Actemra receives approval from FDA to treat CRS patients
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 stocks flu shots, other vaccines for coming season
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 »
Reduction in antibiotic prescriptions in Massachusetts leads national trend
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 »
C. R. Bard wins FDA approval for Lutonix in renal patients
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 »
Wuxi Biologics to pay Ligand $2 million in licensing transfer
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 »
Alkermes depression drug placed on FDA's fast track
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 »
BIO praises president's signature of FDA Reauthorization Act
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 »
ASPEN and Baxter collaborate on 'Smart PN' education
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 »
FDA approves AstraZeneca and Merck's collaborative PARP inhibitor
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 »
Upsher-Smith updates website for epilepsy drug Qudexy XR
To promote its once-daily medication designed to address migraine headaches and seizures, Minnesota-based Upsher-Smith Laboratories recently launched its redesigned website for Qudexy XR (topiramate) extended-release capsules — along with a branded program allowing better product accessibility. Read More »
Phocus Rx program now used by 3 of top 5 U.S. hospital information systems
Grifols, a provider of plasma-derived medicines, recently announced that its noninvasive workflow management system, Phocus Rx, is now used by three of the top five U.S. hospital information systems (HIS). Read More »
Biologics selected as distributor for Pfizer's Besponsa
Biologics Inc., an oncology pharmacy services company under the McKesson Specialty Health umbrella, recently announced that Pfizer selected it to distribute Besponsa, a new IV therapy for adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia. Read More »
Duzallo gains FDA approval to treat patients with gout
The U.S. Food and Drug Administration has approved Ironwood Pharmaceuticals Inc.'s drug Duzallo, a once-daily oral treatment to fight hyperuricemia associated with gout in patients. Read More »
Alerts Sign-up