Pharma News

Amgen announced that the U.S. Food and Drug Administration (FDA) has approved AMJEVITA™ (adalimumab-atto) across all eligible indications of the reference product, Humira® (adalimumab). AMJEVITA is the first adalimumab biosimilar approved by the FDA and has been approved for the treatment of seven inflammatory diseases, including moderate-to-severe rheumatoid arthritis, moderate-to-severe polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, moderate-to-severe chronic plaque psoriasis, adult moderate-to-severe Crohn's disease and moderate-to-severe ulcerative colitis. AMJEVITA is Amgen's first biosimilar to receive regulatory approval.

Allergan plc announced the company has received approval from the U.S. Food and Drug Administration (FDA) to market NATRELLE INSPIRA® Cohesive breast implants, offering women undergoing reconstruction, augmentation or revision surgery a new breast shaping option that combines a high gel fill ratio and Allergan's highly cohesive gel for a customized result. The new NATRELLE INSPIRA® Cohesive line of breast implants is the newest entry into the category of breast implants commonly referred to  as "gummy" implants, designed for women who are interested in increased breast fullness.

Allergan plc and Adamas Pharmaceuticals, Inc announced that all four dosage strengths of NAMZARIC® (memantine and donepezil hydrochlorides) extended-release capsules that allow patients on donepezil 10 mg to start directly on NAMZARIC are now available by prescription in pharmacies throughout the U.S. NAMZARIC is a once-daily, fixed-dose combination of memantine hydrochloride (a NMDA receptor antagonist) and donepezil hydrochloride (an acetylcholinesterase inhibitor, AChEI) for the treatment of moderate to severe Alzheimer's Disease in patients stabilized on 10 mg of donepezil hydrochloride once daily. NAMZARIC'S new indication and dosage strengths were approved by the U.S. Food and Drug Administration (FDA) in July 2016.

A study by scientists at The Scripps Research Institute (TSRI) has helped to de-mystify the molecular workings of the multiple sclerosis (MS) drug Tecfidera®. The drug is the most widely prescribed pill-based therapy for MS, but its biological mechanism remains mysterious.

The U.S. Food and Drug Administration  approved Amjevita (adalimumab-atto) as a biosimilar to Humira (adalimumab) for multiple inflammatory diseases.

Janssen Pharmaceuticals, Inc. (Janssen) announced the U.S. Food and Drug Administration (FDA) has approved INVOKAMET® XR—a once-daily, fixed-dose combination therapy of canagliflozin and metformin hydrochloride extended-release (XR)—for first-line use as an adjunct to diet and exercise to improve blood glucose control in adults with type 2 diabetes when treatment with the two medications is appropriate. INVOKAMET® XR combines INVOKANA® (canagliflozin), the most prescribed sodium glucose co-transporter 2 (SGLT2) inhibitor, with more than 9 million U.S. prescriptions since launch, and an XR formulation of metformin. Metformin is commonly prescribed as an initial therapy for the treatment of type 2 diabetes.

Takeda Pharmaceutical Company Limited and Affilogic jointly announced that the companies have entered into a research collaboration to explore using Affilogic’s proprietary Nanofitins platform in therapies targeting the central nervous system

H. Lundbeck A/S  announced the headline conclusions from the first clinical phase III study, STARSHINE, in the ongoing phase III programme evaluating the efficacy of the investigational drug idalopirdine for the symptomatic treatment of patients with mild to moderate Alzheimer's disease.