News Releases
Novel Migraine Rx Comes to US
JERUSALEM--(BUSINESS WIRE)-- Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) today announced that ZECUITY®, the first and only patch system designed to provide relief from migraine, is now available by prescription through specialty pharmacies.
Positive Results for New Alzheimer's Rx
Today Biogen Idec (NASDAQ:BIIB) announced data from a pre-specified interim analysis of PRIME, the Phase 1b study of aducanumab (BIIB037), in which aducanumab demonstrated an acceptable safety profile and positive results on radiologic and clinical measurements in patients with prodromal or mild Alzheimer’s disease (AD). These data are being presented today at the 12th International Conference on Alzheimer's and Parkinson's Diseases and Related Neurological Disorders in Nice, France.
Top-Line Results for Fibromyalgia Rx
Pfizer Inc. (NYSE:PFE) announced today top-line results of a double-blind Phase 4 study evaluating the safety and efficacy of Lyrica® (pregabalin) Capsules CV in adolescents (ages 12-17 years) with fibromyalgia (FM).
Zogenix Receives FDA Approval of New Formulation of Zohydro(R) ER
Zogenix, Inc. (Nasdaq:ZGNX), a pharmaceutical company developing and commercializing products for the treatment of central nervous system (CNS) disorders, today announced that the U.S. Food and Drug Administration (FDA) has approved a new formulation of Zohydro® ER (hydrocodone bitartrate) Extended-Release Capsules, CII, with BeadTek™.
FDA Approves New Pills for Parkinson's
Impax Pharmaceuticals, a division of Impax Laboratories, Inc. (NASDAQ: IPXL), today announced that the U.S. Food and Drug Administration (FDA) approved RYTARY, an extended-release oral capsule formulation of carbidopa-levodopa, for the treatment of Parkinson's disease, post-encephalitic parkinsonism, and parkinsonism that may follow carbon monoxide intoxication and / or manganese intoxication.
NeuroDerm Parkinson's Rx Shows Promise
NeuroDerm Ltd. (NASDAQ: NDRM), a clinical-stage pharmaceutical company developing drugs for central nervous system (CNS) diseases, today announced that continuous, subcutaneous delivery of the company’s proprietary liquid levodopa/carbidopa (LD/CD) product candidates, ND0612H and ND0612L, led to clinically-significant plasma levodopa levels. These results suggest that the high dose version, ND0612H, intended for severe Parkinson’s disease patients, may provide an effective therapy alternative to current treatments requiring surgery.
Pfizer Initiates Phase 2 Study of PF-06252616 in Duchenne Muscular Dystrophy
Pfizer Inc. (NYSE:PFE) announced today enrollment of the first patient in a multicenter Phase II clinical trial of the investigational compound PF-06252616 in boys with Duchenne muscular dystrophy (DMD), a genetic disorder characterized by progressive muscle degeneration and weakness. PF-06252616 is an experimental, infused, anti-myostatin monoclonal antibody.
FDA Approves Injectable Wireless Device for Back and Leg Pain
Stimwave Technologies Incorporated, a medical device manufacturer and independent research institute headquartered in Miami Beach, Fla., has received FDA clearance to market the world’s first wireless, micro-technology neuromodulation device for relief of chronic back and leg pain.
Epilepsy Rx Recalled Due to Complaints of Empty Capsules
Dayton, NJ, Aurobindo Pharma USA is voluntarily recalling lot GESB14011-A of Gabapentin Capsules, USP 300 mg 100-count bottles to the consumer level. The product lot has been found to contain some empty capsules.
Results from Two Phase III Studies Added to U.S. Label of Genzyme’s Aubagio
Genzyme, a Sanofi company, announced today that the Food and Drug Administration (FDA) has approved the inclusion of efficacy and safety data from the TOWER and TOPIC studies of once-daily, oral Aubagio® (teriflunomide) in the product’s U.S. label.