Recommendation of Approval for the Merz Botulinum Neurotoxin Typ A in European Countries
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- Category: Product
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) in London recommended the approval of the Merz- developed product Botulinum neurotoxin Type A. Merz is expecting approval in ten European countries within the next few months. The company already received approval in Denmark and Sweden.
The U.S. Launch of Neupro® for the Treatment of Early-Stage Parkinson's Disease
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- Category: Product
UCB and SCHWARZ PHARMA announced today that Neupro® (Rotigotine Transdermal System), a new once-daily transdermal dopamine agonist approved for the treatment of the signs and symptoms of early-stage idiopathic Parkinson's disease, is now commercially available in retail pharmacies throughout the United States. Neupro® will be co-promoted by UCB and SCHWARZ PHARMA. These companies have dedicated sales forces that will immediately begin reaching out to physicians who treat Parkinson's disease nationwide.
Novartis Completes Divestment of Medical Nutrition Business
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- Category: Novartis
Novartis has completed the sale of its Medical Nutrition business to Nestlé for USD 2.5 billion, one of the final steps in a divestment program to focus the Group's strategy on healthcare with pharmaceuticals at the core.
Sandoz Receives Positive EU Opinion for Approval of epoetin alfa biosimilar
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- Category: Novartis
Sandoz is the first company to receive a positive opinion from European Union regulators supporting the approval of a biosimilar version of epoetin alfa, achieving another important milestone in its efforts to bring follow-on biological medicines to patients.
More than 250,000 patients in Europe are estimated to be treated with epoetin alfa, which is marketed under various brand names, and similar medicines to regulate the formation of red blood cells. Worldwide annual sales are estimated at more than USD 7 billion, including USD 600 million in Europe.
Merck Provides Update on Status of Supplemental Biologics License Applications (sBLA) for GARDASIL®
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- Category: Merck
Merck & Co., Inc. announced today that the Food and Drug Administration (FDA) has accepted for standard review a supplemental Biologics License Application (sBLA) for GARDASIL [Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine]. The sBLA includes data on protection against vaginal and vulvar cancer caused by HPV types 16 and 18 and data on immune memory. Under the Prescription Drug User Fee Act (PDUFA), for standard sBLAs filed in 2007, the FDA's goal is to review and act on 90 percent of sBLAs within 10 months of receipt. Merck anticipates action by the FDA in the first quarter of 2008.
UK Body Recommends Pfizer's Champix (varenicline) for Smokers
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- Category: Pfizer
Pfizer Inc announced today that the National Institute for Health and Clinical Excellence (NICE) in the United Kingdom has recommended Champix (varenicline) for use on the National Health Service for adult smokers who have expressed a desire to quit. This gives smokers across England, Wales and Northern Ireland access to another important treatment option to help them quit smoking.
JANUVIA Approved in the European Union for the Treatment of Type 2 Diabetes
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- Category: Merck
JANUVIA™ (sitagliptin1), Merck & Co., Inc.'s once-a-day oral treatment for patients with type 2 diabetes, has been granted a license from the European Commission. JANUVIA now becomes the first and only medication in a new class of drugs known as dipeptidyl peptidase-4 inhibitors (DPP-4 inhibitors), which enhance the body's own ability to lower blood sugar when it is elevated, to be adopted by the European Commission.