News Releases
Byetta Approved for Use With Basal Insulin
Amylin Pharmaceuticals, Inc. and Eli Lilly and Company BYETTA ( exenatide twice-daily) as an adjunctive therapy to basal insulin, with or without metformin and/or Actos ( pioglitazone ), for the treatment of type 2 diabetes in adults who have not achieved adequate glycemic control with these agents.
FDA Approves Intelence
Janssen Therapeutics, Division of Janssen Products, LP, announced the U.S. Food and Drug Administration (FDA) has approved INTELENCE ® ( etravirine ) to be administered in combination with other antiretroviral ( ARV ) medications.
Prevnar 13 Shown to be Immunogenic in Adolescents
Pfizer Inc. announced Prevnar 13 ( Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]) met all study endpoints, showing immunogenicity and establishing a safety profile in children and adolescents aged 5 through 17 years.
Allergy Medication Reduces Symptoms
Merck announced the results from a Phase III clinical study of its investigational allergy immunotherapy tablet ( AIT ) for ragweed pollen.
Pfizer Acquires Vitamin Company
Pfizer Inc. announced the acquisition of privately-held Alacer Corp., the maker and distributor of Emergen-C products, the largest selling branded Vitamin C line in the United States.
Abbott Drug Gets Positive Review in Ulcerative Colitis
Abbott announced that the European Committee for Medicinal Products for Human Use ( CHMP ) has issued a positive opinion for Humira ( adalimumab ) in adults with moderate to severely active ulcerative colitis ( UC ) who have not responded to, cannot tolerate or have medical contraindications to conventional therapies.
Roche’s Zelboraf Receives EU Approval for Treatment of Skin Cancer
Roche today announced that the European Commission has approved Zelboraf ( vemurafenib ) as a monotherapy for the treatment of adult patients with BRAF V600 mutation-positive unresectable or metastatic melanoma, the most aggressive form of skin cancer.
Tylenol Nationwide Recall
McNeil Consumer Healthcare, Division of McNEIL-PPC , Inc. (“McNeil”), is voluntarily recalling, at the wholesale and retail levels, seven lots, approximately 574,000 bottles, of Infants’ TYLENOL® Oral Suspension, 1 oz. Grape distributed nationwide in the United States. Infants’ TYLENOL® is an over-the-counter (OTC) product indicated as a pain reliever/fever reducer.
Pfizer’s Tafamidis Approved
Pfizer Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for tafamidis meglumine , the company’s investigational, novel, oral therapy for the treatment of Transthyretin Familial Amyloid Polyneuropathy ( TTR-FAP ).
Merck's Eye Medication Zioptan Approved
Merck, known as MSD outside the United States and Canada, announced that the U.S. Food and Drug Administration (FDA) has approved Zioptan ( tafluprost ophthalmic solution) 0.0015%, the first preservative-free prostaglandin analog ophthalmic solution.