Pharmaceutical News

RSS

Prasco Laboratories to market Stiefel Laboratories' Clobetasol Propionate Foam

Prasco Laboratories announced today that they have signed a distribution and supply agreement with Stiefel Laboratories, Inc., a GlaxoSmithKline company, for Clobetasol Propionate Foam 0.05%, the latest product in Prasco's line of authorized generics. Under the terms of the agreement, Prasco will market and distribute Clobetasol Propionate Foam 0.05% in 50g and 100g canisters in the U.S. under the Prasco label.

22 Dec 2009

Declining use of Advair for COPD, Spiriva patient share increasing

Decision Resources, one of the world's leading research and advisory firms focusing on pharmaceutical and healthcare issues, finds that since the 2008 retrospective analysis of patient-level claims data, Boehringer Ingelheim/Pfizer's Spiriva has closed the gap in patient share between itself and GlaxoSmithKline's Advair in newly diagnosed chronic obstructive pulmonary disease (COPD) patients. Although Advair's patient share in the first line is still greater than Spiriva's, Spiriva has surpassed Advair in the second line and will continue to overcome and widen the gap between itself and Advair over the next two years.

22 Dec 2009

Arena Pharmaceuticals submits lorcaserin NDA to the FDA

Arena Pharmaceuticals, Inc. announced today that it has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for lorcaserin, Arena's internally discovered and developed drug candidate for weight management, including weight loss and maintenance of weight loss. The submission is based on an extensive data package from lorcaserin's clinical development program that includes 18 clinical trials totaling 8,576 patients.

22 Dec 2009

Matrix Laboratories receives FDA tentative approval for Efavirenz NDA under PEPFAR

Mylan Inc. today announced that its subsidiary Matrix Laboratories Limited has received tentative approval from the U.S. Food and Drug Administration (FDA) under the President's Emergency Plan for AIDS Relief (PEPFAR) for its New Drug Application (NDA) for Efavirenz Tablets, 50 mg, 100 mg and 200 mg. These innovative pediatric dosages in tablet form were developed by Matrix for use in treating pediatric HIV/AIDS.

22 Dec 2009

PGxHealth, DHZ announce collaboration in genetic variant study with response to clopidogrel

PGxHealth, a division of Clinical Data, Inc., today announced that it has established a research collaboration with Deutsches Herzzentrum (DHZ), Munich, Germany, to evaluate the predictive value of genetic markers, including PGxHealth proprietary markers, for response to clopidogrel (Plavix®).

22 Dec 2009

Derma Sciences receives licensing rights to wound and skin care products

Derma Sciences, Inc. (OTC Bulletin Board: DSCI), a specialty medical device and pharmaceutical company focused on advanced wound care, today announced that it has completed a comprehensive Heads of Agreement with Comvita New Zealand Ltd. (Comvita) of Paengaroa, New Zealand, covering the worldwide licensing rights for MEDIHONEY® professional wound care and skin care products.

22 Dec 2009

Health Canada approves Prevnar 13 vaccine for invasive pneumococcal disease

Following a Priority Review, Health Canada has approved Prevnar 13 (Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein)) for children aged six weeks through five years for active immunization against invasive pneumococcal disease, a bacterial infection that can include meningitis (inflammation of the coverings of the brain and spinal cord), sepsis (bloodstream infection), bacteremic pneumonia, pleural empyema (accumulation of pus in the cavity surrounding the lungs) and bacteremia (bacteria in the blood).

22 Dec 2009

Schering and MSP Singapore sue Mylan over generic Vytorin ANDA

Mylan Inc. today confirmed that the company and its subsidiary Mylan Pharmaceuticals Inc. have been sued by Schering Corporation and MSP Singapore Company in connection with the filing of an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) for Ezetimibe and Simvastatin Tablets, 10 mg/10 mg, 10 mg/20 mg, 10 mg/40 mg and 10 mg/80 mg. This product is the generic version of Vytorin® Tablets, a cholesterol treatment.

22 Dec 2009

QLT Ophthalmics to distribute Visudyne in the U.S. market

QLT Inc. ("QLT" or the "Company") is pleased to announce the establishment of its commercial presence in the United States through a newly formed U.S. subsidiary, QLT Ophthalmics, Inc. ("QOI"). QOI will take on the sales and marketing of Visudyne(R) in the U.S.

22 Dec 2009

Shire submits REPLAGAL BLA with the FDA

Shire plc , the global specialty biopharmaceutical company, today announced that it has submitted a BLA with the FDA for REPLAGAL(R) (agalsidase alfa), its enzyme replacement therapy for Fabry disease. REPLAGAL first received marketing authorization in the European Union in 2001, and is approved for the treatment of Fabry disease in 45 countries.

22 Dec 2009

Sinovac Biotech selected as Top 10 most competitive companies for 2009

Sinovac Biotech Ltd. (SVA), a leading provider of biopharmaceutical products in China, announced today that Sinovac was selected by China Business Media as one of China's Top 10 most competitive companies listed overseas for 2009.

22 Dec 2009

Prescription medication at lower costs for Oregon state agency employees

Public employees in the state of Oregon will soon have access to a wider range of prescription medication at lower costs.

22 Dec 2009

New quantities of H1N1 vaccine available for walk-in patients; no appointments necessary

U.S. HealthWorks Medical Group, a leading operator of occupational health and urgent care centers in the nation, today announced that most of its 128 medical centers have new quantities of H1N1 vaccine available for walk-in patients – no appointments necessary.

22 Dec 2009

Duane Reade offers H1N1 vaccines for New York residents

Duane Reade, the largest drug store chain in New York City, today announced that H1N1 vaccines are now available. As previously announced, Duane Reade pharmacies are providing New Yorkers with the H1N1 vaccine as part of the Company's commitment to servicing the health and wellness needs of the City's residents.

22 Dec 2009

Cell Therapeutics supports Code on Interactions with Healthcare Professionals

Cell Therapeutics, Inc. announced today its support of the Pharmaceutical Research Manufacturers of America's (PhRMA) "Code on Interactions with Healthcare Professionals, revised July 2008" (PhRMA Code). Adherence to the Code is voluntary for commercial biotechnology and pharmaceutical companies.

22 Dec 2009

Rifampicin resistant tuberculosis

Scientists have identified a strain of antibiotic-resistant tuberculosis that thrives in the presence of rifampin, a front-line drug in the treatment of tuberculosis. The bacterium was identified in a patient in China and is described in a study by researchers at the Johns Hopkins Bloomberg School of Public Health, Chongqing Pulmonary Hospital, Lanzhou University and Fudan University.

22 Dec 2009

Emisphere's oral salmon calcitonin product addresses persistent musculoskeletal pain

Emisphere Technologies, Inc. today announced a meta-analysis published in the December 2009 edition of Rheumatology Reports examining independent evidence of the analgesic action of the hormone calcitonin. This publication restates the potential of calcitonin in filling a significant unmet need for alternative treatments for persistent musculoskeletal pain.

22 Dec 2009

ZEGERID OTC approval triggers $20M milestone payment to Santarus

Santarus, Inc., a specialty biopharmaceutical company, today announced that it has received the $20 million milestone payment previously announced on December 1, 2009 relating to the approval of ZEGERID OTC™ (omeprazole 20 mg/sodium bicarbonate 1100 mg capsules) under its over-the-counter (OTC) licensing agreement with Schering-Plough HealthCare Products, Inc., the consumer healthcare division of Merck & Co., Inc. Schering-Plough and Merck merged on November 3, 2009.

22 Dec 2009

NMA urges parents to protect their children from meningococcal disease

This winter, while many parents are focused on influenza prevention, the National Meningitis Association (NMA) is urging parents to also protect their families from meningococcal disease, a deadly but potentially vaccine preventable bacterial infection.

22 Dec 2009

Research shows morphine dosage can vary greatly in newborns

Dosage recommendations for newborns being cared for in an intensive care unit will in the future most likely be based on more individual characteristics than just body weight.

22 Dec 2009