Pharmaceutical News

RSS

Watson Laboratories' ANDA for generic Toprol XL tablets receives FDA approval

Watson Pharmaceuticals, Inc., today announced that its subsidiary, Watson Laboratories, Inc. - Florida, has received approval from the United States Food and Drug Administration on its Abbreviated New Drug Application for metoprolol succinate extended-release tablets USP in the 100 and 200 mg strengths, the generic equivalent to AstraZeneca's Toprol XL® tablets.

16 Apr 2010

3M Drug Delivery Systems grows its product portfolio in Asia’s pharmaceutical industry

3M Drug Delivery Systems recently advanced its participation in the Asian market with a sponsorship of the Asia Pharma R&D Leaders 2010 event, held March 4 and 5 in Shanghai, China.

16 Apr 2010

Consortium studies gene-drug relationship to determine optimal warfarin doses

If Julie Johnson had her way, doctors would check a patient's genes before writing a prescription. Everyone responds differently to medicines—one that works for you might not work for me, or it could even be harmful. These individual responses depend to an extent on our genetic make-up.

16 Apr 2010

Contura submits PMA for Aquamid

Contura Inc. has submitted a Premarket Approval Application for Aquamid to the U.S. Food and Drug Administration requesting marketing approval in the U.S. for the aesthetic treatment of moderate to severe facial wrinkles and folds.

16 Apr 2010

Smith & Nephew to launch new line extensions to ACTICOAT antimicrobial barrier dressing portfolio

The Advanced Wound Management Division of Smith & Nephew, Inc., a subsidiary of Smith & Nephew plc will launch extensions to its ACTICOAT(TM) Silver Coated Antimicrobial Barrier Dressing portfolio at the upcoming Symposium on Advanced Wound Care Spring meeting April 17-19, 2010, in Orlando, FL. The new dressings will be highlighted at the Smith & Nephew booth, #301.

15 Apr 2010

Study: Atorvastatin may slow down MS progression

A UCSF-led study examining the impact of statins on the progression of multiple sclerosis found a lower incidence of new brain lesions in patients taking the cholesterol-lowering drug in the early stages of the disease as compared to a placebo.

15 Apr 2010

Ibuprofen demonstrates efficacy over acetaminophen for treatment of pain and fever

Cumberland Pharmaceuticals Inc. today announced results from a meta-analysis comparing the efficacy and safety of ibuprofen and acetaminophen, which was published in the March edition of the peer-reviewed journal The Annals of Pharmacotherapy. The publication notes that in a majority of evaluated studies ibuprofen demonstrated superior efficacy compared to acetaminophen for the treatment of pain and fever, and found no significant safety differences between the drugs.

15 Apr 2010

Research reveals demand for over-the-counter oral contraceptives in the US

American women who live along the U.S.-Mexico border frequently buy over-the-counter oral contraceptives from Mexican pharmacies because they don't need a prescription and can send a friend to pick up the pills, according to a study by researchers from two University of Texas campuses and Ibis Reproductive Health.

15 Apr 2010

New data from Pfizer Oncology's pipeline to be presented at AACR 2010

Pfizer Oncology announced today that it will present new data from the company's pipeline, including two novel, dual PI3K/mTOR inhibitors (PF-04691502 and PKI-587, also known as PF-05212384); crizotinib (PF-02341066), an ALK inhibitor that also inhibits c-MET; and PF-04605412, an anti-α5β1 inhibitor.

15 Apr 2010

GBS cases reduce following 2009 H1N1 vaccination: Research study

A new study finds that reports of a neurologic disease called Guillain-Barré syndrome have been low after 2009 H1N1 vaccination, according to a research study that will be presented as part of the late-breaking science program at the American Academy of Neurology's 62nd Annual Meeting in Toronto, April 10 - 17, 2010.

15 Apr 2010

Potential new drug for treatment of MS to be presented at AAN Annual Meeting

Researchers from Mount Sinai School of Medicine will present several studies at the American Academy of Neurology Annual Meeting, including a potential new drug for the treatment of multiple sclerosis and surprising trends showing a reduction in the disease's severity. The meeting will take place April 10-17 in Toronto.

15 Apr 2010

John Muir Physician Network to participate in Generex Oral-lyn FDA Expanded Access Treatment IND program

Generex Biotechnology Corporation, the leader in drug delivery for metabolic diseases through the inner lining of the mouth, today announced that John Muir Physician Network Clinical Research Center has agreed to participate in the United States Food and Drug Administration (FDA) Expanded Access Treatment Investigational New Drug (IND) Program for the Company's flagship product, Generex Oral-lyn™, a proprietary buccal insulin spray product.

15 Apr 2010

Infliximab-azathioprine combination helps more Crohn's disease patients achieve remission

A study led by Mayo Clinic suggests remission from Crohn's disease may be more likely if patients get biologic therapy combined with immune-suppressing drugs first instead of immune-suppressing drugs alone. The study, published in the April 15, 2010 issue of the New England Journal of Medicine, found treatment of moderate to severe Crohn's disease with infliximab plus azathioprine allows more patients to achieve remission and mucosal healing than therapy with azathioprine alone.

15 Apr 2010

FDA: Seven MDIs for treating asthma and COPD to be phased out

The U.S. Food and Drug Administration today announced, in accordance with longstanding U.S. obligations under the Montreal Protocol on Substances that Deplete the Ozone Layer, seven metered-dose inhalers (MDI) used to treat asthma and chronic obstructive pulmonary disease (COPD) will be gradually removed from the U.S. marketplace. These inhalers contain ozone-depleting chlorofluorocarbons (CFCs), which are propellants that move medication out of the inhaler and into the lungs of patients.

15 Apr 2010

Combivent Inhalation Aerosol's "essential use" status effective through 2013

Boehringer Ingelheim Pharmaceuticals, Inc. (BIPI) today announced that the U.S. Food and Drug Administration (FDA) has determined that the "essential use" status of Combivent® (ipratropium bromide and albuterol sulfate) Inhalation Aerosol will be effective through December 31, 2013. With this ruling, COMBIVENT will remain on the market and available to the more than two million chronic obstructive pulmonary disease (COPD) patients who rely on it as a bronchodilator.

15 Apr 2010

ICGC: New era of personalised medicine for cancer patients

Published online today in Nature, a paper authored by over 200 members of the International Cancer Genome Consortium describes the beginnings of a Brave New World, a new era of personalised medicine for cancer patients.

15 Apr 2010

POZEN enters Settlement Agreement with Teva over generic Treximet ANDA patent infringement litigation

POZEN Inc., today announced that it has entered into a Settlement Agreement with Teva Pharmaceuticals USA, Inc. (Teva) to resolve a U.S. patent infringement suit related to Teva's filing of an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) to market a generic version of Treximet® (sumatriptan/naproxen sodium) marketed by POZEN's exclusive U.S. licensee, GlaxoSmithKline.

15 Apr 2010

FDA approves Sagent Pharmaceuticals' two ANDAs to market granisetron

Sagent Pharmaceuticals, Inc., a privately held specialty pharmaceutical company, today announced the U.S. Food and Drug Administration has approved the Company's two abbreviated New Drug Applications to market granisetron hydrochloride injection, USP (granisetron), an antiemetic used to prevent nausea and vomiting caused by chemotherapy.

15 Apr 2010

Epilepsy patients who take Ginkgo products face increased risk of seizures: Report

Restrictions should be placed on the use of Ginkgo biloba - a top-selling herbal remedy - because of growing scientific evidence that Ginkgo may increase the risk of seizures in people with epilepsy and could reduce the effectiveness of anti-seizure drugs, a new report concludes. The article appears in ACS' monthly Journal of Natural Products.

15 Apr 2010

FDA approves J&JPRD's PANCREAZE NDA

Johnson & Johnson Pharmaceutical Research and Development (J&JPRD) announced that the U.S. Food and Drug Administration (FDA) has approved a new drug application (NDA) for PANCREAZE™ (pancrelipase) delayed-release capsules for the treatment of exocrine pancreatic insufficiency due to cystic fibrosis or other conditions. Exocrine pancreatic insufficiency is the inability to properly digest and absorb food due to a lack of enzymes made by the pancreas that are important in the digestion of fats, proteins, and sugars.

15 Apr 2010