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Survey reveals Gamunex as preferred IGIV therapy among neurologists

Talecris Biotherapeutics, Inc., today announced results of a new survey showing that Gamunex® (Immune Globulin Intravenous [Human], 10% Caprylate/Chromatography Purified) is the preferred immune globulin intravenous (IGIV) among neurologists who indicated a brand preference. In the survey, conducted online by Harris Interactive® on behalf of Talecris, neurologists selected Gamunex over four times more often than all other available liquid IGIV therapies, with a statistically significant margin (p<0.05).

13 Apr 2010

More treatment doesn't mean better outcomes, studies show

USA Today reports that "doctors have long been rewarded for providing more care, though more isn't always better. Three recent studies show that a doctor's instincts are no match for hard science." The studies include one of 800 high blood pressure patients that found opening clogged arteries with stents didn't lower blood pressure and actually raised side effects.

13 Apr 2010

College women more likely to be vaccinated against HPV if their mothers approve

College women were more likely to be vaccinated against human papillomavirus if their mothers communicated with them about sex and if they thought their mothers would approve of their getting vaccinated, according to new Dartmouth research in the May issue of Pediatrics (published online April 12).

13 Apr 2010

Pancreaze Delayed Release Capsules receive FDA approval

The U.S. Food and Drug Administration today approved Pancreaze Delayed Release Capsules, a pancreatic enzyme product. It is the third such product to receive FDA approval.

13 Apr 2010

Mylan Pharmaceuticals' ANDA for generic Wellbutrin SR receives FDA final approval

Mylan Inc. today announced that its subsidiary Mylan Pharmaceuticals Inc. received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Bupropion Hydrochloride Extended-Release Tablets USP, (SR), 100 mg, 150 mg and 200 mg, the generic version of GlaxoSmithKline's antidepressant Wellbutrin SR®.

12 Apr 2010

FDA approves Mylan Pharmaceuticals' ANDA for generic Hyzaar

Mylan Inc. today announced that its subsidiary Mylan Pharmaceuticals Inc. received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Losartan Potassium and Hydrochlorothiazide (HCTZ) Tablets 100 mg/12.5 mg, the generic version of Merck and Co., Inc.'s antihypertensive Hyzaar®.

12 Apr 2010

Epix Pharmaceuticals' MRI imaging intellectual properties to be auctioned on May 28, 2010

Joseph F. Finn, Jr., C.P.A., Assignee for the Benefit of Creditors of Epix Pharmaceuticals, Inc. ("Epix"), announced today that the MRI imaging intellectual properties will be auctioned on May 28, 2010. The assets of Epix were transferred to him on July 20, 2009 and he is liquidating them for the benefit of Epix creditors. He recently reached an agreement with Bayer Schering Pharma that permits the sale of the MRI imaging programs.

12 Apr 2010

FDA approves Sinapis Pharma's IND for IV methamphetamine in treatment of acute stroke

Sinapis Pharma is pleased to announce that it has received notice from the FDA that its Investigational New Drug application (IND) for the use of IV methamphetamine for acute stroke was approved on April 9, 2010. "We have accomplished a great deal of work for a small company on a very tight budget. We have GMP drug ready for the Phase I clinical trial and the Phase I site is prepared to begin this protocol," said Dr. Donald Picker , the company CEO.

12 Apr 2010

Medinox, Orient Europharma form partnering agreement for NOX-100 anti-hypotensive drug

Medinox, Inc. in Carlsbad, California and Orient Europharma in Taiwan announce today that they have entered into a partnering agreement to develop and market NOX-100, a new anti-hypotensive drug. Under the terms of the agreement, Orient Europharma holds the exclusive distribution rights of NOX-100 in Taiwan, China, Korea, Australia, New Zealand and Southeast Asia. Medinox retains the marketing rights in the United States, Japan and Europe.

12 Apr 2010

Oceana Therapeutics, Q-Med submit Solesta PMA application for treatment of fecal incontinence

Oceana Therapeutics and Q-Med AB today announced the filing of a Premarket Approval (PMA) application with the U.S. Food and Drug Administration (FDA) for Solesta® for the treatment of Fecal (or Bowel) Incontinence, a largely unsatisfied medical need afflicting millions of Americans.

12 Apr 2010

Meijer adds Metformin Immediate Release to free medication program

With diabetes affecting the lives of millions of people throughout the Midwest, Meijer announced plans today to begin offering Metformin Immediate Release, the most commonly prescribed treatment for type 2 diabetes, at no cost to those with a medical prescription. Meijer's program will include doses prescribed in 500mg, 850mg and 1000mg tablets.

12 Apr 2010

High OOP costs discouraging many cancer patients from filling prescriptions

A new study presented today at the Academy of Managed Care Pharmacy's 22nd Annual Meeting finds that one in six cancer patients with high out-of-pocket (OOP) costs abandons their medication. The study by Prime Therapeutics (Prime), a thought leader in pharmacy benefit management, found patients with an OOP cost greater than $200 were at least three times more likely to not fill their prescription than those with OOP costs of $100 or less.

12 Apr 2010

Global study shows wide variations in treatment of women with early breast cancer

A global study of nearly 10,000 women with early breast cancer has found wide variations in how they were treated, despite international consensus on best practice, according to the May issue of the British Journal of Surgery.

12 Apr 2010

Sun Pharmaceutical Industries' generic Namenda ANDA: USFDA grants tentative approval

Sun Pharmaceutical Industries Ltd. announced that USFDA has granted its subsidiary a tentative approval for its Abbreviated New Drug Application (ANDA) to market a generic version of Forest Laboratories, Inc.'s Namenda 5 mg and 10 mg tablets.

12 Apr 2010

FDA holds public meeting to obtain comments on PDUFA program

The U.S. Food and Drug Administration will hold a public meeting on April 12, 2010, to obtain comments on the Prescription Drug User Fee Act program. The program authorizes user fees for FDA product reviews, which currently fund more than half of new drug review costs.

12 Apr 2010

Three in ten women use letrozole to treat infertility: Study

About three in ten patients using letrozole (Femara), a common medication for treating breast cancer, are likely taking the medication to treat infertility, according to a new study presented today at the Academy of Managed Care Pharmacy's 22nd Annual Meeting in San Diego by Prime Therapeutics, a thought leader in pharmacy benefit management.

12 Apr 2010

FDA issues complete response letter regarding the NDA for OMAPRO

ChemGenex Pharmaceuticals announces that the U.S. Food and Drug Administration's Office of Oncology Drug Products has issued a complete response letter regarding the new drug application for OMAPRO for the treatment of adults with chronic myeloid leukemia who have failed prior therapy with imatinib and have the Bcr-Abl T315I mutation.

12 Apr 2010

Resverlogix highlights features of RVX-208 drug at ATVB conference

Resverlogix Corp. announced today that key scientific data was communicated in an oral presentation highlighting the novel features of RVX-208, the Company's lead drug, during the Atherosclerosis, Thrombosis, Vascular Biology conference being held in San Francisco, California.

12 Apr 2010

Cempra to make poster presentations on CEM-101 and CEM-102 at ECCMID 2010

Cempra Pharmaceuticals today announced poster presentations on its novel antibiotic CEM-101, a next-generation macrolide, and CEM-102, the company's proprietary front-loading oral dosing regimen of sodium fusidate, at the 20th European Congress of Clinical Microbiology and Infectious Disease, April 10 to 13, 2010, in Vienna Austria.

12 Apr 2010

AED Vimpat to be the subject of numerous studies and analyses at AAN meeting

The antiepileptic drug Vimpat- (lacosamide) (C-V) will be the subject of numerous studies and analyses-both UCB-sponsored and independent-at the 62nd annual American Academy of Neurology meeting, taking place at the Metro Toronto Convention Centre in Toronto from April 10-17.

9 Apr 2010