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FDA grants orphan drug designation for Synageva BioPharma's SBC-102

Synageva BioPharma Corp., a privately held biopharmaceutical company, announced that the U.S. Food and Drug Administration has granted orphan drug designation for SBC-102, the Company's enzyme replacement therapy in development to treat Lysosomal Acid Lipase Deficiency, also known as Wolman Disease and Cholesteryl Ester Storage Disease, a condition for which there is currently no approved treatment.

7 Jul 2010

Cipher Pharmaceuticals reaches cumulative sales milestone for Lipofen

Cipher Pharmaceuticals Inc. today announced that it reached a cumulative sales milestone for Lipofen, the Company's fenofibrate product. Achieving this target triggers a US$1.0 million milestone payment from Kowa Pharmaceuticals America Inc., Cipher's U.S. marketing and distribution partner, which will be reflected in Cipher's revenue for the second quarter of fiscal 2010.

7 Jul 2010

Use of NSAIDs do not increase risk of heart attack in elderly patients: Study

Commonly used painkillers like ibuprofen do not increase the risk of heart attack in the elderly population, according to a new study. Researchers found that the use of these drugs - also called non-steroidal anti-inflammatory drugs - was also associated with a lower risk of death although they are not sure why.

7 Jul 2010

CREW calls for antitrust investigation into drug companies

Today, Citizens for Responsibility and Ethics in Washington (CREW) sent a letter to the Federal Trade Commission (FTC) asking for an antitrust investigation into drug companies that offer significant discounts to doctors for providing patients with only that company's vaccines. CREW sent its letter after learning that Sanofi Pasteur and Merck require physician healthcare groups purchasing their vaccines to enter into contracts prohibiting them from purchasing vaccines made by other companies.

7 Jul 2010

ASPREE study aims to assess health benefits of aspirin

In an effort to extend the length of a disability-free life for older adults, researchers from Rush University Medical Center are partnering with colleagues from across the U.S. and Australia in the largest international trial ever sponsored by the National Institute on Aging.

7 Jul 2010

European Commission approves new indication for ORENCIA in combination with MTX for RA

Bristol-Myers Squibb Company has today announced that on 1 July 2010 the European Commission approved a new indication for ORENCIA® (abatacept), in combination with methotrexate (MTX), for the treatment of moderate to severe active rheumatoid arthritis (RA) in adult patients who have responded inadequately to previous therapy with one or more disease-modifying anti-rheumatic drugs (DMARDs) including MTX or a TNF-alpha inhibitor.

7 Jul 2010

Extended treatment with blood thinner benefits patients immobilized by acute medical illness: Study

A treatment plan used to prevent potentially dangerous blood clots in recovering surgical patients can also benefit some patients immobilized by acute medical illness, doctors have found in a multi-institutional study.

7 Jul 2010

Polyethylene glycol "works a bit better" than lactulose for chronic constipation: Study

When ordinary over-the-counter laxatives fail to work, doctors turn to other medications to treat people with constipation. Now, a new review of existing research finds that one common drug treatment is better than another is at helping patients who are desperate to get things moving.

7 Jul 2010

Perseid Therapeutics achieves second milestone for CTLA4-Ig therapeutics

Maxygen, Inc., a biotechnology company focused on the development of improved protein drugs, today announced that its majority-owned subsidiary, Perseid Therapeutics LLC, achieved a second preclinical milestone under its collaboration with Astellas Pharma Inc. to co-develop and commercialize next-generation CTLA4-Ig therapeutics.

7 Jul 2010

Retin-A Micro Pump combines tretinoin for treating acne: Study

From the minute they wake until the minute they sleep, today's teenagers have busy, demanding schedules. Life may be hectic, but an acne care routine doesn't have to get in the way, according to a new study published in the July 2010 issue of Journal of Drugs in Dermatology.

7 Jul 2010

Apicore files DMF for Fondaparinux Sodium API with U.S. FDA

Apicore LLC announced today that they filed a drug master file (DMF) for Fondaparinux Sodium active pharmaceutical ingredient (API) with the U.S. Food and Drug Administration (FDA) on June 28, 2010.

7 Jul 2010

FDA grants Fougera first generic approval for Adapalene Cream 0.1%

E. Fougera & Co., a leading specialty pharmaceutical manufacturer, announced it has received first generic approval from the FDA for Adapalene Cream 0.1% (Rx). Fougera's Adapalene Cream 0.1% is rated AB, generically equivalent to Differin® by Galderma Pharmaceuticals. According to industry data, U.S. sales of the brand named product in 2009 exceeded $55 million. This approval also marks the fourth product approval that the FDA has granted to Fougera this year.

7 Jul 2010

Caraco Pharmaceutical Laboratories commences shipping azelastine ophthalmic solution

Caraco Pharmaceutical Laboratories, Ltd. has started shipping azelastine ophthalmic solution, 0.05%. This product was recently approved by the US Food and Drug Administration (FDA) for Sun Pharma's Abbreviated New Drug Application (ANDA).

7 Jul 2010

FDA approves Glassia for treating Alpha 1 deficiency

Kamada, today announced that the United States Food and Drug Administration has approved Glassia (Alpha 1 Proteinase inhibitor, also known as Alpha-1-Antitrypsin) for the treatment of Alpha 1 deficiency. GlassiaM is now the first and only liquid Alpha- 1-Proteinase Inhibitor worldwide available liquid, ready to use, Alpha- 1-Proteinase Inhibitor on the market.

7 Jul 2010

Shire receives FDA approval of Daytrana for ADHD in adolescents

Shire plc, the global specialty biopharmaceutical company, announced the US Food and Drug Administration (FDA) approval of Daytrana® (methylphenidate transdermal system) for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adolescents aged 13 to 17 years. Daytrana, the first and only transdermal ADHD patch, is already an FDA-approved ADHD treatment for children 6 to 12 years. Daytrana is indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, and social).

7 Jul 2010

US WorldMeds launches Revonto for malignant hyperthermia

US WorldMeds is proud to announce the launch of Revonto™ (dantrolene sodium for injection), the first patented scientific advancement in the treatment of malignant hyperthermia (MH). The time to reconstitute dantrolene sodium for injection has been dramatically reduced to approximately 20 seconds or until the solution is clear. Revonto™ retains the cost-savings of the original dantrolene sodium for injection product while offering a significant improvement in pharmacotherapy.

7 Jul 2010

Pfizer's new chewable Lipitor for children receives European Commission approval

Pfizer Inc. announced it has received European Commission approval of a new chewable form of Lipitor (atorvastatin calcium) suitable for use in children aged 10 or older with high levels of LDL ("bad") cholesterol and high triglycerides due to the inherited disorder familial hypercholesterolemia and other primary causes, which can increase the risk of heart disease and premature death. This pediatric indication has also been approved for the currently available tablet form of Lipitor.

7 Jul 2010

Three Rivers Pharmaceuticals receives FDA expanded labeling for INFERGEN

Three Rivers Pharmaceuticals, LLC, today received expanded labeling from the U.S. Food and Drug Administration (FDA) to include daily use of INFERGEN (Consensus Interferon) in combination with ribavirin (RBV) for retreatment of chronic hepatitis C patients. The expanded labeling targets hepatitis C patients who need retreatment.

6 Jul 2010

HTDS, Shenzhen Mellow Hope secure new business partner in Ethiopia

Hard to Treat Diseases, Inc. and Shenzhen Mellow Hope are excited to announce that the company has secured a new business partner in Ethiopia through which Mellow Hope will distribute biomedical vaccines.

6 Jul 2010

EMA completes validation process for Dyax's ecallantide MAA

Dyax Corp. announced today that the European Medicines Agency (EMA) has completed its validation process for the Marketing Authorization Application (MAA) for potential approval to market DX-88 (ecallantide) in the European Union (EU).

6 Jul 2010