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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

Columbia closes sale of progesterone related assets and 11.2M shares to Watson

Columbia Laboratories, Inc. announced today that it has closed the sale of its progesterone related assets and 11.2 million shares of common stock to Watson Pharmaceuticals, Inc.. Columbia's business now consists of its royalty and manufacturing revenues, potential milestone payments, its collaboration with Watson on the development of next-generation progesterone products, and its novel bioadhesive drug delivery technologies and other products.

6 Jul 2010

EUSA grants Ohara Japanese rights to Erwinase oncology therapy

EUSA Pharma, a transatlantic specialty pharmaceutical company focused on oncology, pain control and critical care, today announced that it has granted the Japanese development and commercialization rights to its oncology therapy Erwinase(R) to Ohara Pharmaceutical Company Limited. The agreement represents the first product partnership EUSA has established in Japan.

6 Jul 2010

$CTI submits expanded PIP to EMEA for pixantrone MAA for relapsed or refractory, aggressive NHL$

CTI submits expanded PIP to EMEA for pixantrone MAA for relapsed or refractory, aggressive NHL

Cell Therapeutics, Inc. announced today that it has submitted an expanded Pediatric Investigation Plan to the European Medicines Agency, as part of the process for its submission for a Marketing Authorization Application for pixantrone in the E.U. for the treatment of relapsed or refractory, aggressive non-Hodgkin's lymphoma (NHL).

6 Jul 2010

APP receives FDA marketing clearance for preservative-free Heparin Lock Flush Solution

APP Pharmaceuticals, Inc., a wholly owned subsidiary of Fresenius Kabi Pharmaceuticals Holding, Inc., announced today that it has received clearance from the U.S. Food and Drug Administration (FDA) to market preservative-free Heparin Lock Flush Solution, USP in two dosage strengths, 10 USP Units/1 mL and 100 USP Units/1 mL, and will soon launch these single dose vial presentations.

6 Jul 2010

Antioxidant supplements increase artery elasticity in patients with multiple cardiovascular risk factors

Long-term supplementation with dietary antioxidants has beneficial effects on sugar and fat metabolism, blood pressure and arterial flexibility in patients with multiple cardiovascular risk factors. Researchers writing in BioMed Central's open access journal Nutrition and Metabolism report these positive results in a randomized controlled trial of combined vitamin C, vitamin E, coenzyme Q10 and selenium capsules.

6 Jul 2010

Novel therapy slows tumor growth in 85% of advanced breast cancer patients: Study

A novel therapy designed to attack tumors in patients with a genetic mutation in either BRCA1 or BRCA2, slowed tumor growth in 85 percent of advanced breast cancer patients treated in a small study, researchers report in the July 6 issue of The Lancet.

6 Jul 2010

Pharmaceutical News

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

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

Perseid Therapeutics achieves second milestone for CTLA4-Ig therapeutics

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

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

FDA grants Fougera first generic approval for Adapalene Cream 0.1%

Caraco Pharmaceutical Laboratories commences shipping azelastine ophthalmic solution

FDA approves Glassia for treating Alpha 1 deficiency

Shire receives FDA approval of Daytrana for ADHD in adolescents

US WorldMeds launches Revonto for malignant hyperthermia

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

Three Rivers Pharmaceuticals receives FDA expanded labeling for INFERGEN

HTDS, Shenzhen Mellow Hope secure new business partner in Ethiopia

EMA completes validation process for Dyax's ecallantide MAA

Columbia closes sale of progesterone related assets and 11.2M shares to Watson

EUSA grants Ohara Japanese rights to Erwinase oncology therapy

CTI submits expanded PIP to EMEA for pixantrone MAA for relapsed or refractory, aggressive NHL

APP receives FDA marketing clearance for preservative-free Heparin Lock Flush Solution

Antioxidant supplements increase artery elasticity in patients with multiple cardiovascular risk factors

Novel therapy slows tumor growth in 85% of advanced breast cancer patients: Study

Real-time Raman monitoring for pharmaceutical hot melt extrusion

Synthetic Psychedelics: A Growing Public Health Concern

How the Vutara VXL simplifies single-molecule imaging

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