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Amira granted UK patents for AM103, AM803 FLAP inhibitors for respiratory disorders

Amira Pharmaceuticals, Inc. today announced that the U.K. Intellectual Property Office has granted patent number GB2431927, titled, "5-Lipoxygenase Activating Protein (FLAP) Inhibitors," which includes coverage of Amira's AM103 and AM803 FLAP inhibitors for the treatment of respiratory disorders.

14 Jul 2010

CMAJ publishes new, updated guidelines on vitamin D

New and updated guidelines on recommended vitamin D intake have been published this week in the online issue of the Canadian Medical Association Journal.

14 Jul 2010

K-V announces resubmission to FDA's Complete Response action letter for Gestiva

K-V Pharmaceutical Company, a specialty pharmaceutical company, announced today that it has been informed by Hologic, Inc. that a resubmission to the FDA's Complete Response action letter received in January 2009 has been submitted for Gestiva™ (hydroxyprogesterone caproate injection), 250 mg/mL.

14 Jul 2010

FDA to decide on Avandia’s fate Wednesday

Avandia, a drug used as a treatment for type 2 diabetes was approved for use in 1999. However controversies have surrounded it since 2007 when a Cleveland Clinic cardiologist Steven E. Nissen published a study in the acclaimed New England Journal of Medicine that concluded that the drug significantly increased the risk for heart problems like heart attacks, heart failure and deaths.

13 Jul 2010

Cognis exclusively licensed two new active ingredients from IMD

Specialty chemicals supplier Cognis and InterMed Discovery, a world class natural product lead-discovery company, are continuing their strategic cooperation: Cognis has now exclusively licensed two new active ingredients for weight management and cognitive performance from IMD, further expanding the company's innovation pipeline.

13 Jul 2010

Protalix BioTherapeutics' taliglucerase alfa for Gaucher disease granted French ATU

Protalix BioTherapeutics, Inc. announced today that the French regulatory authority has granted an Autorisation Temporaire d'Utilisation (ATU), or Temporary Authorization for Use, for taliglucerase alfa for the treatment of Gaucher disease. An ATU is the regulatory mechanism used by the French Health Products and Safety Agency to make non-approved drugs available to patients in France when a genuine public health need exists.

13 Jul 2010

SPET-085 is effective in blocking critical enzyme that leads to BPH: Study

A new study, published in the July issue of Advances in Therapy, revealed that a novel saw palmetto extract, SPET-085, is as effective as finasteride, the standard prescription drug therapy, in blocking the critical enzyme that leads to benign prostatic hyperplasia.

13 Jul 2010

Anika to defend patent infringement lawsuit for MONOVISC product

Anika Therapeutics, Inc., a leader in products for tissue protection, healing and repair, based on hyaluronic acid technology, announced today that they had been served with a complaint alleging patent infringement with respect to the MONOVISC product by Genzyme Corporation.

13 Jul 2010

Watson Laboratories files ANDA with FDA for generic Renvela for oral suspension

Watson Pharmaceuticals, Inc. today confirmed that its subsidiary, Watson Laboratories, Inc., filed an Abbreviated New Drug Application with the U.S. Food and Drug Administration seeking approval to market sevelamer carbonate for oral suspension, 0.8g and 2.4g per packet. Watson's sevelamer carbonate for oral suspension product is the generic version of Genzyme's Renvela for Oral Suspension.

13 Jul 2010

Preclinical results of TH-302 presented at AACR Translational Cancer Medicine Meeting

Threshold Pharmaceuticals, Inc., today announced two preclinical presentations on its clinical stage hypoxia-activated prodrug, TH-302, at the American Association for Cancer Research Translational Cancer Medicine Meeting, being held July 11 to 14, 2010, in San Francisco, CA. The preclinical presentations describe new findings regarding the efficacy of TH-302 when combined with multi-kinase inhibitors that inhibit VEGF signaling, as well as the efficacy of TH-302 in combination with gemcitabine in models of pancreatic cancer.

13 Jul 2010

Efficacy data of Caldolor Injection in treating fever associated with falciparum malaria published

Cumberland Pharmaceuticals Inc. today announced that data supporting the efficacy of Caldolor in treating fever associated with falciparum malaria was published in the July edition of the peer-reviewed American Journal of Tropical Medicine and Hygiene. The study, which is the first to document an antipyretic effect of an injectable non-steroidal anti-inflammatory drug on fever caused by malaria, demonstrated that patients who received intravenous ibuprofen experienced a greater reduction in their temperatures than those who received placebo.

13 Jul 2010

Obesity crisis in the spotlight as FDA reviews weight loss drugs

The Washington Post explores the obesity epidemic by reporting from Manchester, Ky., which has an obesity rate as high as 52 percent in a nation where the obesity rate is 24 percent. "The residents of this town of 2,100 — 95 miles southeast of Lexington and deep in the Appalachian foothills — indeed appear to celebrate the joys of community closeness.

13 Jul 2010

B. Braun Medical announces availability of large volume heparin infusion solutions

B. Braun Medical Inc. announced today the availability of large volume heparin infusion solutions.

From B. Braun Melsungen AG 12 Jul 2010

Brand-Nu Laboratories adds Chlophedianol Hydrochloride to API line

Brand-Nu Laboratories, a leading US-based high purity chemical manufacturer and distributor, has introduced Chlophedianol Hydrochloride, also known as Clofedanol Hydrochloride JP, to its product portfolio of active pharmaceutical ingredients (APIs).

12 Jul 2010

Rohto launches AFC Medirepair with Signum's compound Arazine in Japan

Signum Biosciences announced that its partner, Rohto Pharmaceutical Co., Ltd., has launched AFC Medirepair® with Signum's compound Arazine™ (n-acetyl-s-farnsylcysteine or AFC) in Japan. Arazine™ is the first compound from Signum's novel anti-inflammatory platform to be commercialized from Signum's pipeline of Signal Transduction Modulators (STMs).

12 Jul 2010

Bedford Laboratories launches Dactinomycin for Injection

Bedford Laboratories™, a division of Ben Venue Laboratories, Inc., is pleased to announce the addition of Dactinomycin for Injection USP 500 mcg (0.5 mg) to its comprehensive line of generic oncology products. Dactinomycin was approved earlier this year by the U.S. Food and Drug Administration (FDA) and is AP rated and equivalent to Cosmegen® by Lundbeck Inc. Each single dose vial contains 0.5 mg (500mcg) of dactinomycin and 20 mg of mannitol and is individually boxed.

12 Jul 2010

GE Healthcare Medical Diagnostics reintroduces Optison ultrasound contrast agent for echocardiograms

GE Healthcare Medical Diagnostics today announced the market reintroduction of Optison™ (Perflutren Protein-Type A Microspheres Injectable Suspension, USP), a diagnostic ultrasound contrast agent for use in select echocardiograms. Optison is indicated for use in patients with suboptimal echocardiograms to opacify the left ventricle and to improve the delineation of the left ventricular endocardial borders. The safety and efficacy of Optison with exercise stress or pharmacologic stress testing have not been established.

12 Jul 2010

Stanford University, OHSU receive grants to study VIAject for treating patients with diabetes

Biodel Inc. announced today the award of two research grants by the Juvenile Diabetes Research Foundation to Stanford University and Oregon Health & Science University to evaluate the use of VIAject (ultra-rapid-acting injectable human insulin) in the treatment of diabetes.

12 Jul 2010

New research evaluates effectiveness of popular slimming supplements

New research evaluating the effectiveness of a broad selection of popular slimming supplements sold in pharmacies and health food shops has found no evidence that any of them facilitate weight loss beyond the placebo effect.

12 Jul 2010

Experimental anti-obesity and diabetes drug avoids risk of psychiatric side effects: Study

A second-generation experimental anti-obesity and diabetes drug has shown promise in reducing body weight in rodents just as effectively as the predecessor rimonabant while avoiding the risk of psychiatric side effects that led to the withdrawal of rimonabant from the market and stopped further development of other brain-penetrating drugs of its type.

12 Jul 2010

Pharmaceutical News

Amira granted UK patents for AM103, AM803 FLAP inhibitors for respiratory disorders

CMAJ publishes new, updated guidelines on vitamin D

K-V announces resubmission to FDA's Complete Response action letter for Gestiva

FDA to decide on Avandia’s fate Wednesday

Cognis exclusively licensed two new active ingredients from IMD

Protalix BioTherapeutics' taliglucerase alfa for Gaucher disease granted French ATU

SPET-085 is effective in blocking critical enzyme that leads to BPH: Study

Anika to defend patent infringement lawsuit for MONOVISC product

Watson Laboratories files ANDA with FDA for generic Renvela for oral suspension

Preclinical results of TH-302 presented at AACR Translational Cancer Medicine Meeting

Efficacy data of Caldolor Injection in treating fever associated with falciparum malaria published

Obesity crisis in the spotlight as FDA reviews weight loss drugs

B. Braun Medical announces availability of large volume heparin infusion solutions

Brand-Nu Laboratories adds Chlophedianol Hydrochloride to API line

Rohto launches AFC Medirepair with Signum's compound Arazine in Japan

Bedford Laboratories launches Dactinomycin for Injection

GE Healthcare Medical Diagnostics reintroduces Optison ultrasound contrast agent for echocardiograms

Stanford University, OHSU receive grants to study VIAject for treating patients with diabetes

New research evaluates effectiveness of popular slimming supplements

Experimental anti-obesity and diabetes drug avoids risk of psychiatric side effects: Study

Advancing brain microphysiological systems (bMPS)

PhD researcher at LifeArc

Unveiling Hidden Potential: Organoids for Disease Modeling in Neuroscience Research

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