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Clinical evaluation of benzodiazepine products is now allowed using Acura's Aversion Technology

Acura Pharmaceuticals, Inc. today announced clinical evaluation is now allowed under an Investigational New Drug application ("IND") filed with the U.S. Food and Drug Administration ("FDA") for a benzodiazepine product candidate utilizing our Aversion® Technology.

16 Mar 2010

Savient Pharmaceuticals resubmits KRYSTEXXA BLA

Savient Pharmaceuticals, Inc. announced that it has resubmitted its Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for KRYSTEXXA™ (pegloticase) as a treatment for chronic gout in patients refractory to conventional therapy. Chronic gout that is refractory to conventional therapy occurs in patients who have failed to normalize serum uric acid and whose signs and symptoms are inadequately controlled with xanthine oxidase inhibitors at the maximum medically appropriate dose or for whom these drugs are contraindicated.

16 Mar 2010

FDA approves Watson Pharmaceuticals' ANDA for generic Cardizem LA

Watson Pharmaceuticals, Inc. today announced that its subsidiary, Watson Laboratories, Inc. – Florida, has received approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Diltiazem Hydrochloride Extended-Release tablets, the generic equivalent to Biovail Laboratories International SRL's Cardizem® LA product. Watson intends to launch its generic version of Cardizem® LA immediately.

16 Mar 2010

Lilly receives exclusive rights to commercialize Acrux's testosterone solution

Eli Lilly and Company and Acrux announced today that they have entered into an exclusive worldwide license agreement for the potential commercialization of Acrux's experimental underarm testosterone solution (proposed tradename AXIRON™).

16 Mar 2010

Impax Laboratories initiates challenge of patent over generic TRILIPIX

Impax Laboratories, Inc. today confirms that it has initiated a challenge of the patent listed by Abbott Laboratories and Fournier Laboratories Ireland Ltd. in connection with its TRILIPIX® (choline fenofibrate) delayed-release capsules, 135 mg and 45 mg.

15 Mar 2010

Gardasil vaccine: Two complaints filed in Washington Federal Claims court

Anapol Schwartz attorneys Lawrence Cohan and Melissa Fry Hague recently filed two Gardasil vaccine complaints – one on behalf of a Kensington, Calif., family, whose 15-year old daughter died after suffering from severe adverse reactions, and another on behalf of a 19-year old Lapeer, Mich., woman, who has a chronic, autoimmune disorder. The cases, filed in The Court of Federal Claims in Washington, D.C., seek recovery under the National Vaccine Injury Compensation Program.

15 Mar 2010

Also in Global Health News: East Africa food security; Issues with humanitarian aid; Texting to fight counterfeit drugs

The Intergovernmental Committee of Experts (ICE) meeting this week in Kigali, Rwanda "will provide a forum for experts, government ministers, regional economic communities and other stakeholders to discuss how best to handle the food security issue in" East Africa, New Times/allAfrica.com reports. The U.N. Economic Commission for Africa's Sub-Regional Office, East Africa (SRO-EA) will host the meeting. "East Africa is the sub-region most affected by food insecurity," according to an SRO-EA report, New Times/allAfrica.com writes (3/13).

15 Mar 2010

Forensic Laboratories introduces first oral fluid test for Tapentadol

Forensic Laboratories, a Denver-based laboratory specializing in toxicology services for drug abuse, has unveiled the first oral fluid test for Tapentadol, a new federally approved drug prescribed by doctors for pain management. Previously, laboratories could only detect the drug through urine using liquid chromatography-mass spectrometry-mass spectrometry (LC/MS/MS) technology.

15 Mar 2010

'Vaccine court' finds no link between vaccines and autism

A federal court finds no link between vaccines and autism after examining three cases that started in 2007. CNN reports: "A federal court ruled Friday that the evidence supporting an alleged causal link between autism and a mercury-containing preservative in vaccines is unpersuasive, and that the families of children diagnosed with autism are not entitled to compensation.

15 Mar 2010

Perrigo introduces generic Zaditor

Perrigo Company today announced that it has begun shipping Ketotifen Fumarate ophthalmic solution, 0.025%, a generic version of Zaditor™.

15 Mar 2010

MannKind receives FDA Complete Response letter for AFREZZA NDA

MannKind Corporation today announced that it has received a Complete Response letter from the U.S. Food & Drug Administration (FDA) regarding the New Drug Application (NDA) for AFREZZA™ (insulin human [rDNA origin]) Inhalation Powder for the treatment of adult patients with type 1 and type 2 diabetes mellitus for the control of hyperglycemia.

15 Mar 2010

Ranbaxy resolves generic Actos patent litigation

Ranbaxy Laboratories Limited, along with its wholly owned subsidiary Ranbaxy Pharmaceuticals Inc. (collectively, "Ranbaxy"), announced today that they have reached an agreement with Takeda Pharmaceutical Company Limited and Takeda Pharmaceuticals North America resolving outstanding patent litigation related to Ranbaxy's generic equivalent version of Actos® (Pioglitazone Hydrochloride) 15 mg, 30 mg and 45 mg tablets.

15 Mar 2010

MicuRx Pharmaceuticals files IND for MRX-I antibiotic drug candidate with Chinese SFDA

MicuRx Pharmaceuticals, Inc., a privately-held biopharmaceutical company developing next-generation antibiotics, today announced that it has filed an Investigational New Drug (IND) application with the State Food and Drug Administration (SFDA) in China for MRX-I, its first development-stage antibiotic drug candidate. MRX-I, an orally-administered oxazolidinone, targets multi-drug resistant Gram-positive bacteria including methicillin-resistant Staphylococcus aureus (MRSA) and vancomycin-resistant enterococci (VRE).

15 Mar 2010

Cephalon Australia granted exclusive license to develop Innate Immune's antibodies for treatment of asthma, SLE

Innate Immune, Inc., a privately held biotechnology company, today announced that it has granted to Cephalon Australia Pty Ltd an exclusive license to patents for the development of its antibodies for the treatment of asthma and systemic lupus erythematosis (SLE).

15 Mar 2010

BioSante Pharmaceuticals receives receipt of Orphan Drug designation for GVAX Pancreas Vaccine

BioSante Pharmaceuticals, Inc. today announced BioSante’s receipt of Orphan Drug designation from the FDA’s Office of Orphan Products Development for GVAX Pancreas Vaccine in the treatment of pancreatic cancer.

15 Mar 2010

GTx reacquires full rights to Ostarine

GTx, Inc. today provided a company update and reported financial results for the fourth quarter and full year 2009.

15 Mar 2010

CPF, PFF applaud PF patients' efforts to plead with FDA Advisory Panel regarding lack of treatment options

The Coalition for Pulmonary Fibrosis and the Pulmonary Fibrosis Foundation are applauding the efforts of Pulmonary Fibrosis (PF) patients and family members for their work to convey to the FDA and an FDA Advisory Committee the sense of urgency and desperation regarding the disease and the lack of treatment options.

15 Mar 2010

NDA for BYDUREON: FDA issues complete response letter

Amylin Pharmaceuticals, Inc., Eli Lilly and Company and Alkermes, Inc. today announced that the U.S. Food and Drug Administration has issued a complete response letter regarding the New Drug Application for BYDUREON™ (exenatide for extended-release injectable suspension).

15 Mar 2010

U.S. prescribing information for PLAVIX revised

Sanofi-aventis U.S. and Bristol-Myers Squibb Company today announced revisions to the U.S. prescribing information for PLAVIX® (clopidogrel bisulfate), which include a boxed warning. The boxed warning concerns the diminished effectiveness of PLAVIX in patients who have a genetic variation leading to reduced formation of the active metabolite.

15 Mar 2010

Sigma-Aldrich and Pfizer sign new agreement

Sigma-Aldrich® today announced that it has entered into an agreement with Pfizer under which Sigma-Aldrich will sell approximately 100 Pfizer-developed small molecule compounds to life science researchers for target characterization, assay development, screening and in vivo animal model applications.

15 Mar 2010