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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

Latest treatment options for colorectal cancer highlighted at NCCN Annual Conference

Despite statistics stating that colorectal cancer is the fourth most frequently diagnosed cancer in men and women in the United States, mortality from colon cancer has decreased slightly over the past 30 years, possibly because of earlier diagnoses through screening and better treatment modalities.

15 Mar 2010

SafeMinds: Government refusal to compensate vaccine-injured children casts doubt on the integrity of national immunization program

Autism and mercury advocacy organization SafeMinds regrets today's ruling by the U.S. Court of Federal Claims against three families who argued that vaccines which contained the mercury-based preservative thimerosal contributed to their child's autism.

15 Mar 2010

Orexigen Therapeutics, Patheon sign long-term agreement for commercial manufacturing of Contrave

Orexigen® Therapeutics, Inc., a biopharmaceutical company focused on the treatment of obesity, and Patheon Inc., a global provider of drug development and manufacturing services, announced today a long-term agreement for commercial manufacturing of Contrave® (naltrexone HCL sustained release (SR)/bupropion HCL SR) as well as development of future formulations of Orexigen products.

15 Mar 2010

Combination therapy does not reduce cardiovascular risk in type 2 diabetes patients

Lowering blood pressure to normal levels - below currently recommended levels - did not significantly reduce the combined risk of fatal or nonfatal cardiovascular disease events in adults with type 2 diabetes who were at especially high risk for cardiovascular disease events, according to new results from the landmark Action to Control Cardiovascular Risk in Diabetes (ACCORD) clinical trial.

15 Mar 2010

Ligand Pharmaceuticals: GSK granted marketing authorization from EC for Revolade

Ligand Pharmaceuticals Incorporated today announced that GlaxoSmithKline was granted marketing authorization from the European Commission for Revolade® (eltrombopag) for the oral treatment of thrombocytopenia (reduced platelet count) in adults with the blood disorder chronic immune (idiopathic) thrombocytopenic purpura (ITP).

15 Mar 2010

GAVI Alliance reaches agreement with drugmakers on reduced-price pneumococcal vaccines

Several drugmakers have reached an agreement "to supply up to 200 million doses a year of cut-price pneumococcal vaccines to developing nations," according to GAVI Alliance, Reuters reports.

15 Mar 2010

Pharmaceutical News

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

Forensic Laboratories introduces first oral fluid test for Tapentadol

'Vaccine court' finds no link between vaccines and autism

Perrigo introduces generic Zaditor

MannKind receives FDA Complete Response letter for AFREZZA NDA

Ranbaxy resolves generic Actos patent litigation

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

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

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

GTx reacquires full rights to Ostarine

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

NDA for BYDUREON: FDA issues complete response letter

U.S. prescribing information for PLAVIX revised

Sigma-Aldrich and Pfizer sign new agreement

Latest treatment options for colorectal cancer highlighted at NCCN Annual Conference

SafeMinds: Government refusal to compensate vaccine-injured children casts doubt on the integrity of national immunization program

Orexigen Therapeutics, Patheon sign long-term agreement for commercial manufacturing of Contrave

Combination therapy does not reduce cardiovascular risk in type 2 diabetes patients

Ligand Pharmaceuticals: GSK granted marketing authorization from EC for Revolade

GAVI Alliance reaches agreement with drugmakers on reduced-price pneumococcal vaccines

Advancing brain microphysiological systems (bMPS)

PhD researcher at LifeArc

Unveiling Hidden Potential: Organoids for Disease Modeling in Neuroscience Research

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