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Health Canada approves Trajenta (linagliptin) for type 2 diabetes

Boehringer Ingelheim Canada and Eli Lilly Canada today announced that Health Canada has approved Trajenta (linagliptin), a new oral therapy to improve glycemic control in Canadian adults with type 2 diabetes.

3 Oct 2011

Alkermes initiates ALKS 37 phase 2b study in opioid-induced constipation

Alkermes plc today announced the initiation of a phase 2b study of ALKS 37, an orally active, peripherally restricted opioid antagonist for the treatment of opioid-induced constipation.

3 Oct 2011

EMA accepts Inspiration's IB1001 MAA for treatment of hemophilia B

Inspiration Biopharmaceuticals, Inc. today announced that the European Medicines Agency (EMA) has validated and accepted the filing of the Marketing Authorization Application (MAA) for Inspiration's IB1001, a recombinant factor IX (FIX) product for the treatment and prevention of bleeding in individuals with hemophilia B.

3 Oct 2011

Residential treatment may motivate young adults with addiction for recovery

Young adults undergoing addiction treatment arrive ready and willing to make the personal changes that bring about recovery, but it's the help and guidance received during treatment that build and sustain those changes, according to a longitudinal study published electronically and in press within the journal Drug and Alcohol Dependence.

1 Oct 2011

Bristol-Myers to present abstracts on research in liver disease at The Liver Meeting 2011

Bristol-Myers Squibb Company announced today that 22 abstracts on the Company's research in liver disease have been accepted for presentation at The Liver Meeting 2011, the 62nd annual meeting of the American Association for the Study of Liver Diseases, in San Francisco, November 4 - 8.

1 Oct 2011

Novel bipartite gene therapy for retinitis pigmentosa

In a paper published in the October 2011 issue of Experimental Biology and Medicine, a team of researchers at Columbia University Medical Center led by Stephen Tsang, MD, Ph.D have achieved temporary functional preservation of photoreceptors in a mouse model for retinitis pigmentosa (RP) using novel bipartite gene therapy.

1 Oct 2011

Researchers identify protein-based blood biomarkers in patients treated with EPO

Biomarkers in the bloodstream could provide a rapid assessment of therapeutic intervention in ischemic stroke and allow patient stratification

1 Oct 2011

New analyses from Phase III studies of VICTRELIS to be presented at AASLD 2011

Merck, known as MSD outside of the United States and Canada, announced today that several new analyses from Phase III studies of VICTRELIS (boceprevir), the company's first-in-class, oral hepatitis C virus NS3/4A protease inhibitor will be presented at the 62nd Annual Meeting of the American Association for the Study of Liver Diseases.

1 Oct 2011

Vertex announces abstracts from hepatitis C program to be presented at The Liver Meeting

Vertex Pharmaceuticals Incorporated today announced that abstracts from its hepatitis C program, including two late-breaking posters from studies of INCIVEK (telaprevir) tablets and VX-222, were accepted for presentation at The Liver Meeting, the 62nd Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) in San Francisco, November 4-8, 2011.

1 Oct 2011

Baxter seeks European marketing authorization for HyQ to treat PI

Baxter International Inc. announced today that it has submitted an application to the European Medicines Agency's Committee for Human Medicinal Products seeking marketing authorization for HyQ. HyQ is Baxter's investigational immunoglobulin (IG) therapy administered subcutaneously and facilitated by recombinant human hyaluronidase, a dispersion and permeation enhancer, for use in patients with primary immunodeficiencies.

From Baxter International Inc. 1 Oct 2011

JenaValve's transapical TAVI system receives CE mark approval to treat aortic valve stenosis

JenaValve Technology GmbH, a German medical device company specializing in the development of transcatheter heart valve implantation systems, announced today that the Company has received CE mark approval for its transapical TAVI system of the second-generation. This system is used to treat severe aortic valve stenosis in elderly high-risk patients, especially in patients for whom conventional open-heart surgery is not an option.

1 Oct 2011

Four teams receive commercialization grant awards for development of new health-care products

Four Washington-based teams of investigators will receive up to $150,000 each to support commercial development of new health and health-care products, the Life Sciences Discovery Fund announced today.

30 Sep 2011

Array announces results from selumetinib Phase 2 combination study on KRAS-mutant NSCLC

Array BioPharma Inc. today announced results from a randomized Phase 2 placebo-controlled study conducted by AstraZeneca comparing the efficacy of selumetinib in combination with docetaxel with docetaxel alone in the second-line treatment of 87 patients prospectively selected with KRAS-mutant, locally advanced or metastatic non-small cell lung cancer.

30 Sep 2011

Enrollment begins in Boston Scientific's vagal nerve stimulation trial for heart failure

Boston Scientific Corporation has enrolled the first patients in its NECTAR-HF (NEural Cardiac TherApy foR Heart Failure) clinical trial. NECTAR-HF is a prospective, randomized, international clinical feasibility study designed to assess preliminary safety and efficacy of chronic vagal nerve stimulation in heart failure patients.

30 Sep 2011

Almirall seeks European approval for linaclotide to treat irritable bowel syndrome with constipation

Almirall, S.A. announced today that it has submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) for linaclotide, an investigational guanylate cyclase-C (GC-C) receptor agonist for the treatment of irritable bowel syndrome with constipation (IBS-C). Once approved, linaclotide will be marketed in Europe under the trademark Constella®.

29 Sep 2011

Appalachia pediatricians less likely to encourage HPV vaccination than other area doctors

Pediatricians in Appalachia are less likely than doctors in other areas to encourage parents to have their children receive the human papillomavirus (HPV) vaccine, according to a new study.

29 Sep 2011

Positive new data from Otonomy's OTO-104 Phase 1b study on Meniere's disease

Otonomy, Inc., a clinical stage biopharmaceutical company developing innovative therapeutics for diseases and disorders of the inner and middle ear, today announced that researchers presented positive new data from a Phase 1b study of the company's lead product candidate, OTO-104, in patients with Meniere's disease.

29 Sep 2011

WSJ: Federal judge advances medical records case

The lawsuit, brought by the newspaper's publisher, seeks to overturn an injunction that keeps the public from being able to see Medicare billing records. In related news, The Fiscal Times examines Medicare waste and improper payments.

29 Sep 2011

Almirall submits linaclotide MAA to EMA for treatment of IBS-C

Ironwood Pharmaceuticals, Inc. today announced that its European partner Almirall, S.A. submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for linaclotide, a guanylate cyclase type-C (GC-C) agonist, for the treatment of irritable bowel syndrome with constipation.

29 Sep 2011

VOICE HIV prevention trial to discontinue use of tenofovir tablets

VOICE, an HIV prevention trial evaluating two antiretroviral (ARV)-based approaches for preventing the sexual transmission of HIV in women - daily use of one of two different ARV tablets or of a vaginal gel - will be dropping one of the oral tablets from the study.

29 Sep 2011

Efficacy News and Research

Health Canada approves Trajenta (linagliptin) for type 2 diabetes

Alkermes initiates ALKS 37 phase 2b study in opioid-induced constipation

EMA accepts Inspiration's IB1001 MAA for treatment of hemophilia B

Residential treatment may motivate young adults with addiction for recovery

Bristol-Myers to present abstracts on research in liver disease at The Liver Meeting 2011

Novel bipartite gene therapy for retinitis pigmentosa

Researchers identify protein-based blood biomarkers in patients treated with EPO

New analyses from Phase III studies of VICTRELIS to be presented at AASLD 2011

Vertex announces abstracts from hepatitis C program to be presented at The Liver Meeting

Baxter seeks European marketing authorization for HyQ to treat PI

JenaValve's transapical TAVI system receives CE mark approval to treat aortic valve stenosis

Four teams receive commercialization grant awards for development of new health-care products

Array announces results from selumetinib Phase 2 combination study on KRAS-mutant NSCLC

Enrollment begins in Boston Scientific's vagal nerve stimulation trial for heart failure

Almirall seeks European approval for linaclotide to treat irritable bowel syndrome with constipation

Appalachia pediatricians less likely to encourage HPV vaccination than other area doctors

Positive new data from Otonomy's OTO-104 Phase 1b study on Meniere's disease

WSJ: Federal judge advances medical records case

Almirall submits linaclotide MAA to EMA for treatment of IBS-C

VOICE HIV prevention trial to discontinue use of tenofovir tablets

Achieving and maintaining ISO/IEC 27001 and BS 10012 certifications

Expanding research and clinical options for children with cancer

Examining how pain could play a direct protective role in the gut

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