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EC approves Vertex's KALYDECO for treatment of cystic fibrosis

Vertex Pharmaceuticals Incorporated announced today that the European Commission has approved KALYDECOTM (ivacaftor) for people with cystic fibrosis (CF) ages 6 and older who have at least one copy of the G551D mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.

28 Jul 2012

Long-term linagliptin effective treatment for Type 2 diabetes

Linagliptin is an effective and well-tolerated therapy for the long-term management of Type 2 diabetes, say the authors of an open-label extension study published in the International Journal of Clinical Practice.

27 Jul 2012

Anakinra can dramatically limit amount of brain damage in stroke patients

Scientists led by the President of The University of Manchester have demonstrated a drug which can dramatically limit the amount of brain damage in stroke patients.

From The University of Manchester 27 Jul 2012

FDA approves Horizon Pharma's RAYOS to treat key IL-6 mediated diseases

Horizon Pharma, Inc., announced today that the U.S. Food and Drug Administration (FDA) has approved RAYOS (prednisone) delayed-release tablets (1 mg, 2 mg and 5 mg) to treat a broad range of diseases including rheumatoid arthritis (RA), polymyalgia rheumatica (PMR), psoriatic arthritis (PsA), ankylosing spondylitis (AS), asthma and chronic obstructive pulmonary disease (COPD).

26 Jul 2012

Preliminary findings from Protalex's PRTX-100 Phase 1b study on active rheumatoid arthritis

Protalex, Inc., a clinical stage biopharmaceutical company that is developing a class of drugs designed to treat a wide array of autoimmune and inflammatory diseases today announced preliminary findings from its recently completed Phase 1b randomized, multiple-dose, dose-escalation study.

26 Jul 2012

Takeda, Sucampo file AMITIZA sNDA with FDA for treatment of opioid-induced constipation

Sucampo Pharmaceuticals, Inc. and Takeda Pharmaceuticals U.S.A. Inc. today announced the filing of a supplemental new drug application (sNDA) with the US Food and Drug Administration (FDA) seeking approval for a new indication for AMITIZA (lubiprostone) for the treatment of opioid-induced constipation (OIC) in patients with chronic, non-cancer pain.

26 Jul 2012

Insomnia: an interview with Dr Darryle Schoepp

Insomnia is a very common disorder. In medical terms it can affect a third of people. It affects elderly as well as non-elderly people, and is more common in women.

26 Jul 2012

Raising dopamine levels in frontal cortex reduces impulsivity in healthy adults

Raising levels of the neurotransmitter dopamine in the frontal cortex of the brain significantly decreased impulsivity in healthy adults, in a study conducted by researchers at the Ernest Gallo Clinic and Research Center at the University of California, San Francisco.

26 Jul 2012

Combination of two stress hormones shuts down brain activity for goal-directed behaviour

Cognition psychologists at the Ruhr-Universit-t together with colleagues from the University Hospital Bergmannsheil (Prof. Dr. Martin Tegenthoff) have discovered why stressed persons are more likely to lapse back into habits than to behave goal-directed. The team of PD Dr. Lars Schwabe and Prof. Dr. Oliver Wolf from the Institute for Cognitive Neuroscience have mimicked a stress situation in the body using drugs.

26 Jul 2012

CytRx commences aldoxorubicin plus doxorubicin Phase 1b trial in advanced solid tumors

CytRx Corporation, a biopharmaceutical company specializing in oncology, today announced the initiation of a Phase 1b clinical trial to determine the maximum tolerated dose and to evaluate preliminary efficacy of aldoxorubicin (formerly INNO-206) administered in combination with the commonly used chemotherapeutic agent doxorubicin in patients with advanced solid tumors who have failed other therapies.

26 Jul 2012

EC grants Marketing Authorisation to Boehringer Ingelheim and Lilly’s Jentadueto for diabetes

Boehringer Ingelheim and Eli Lilly and Company received Marketing Authorisation from the European Commission for Jentadueto which combines the DPP-4 inhibitor, linagliptin and metformin in a single tablet.

25 Jul 2012

Elan second quarter total revenue increases 6% to $288.0 million

Elan Corporation, plc today reported its second quarter and first half 2012 financial results.

25 Jul 2012

Dapivirine Phase III trial now underway in Africa to treat HIV in women

A large clinical trial testing the long-term safety and effectiveness of a new approach for preventing HIV in women - a vaginal ring used once a month - is now underway in Africa, researchers announced today at the XIX International AIDS Conference (AIDS 2012).

25 Jul 2012

Favorable results from BioCryst’s ulodesine plus allopurinol Phase 2b trial on gout

BioCryst Pharmaceuticals, Inc. announced favorable 52-week safety results and sustained efficacy from the extension phase of its randomized Phase 2b trial of ulodesine (BCX4208) added to allopurinol in patients with gout who had failed to reach the serum uric acid (sUA) therapeutic goal of <6 mg/dL on allopurinol alone, as well as positive Phase 2 safety results in patients with mild to moderate renal impairment.

25 Jul 2012

Latest polypill trial yields largest improvements yet

The results of the first trial to administer the polypill on the basis of age alone has shown the largest reductions in blood pressure and cholesterol level of any polypill trial to date, researchers report.

24 Jul 2012

VEGF inhibitor fails to improve nonsquamous NSCLC overall survival

Adding motesanib to carboplatin–paclitaxel does not boost overall survival in patients with advanced nonsquamous non-small-cell lung cancer, including those with adenocarcinoma, say MONET1 investigators.

24 Jul 2012

Findings cast doubt on sepsis drug withdrawal

A meta-analysis of clinical trial and real-world data suggests that drotrecogin alfa may in fact reduce mortality in patients with severe sepsis.

24 Jul 2012

Topline results from first of four Phase 3 studies of Pfizer's bapineuzumab for Alzheimer's

Pfizer Inc. announced today that the co-primary clinical endpoints, change in cognitive and functional performance compared to placebo, were not met in the Janssen Alzheimer Immunotherapy R&D LLC (Janssen AI)-led Phase 3 trial of intravenous (IV) bapineuzumab in patients with mild-to-moderate Alzheimer's disease who carry the ApoE4 (apolipoprotein E epsilon 4) genotype.

24 Jul 2012

Pfizer’s Lyrica does not affect reproductive function in healthy males

Pfizer Inc. announced today that top-line results for Lyrica (pregabalin) capsules CV Study A0081104 - Assessment of the Impact of Lyrica on Sperm Production in Healthy Volunteers - demonstrate that Lyrica does not affect the reproductive function in healthy males when compared to placebo.

24 Jul 2012

Top-line result from Pfizer Bapineuzumab Phase 3 studies on Alzheimer's

Elan Corporation, plc announced today that Pfizer has issued a top-line result in the first of four Bapineuzumab Phase 3 studies carried out by Pfizer and Janssen AI.

24 Jul 2012

Placebo News and Research

EC approves Vertex's KALYDECO for treatment of cystic fibrosis

Long-term linagliptin effective treatment for Type 2 diabetes

Anakinra can dramatically limit amount of brain damage in stroke patients

FDA approves Horizon Pharma's RAYOS to treat key IL-6 mediated diseases

Preliminary findings from Protalex's PRTX-100 Phase 1b study on active rheumatoid arthritis

Takeda, Sucampo file AMITIZA sNDA with FDA for treatment of opioid-induced constipation

Insomnia: an interview with Dr Darryle Schoepp

Raising dopamine levels in frontal cortex reduces impulsivity in healthy adults

Combination of two stress hormones shuts down brain activity for goal-directed behaviour

CytRx commences aldoxorubicin plus doxorubicin Phase 1b trial in advanced solid tumors

EC grants Marketing Authorisation to Boehringer Ingelheim and Lilly’s Jentadueto for diabetes

Elan second quarter total revenue increases 6% to $288.0 million

Dapivirine Phase III trial now underway in Africa to treat HIV in women

Favorable results from BioCryst’s ulodesine plus allopurinol Phase 2b trial on gout

Latest polypill trial yields largest improvements yet

VEGF inhibitor fails to improve nonsquamous NSCLC overall survival

Findings cast doubt on sepsis drug withdrawal

Topline results from first of four Phase 3 studies of Pfizer's bapineuzumab for Alzheimer's

Pfizer’s Lyrica does not affect reproductive function in healthy males

Top-line result from Pfizer Bapineuzumab Phase 3 studies on Alzheimer's

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How Omics Technologies Are Transforming Biological Research and Drug Discovery

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