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Watson Pharmaceuticals' TRELSTAR receives FDA approval for treatment of advanced prostate cancer

Watson Pharmaceuticals, Inc., today announced the U.S. Food and Drug Administration approval of TRELSTAR® 22.5 mg (triptorelin pamoate for injectable suspension), a new twice-yearly formulation of TRELSTAR®, a proven, simple and effective palliative treatment of advanced prostate cancer.

11 Mar 2010

DSPA's lurasidone NDA accepted for FDA review

Dainippon Sumitomo Pharma America, Inc., a U.S. subsidiary of Dainippon Sumitomo Pharma Co., Ltd., today announced that the U.S. Food and Drug Administration recently accepted for review the lurasidone New Drug Application (NDA) for the treatment of patients with acute schizophrenia. The NDA was submitted to FDA on December 30, 2009 and will receive a standard review.

10 Mar 2010

Idera Pharmaceuticals announces net income of $3.9M for fourth-quarter 2009

Idera Pharmaceuticals, Inc. today reported financial results for the fourth quarter and full year ended December 31, 2009.

10 Mar 2010

Exelixis fourth-quarter revenues rise from $29.6M to $44.1M

Exelixis, Inc. today reported financial results for the fourth quarter and year ended December 31, 2009.

9 Mar 2010

FDA's recommendations over LABAs: AANMA advises patients to make informed decisions

Allergy & Asthma Network Mothers of Asthmatics (AANMA) encourages patients to make informed decisions about recent U.S. Food and Drug Administration (FDA) recommendations affecting patients using asthma medications known as long-acting beta agonists (LABAs) or 12-hour bronchodilators: Advair, Foradil, Serevent and Symbicort.

3 Mar 2010

Merck’s MF/F Phase III study data presented at AAAAI annual meeting

Data from two Phase III studies of Merck’s investigational fixed-dose combinations of mometasone furoate and formoterol fumarate (MF/F) were presented by researchers today in two poster presentations at the American Academy of Allergy, Asthma & Immunology (AAAAI) annual meeting.

3 Mar 2010

Study: LABA can be effective step-up treatment for children whose asthma is not well controlled

For children whose asthma is not well controlled and on low doses of inhaled corticosteroids, a long-acting beta-agonist (LABA) may be the most effective of three possible step-up treatments. National Jewish clinician-scientists Stanley Szefler, Joseph Spahn, Ronina Covar Gary Larsen and Lynn Taussig, and colleagues in the NIH-funded Childhood Asthma Research and Education Network published their findings March 2, 2010, online in the New England Journal of Medicine.

3 Mar 2010

Study: EIB may affect lives and health of public if not addressed properly

For the vast majority of the general public, respiratory symptoms such as shortness of breath, wheezing or coughing are a common part of the exercise experience. However, together with chest tightness, noisy breathing and trouble taking a deep breath, these six symptoms make up the phenomenon known as exercise-induced bronchospasm (EIB), which has physical, emotional and psychological consequences if not addressed properly.

2 Mar 2010

Study shows ghrelin prevents acute liver damage, reduces oxidative stress and inflammation

Spanish researchers determined that rats treated with recombinant ghrelin displayed a reduction in liver fibrosis. Ghrelin, a stomach hormone, reduced the amount of fibrogenic cells by 25% in the treated rodents. Research further showed ghrelin prevented acute liver damage and reduced oxidative stress and inflammation in the animal models.

1 Mar 2010

Adolor announces $14.6M net product sales of ENTEREG for year ended December 31, 2009

Adolor Corporation today reported a net loss of $47.9 million, or $(1.03) per basic and diluted share, for the year ended December 31, 2009, compared to a net loss of $30.1 million, or $(0.65) per basic and diluted share, for the year ended December 31, 2008.

25 Feb 2010

Inverseon comments on LABAs and INV102CR drugs

Inverseon, Inc. (http://www.inverseon.com) comments on Long Acting Beta-Agonists (LABAs) and INV102CR.

25 Feb 2010

FDA's warning over LABA medications for asthma: AANMA offers guidance

Today Allergy & Asthma Network Mothers of Asthmatics (AANMA) offered guidance to help patients understand recent Food and Drug Administration (FDA) warnings about Advair ® (fluticasone and salmeterol), Foradil ® (formoterol), Severent ® (salmeterol) and Symbicort ® (budesonide and formoterol), daily inhaled medications containing a long-acting beta agonist (LABA, a 12-hour bronchodilator).

24 Feb 2010

Idera Pharmaceuticals presents IMO-3100 TLR antagonist mechanism of action data at Keystone conference

Idera Pharmaceuticals, Inc. today presented data on the mechanism of action of IMO-3100, an antagonist of Toll-like Receptor (TLR) 7 and TLR9, in a preclinical primate model at the Keystone Symposia conference “Tolerance and Autoimmunity” being held February 21-26 in Taos, New Mexico. Idera is developing IMO-3100 for the treatment of autoimmune diseases. The presentation entitled “IMO-3100, a novel antagonist, suppresses TLR7- and TLR9-mediated immune responses in non-human primates” was made by Idera scientists.

24 Feb 2010

Obecure granted patent covering betahistine with olanzapine for mitigating antipsychotic drug associated weight gain

Obecure Ltd., a subsidiary of Bio-Light Israeli Life Science Investments Ltd., has received notice of allowance from the US Patent Office for its two key patent applications covering methods of use and compositions covering the use of betahistine with olanzapine for the mitigation of the serious weight gain associated as a side effect of the antipsychotic drug.

23 Feb 2010

FDA's proposed label changes for LABA asthma medications: GSK reviews

GlaxoSmithKline is reviewing label changes proposed today by the US Food and Drug Administration (FDA) for asthma medications containing long-acting beta-agonists (LABAs), such as GSK's Advair (salmeterol / fluticasone propionate). GSK and makers of the other affected medicines containing LABAs have 30 days to agree with the proposed changes or state why they are not warranted.

19 Feb 2010

Asthma: LABAs should not be used alone

The U.S. Food and Drug Administration today announced that drugs in the class of long-acting beta agonists (LABAs) should never be used alone in the treatment of asthma in children or adults. Manufacturers will be required to include this warning in the product labels of these drugs, along with taking other steps to reduce the overall use of these medications.

19 Feb 2010

Marcadia Biotech commences Phase 1 clinical trial of MAR701 for type 2 diabetes

Marcadia Biotech Inc. today announced that it has initiated a Phase 1 clinical trial of MAR701, a novel dual agonist of the incretin hormone receptors for glucagon-like peptide-1 (GLP-1) and gastric inhibitory peptide (GIP). Marcadia plans to initially develop this compound as a treatment for type 2 diabetes with once-weekly dosing. The Phase 1 trial will evaluate MAR701 in healthy volunteers at escalating dose levels.

17 Feb 2010

Obecure enters into licensing and clinical supply agreement with Grunenthal's subsidiary for XR betahistine

Obecure Ltd (http://www.obecure.com)., a subsidiary of Bio-Light Israeli Life Science Investments Ltd., announced today the execution of a licensing and clinical supply agreement with Farmaceutici Formenti SPA, the Italian Subsidiary of the Grunenthal Group.

17 Feb 2010

Positive topline data from Alkermes' phase 1 clinical study of ALKS 37 announced

Alkermes, Inc. today announced positive topline data from a phase 1 clinical study of ALKS 37, an orally active, peripherally-restricted opioid antagonist with potential to block the effects of opioid agonists on gastrointestinal motility, commonly referred to as opioid-induced constipation (OIC).

16 Feb 2010

Fourth-quarter and full-year 2009 results announced by Vanda Pharmaceuticals

Vanda Pharmaceuticals Inc., a biopharmaceutical company focused on the development and commercialization of clinical-stage products for central nervous system disorders, today announced financial and operational results for the fourth quarter and full year ended December 31, 2009.

16 Feb 2010

Agonist News and Research

Watson Pharmaceuticals' TRELSTAR receives FDA approval for treatment of advanced prostate cancer

DSPA's lurasidone NDA accepted for FDA review

Idera Pharmaceuticals announces net income of $3.9M for fourth-quarter 2009

Exelixis fourth-quarter revenues rise from $29.6M to $44.1M

FDA's recommendations over LABAs: AANMA advises patients to make informed decisions

Merck’s MF/F Phase III study data presented at AAAAI annual meeting

Study: LABA can be effective step-up treatment for children whose asthma is not well controlled

Study: EIB may affect lives and health of public if not addressed properly

Study shows ghrelin prevents acute liver damage, reduces oxidative stress and inflammation

Adolor announces $14.6M net product sales of ENTEREG for year ended December 31, 2009

Inverseon comments on LABAs and INV102CR drugs

FDA's warning over LABA medications for asthma: AANMA offers guidance

Idera Pharmaceuticals presents IMO-3100 TLR antagonist mechanism of action data at Keystone conference

Obecure granted patent covering betahistine with olanzapine for mitigating antipsychotic drug associated weight gain

FDA's proposed label changes for LABA asthma medications: GSK reviews

Asthma: LABAs should not be used alone

Marcadia Biotech commences Phase 1 clinical trial of MAR701 for type 2 diabetes

Obecure enters into licensing and clinical supply agreement with Grunenthal's subsidiary for XR betahistine

Positive topline data from Alkermes' phase 1 clinical study of ALKS 37 announced

Fourth-quarter and full-year 2009 results announced by Vanda Pharmaceuticals

Industry Focus eBook - Neurology/Neuroscience - 2nd edition eBook

Bringing real-time analytics to downstream bioprocess monitoring

Designing fluidic architecture for scalable diagnostic platforms

Evaluating new approaches for rare disease genomics

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