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Labopharm's trazodone API supplier Angelini resolves manufacturing facility deficiencies

Labopharm Inc. today announced that it has been informed by Angelini, the manufacturer of the active pharmaceutical ingredient (API) for the Company's novel trazodone formulation, that it has received a letter from the U.S. Food and Drug Administration (FDA) stating that Angelini has appropriately addressed all deficiencies cited by the FDA following its inspection of the manufacturing facility in June and July of this year.

8 Oct 2009

Triple therapy may benefit patients with chronic obstructive pulmonary disease

Patients with moderate to severe chronic obstructive pulmonary disease (COPD) can benefit from triple therapy that includes a long-acting β-agonist (LABA), an inhaled corticosteroid (ICS) and an anti-muscarinic agent, according to researchers in Germany.

8 Oct 2009

Zenvia patent application: AVANIR Pharmaceuticals receives USPTO "Notice of Allowance"

AVANIR Pharmaceuticals, Inc. today announced that it has received a “Notice of Allowance” from the United States Patent and Trademark Office (USPTO) announcing that it intends to grant the Company a new patent, extending the period of commercial exclusivity for its lead drug candidate Zenvia™ well into 2025.

8 Oct 2009

Entest BioMedical applies for Phase II grant from National Cancer Institute

Entest BioMedical, Inc. a majority owned subsidiary of Bio-Matrix Scientific Group, Inc. announced today that it has applied for an Exploratory/Development Phase II grant from the National Cancer Institute (NCI).

8 Oct 2009

Amarillo Biosciences, Intas Pharmaceuticals enter strategic partnership to combat influenza in India

Amarillo Biosciences, Inc. today announced that it has agreed to a strategic partnership with Intas Pharmaceuticals Limited (Intas), one of the top 20 pharmaceutical companies in India, whereby Intas will sponsor clinical trials of ABI's orally administered interferon-alpha lozenges in order to combat influenza. Intas will pay ABI a royalty on net sales after marketing approval is obtained in India.

8 Oct 2009

Paper outlines the benefits of how social support can affect behavior change

As waistlines and healthcare costs continue to expand, organizations face an ongoing challenge -- how to change unhealthy employee habits that affect sick time, productivity, and medical expenses. One of the most effective ways to engage employees in workplace wellness programs is having them work with colleagues, family, and friends to reach their goals.

7 Oct 2009

Biostar Pharmaceuticals' new drug application granted clearance for clinical trials

Biostar Pharmaceuticals, Inc. ("Biostar" or "the Company"), a Xianyang-based developer, manufacturer and supplier of pharmaceutical products and medical nutrients addressing a variety of diseases and conditions, today announced that the Chinese Military Drug Administration has granted clearance to begin clinical trials on the Company's new drug application, the Zushima Analgesic Aerosol Spray.

7 Oct 2009

Relypsa commences patient enrollment in Phase 2b clinical trial of RLY5016 for treating hyperkalemia

Relypsa, Inc., today announced the initiation of patient enrollment in the PEARL-HF study, a Phase 2b clinical trial of the company’s lead compound, RLY5016. A novel potassium binder designed for chronic use, RLY5016 is being evaluated in the prevention and treatment of hyperkalemia, for which there are no current satisfactory treatments.

7 Oct 2009

FDA approves Daiichi Sankyo's sNDA for Welchol

Daiichi Sankyo, Inc. (DSI) announced today that the U.S. Food and Drug Administration (FDA) has approved the supplemental new drug application (sNDA) for Welchol® (colesevelam HCl) to be used as an adjunct to diet and exercise for the reduction of elevated low-density lipoprotein cholesterol (LDL-C) in boys and postmenarchal girls, 10 to 17 years of age, with heterozygous familial hypercholesterolemia (heFH) alone or in combination with a statin after failing an adequate trial of diet therapy.

7 Oct 2009

Zelos Therapeutics commences patient dosing of ZT-034 for treating osteoporosis

Zelos Therapeutics, Inc. has initiated patient dosing in a single dose study of three proprietary subcutaneous formulations of ZT-034 (hPTH (1-34), teriparatide). ZT-034 is being developed to compete with Eli Lilly and Company’s Forteo (teriparatide [rDNA origin]) in its existing market of approximately $800M in annual sales in 2008 for the treatment of osteoporosis.

7 Oct 2009

Minimally invasive sling operations for stress urinary incontinence found promising

New, less invasive surgical treatments for stress urinary incontinence in women are just as effective as traditional open surgical approaches, according to Cochrane Researchers. The researchers carried out a systematic review of trials comparing different surgical approaches to treating the condition.

7 Oct 2009

Shire publishes efficacy study results of FOSRENOL and Renagel

Shire plc, the global specialty biopharmaceutical company, today announces the publication in Clinical Nephrology of findings from a head-to-head clinical study comparing the efficacy of two non-calcium based phosphate binders, FOSRENOL(R) (lanthanum carbonate) and sevelamer hydrochloride (Genzyme's Renagel(R)) in chronic kidney disease (CKD) patients on haemodialysis.

7 Oct 2009

DestinationRx celebrates 10th anniversary

DestinationRx celebrated the company’s 10th anniversary with an announcement at the Health 2.0 Conference today. Even as sweeping healthcare reform is debated in Congress, this observance marks an important milestone for the health plan and drug comparison industry leader.

7 Oct 2009

Scientists develop new molecule that can deliver genetic-based drugs into cells

Theresa M. Reineke, associate professor of chemistry in the College of Science, and colleagues in her lab at Virginia Tech and at the University of Cincinnati have developed a new molecule that can travel into cells, deliver genetic cargo, and packs a beacon so scientists can follow its movements in living systems.

7 Oct 2009

GlobeImmune to present an abstract of GI-5005 drug at AASLD's annual meeting

GlobeImmune Inc. today announced that a late breaking abstract related to GI-5005, its investigational hepatitis C virus (HCV) product candidate, has been accepted for presentation at the 60th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD), which will take place Oct. 31 through Nov. 4, 2009, in Boston, Mass.

7 Oct 2009

HHS and PEPFAR approve the 100th HIV/AIDS antiretroviral drug

The U.S. Department of Health and Human Services (HHS) today marked today marked the recent approval of the 100th antiretroviral drug in association with the President's Emergency Plan for AIDS Relief (PEPFAR), aimed at the prevention, treatment, and care of people infected with and affected by HIV/AIDS worldwide.

7 Oct 2009

FDA provides Genzyme a complete response letter for Clolar NDA

Genzyme Corporation announced today that the FDA provided a complete response letter regarding the company's supplemental New Drug Application for Clolar® (clofarabine) in previously untreated older adult patients with acute myeloid leukemia (AML) and at least one unfavorable baseline prognostic factor. The agency recommended a randomized, controlled clinical study be conducted for label expansion of Clolar in this indication.

7 Oct 2009

More studies needed to compare the efficacy of different biologic drugs for RA, say researchers

More studies that directly compare the effectiveness of different biologic drugs for rheumatoid arthritis (RA) are needed, say Cochrane Researchers. The researchers reviewed all previous Cochrane Systematic Reviews assessing the effectiveness of biologic disease-modifying drugs for treatment of RA and found that although all were very effective, there was little data on direct comparisons between the drugs that could help doctors decide which to prescribe.

7 Oct 2009

Opioid drugs may not be effective for osteoarthritis

Should you take opioid drugs for hip and knee pain caused by osteoarthritis? Probably not, suggests a new review of the best research on the subject.

7 Oct 2009

Cochrane Systematic Review finds Abatacept effective against rheumatoid arthritis

Abatacept, a member of a new class of drug that targets immune cells to treat rheumatoid arthritis (RA), is effective against RA, according to a new Cochrane Systematic Review. The review examines recent trials to assess safety and efficacy of the drug.

7 Oct 2009

Efficacy News and Research

Labopharm's trazodone API supplier Angelini resolves manufacturing facility deficiencies

Triple therapy may benefit patients with chronic obstructive pulmonary disease

Zenvia patent application: AVANIR Pharmaceuticals receives USPTO "Notice of Allowance"

Entest BioMedical applies for Phase II grant from National Cancer Institute

Amarillo Biosciences, Intas Pharmaceuticals enter strategic partnership to combat influenza in India

Paper outlines the benefits of how social support can affect behavior change

Biostar Pharmaceuticals' new drug application granted clearance for clinical trials

Relypsa commences patient enrollment in Phase 2b clinical trial of RLY5016 for treating hyperkalemia

FDA approves Daiichi Sankyo's sNDA for Welchol

Zelos Therapeutics commences patient dosing of ZT-034 for treating osteoporosis

Minimally invasive sling operations for stress urinary incontinence found promising

Shire publishes efficacy study results of FOSRENOL and Renagel

DestinationRx celebrates 10th anniversary

Scientists develop new molecule that can deliver genetic-based drugs into cells

GlobeImmune to present an abstract of GI-5005 drug at AASLD's annual meeting

HHS and PEPFAR approve the 100th HIV/AIDS antiretroviral drug

FDA provides Genzyme a complete response letter for Clolar NDA

More studies needed to compare the efficacy of different biologic drugs for RA, say researchers

Opioid drugs may not be effective for osteoarthritis

Cochrane Systematic Review finds Abatacept effective against rheumatoid arthritis

Leveraging the power of automation to boost research

Automating research - solutions and best practices

How can microdialysis benefit drug development

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