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Bristol-Myers Squibb and AstraZeneca receive marketing authorisation for ONGLYZA in Europe

Bristol-Myers Squibb Company and AstraZeneca announced today that the European Commission has granted marketing authorisation for ONGLYZATM in the 27 countries of the European Union.

5 Oct 2009

Alnara to announce Phase 3 study results of liprotamase for treating cystic fibrosis at the 23rd NACFC

Alnara Pharmaceuticals, Inc., a pharmaceutical company developing novel, non-systemic orally-delivered protein therapeutics for the treatment of metabolic diseases, announced today that results from a landmark, international Phase 3 study of the long-term safety and nutritional benefits of liprotamase for the treatment of pancreatic insufficiency in patients with cystic fibrosis (CF) will be presented at the 23rd Annual North American Cystic Fibrosis Conference (NACFC) being held October 15-17, 2009 in Minneapolis, Minnesota.

5 Oct 2009

Baxter launches HYLENEX recombinant for pediatric rehydration at the 2009 ACEP

Baxter International Inc. today announced the commercial launch of HYLENEX recombinant (hyaluronidase human injection) for use in pediatric rehydration at the 2009 American College of Emergency Physicians (ACEP) scientific assembly (Boston). HYLENEX, an enzyme, allows fluids to be administered under the skin (subcutaneously) rather than through a vein.

From Baxter International Inc. 5 Oct 2009

Preclinical study results of AVL-181 protease inhibitor presented

Avila Therapeutics, Inc., a biotechnology company developing novel covalent drugs that treat diseases through protein silencing, presented results of preclinical studies on its highly selective, pan-genotype, small molecule Hepatitis C Virus (HCV) protease inhibitor, AVL-181.

5 Oct 2009

Positive results from Depomed's Phase 3 clinical trial of DM-1796 for postherpetic neuralgia

Depomed, Inc. today announced top-line results from a Phase 3 clinical trial demonstrating DM-1796 (also referred to as gabapentin ER) achieved a statistically significant reduction in pain associated with postherpetic neuralgia (PHN) versus placebo using the baseline observation carried forward (BOCF) method required by FDA.

5 Oct 2009

GVK Biosciences and Quantitative Solutions to develop and market clinical trial outcome databases

GVK Biosciences (GVK BIO), Asia’s leading integrated research services provider and Quantitative Solutions (QS), a modeling and simulation (M&S) consultancy to the pharmaceutical and biotech industry, announced a strategic partnership to develop and market clinical trial outcome databases.

5 Oct 2009

Phase I clinical trial results to test the safety and immunogenicity of VGX-3100 released

Inovio Biomedical Corporation, a leader in DNA vaccine design, development and delivery, announced today interim safety and immunogenicity data from its therapeutic cervical cancer vaccine (VGX-3100) trial. VGX-3100 is a DNA vaccine targeting the E6 and E7 proteins of human papillomavirus (HPV) types 16 and 18 and is delivered via in vivo electroporation.

5 Oct 2009

Genentech announces two Phase III study results of Lucentis

Genentech, Inc., a wholly-owned member of the Roche Group, today announced results from two Phase III studies of Lucentis (ranibizumab injection) in macular edema due to retinal vein occlusion (RVO), which showed, on average, patients given either of two doses of Lucentis had a clinically and statistically significant improvement in vision as measured by the primary endpoint of mean change from baseline in best-corrected visual acuity (BCVA) at six months compared to patients receiving sham injections.

5 Oct 2009

Radiofrequency ablation used to treat snoring patients

Radiofrequency ablation, a procedure that uses heat to shrink the tissue of the soft palate, is an effective and minimally invasive procedure that can be used to treat patients who snore.

5 Oct 2009

Lawsuit filed against MultiCare Health System for unilaterally implementing a mandatory vaccination policy

Washington State Nurses Association (WSNA), representing more than 16,000 registered nurses in Washington State, has filed a lawsuit in federal court against MultiCare Health System for unilaterally implementing a mandatory vaccination policy. This new policy will force nurses to get the flu vaccination or to wear face masks as a condition of employment and may result in the firing of nurses who do not comply with the policy.

3 Oct 2009

Report on the worldwide market for anti-infectives

Drug resistance is a key public health problem and also a problem for makers of branded antibacterial products, according to the findings of a new report. Traditional antibiotics: quinolones, cephalosporins, and penicillins, have seen their market share erode due to loss of effectiveness, while at the same time they are facing heavy generic competition.

3 Oct 2009

Surgical masks nearly as effective as N95 respirators in protecting health care workers against influenza

Surgical masks appear to be no worse than, and nearly as effective as N95 respirators in preventing influenza in health care workers, according to a study released early online today by JAMA. The study was posted online ahead of print because of its public health implications. It will be published in the November 4 issue of JAMA.

3 Oct 2009

Cardium announces positive results from the Phase 1 / 2 clinical study of Excellarate

Cardium Therapeutics announced plans to report on preliminary safety and efficacy data from its Matrix Phase 2b Excellarate clinical study. Based on guidance from Cardium's independent clinical data management company which is currently completing the statistical analysis of all data for the Matrix clinical trial, Cardium expects to receive the locked unblinded data set and be in position to announce preliminary results on or before October 14, 2009.

3 Oct 2009

Quest PharmaTech acquires immunotherapeutic antibody products from Paladin Labs

Quest PharmaTech Inc. ("Quest" or the "Company"), a pharmaceutical company developing and commercializing products for the treatment of cancer, today announced that it has acquired a pipeline of late-stage immunotherapy product candidates from Paladin Labs Inc. ("Paladin").

3 Oct 2009

Clinical study data of Thymosin beta 4 presented

REGENERX BIOPHARMACEUTICALS, INC. today reported on several clinical studies with Thymosin beta 4 (Tβ4) presented the Second International Symposium on Thymosins in Health and Disease, in Catania, Italy.

3 Oct 2009

Avexa's ATC Phase III study concludes

Avexa Limited today announced that the apricitabine (ATC) Phase III study will be closed and the data will be subsequently unblinded and analyzed. After extensive interaction with the regulatory authorities and potential partners, the decision was made to evaluate the 24 week data with the results due in the first quarter of 2010.

3 Oct 2009

KYTHERA Biopharmaceuticals presents its two Phase 2 clinical study results

KYTHERA Biopharmaceuticals, Inc. (KYTHERA) today presented detailed results from two double-blind Phase 2 studies, each designed to evaluate the safety and effectiveness of ATX-101, a first-in-class injectable drug for the reduction of small volumes of fat.

3 Oct 2009

Five-year follow-up study reveals the efficacy of OsseoSpeed implant

The five-year follow-up study was made by Dr. Steveling and co-workers at the Department of Oral and Maxillofacial Surgery at the Heidelberg University in Germany. The conclusion is that the OsseoSpeed implant shows very good results also in compromised sites when using an early loading protocol.

3 Oct 2009

FDA grants Fast Track designation to Corthera's relaxin for treating acute heart failure

Corthera Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to relaxin, the company's investigational drug for the treatment of acute heart failure (AHF). The Fast Track program facilitates the development and expedites the review of new drugs intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs.

3 Oct 2009

CNN, TIME examine increasing antibiotic resistance

CNN examines a recent report by researchers that warns of increasing antibiotic resistance and appeals for governments to take action to develop new antibiotics to avert a health crisis.

3 Oct 2009

Efficacy News and Research

Bristol-Myers Squibb and AstraZeneca receive marketing authorisation for ONGLYZA in Europe

Alnara to announce Phase 3 study results of liprotamase for treating cystic fibrosis at the 23rd NACFC

Baxter launches HYLENEX recombinant for pediatric rehydration at the 2009 ACEP

Preclinical study results of AVL-181 protease inhibitor presented

Positive results from Depomed's Phase 3 clinical trial of DM-1796 for postherpetic neuralgia

GVK Biosciences and Quantitative Solutions to develop and market clinical trial outcome databases

Phase I clinical trial results to test the safety and immunogenicity of VGX-3100 released

Genentech announces two Phase III study results of Lucentis

Radiofrequency ablation used to treat snoring patients

Lawsuit filed against MultiCare Health System for unilaterally implementing a mandatory vaccination policy

Report on the worldwide market for anti-infectives

Surgical masks nearly as effective as N95 respirators in protecting health care workers against influenza

Cardium announces positive results from the Phase 1 / 2 clinical study of Excellarate

Quest PharmaTech acquires immunotherapeutic antibody products from Paladin Labs

Clinical study data of Thymosin beta 4 presented

Avexa's ATC Phase III study concludes

KYTHERA Biopharmaceuticals presents its two Phase 2 clinical study results

Five-year follow-up study reveals the efficacy of OsseoSpeed implant

FDA grants Fast Track designation to Corthera's relaxin for treating acute heart failure

CNN, TIME examine increasing antibiotic resistance

Leveraging the power of automation to boost research

Automating research - solutions and best practices

How can microdialysis benefit drug development

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