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GSK Consumer Healthcare applauds two smoking cessation organizations for improving smoking cessation aids

GlaxoSmithKline Consumer Healthcare, marketer of nicotine replacement therapy (NRT) products, including Nicorette®, NicoDerm® CQ® and Commit®, applauds two leading smoking cessation organizations for their efforts to improve the regulation of smoking cessation aids designed to help people quit smoking.

18 Feb 2010

Javelin Pharmaceuticals’ Dyloject NDA receives FDA PDUFA date

Javelin Pharmaceuticals, Inc., a leading developer and marketer of specialty pharmaceutical products for pain management, today announced that its New Drug Application (NDA) submitted on December 2, 2009 to the US Food and Drug Administration (FDA) for its investigational product candidate, Dyloject™ (diclofenac sodium) Injection, has received an FDA PDUFA date of October 3, 2010. This NDA review is in support of US marketing approval and registration of Dyloject for the management of acute moderate-to-severe pain in adults.

18 Feb 2010

Tioga Pharmaceuticals to utilize $18M equity funding for Phase 3 clinical trial of asimadoline

Tioga Pharmaceuticals, Inc. today announced the closing of an $18 million equity financing. Current investors Forward Ventures, New Leaf Venture Partners and BB Biotech Ventures were joined by new investor Genesys Capital Partners.

17 Feb 2010

FDA clears Otonomy's IND for clinical trial of OTO-104 in Meniere's disease patients

Otonomy, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted clearance of the company's Investigational New Drug (IND) application for the clinical trial of OTO-104 in patients with Meniere's disease, a debilitating disorder of the inner ear affecting balance and hearing.

17 Feb 2010

Phase III study: GARDASIL prevents 77.5% of pre-cursor lesions to anal cancer

In a new phase III study, GARDASIL(R) (Quadrivalent Human Papillomavirus (Types 6, 11, 16 and 18) Recombinant Vaccine) prevented 77.5 per cent of anal intraepithelial neoplasia (AIN) associated with human papillomavirus (HPV) types 6, 11, 16 and 18 in 16-to-26 year-old men who have sex with men.

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

Postmenopausal women undergoing combination hormone therapy at increased risk of heart disease: WHI confirms

New analyses from the Women's Health Initiative (WHI) confirm that combination hormone therapy increases the risk of heart disease in healthy postmenopausal women. Researchers report a trend toward an increased risk of heart disease during the first two years of hormone therapy among women who began therapy within 10 years of menopause, and a more marked elevation of risk among women who began hormone therapy more than 10 years after menopause. Analyses indicate that overall a woman's risk of heart disease more than doubles within the first two years of taking combination HT.

17 Feb 2010

Oxytocin hormone improves social behavior in autistic patients

Autism is a disease characterized by difficulties in communicating effectively with other people and developing social relationships. The team led by Angela Sirigu at the Centre de Neuroscience Cognitive (CNRS) has shown that the inhalation of oxytocin, a hormone known to promote mother-infant bonds and social relationships, significantly improved the abilities of autistic patients to interact with other individuals.

17 Feb 2010

Adding daclizumab to standard treatment reduces enlarged brain lesions in patients with relapsing MS

An international team of researchers has found that adding a humanized monoclonal antibody called daclizumab to standard treatment reduces the number of new or enlarged brain lesions in patients with relapsing multiple sclerosis. This new study was published online Feb. 16, 2010, and in the March edition of the Lancet Neurology.

17 Feb 2010

Combination of daclizumab and interferon beta significantly reduces MS lesion formation

Biogen Idec and Facet Biotech Corporation today announced the publication of Phase 2 data showing that the addition of daclizumab to interferon beta (IFNβ) led to a significant reduction in the number of new or enlarged multiple sclerosis (MS) lesions when compared to IFNβ alone in patients with active relapsing forms of MS.

17 Feb 2010

Embera NeuroTherapeutics establishes clinical development partnership for its cocaine dependence program

Embera NeuroTherapeutics, Inc., a specialty pharmaceutical company developing novel treatments for drug dependence, smoking cessation and obesity, announced today that the company has retained Exponential Pharma Ventures LLC to assist in establishing a clinical development partnership for its cocaine dependence program with a fully integrated pharmaceutical company.

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

Oncolytics Biotech receives U.K. MHRA approval for REOLYSIN combination Phase 3 trial

Oncolytics Biotech Inc. today announced that it has received a letter of approval from the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) to conduct its Phase 3 trial examining REOLYSIN in combination with paclitaxel and carboplatin in patients with platinum-refractory head and neck cancers. This is the same trial that the Company previously reached an agreement on with the U.S. Food and Drug Administration (FDA) under the Special Protocol Assessment (SPA) process.

16 Feb 2010

Medivir, Meda announce agreement to commercialize Medivir’s cold sore product, Xerese

Medivir and Meda today announced an agreement for the commercialization of Medivir’s cold sore product which will be marketed in North America under the trade name Xerese™.

15 Feb 2010

Botulinum injection used for cosmetic purposes may reduce migraine headaches

A preliminary study suggests the same type of botulinum injection used for cosmetic purposes may be associated with reduced frequency of migraine headaches that are described as crushing, vicelike or eye-popping (ocular), but not pain that is experienced as a buildup of pressure inside the head, according to a report in the February issue of Archives of Dermatology, one of the JAMA/Archives journals.

15 Feb 2010

Ragweed pollen allergy: SLIT safe and effective alternative to injections

An oral allergy treatment administered in drops under the tongue is a safe and effective alternative to injections for adults who are allergic to ragweed pollen, according to a study published today in the Journal of Allergy and Clinical Immunology by allergic disease specialist at Allegheny General Hospital.

15 Feb 2010

Encouraging results from Circassia's ToleroMune ragweed allergy T-cell vaccine phase II clinical trial

Circassia Ltd, a specialty biopharmaceutical company focused on allergy, today announced that its ToleroMune(R) ragweed allergy T-cell vaccine achieved positive results in a recently completed phase II clinical trial. Ragweed allergy is particularly common in America, where it affects approximately 25% of the population. Circassia's latest clinical results follow two earlier successful phase II studies with the company's T-cell vaccine against cat allergy.

12 Feb 2010

Third party reexamination of Phase III study of Ereska meets primary endpoint

Javelin Pharmaceuticals, Inc. today announced that a reexamination conducted by a third party of pain score measurements from its Phase III study of Ereska™ (intranasal ketamine) showed that top line results for its primary endpoint were statistically significant. Previously, Javelin had reported that the top line results for its primary endpoint were not statistically significant.

12 Feb 2010

Genzyme announces 2-year data from eliglustat tartrate Phase 2 trial for Gaucher disease

Genzyme Corporation announced today two-year follow-up data from patients enrolled in the phase 2 clinical trial for its investigational oral therapy for Gaucher disease type 1 known as eliglustat tartrate (formerly Genz-112638). Continued improvements were observed across all endpoints, including bone disease, at the two-year timepoint, compared with baseline. The two-year results were presented for the first time today at the Lysosomal Disease Network WORLD Symposium in Miami, Fla.

12 Feb 2010

First FDA-approved umbilical cord blood stem cells infusion trial in children with cerebral palsy

Medical College of Georgia researchers are conducting the first FDA-approved clinical trial to determine whether an infusion of stem cells from umbilical cord blood can improve the quality of life for children with cerebral palsy.

12 Feb 2010

Placebo News and Research

GSK Consumer Healthcare applauds two smoking cessation organizations for improving smoking cessation aids

Javelin Pharmaceuticals’ Dyloject NDA receives FDA PDUFA date

Tioga Pharmaceuticals to utilize $18M equity funding for Phase 3 clinical trial of asimadoline

FDA clears Otonomy's IND for clinical trial of OTO-104 in Meniere's disease patients

Phase III study: GARDASIL prevents 77.5% of pre-cursor lesions to anal cancer

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

Postmenopausal women undergoing combination hormone therapy at increased risk of heart disease: WHI confirms

Oxytocin hormone improves social behavior in autistic patients

Adding daclizumab to standard treatment reduces enlarged brain lesions in patients with relapsing MS

Combination of daclizumab and interferon beta significantly reduces MS lesion formation

Embera NeuroTherapeutics establishes clinical development partnership for its cocaine dependence program

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

Oncolytics Biotech receives U.K. MHRA approval for REOLYSIN combination Phase 3 trial

Medivir, Meda announce agreement to commercialize Medivir’s cold sore product, Xerese

Botulinum injection used for cosmetic purposes may reduce migraine headaches

Ragweed pollen allergy: SLIT safe and effective alternative to injections

Encouraging results from Circassia's ToleroMune ragweed allergy T-cell vaccine phase II clinical trial

Third party reexamination of Phase III study of Ereska meets primary endpoint

Genzyme announces 2-year data from eliglustat tartrate Phase 2 trial for Gaucher disease

First FDA-approved umbilical cord blood stem cells infusion trial in children with cerebral palsy

Sensing a Healthier Future

Achieving and maintaining ISO/IEC 27001 and BS 10012 certifications

Expanding research and clinical options for children with cancer

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