Contrave (naltrexone SR/bupropion SR), an investigational drug aimed at combination therapy to address both biological and behavioral drivers of obesity, will be developed and commercialized by Orexigen Therapeutics, Inc. and Takeda Pharmaceutical Company Limited in the USA, Canada and Mexico. The two drug firms have just signed an exclusive partnership for the North American area...
BIO today announced the preliminary set of speakers who will be featured on the Therapeutic Workshops during the 9th Annual BIO Investor Forum - a national meeting focused on investment trends and opportunities in the life-sciences with a focus on public and venture-stage growth companies...
Eisai Co., Ltd. (Headquarters: Tokyo, Japan, President & CEO: Haruo Naito, "Eisai") announced today the start of the first patient enrolled clinical study with BAN2401, a novel monoclonal antibody that is being developed as a potential next-generation therapeutic treatment for Alzheimer's disease...
Merck (known as MSD outside the United States and Canada) (NYSE:MRK) and Cardiome Pharma Corp...
The Swiss health authority Swissmedic has granted approval for Tasigna® (nilotinib) 300 mg twice daily for the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase...
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced that the U.S. Food and Drug Administration (FDA) issued a Refuse to File letter for accelerated approval for the company's trastuzumab-DM1 (T-DM1) Biologics License Application (BLA). As planned Roche will continue with its ongoing Phase III EMILIA registration study...
QRxPharma (ASX: QRX and OTCQX: QRXPY) announced a successful interim analysis of its final MoxDuo IR pivotal Phase 3 study required for New Drug Application (NDA) submission. The analysis indicated the planned sample size of 140 patients has greater than 90% power to detect differences of analgesic effect, indicating there is no need to enrol additional patients...
Agensys, Inc., an affiliate of Tokyo-based Astellas Pharma Inc., announced that they have initiated a Phase I clinical trial of AGS-16M8F an antibody-drug conjugate (ADC) that is being developed for the treatment of metastatic renal cancer. An ADC uses the specific binding properties of an antibody to target a toxin in tumor cells, resulting in selective tumor cell killing...
A recent study conducted by oculoplastic surgeon Charles Soparkar, M.D., Ph.D. (The Methodist Hospital, Houston, TX) utilizing a patent-pending formulation of zinc and phytase (trademarked as ZYTAZE™), demonstrated that increasing zinc levels by oral administration for 4 days prior to a planned injection of botulinum toxin improved efficacy and/or duration in 41 of 44 patients tested (93%)...
ReVision Therapeutics Inc. announced that data from a Phase 2b trial show that fenretinide (RT-101) reduced the incidence of choroidal neovascularization (CNV, wet age related macular degeneration) by about 50 percent in patients with geographic atrophy (GA), the most advanced form of dry age related macular degeneration (AMD). The data, presented Monday by Alexander M. Eaton, M.D...
ThromboGenics NV (Euronext Brussels: THR), a biopharmaceutical company focused on the discovery and development of innovative treatments for eye disease, vascular disease and cancer announces that its second Phase III trial evaluating microplasmin for the non-surgical treatment of vitreomacular adhesion (VMA) has met its primary endpoint...
Actavis has received approval from the U.S. Food & Drug Administration to market Atomoxetine HCl capsules for the treatment of attention deficit/hyperactivity disorder (ADHD). Actavis intends to market Atomoxetine HCl in 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg and 100 mg strengths...
Two new groundbreaking scientific papers by researchers at UC Santa Barbara demonstrate the synthesis of nanosize biological particles with the potential to fight cancer and other illnesses. The studies introduce new approaches that are considered "green" nanobiotechnology because they use no artificial compounds...
Allergan Inc., the makers of BOTOX (onabotulinumtoxinA) announced that it has agreed to pay US $600 million and to plead guilty to misdemeanor, thus reaching a resolution with the DOJ (US Department of Justice) regarding a previously reported Government investigation into the company's past sales and marketing practices related to specific therapeutic uses of BOTOX...
A substantial proportion (up to 86%) of the population living in low and middle income countries would be pushed into poverty as a result of purchasing common life-saving medicines. These are the findings of a study by Laurens Niens from Erasmus University Rotterdam and colleagues and published in this week's PLoS Medicine...
Glenmark Pharmaceuticals announced the discovery of a Novel Chemical Entity(NCE) 'GRC 17536'. The new NCE program is targeting TRPA1 receptor antagonists for pain and respiratory disorders...
Naurex Inc., a clinical stage company developing innovative treatments for depression and other CNS disorders, reported that its clinical stage candidate for the treatment of depression, GLYX-13, and its second-generation NRX-1050 series have been selected for inclusion on Windhover's list of the "Top 10 Most Interesting Neuroscience Projects to Watch...
GlaxoSmithKline (NYSE: GSK) and Valeant Pharmaceuticals International (NYSE: VRX) announced the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) goal date for ezogabine to 30 November 2010. The original goal date was 30 August 2010...
Bionovo, Inc. (Nasdaq: BNVI, BNVID) announced that it has received positive guidance from the U.S. Food and Drug Administration (FDA) regarding the Company's Chemistry, Manufacturing and Controls (CMC) plan for its lead drug candidate Menerba®. The FDA indicated its agreement with Bionovo's plan...
BioMarin Pharmaceutical Inc. (Nasdaq: BMRN) announced that it has received orphan drug designation from the U.S. Food and Drug Administration (FDA) for BMN-701, a novel fusion of insulin-like growth factor 2 and alpha glucosidase (IGF2-GAA) in development for the treatment of Pompe disease...
Sangart, Inc., announced positive results from its Phase IIa proof-of-concept study of MP4OX (oxygenated pegylated hemoglobin) in severely injured trauma patients with hemorrhagic shock causing lactic acidosis. The study demonstrated that MP4OX, when given in addition to standard of care, was effective at decreasing lactate levels in treated patients...
MDGs Are Less About Timeline, More About Identifiable Progress "Between the catastrophes of the Haiti earthquake and the Pakistan floods, there was actually some good news this spring on the global health front, which offers hope that the United Nations' ambitious Millennium Development Goals might not be at a standstill...
Malaysia Considers GM Mosquito Release To Control Dengue Fever Malaysia is still "considering releasing" up to 3,000 mosquitoes that are genetically modified to "combat dengue fever, in a landmark field trial that has come in for criticism from environmentalists," Agence France-Presse reports...
New treatments for some of our most common diseases and conditions could be on the horizon with the launch of a new drug discovery venture in Aberdeen. The University of Aberdeen will next month officially open its new Kosterlitz Centre for Therapeutics which will take the findings of researchers and clinicians and support their development towards new patient therapies...
Authorities have arrested more than 80 people and seized 10 tons of counterfeit medicines across six East African countries, the international police agency Interpol announced Thursday, United Press International reports (8/26). Interpol, together with a WHO unit, "targeted alleged networks of counterfeit drugs makers, traffickers and vendors," the Canadian Press reports (8/26)...







