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Jun30
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Wythe Therapeutics, Inc. (Wythe) and VeroScience LLC (Vero) just announced the completion of the worldwide exclusive license for the manufacture, marketing and distribution of Cycloset® from Vero to Wythe.
Cycloset® is a patented novel oral formulation of bromocriptine mesylate, for the treatment of Type-2 Diabetes that Vero is seeking approval to market. According to Charles P. Sutphin, CEO of Wythe:
If approved, Cycloset® will be a 'First in Class' compound in the treatment of Type II Diabetes utilizing a CNS mode of action.
Type 2 Diabetes currently affects over 20 million Americans, and the number of affected individuals is growing over 5% annually. Wythe believes Cycloset® will provide patients and doctors a new and additive weapon in the treatment of this devastating disease, which is nearing pandemic proportions.
While Vero is managing the the completion of the Cycloset(R) phase III b safety trial in the coming months, Wythe's responsibility will be focused on preparing for the commercialization of Cycloset® in the United States and Canada.
Read more of the press release.
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Jun30
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Genaera Corporation has commenced its multi-center, open-label, pharmacodynamic Phase II clinical trial, MSI-1256F-212 ("Study 212") that will evaluate the efficacy and safety of EVIZON™ (squalamine lactate) at higher doses. EVIZON™ (squalamine lactate) is Genaera's lead product under development indicated for...
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The USFDA has just approved Abbott’s HUMIRA Pen, a new device for administering HUMIRA® (adalimumab), a treatment approved for moderate to severe rheumatoid arthritis (RA) and psoriatic arthritis (PsA). The HUMIRA pen offer offers improved ease of use for arthritic...
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Wyeth Pharmaceuticals recently submitted two New Drug Applications (NDA) to the USFDA: 1) bazedoxifene: a Selective Estrogen Receptor Modulator (SERM) investigated for the prevention of postmenopausal osteoporosis. 2) desvenlafaxine succinate: a non-hormonal agent studied for the treatment of moderate to...
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Lupin Pharmaceuticals, Inc.’s Abbreviated New Drug Application (ANDA) for Quinapril Tablets USP in 5 mg, 10 mg, 20 mg and 40 mg strengths has recently received final approval from the USFDA. A product for the treatment of hypertension, Lupin's...
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Jun29
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Recently presented at the 7th Annual European Congress of Rheumatology (EULAR), ZymoGenetics, Inc. and Serono reported the positive results of a Phase 1b clinical trial with TACI-Ig in 73 patients with rheumatoid arthritis (RA). TACI-Ig is a soluble fusion protein...
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The 2,414-patient phase III ACCLAIM trial of Vasogen, Inc.’s Celacade™ technology (Celacade) in advanced chronic heart failure (HF) only showed significant reduction of the risk of death and cardiovascular hospitalization in the subgroup of 692 patients with New York Heart...
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Many may not have found out through this blog alone that I am a mother (a single mom at that) to a 3.5 year-old boy. Well, I am and while it is a blessing that my son is most of...
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In its ongoing Phase 1b clinical trial with ANA975, Anadys Pharmaceuticals, Inc. suspended the dosing of Hepatitis C virus (HCV) in patients in lieu of pending additional analysis of recently obtained information from pre-clinical 13-week toxicology studies in animals. "Although...
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These days, medications like Ritalin (available in pill and patch) in managing the symptoms of attention deficit hyperactivity disorder (ADHD) are being relied upon by sufferers of this disorder. However, scientists had difficulty pinpointing how these drugs work in the brain. Recently,...
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Iomai received a new US patent which outlines the methods for inducing an immune reponse to Iomai’s novel skin-patch-based vaccine thereby solidifying the company’s position in transcutaneous immunization (TCI). The company’s TCI technology is a unique method of vaccine delivery...
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Jun28
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The United States Patent and Trademark Office recently issued patent number 7,056,698 entitled: Nucleic Acids Encoding Interleukin-9 Receptor Variants, to Genaera Corporation. The patent will expire on November 2018 which relates to the diagnosis, treatment and methods for discovery of...
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The USFDA granted approval to Ranbaxy Pharmaceuticals, Inc. to manufacture and market Simvastatin Tablets USP, 80mg with 180-day exclusivity in the United States. Ranbaxy's 80mg Simvastatin Tablets USP is the bioequivalent and generic version of Merck’s Zocor® Tablets, 80mg, a...
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Jaw disease or osteonecrosis of the jaw (ONJ) is an emerging condition for which no effective treatment currently exists. Cases of ONJ have been detected following oral infections associated with dental procedures and are linked to individuals with osteoporosis taking...
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According to a small intervention study in the US, drinking cherry juice could reduce the pain and damage in muscles induced by exercise. The US-based company called Cherrypharm, the maker of the tart cherry juice which is marketed to athletes...
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What: 4th Annual Pharmaceutical Leadership Forum When: October 10-11, 2006 Where: Park Hyatt Hotel at the Bellevue, Philadelphia, PA This is a unique event that brings together a hard-hitting roster of attendees from pharmaceuticals, biotechnology, government, industry think-tanks, special interest...
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Jun27
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What: 4th Annual Drug Development Summit When: January 21-24, 2007 Where: Pointe South Mountain Resort, Phoenix, AZ The Drug Development Summit is an essential symposium for all pharmaceutical research and development professionals, encompassing all therapeutic categories. This is a...
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An investigational agent under clinical development by Vanda Pharmaceuticals for the treatment of insomnia, VEC-162 is a novel melatonin agonist whose Phase II clinical trial showed improved key sleep measures and provided immediate phase advance in adults suffering from transient...
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What: Patient-Centric Marketing When: September 26-27, 2006 Where: Doral Forrestal Conference Center and Spa, Princeton, NJ Hear about how to build consumer loyalty through a better understanding of your patients' needs, improved patient relationship marketing, and more effective cross-cultural communications...
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MorphoSys AG is expanding its existing therapeutic antibody collaboration with Novartis. The original agreement of a three-year term will now go through May 2011. In lieu of this expanded collaboration, MorphoSys is currently reviewing the status of its financial guidance...
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Pfizer has agreed to sell its consumer healthcare division to Johnson & Johnson for $16.6 billion. The deal will include OTC brands such as Listerine, Nicorette, Visine, Sudafed and Neosporin. Pfizer is selling this division, which netted $3.9 billion last...
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Jun26
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Novartis is seeking regulatory approval to market its anti-allergy drug in Japan. Xolair (omalizumab) is a monoclonal antibody already approved in the US and 45 other countries for the treatment of asthma. It is administered via injection, every 2 to...
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The USFDA has approved Johnson & Johnson's first HIV drug last Friday. Prezista™ (darunavir, previously labelled as TMC114) is a protease inhibitor, and the 10th HIV drug of its class the FDA has approved so far. PREZISTA™, co-administered with 100...
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The USFDA has granted final approval to Endo Pharmaceuticals Inc.'s two new oral oxymorphone analgesics. The two opioid formulations, and extended-release and an immediate-release formulation will be marketed as Opana® ER tablets and Opana® tablets, respectively. Opana® ER will be...
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Altus Pharmaceuticals announce that their experimental recombinant human growth hormone, ALTU-238, confirmed previously observed pharmacokinetic and pharmacodynamic profile, demonstrating that once-a-week dosing resulted in a consistent linear dose responsive levels of hGH ang IGF-1 in the blood. "We believe that...
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The USFDA has approved Allergan, Inc's prescription eye-drop, Lumigan® (bimatoprost ophthalmic solution) 0.03% as a first-line treatment for elevated intraocular pressure (IOP) associated with open-angle glaucoma or ocular hypertension. Lumigan has been previously approved by the FDA as second-line use....
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Jun24
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Malaria is a widespread global problem, especially in poor and developing countries in the tropics. The disease – transmitted by mosquitoes infected with the parasite Plasmodium falciparum -- infects 300 to 500 million people each year. Each year, about 1.5...
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Rib-X Pharmaceuticals, Inc. has raised $50 million in Series C financing round, bringing the total amount raised by the company since 2001 to $123 million. Rib-X is a biopharma company focusing on small molecule drug discovery and development, particularly on...
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In lieu of the 2006 World Cup, it will take more than good strong and a strong team to win but also the team’s testosterone level. It was previously known that levels of testosterone are elevated in men during competitive...
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For cardiovascular disease prevention, statins are widely used to decrease blood cholesterol but have also shown to have antioxidant activity. The most common type of age-related cataract, the one that occurs in the center of the lens, called nuclear cataract...
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Jun23
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Favrille, Inc.’s electronic Investigational New Drug (IND) application for FAV-201 (a patient-specific immunotherapy for the treatment of T-cell lymphoma) has been cleared by the USFDA. "This new product candidate represents an extension of our platform and draws on our success...
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Last week, the National Institutes of Health (NIH) started enrolling participants in MedImmune, Inc.’s Phase 1 study of an intranasal H5N1 influenza vaccine candidate based on the company's live, attenuated vaccine technology. The study will be conducted at Johns Hopkins...
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The results of a Phase 3 REACH study of EFAPROXYN™ (efaproxiral) plus whole brain radiation therapy in patients with brain metastases from various primary cancers as announced by Allos Therapeutics, Inc. were were reported in the June 13th edition of...
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As determined by the Pharmacy Times 2006 Over-the-Counter (OTC) Survey of Pharmacists Recommendations, Adams Respiratory Therapeutics, Inc.’s Mucinex® (600 mg guaifenesin extended-release bi-layer tablets) is the No. 1 recommended adult expectorant brand. Mucinex® has only been on the market since...
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A leading Chinese pharmaceutical company focused on the development, manufacturing and distribution of innovative drugs in China : China Biopharmaceuticals Holdings, Inc. is progressing towards the completion of its acquisition of all the shares in RACP Pharmaceutical Holdings Ltd. and...
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Jun22
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Corgentech, Inc. recently announced the positive results from a Phase 2 clinical trial in total knee replacement surgeries of 4975, the company's novel, long-acting, non-opioid drug candidate being developed for site-specific, moderate-to-severe pain. The pain drug 4975 showed significant pain...
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Anacor Pharmaceuticals announced the positive results of the phase 2a study of ANO128, a novel topical anti-inflammatory drug candidate for atopic dermatitis (AD). Atopic dermatitis, affecting approximately 15 million patients in the is a chronic rash characterized by inflammation and...
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Dermisonics, Inc. is a medical device company focused on the development of a painless, needle-free drug-delivery technology. Recently, the company announced that it has received a Notice of Allowance from the United States Patent & Trademark Office on its second...
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GlaxoSmithKline’s Hycamtin (topotecan HCl) has been approved by the USFDA in combination with cisplatin for the treatment of stage IV-B, recurrent, or persistent carcinoma of the cervix that did not respond to surgery and/or radiation therapy. "Advanced cervical cancer can...
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Last March 24, Encysive Pharmaceuticals got an approvable letter form the UDFDA for its New Drug Application (NDA) for Thelin™ (sitaxsentan sodium) 100 mg tablets that is currently being evaluated as a potential new oral treatment for patients with pulmonary...
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Jun21
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VYTORIN® is significantly more effective than Crestor® (rosuvastatin) in reducing LDL "bad" cholesterol across all study dose comparisons as shown in a new clinical study which included 2,855 patients with high cholesterol. "In this study, VYTORIN was significantly more effective...
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RLS or restless legs syndrome is a common, yet often undiagnosed, neurological sensorimotor disorder. Sufferers often experience an urge to move their legs at night due to uncomfortable leg sensations that worsen during periods of rest or inactivity, often interfere...
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Novartis Consumer Health is conducting a nationwide voluntary recall of all Vapor Patch product marketed under the Triaminic® brand due to the serious adverse health effects that could result if the product is ingested by the child removing the patch...
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Viagra® (sildenafil) has been approved by the USFDA in 1998 for the treatment of erectile dysfunction. Since then it has become a household term and prolific spam content as well. Erectile dysfunction was once an unmentionable condition but many men...
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PRA International, a global clinical research organization has acquired Dutch clinical development firm Pharma Bio-Research for €85 million. "We will quickly integrate PBR to better serve our biotech and pharmaceutical clients earlier in the drug development cycle, providing high-end first-in-man...
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Jun20
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ISTA Pharmaceuticals has acquired rights to two of Senju Pharmaceuticals, Co.'s drug candidates for the treatment of glaucoma, a chronic disease that, according to the Glaucoma Research Foundation, is the second leading cause of blindness. Senju's lead candidates licensed by...
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Results from a 113-patient clinical study showed that supplementation with the pine bark extract (commercially available as Pycnogenol®) improves blood flow to the muscles, thus relieving muscle cramp and pain. "With the millions of athletes worldwide, this truly is a...
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The Perrigo Company has been granted USFDA marketing approval for the over-the-counter (OTC) coated nicotine polacrilex gum USP, 2 mg (mint) and 4 mg (mint): a product that will be marketed under store brand labels that is comparable to GlaxoSmithKline's...
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According to recent research, women with higher levels of depression may likely suffer from greater diability due to chronic pain. Researchers therefore advise that to help reduce disability form chronic conditions such as arthritis and back pain, they should get...
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Psychologists from the University of Washington have identified two physiological markers for a behavioral aberration called self-harming (SH), which involves a deliberate infliction of physical injury to one's own body. In a study of adolescent females, the researchers have linked...
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Jun19
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Neutec Pharma announced having completed recruitment for the clinical trials for Aurograb, a recombinant antibody antiinfective against Methicillin Resistant Staphylococcus aureus (MRSA). The study, which will compare the efficacy of a combination of Aurograb and vancomycin and vancomycin alone, will...
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Auxulium Pharmaceuticals, Inc. announced the positive results of its Phase IV randomized trial of Testim® 1%, its topical testosterone gel, treatment in patients with Type II diabetes. The study showed that treatment with Testim® showed a statistically significant improvement in...
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Alltracel Pharmaceuticals Plc announced the successful completion of the sterol based products and Alltracel Bioactive combination pre-clinical studies. These studies conducted in partnership with a number of existing functional food companies was part of the current series of pre-clinical trials...
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The brains of people suffering from Alzheimer's disease are cluttered with a plaque made up of a small protein called amyloid beta, or Ab. These plaque deposits that are blamed for this disorder are being reduced by an experimental DNA-based...
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The new sleep medication, ramelteon (brand name Rozerem) approved by the USFDA in July 2005, has been found to spare users the potential for dependence and abuse found with other sleep aids. This has been proven in laboratory studies which...
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Jun17
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Working with mice models, scientists from the University of British Columbia's Centre for Molecular Medicine and Therapeutics (CMMT) have identified what could possibly developed into the first cure for Huntington's Disease. In the study, researchers confirmed that the deadly cleavage...
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The FDA has approved Zelapar® (selegiline HCl) Orally Disintegrating Tablets, a once-daily adjunct therapy for Parkinson's disease patients. Zelapar, a monoamine oxidase-B (MAO-B) inhibitor, is the first Parkinson's disease treatment to use a novel oral delivery system called Zydis® Technology,...
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The US FDA has granted orphan drug status toSurfaxin, Discovery Laboratories' drug candidate against bronchopulmonary dysplasia (BPD). BPD is a chronic lung disease common among prematurely born infants resulting from damage from environmental factors, infection, or from the use of...
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Genelabs Technologies, Inc. has recently entered into a license and collaboration agreement with Novartis for the development and commercialization of compounds from Genelabs' Hepatitis C Virus (HCV) non-nucleoside drug discovery program. In the terms of agreement, Genelabs is eligible to...
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Jun16
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The report released recently by the USFDA Counterfeit Drug Task Force recommends new steps on order to strengthen the existing protections against the growing problem of counterfeit drugs. The measures recommended emphasize certain regulatory actions and the use of new...
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Evotec AG announced the positive results of its Phase I/II study of its GABAA modulator EVT 201, for the treatment of insomnia. The study was conducted in an established clinical model of insomnia in healthy adults. While significantly increasing the...
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AstraZeneca and Array BioPharma Inc. have initiated its Phase II study for AZD6244 (ARRY-142886) in malignant melanoma. AZD6244 is a selective MEK inhibitor that was in-licensed by AstraZeneca from Array in December 2003. The clinical trial will be a randomised...
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The NY Times reported that the USFDA is now imposing on the long-delayed rule of requiring most wholesalers to track prescription drugs from the factory to the pharmacy which will take effect in December. Such regulations originated from a 1988...
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Aegerion Pharmaceuticals, Inc. announced having secured $22.5 million in its first round of venture capital. Teh company focuses on developing compounds for managing cardiovascular disease, particularly in reducing LDL cholesterol. The following firms were involved in this round of financing:...
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Jun15
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Arena Pharmaceuticals, Inc.'s drug candidate for obesity, lorcaserin hydrochloride (formerly APD356) demonstrated favorable Phase IIb clinical trial results. Compared to placebo, patients treated with lorcaserin showed highly statistically significant average weight loss and reductions in other physical measures, including body...
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The US FDA has accepted MGI Pharma's new drug application for Saforis (glutamine in UpTec™) Powder for Oral Suspension, a drug candidate against oral mucositis in patients receiving mucotoxic cancer therapy, including chemotherapy. FDA will conduct a priority review and...
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What: Paris Anti-Avian Influenza 2006 World Congress When: June 29-30 2006 Where: Institut Pasteur, Paris, France The aim of this conference is to bring together world specialists in order to discuss the latest advances on Avian Influenza, especially on new...
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Data from a 3-year Phase III clinical trials show that Eli Lilly and Company's drug candidate for diabetic retinopathy (DR), ruboxistaurin mesylate (proposed brand name Arxxant™), reduced the risk of vision loss in DR patients. "These data are exciting because...
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Depomed, Inc. released the results of a second Phase III clinical trials with Glumetza(TM) (metformin hydrochloride extended-release tablets) for the treatment of Type 2 diabetes mellitus. According to the results, adding Glumetza to a sulfonylurea treatment regimen provided more effective...
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Jun13
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The Biologic License Application (BLA) for panitumumab, Amgen's investigational human monoclonal antibody targeting the epidermal growth factor receptor (EGFr), has been granted priority review by the US FDA. The application covers the use of panitumumab for the treatment of metastatic...
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