Copyright 2009 Medical News Today Latest Pharma Industry / Biotech Industry News From Medical News Today. http://www.medicalnewstoday.com/sections/pharma_industry/ admin@medicalnewstoday.com (MNT Admin) editors@medicalnewstoday.com (MNT Editors) en-us Sat, 04 Jul 2009 02:00:00 PDT http://www.medicalnewstoday.com/articles/156435.php http://www.medicalnewstoday.com/articles/156435.php Watson Pharmaceuticals, Inc. (NYSE: WPI), a leading specialty pharmaceutical company, today announced that its subsidiary, Watson Laboratories, Inc., has received approval today from the United States Food and Drug Administration on its Abbreviated New Drug Application (ANDA) for levonorgestrel tablets, 0.75 mg, for women seventeen years and younger. Fertility Sat, 04 Jul 2009 01:00:00 PDT http://www.medicalnewstoday.com/articles/156423.php http://www.medicalnewstoday.com/articles/156423.php BioCis Pharma Ltd., a privately held drug development company with its headquarters in Turku, Finland, announced positive results from its Phase IIa clinical trial of ProtoCure(TM) emulsion cream, the company's novel topical drug for dermatology. This double-blind, placebo-controlled study, conducted in Finland, included 13 patients with mild to moderate atopic dermatitis who applied the ProtoCure emulsion cream to the affected skin areas twice daily for up to four weeks. Dermatology Sat, 04 Jul 2009 01:00:00 PDT http://www.medicalnewstoday.com/articles/156424.php http://www.medicalnewstoday.com/articles/156424.php ThromboGenics NV (Euronext Brussels: THR) and co-development partner BioInvent International (OMXS: BINV) announce that they have started recruitment of a second cohort of patients for their Phase II trial of TB-402. This follows completion of recruitment of the first cohort of 100 patients ahead of schedule. TB-402 is a novel, long acting anticoagulant that is being developed for the prevention of deep vein thrombosis (DVT) following orthopaedic surgery. Vascular Sat, 04 Jul 2009 01:00:00 PDT http://www.medicalnewstoday.com/articles/156429.php http://www.medicalnewstoday.com/articles/156429.php Biogen Idec (NASDAQ: BIIB) announced data results from the CHAMPIONS (Controlled High-Risk AVONEX® (interferon beta-1a) Multiple Sclerosis (MS) Prevention Study In Ongoing Neurologic Surveillance) study, an open label follow-up to CHAMPS (Controlled High Risk Subjects AVONEX MS Prevention Study). Based on the CHAMPS study, AVONEX was granted approval for use in patients who experienced their first clinical MS episode with MRI findings. Multiple Sclerosis Sat, 04 Jul 2009 01:00:00 PDT http://www.medicalnewstoday.com/articles/156431.php http://www.medicalnewstoday.com/articles/156431.php Bristol-Myers Squibb Company (NYSE: BMY) and AstraZeneca (NYSE: AZN) announced that their marketing authorization application for ONGLYZA™ (saxagliptin) received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) for the treatment of type 2 diabetes in adults as add-on therapy with metformin, a thiazolidinedione or a sulphonylurea. Diabetes Sat, 04 Jul 2009 01:00:00 PDT http://www.medicalnewstoday.com/articles/156432.php http://www.medicalnewstoday.com/articles/156432.php Genentech, Inc. announced today that the Phase III study BRAVO showed Lucentis® (ranibizumab injection) improved vision, as measured by the primary endpoint of mean change from baseline in best-corrected visual acuity at six months, in patients with macular edema due to branch retinal vein occlusion. The safety profile of Lucentis was consistent with previous experience and no new adverse events related to Lucentis were observed in the study. Eye Health / Blindness Fri, 03 Jul 2009 03:00:00 PDT http://www.medicalnewstoday.com/articles/156297.php http://www.medicalnewstoday.com/articles/156297.php The WHO on Wednesday announced plans for a clinical trial to test a new drug that "could halve the treatment period for river blindness [or onchocerciasis], a disease that threatens 100 million people mostly in Africa," AFP/Dow Jones Newswires/CNN Money reports (7/1). Tropical Diseases Fri, 03 Jul 2009 02:00:00 PDT http://www.medicalnewstoday.com/articles/156266.php http://www.medicalnewstoday.com/articles/156266.php Sanofi-aventis (EURONEXT: SAN and NYSE: SNY) announced that the U.S. Food and Drug Administration (FDA) has approved Multaq(R) (dronedarone) 400 mg Tablets. Patients with atrial fibrillation (AF) or atrial flutter (AFL) soon will have a new treatment option to help improve current management of their disease. Multaq(R) is the first drug approved in the United States that has shown a clinical benefit to reduce cardiovascular hospitalization in patients with AF/AFL. Cardiovascular / Cardiology Fri, 03 Jul 2009 02:00:00 PDT http://www.medicalnewstoday.com/articles/156267.php http://www.medicalnewstoday.com/articles/156267.php Novavax, Inc. (Nasdaq: NVAX) announced its initial agreement to license its proprietary, recombinant virus-like-particle (VLP) vaccine technology to ROVI Pharmaceuticals (Madrid: ROVI) of Spain. Flu / Cold / SARS Fri, 03 Jul 2009 02:00:00 PDT http://www.medicalnewstoday.com/articles/156271.php http://www.medicalnewstoday.com/articles/156271.php Eisai Co., Ltd. (Headquarters: Tokyo, President & CEO: Haruo Naito, "Eisai") and Eisai Corporation of North America (Headquarters: Woodcliff Lake, NJ, Chairman and CEO Hajime Shimizu) are currently focusing on three clinical development programs for the company's major product Aricept(R) (donepezil hydrochloride tablets) to further contribute to patients with Alzheimer's disease. As progress in those programs has been made, Eisai announces the status as follows: 1. Alzheimer's / Dementia Fri, 03 Jul 2009 01:00:00 PDT http://www.medicalnewstoday.com/articles/156264.php http://www.medicalnewstoday.com/articles/156264.php Lixte Biotechnology Holdings (OTC Bulletin Board: LIXT) announced that investigators of the National Institute of Neurological Disorders and Stroke (NINDS) and the National Cancer Institute (NCI), National Institutes of Health and Lixte reported that its novel compound, LB-1.2, enhances the effectiveness of two standard chemotherapy drugs in mouse models of human cancers. This research is being conducted under a Cooperative Research and Development Agreement between NINDS and Lixte. Cancer / Oncology Fri, 03 Jul 2009 01:00:00 PDT http://www.medicalnewstoday.com/articles/156265.php http://www.medicalnewstoday.com/articles/156265.php Acura Pharmaceuticals, Inc. (Nasdaq: ACUR) and King Pharmaceuticals, Inc. (NYSE: KG) announced today that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter regarding the New Drug Application (NDA) for Acurox (oxycodone HC1, USP and niacin, USP) Tablets CII, an immediate release product intended for the relief of moderate-to-severe pain. The Complete Response Letter raises issues regarding the potential abuse deterrent benefits of Acurox(R). Pain / Anesthetics Thu, 02 Jul 2009 04:00:00 PDT http://www.medicalnewstoday.com/articles/156152.php http://www.medicalnewstoday.com/articles/156152.php "As details emerge of the pharmaceutical industry's agreement to kick in $80 billion to help pay for health care reform, the deal is facing increasing skepticism from inside and outside the health care industry," Politico reports. Health Insurance / Medical Insurance Thu, 02 Jul 2009 04:00:00 PDT http://www.medicalnewstoday.com/articles/156158.php http://www.medicalnewstoday.com/articles/156158.php The drug industry began ramping up its lobbying efforts in 2003, when Medicare Part D began, and now is targeting Democrats. CQ Politics reports: "The industry is increasingly employing Democratic lobbyists with ties to the Obama administration and congressional leaders such as Sen. Max Baucus, D-Mont., chairman of the Senate Finance Committee. Pharma Industry / Biotech Industry Thu, 02 Jul 2009 03:00:00 PDT http://www.medicalnewstoday.com/articles/156116.php http://www.medicalnewstoday.com/articles/156116.php Like astronomers counting stars in the familiar universe of outer space, chemists in Switzerland are reporting the latest results of a survey of chemical space - the so-called chemical universe where tomorrow's miracle drugs may reside. The scientists conclude, based on this phase of the ongoing count, that there are 970 million chemicals suitable for study as new drugs. Pharma Industry / Biotech Industry Thu, 02 Jul 2009 03:00:00 PDT http://www.medicalnewstoday.com/articles/156138.php http://www.medicalnewstoday.com/articles/156138.php The pharmaceutical company Roche on Wednesday announced a program to help ensure developing countries have access to its antiviral Tamiflu, for "the management of a novel influenza strain defined by the WHO as having significant and current pandemic potential," Reuters reports (Egenter, 7/1). Swine Flu Thu, 02 Jul 2009 01:00:00 PDT http://www.medicalnewstoday.com/articles/156084.php http://www.medicalnewstoday.com/articles/156084.php The largest study of the genetics of schizophrenia ever undertaken has revealed several new common single-letter variants in the sequence of the human genome (SNPs) linked to risk of the disease. The study, by a multinational consortium of scientists led by a team from deCODE genetics (Nasdaq: DCGN), analyzed the genomes of more than 50,000 patients and control participants from fourteen countries. It is published today in the online edition of Nature. Schizophrenia Thu, 02 Jul 2009 01:00:00 PDT http://www.medicalnewstoday.com/articles/156085.php http://www.medicalnewstoday.com/articles/156085.php Peregrine Pharmaceuticals, Inc. (Nasdaq: PPHM) today announced that it has been awarded a European patent for a novel device and methods for linking biological agents to labels for diagnostic and therapeutic applications. The technology, which is known as In-Line labeling, was developed for the production of radiolabeled anti-cancer antibodies, but is applicable to other agents as well. Neurology / Neuroscience Wed, 01 Jul 2009 02:00:00 PDT http://www.medicalnewstoday.com/articles/155919.php http://www.medicalnewstoday.com/articles/155919.php Calixa Therapeutics Inc. today announced the initiation of a Phase 2 clinical trial of CXA-101 in patients with complicated urinary tract infections. CXA-101 is a new broad-spectrum, parenteral cephalosporin antibiotic with excellent in vitro and in vivo activity against Pseudomonas aeruginosa, including drug resistant isolates. Calixa is investigating CXA-101 as a potential treatment for serious bacterial infections in hospitalized patients. Urology / Nephrology Wed, 01 Jul 2009 01:00:00 PDT http://www.medicalnewstoday.com/articles/155914.php http://www.medicalnewstoday.com/articles/155914.php Amira Pharmaceuticals, Inc. announced initial positive data from a Phase 1 clinical study of AM211, the company's oral selective antagonist of the DP2 (also known as CRTH2) receptor. The interim results demonstrate that a sustained pharmacodynamic (PD) effect can be achieved with a single dose of AM211. The pharmacokinetic profile indicates safety multiples as compared to exposures observed in safety species. Respiratory / Asthma Wed, 01 Jul 2009 01:00:00 PDT http://www.medicalnewstoday.com/articles/155916.php http://www.medicalnewstoday.com/articles/155916.php PROLOR Biotech, Inc. (OTC Bulletin Board: PBTH), formerly Modigene Inc., announced that the U. S. Patent and Trademark Office (PTO) has issued two new patents for the company's long-acting CTP-enhanced human growth hormone (hGH-CTP) and human erythropoietin (EPO-CTP). The patents cover the composition of PROLOR's proprietary pharmaceutical compounds as well as certain associated methods. Endocrinology Wed, 01 Jul 2009 01:00:00 PDT http://www.medicalnewstoday.com/articles/155917.php http://www.medicalnewstoday.com/articles/155917.php Cephalon, Inc. (Nasdaq: CEPH) announced that it has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) requesting approval of NUVIGIL(R) (armodafinil) Tablets [C-IV] for the indication of improved wakefulness in patients with excessive sleepiness associated with jet lag disorder resulting from eastbound travel. Sleep / Sleep Disorders / Insomnia Tue, 30 Jun 2009 06:00:00 PDT http://www.medicalnewstoday.com/articles/155861.php http://www.medicalnewstoday.com/articles/155861.php Centocor Ortho Biotech Inc. announced today that a federal jury has returned a verdict of $1.67 billion against Abbott Laboratories in a patent infringement suit. "We are pleased that the jury has ruled in our favor in the patent litigation case against Abbott," said Kim Taylor, President, Centocor Ortho Biotech Inc. Litigation / Medical Malpractice Tue, 30 Jun 2009 06:00:00 PDT http://www.medicalnewstoday.com/articles/155862.php http://www.medicalnewstoday.com/articles/155862.php Baxter International Inc. (NYSE:BAX) announced today a definitive agreement with Edwards Lifesciences Corporation (NYSE:EW) under which Baxter will acquire certain assets related to Edwards' hemofiltration product line, also known as Continuous Renal Replacement Therapy (CRRT). The transaction is expected to close in the third quarter of 2009, pending regulatory approvals. Pharma Industry / Biotech Industry Tue, 30 Jun 2009 04:00:00 PDT http://www.medicalnewstoday.com/articles/155823.php http://www.medicalnewstoday.com/articles/155823.php As Vietnam's industrial capabilities have developed rapidly in recent decades, government officials have recognized the importance of helping to secure the nation's supply of medicines. In an important milestone addressing this need, the Vietnamese Pharmacopoeia Commission (VPC) has signed a memorandum of understanding (MOU) with the U.S. Pharmacopeial (USP) Convention. Regulatory Affairs / Drug Approvals