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Apr30
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Locteron™ is Octoplus’ controlled release formulation of alfa interferon for the treatment of chronic hepatitis C. On 27th April, the dutch drug delivery and development company (Octoplus) announced the results of the completed Phase 1 study on Locteron™.
Phase I results show that a single dose of Locteron delivered to healthy volunteers is safe and results supported that Locteron could be effectively dosed once every two weeks, which is a substantial improvement over the current pegylated interferons that require dosing every week.
These results have been presented at the 41st Annual Meeting of the European Association for the Study of Liver Disease (EASL) meeting in Vienna, Austria.
Locteron™ has been designed to be a best-in-class therapeutic for patients with chronic hepatitis C which has the potential to induce less side effects and to increase therapeutic efficacy and patient compliance compared with current therapies; will enter into Phase II studies in the second half of 2006.
Source: Octoplus News
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Apr30
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Aminoglycosides are inexpensive antibiotics used worldwide for the past 60 years as treatment against acute infections and tuberculosis and as antibacterial prophylaxis in cystic fibrosis patients and in other conditions. However, these antibiotics have been widely link to irreversible hearing...
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Researchers at the Ohio State University found evidence that combining the arthritis drug Etanercept might help reduce fatigue and muscle wasting which often afflicts cancer patients. “This shows promise in helping reduce fatigue in cancer patients while increasing their ability...
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Marburg virus is a filovirus that causes internal bleeding at multiple sites with patients usually dying as a result of multiple organ failure. Like the Ebola virus, Marburg virus is also considered a bioterrorism threat which currently has no...
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Cytos Biotech’s vaccine for allergic diseases has shown significant long-term efficacy in people who are allergic to house dust mites -- a common cause of sneezing, wheezing, eye inflammation and asthma; according to the Switzerland Company’s study results. The intermediate-phase...
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Schizophrenia is one of the most common psychiatric health disorders that affect an average of one per cent of the world’s population. The most recent methods of treatment can just partially alleviate the symptoms of this disorder but many patients...
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ADVENTRX Pharmaceuticals, Inc. acquired all shares of SD Pharma, obtaining worldwide (excluding China, Taiwan, Hong Kong and Macau) intellectual property rights to eight oncology and infectious disease therapeutic product candidates: Reformulated Vinorelbine I (SDP-012) Reformulated Docetaxel (SDP-014) Reformulated Paclitaxel (SDP-013)...
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Apr27
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Novartis submitted an new drug application (NDA) to the US FDA for the use of Exforge as a new treatment option for people with high blood pressure. In clinical trials involving more than 5,000 hypertensive patients, a single daily dose...
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Following regulatory approval, A.P. Pharma will soon commence Phase 3 clinical trials for APF530, the company's drug candidate against acute and delayed chemotherapy-induced nausea and vomiting (CINV) in patients undergoing either moderately or highly emetogenic chemotherapy for cancer. The APF530...
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Pravachol is a drug indicated for patients with high cholesterol levels and those with increased risk for atherosclerosis-related cardiac and cardiovascular events, such as heart attack and stroke. Last year it was the 22nd highest-selling brand-name drug in the US....
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Array BioPharma Inc.'s new drug candidate for the inflammatory disease enters Phase 1 clinical trials in the US. The molecule, designated as ARRY-438162, is a novel MEK inhibitor, which has been shown in preclinical studies to interfere with a protein...
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Apr26
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Antares Pharma Inc. announced the development of a novel method of topical and trans-mucosal drug delivery: the TecTix(TM) system. The TecTix system is based on transiently reducing the melting point of an active drug by using a combination of known...
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The Men’s Health Biotech Company, GTx, Inc., recently announced that it is going into a separate Phase IIIb clinical trial as an extension of the pivotal Phase III ADT clinical trial of ACAPODENE® (toremifene citrate) in an 80mg dose for...
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Sirtis Pharmaceuticals, the leading sirtuin therapeutics company has been awarded by The ALS Association with research funding for a novel compound developed by the company that has potential for the treatment of amyotrophic lateral sclerosis (ALS) or sometimes called...
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As announced recently by Advancis Pharmaceutical Corporation (Nasdaq: AVNC), the company’s supplemental NDA (new drug application) for additional Keflexâ (cephalexin capsules, USP) is still being reviewed by the USFDA. "We were notified yesterday that the Agency has not yet completed...
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Abbot (NYSE: ABT) has completed its acquisition of Guidant’s vascular business giving birth to one of the leading global vascular devices companies. This combined Abbott-Guidant business offers a broad line of leading coronary and endovascular products which will transform the...
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Apr25
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On 21st April, Spectrum Pharmaceuticals, Inc. (Nasdaq: SPPI) announced the closing of its transaction to acquire the oncology drug assets of Targent, Inc. Spectrum Pharmaceuticals, Inc. is a specialty pharmaceutical company (based in Irvine, California) that is in the business...
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CaraMedica Pharmaceuticals, Inc has just launched BioCorneum®, a patented, topical, self-drying silicone gel scar treatment which is only available to patients from licensed medical professionals. BioCorneum®, classified by the FDA under a 510(k) as a medical device, manages old and...
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What: Impact China II: Pharmaceutical R&D Global Summit When: May 21 to 24, 2006 Where: Shangri-La Hotel - Beijing, China The growing impact that China is having on the global pharmaceutical marketplace is currently being felt by the industry on...
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Fox Chase researcher Jeffrey R. Peterson, Ph.D. and his colleagues describe a new way in chemical genetics to swiftly find the proteins targeted by small molecule inhibitors during high-throughput screening (HTS) experiments. This new finding highlighted on the April cover...
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Visceral leishmaniasis (LEASH-ma-NIGH-a-sis) is a parasitic disease that kills about 60,000 people annually. The current issue of ACS Chemical Biology reported a development of a new candidate or potential vaccine for leishmaniasis disease. Peter H. Seeberger, Ph.D., of the Laboratory...
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Apr24
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Rensselaer Polytechnic Institute and University of Toronto researchers designed a nanoscale assembly of molecules that successfully counteracts and inhibits anthrax toxin in animal and laboratory experiments. Anthrax toxin is a polyvalent protein complex secreted by the anthrax bacterium that inflicts...
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Omnitrop, the first biosimilar or biogeneric drug to be commercialized in the EU has just been given the green light in Brussels . As biotech patents expire, this new market for biosimilar products in the EU is an access to...
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Apr22
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Bayer Pharmaceuticals Corporation (NYSE:BAY) and Onyx Pharmaceuticals, Inc’s. (Nasdaq:ONXX) Nexavar® (sorafenib) tablets has been granted Orphan Medicinal Product (OMP) status for the treatment of hepatocellular carcinoma (HCC), or liver cancer, by the European Commission. "This orphan medicinal product designation demonstrates...
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Neurochem’s NDA of eprosidate (Fibrillex™) for the treatment of Amyloid A (AA) amyloidosis has been filed and granted priority review by the USFDA. The priority review means that a target six-month review period (from the date of receipt of the...
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Tramadol Extended Release (ER) for the treatment of painful HIV-associated neuropathy has been designated Fast Track Product by the USFDA. Theraquest Bioscences is a private development stage pain management company is the maker of Tramadol ER, the company’s proprietary abuse...
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Primagen Holding BV has been granted a patent by the US Patent and Trademark Office for Mitox™ mitochondrial DNA quantification technology as biomarkers for efficacy and adverse events of treatment. Primagen Holding BV is a molecular diagnostics company specializing in...
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Sirtris Pharmaceuticals secured $37 million in new financing, out of which $22M comes form Series C equity placement and $15M in venture debt. Proceeds from this financing will be used to accelerate Sirtris' therapeutic programs, particularly those focused on metabolic...
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Bangalore-based Biocon plans to launch , a novel monoclonal antibody for the treatment of head and neck cancer by the end of the year. Clinical trials have been completed and the company will file for regulatory approval at the Drug...
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Apr20
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According to the results of a proof-of-concept clinical study, Acadia Pharmaceutical Inc's drug candidate ACP-103 has been able to improve the quality of sleep in healthy older volunteers by increasing slow wave sleep. "This suggests that ACP-103 has potential as...
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The US FDA granted a Fast Track designation for Schering-Plough's investigational cardiovascular drug, SCH 530348 . The FDA granted Fast Track designation for the following reasons: Cardiovascular disease, as evidenced in patients with acute coronary syndrome or in patients with...
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Shikimic acid is the main starting material of Tamiflu , the #1 doctor-prescribed flu drug. Roche, the maker of Tamiflu is in continued battle to meet the market’s demand for for the flu drug: increasing external contractors and finding news...
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In any product-related business, counterfeiting is bad and is the major headache in the pharma-industry. Now, there is a new approach developed to halt counterfeiting of glass drug products. This new marking technology, Validate™ came about with the partnership of...
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Apr19
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As announced on its website on 14th April, the USFDA has approved Vivitrol™ (naltrexone for extended-release injectable suspension) for the treatment of alcoholism. Although Alkermes, Inc. developed Vivitrol™, Cephalon is responsible for the marketing and sales of the drug under...
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Since COX-2 inhibitors, drugs like Celebrex® and Vioxx® have been strongly linked to heart problems, the mechanism by which these associations occur have been intensely interesting to researchers. In a mice study, Researchers at Queen's University and the University...
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STAR or the Study of Tamoxifen and Raloxifene showed that the drug raloxifene works well like tamoxifen in reducing breast cancer risk for postmenopausal women. Raloxifene is an osteoporosis drug currently used to prevent and treat osteoporosis in postsmenopausal...
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Apr18
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Reata Pharmaceuticals, Inc., a biopharmaceutical company focused on developing novel treatments for cancer, inflammation, and neurodegenerative diseases announced the completion of its license agreement with Dartmouth College and The University of Texas M. D. Anderson Cancer Center. This license agreement...
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Walgreens Home Care Inc. (a subsidiary of Walgreens Co. NYSE, Nasdaq: WAG), the nation's largest drugstore chain, has completed its acquisition of Canadian Valley Medical Solutions, Inc. Located in Oklahoma City, CV Medical Solutions Inc. has provided home care services...
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Summex Corporation, a provider of comprehensive health and wellness programs that include online and offline health risk assessments, lifestyle education and personalized telephonic health coaching, have now been acquired (through a definite agreement) by WebMD Health Corporation (Nasdaq: WBMD), the...
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Novavax, Inc. (Nasdaq: NVAX) is a company focused on creating differentiated, value-added pharmaceutical and vaccine products and technologies: which include the virus-like particle (VLP) manufacturing technology utilizing the baculovirus expression system in insect cells, as well as novel vaccine adjuvants...
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Before testing a new drug in human volunteers, in clinical trials for example, there wouldn’t be a way of knowing beforehand if the drug to be tested will be harmful to humans. Well, not before the effects become visible....
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Apr17
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Athenagen, Inc. a private biopharmaceutical company located in South San Francisco , is engaged in the development of (oral and topical compounds) small-molecule drugs designed to either inhibit or enhance angiogenesis, based on the discovery of a new endothelial cell...
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MEDI-545 is MedImmune’s monoclonal antibody (MAb) targeting interferon-alpha being developed for the potential treatment of patients with systemic lupus erythematosus (SLE or lupus), a chronic inflammatory disease that causes the body to attack its own tissues and organs, including the...
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Spectrum Pharmaceutical Inc.’s EOquin™ (Apaziquone, E09) is a bioreductive prodrug (an anti-cancer formulated to be administered directly into the bladder) into its Phase III clinical trial for the indication of superficial bladder cancer. However, data from current study shows that...
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Apr16
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Artemisinin, the expensive life-saving anti-malarial drug is now being extracted from Artemesia annua, a wormwood plant. UC Berkeley researchers have succeeded two years ago in engineering bacteria to make a chemical precursor of artemisinin. The researchers’ ultimate goal was to...
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Happy Easter everyone…I have just been over the forums at b5media, the other blog network where I write about life here in the Philippines and bumped into a new blogger named Juan who will be co-blogging at b5’s The After...
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What: 2nd Annual PharmaDiscovery Conference When: May 10-12, 2006 Where: Bethesday North Marriott Hotel & Conference Center, Maryland, USA This 3-day multi-track program is targeted to maximize networking opportunitites among leaders in the pharmaceutical industry, academia, regulation and technology development....
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Apr13
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Recently, I moved back home and it has been a great week adjusting to my new found routine. This week however is the Holy Week in the Christian world and it has been a national holiday here in the Philippines...
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Abbott, a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics recently announced that the European Commission has cleared its proposed acquisition of Guidant's vascular business....
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In February 2004, the USFDA approved Avastin® for use in combination with intravenous 5-Fluorouracil-based chemotherapy as a treatment for patients with colorectal cancer. Just recently, Genentech, Inc., the maker of the drug submitted a supplemental Biologics License Application...
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The USFDA recently granted the final approval for Mayne Pharma (USA) Inc.’s Abbreviated New Drug Application for Mitoxantrone Injection, USP packaged in 20mg, 25mg and 30mg multiple-dose presentations. Mitoxantrone is the generic version of Serono's Novantrone®, the only USFDA-approved...
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Apr12
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The Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMEA) has recommended orphan medicinal product designation for Amigal™ (migalastat hydrochloride or AT1001), an oral therapy being developed by Amicus Therapeutics for the treatment of Fabry disease, a...
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Bicifadine is DOV Pharmaceutical Inc.’s novel analgesic. Yesterday (11th April) the company announced that the US Patent and Trademark Office has issued a Notice of Allowance for its patent application on a new polymorphic (or crystalline) form of bicifadine. "We...
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During the 58th Annual Meeting of the American Academy of Neurology in San Diego; Sangamo BioSciences, Inc. presented the data from the Phase 1 human clinical trial of SB-509, a ZFP drug for the treatment of diabetic neuropathy, one...
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Apr11
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That’s right. In time for the spring season is the start of soccer excitement and increased pollen count: too bad for allergy sufferers. The maker of Claritin®, Schering-Plough, has teamed up with US Men's National Soccer Team member Landon...
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Ritalin® is the first attention deficit (AD) patch approved by FDA. This patch was developed by U.K.-based Shire Pharmaceuticals Group PLC with Noven Pharmaceuticals, the maker of the ADHD drug Daytrana™. Methylphenidate, the stimulant contained in the recently approved transdermal...
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Adhibit™ is an Angiotech Pharmaceuticals, Inc. product that is sold and marketed by Baxter Healthcare Corporation worldwide, excluding the It is a fully-synthetic, sprayable hydrogel designed to reduce or prevent the formation of post-operative surgical adhesions that is safely resorbed...
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Apr10
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A new clinical study presented at the 16th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) in Nice, France showed that AVELOX® (moxifloxacin HCl) monotherapy at 400 mg once daily is as effective as the high-dose combination of...
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Senator Thad Cochran introduced a bill requiring drug plans to promptly pay pharmacies within 14 days of submitting their Medicare claims. Called the Pharmacist Access and Recognition in Medicare (PhARM) Act which ensures pharmacists in neighborhoods across...
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Cell Therapeutics, Inc. has been granted a patent by the US Patent and Trademark Office for its anti-cancer drug. CT-45099 is a new class of small molecule antitubulin agents shown to have potent antiproliferative and tumor killing activity in pre-clinical...
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Pfizer Inc. recently divulged that it has entered into an agreement to acquire Rinat Neuroscience Corporation. "More than one billion people around the world suffer from neurological conditions and diseases, and finding new, more effective treatments for patients is a...
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Macugen® is indicated for the treatment of neovascular (wet) age-related macular degeneration. This product is manufactured by Pfizer Pharmaceuticals and is administered once every six weeks by intravitreous injection. Pfizer Pharmaceuticals recently notified healthcare professionals of important changes in...
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Apr 9
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GlaxoSmithKline and Sirna Therapeutics, Inc. announced on 3rd April the formation of their exclusive multi-year strategic alliance focused on discovery, development and commercialisation of novel RNA interference (RNAi)-based therapeutics for respiratory diseases. This alliance gives birth to the combination of Sirna's...
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Last month, the Coalition for Healthcare Communication filed a Citizen Petition to the USFDA asking for the formulation of new rules governing consumer advertising of prescription drugs in order to make consumer advertising simpler and clearer, and also to stimulate...
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Pharmacopeia, a leader in the discovery and development of novel small molecule therapeutics recently announced its exclusive licensing agreement with Bristol-Myers Squibb Company for worldwide development and commercialization rights to compounds discovered by Bristol-Myers Squibb that possess dual angiotensin (AT1)...
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Apr 8
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Bioniche Life Sciences Inc., a research-based, technology-driven Canadian biopharmaceutical company, has been approved by USFDA to proceed with the second of two Phase III clinical trials using the Company’s proprietary Mycobacterial Cell Wall-DNA Complex (MCC) for the treatment of bladder...
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Takeda Global Research & Development Center (TGR&D) recently submitted a New Drug Application (NDA) for an extended-release version of the combination medication ACTOplus met™ (pioglitazone HCl and metformin HCl) to the USFDA for the treatment of type 2 diabetes....
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As recommended by an Independent Data Monitoring Committee (IDMC), GlaxoSmithKline (GSK), stopped enrolment in its Phase III clinical trial evaluating the combination of Tykerb® (lapatinib ditosylate) and capecitabine (Xeloda®) versus capecitabine alone. The trial evaluated women with refractory advanced or...
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Peregrine Pharmaceuticals, Inc. presented two groundbreaking preclinical studies at the 97th Annual Meeting of the American Association for Cancer Research (AACR) demonstrating that a mouse equivalent to its first-in-class anti-phospholipid (PS) agent Tarvacin™ (bavituximab) significantly increases survival in cisplatin-resistant breast...
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Veronate® failed its Phase III clinical trial for the prevention of hospital-associated infections due to Staphylococcus aureus (S. aureus) in premature infants (weighing between 500 and 1,250 grams at birth). This news was announced recently by Veronate®'s maker, Inhibitex, Inc....
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Apr 5
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In recent news, GlaxoSmithKline (GSK)announced that it has started human trials of its two new bird flu vaccines. These bird flu vaccines, if found effective in treating the H5N1 influenza virus will be ready for manufacture towards the end of...
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In the recent collaboration of Wyeth Pharmaceuticals (a Wyeth division) with the Health Ministry of Scotland, the creation of the Translational Medicine Research Collaboration (TMRC) was announced. This is a collaboration that Wyeth has invested almost $86 million dollars....
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You will remember that the arthritis drug Celebrex has been linked with heart attack. Just very recently, two major long-term clinical trials has been presented at the American Association for Cancer Research meeting showing that the Pfizer's COX-2 inhibitor, Celebrex...
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Apr 4
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A new tissue culture study suggests that a pain-killing medication called nimesulide, appears to prevent the production of an enzyme associated with a common form of breast cancer in postmenopausal women. Aromatase is the enzyme implicated in estrogen-dependent breast...
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The USFDA recently approved the first generic capsule dosage form of zidovudine ((zye-DOE-vue-deen), an HIV/AIDS drug for the United States market. Oral solution and tablet dosage forms of this drug has been previously approved for sale in the U.S. The...
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Apr 3
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A biopharmaceutical company pioneering the oral delivery of otherwise injectable drugs, Emisphere Technologies, Inc., announced the positive results of the clinical study of its lead product, Eligen® (Oral heparin), an antithrombotic/anticoagulant used to prevent deep vein thrombosis following surgery....
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San Diego-based Gen-Probe Incorporated (makers of rapid, accurate and cost-effective nucleic acid tests (NATs) that are used primarily to diagnose human diseases and screen donated human blood) recently resubmitted to the USFDA the new assay of its PROCLEIX® ULTRIO® in...
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Prograf® (tacrolimus), is indicated for the prophylaxis of organ rejection in patients receiving a kidney and liver transplant in the and has been marketed in North America, Europe and . Prograf® is also commercially available worldwide, in approximately 70 countries....
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