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Nov29
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AEterna Zentaris Inc. (TSE: AEZ; NASDAQ: AEZS) recently announced the additional positive top line Phase 1 results for its cytotoxic conjugate AN-152 in patients with gynaecological and breast cancers. Clinical data revealed the compound's good safety profile and established the maximum tolerated dose (MTD) at 267 mg/m(2) which will be the recommended dose for a Phase 2 trial.  The said trial also provided a hint of efficacy as disease stabilization and regression of lesions were observed at the 160 mg/m(2) and 267 mg/m(2) dose levels.
Find more details from the press release. [Note: I don't undertand the unit: mg/m(2). is that mg per m squared (square meter)? Square meter of what? Surface area? or should it be mg/ml referring to the concentration/volume of the compound? or should it be mm as in millimeter?]
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Nov29
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Cytogen Corporation (Nasdaq: CYTO) has recently been issued United States patent number 7,135,457 covering its oral drug delivery agents: random peptide compositions that bind to gastro-intestinal tract (GIT) transport receptors. The particular patent (United States patent number 7,135,457) covers...
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Anesiva, Inc. (Nasdaq: ANSV) filed a New Drug Application (NDA) to the USFDA for the marketing clearance of Zingo™ to treat the pain associated with venous access procedures in children. Zingo™, previously known as 3268, is a fast-acting, local...
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Nov28
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A company focused on discovering, developing and commercializing treatments for diabetes and cancer – MannKind Corporation (Nasdaq: MNKD) – has recently received USFDA clearance for its Investigational New Drug (IND) application for MKC1106-PP Immunotherapy in Solid Malignancies. The said...
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Mayne Pharma Ltd. (ASX: MYP) has agreed to acquire the remaining worldwide rights to Nipent® (pentostatin for injection) for a total consideration of US $8 million. Mayne Pharma acquired in August 2006 the North American rights to Nipent® from...
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A leading Australian antiviral drug development company - Biota Holdings Limited (ASX: BTA) - have entered into a worldwide research collaboration and licensing agreement with Boehringer Ingelheim (10922165) for the development and commercialization of Biota's novel nucleoside analogues designed...
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Cytokinetics, Incorporated (Nasdaq: CYTK) has amended its collaboration and license agreement with GlaxoSmithKline (NYSE:GSK) where Cytokinetics will assume responsibility for the costs and activities of continued development of the kinesin spindle protein (KSP) inhibitors ispinesib (SB-715992) and SB-743921, subject...
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Schering AG, Germany (NYSE: SHR)’s Betaferon® (interferon beta-1b) has been granted expanded indication by the Australian Therapeutic Goods Administration to include patients with a first clinical event suggestive of multiple sclerosis (MS). The said approval provides an important treatment...
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DRAXIS Health Inc. (TSX: DAX, NASDAQ: DRAX)’s radiopharmaceutical business unit – DRAXIMAGE – received USFDA approval to conduct two clinical trials using radioactive Iobenguane I-131 Injection (also known as (131)I metaiodobenzylguanidine, or I-131 MIBG) for the treatment of high-risk neuroblastoma....
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Nov27
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In order to distribute an authorized generic version of metoprolol succinate (25 mg dosage strength) in the United States, AstraZeneca (NYSE: AZN) entered into a supply and distribution agreement with Par Pharmaceutical (11855577).However, the said agreement does not affect the...
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Hope everyone had a great Thanksgiving weekend. We do not have one here in the Philippines, but nevertheless, my weekend was spent as a thanksgiving of sorts by meeting co-bloggers here at Know More Media. Over the weekend I met...
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Nov22
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The Cologne-based Artemis Pharmaceuticals GmbH entered into a research agreement with Merck & Co., Inc. (NYSE: MRK) for the construction of a large number of shRNA interference ("shRNAi ") - genetically engineered mouse models for the in vivo functional analysis...
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Under a signed strategic collaboration agreement, PARI and Kamada Ltd. (TLV: KMDA) will develop Kamada's Alpha-1 Antitrypsin (AAT) liquid drug candidate for inhalation through PARI's eFlow for the treatment of AAT deficient patients. Also known as Alpha-1 Proteinase Inhibitor (API),...
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Also, GlaxoSmithKline (NYSE: GSK) has been awarded a contract to supply pre-pandemic vaccines to the US strategic national stockpile. GSK has received a an initial $40 million order under the contract from the U.S. Department of Health and Human Services...
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The vaccines business of the sanofi-aventis Group (NYSE: SNY; EPA: SAN) - Sanofi pastuer (8788819) - has bagged a contract with the Office of Public Health and Emergency Preparedness (a division of the U.S. Department of Health and Human Services)...
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Nov21
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After receiving a favorable opinion from the European Committee for Orphan Medicinal Products (COMP), the European Medicines Agency (EMEA) has granted an "Orphan Medicinal Product Designation" to BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX)’s anticancer drug Fodosine™ for the treatment of T-Cell...
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Pooled results from Pharmacyclics, Inc. (Nasdaq: PCYC)’s two randomized Phase 3 clinical trials indicated that Xcytrin® (motexafin gadolinium) Injection combined with whole brain radiation therapy (WBRT) significantly prolonged time to neurologic progression in non-small cell lung cancer (NSCLC) patients with...
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Presented for the first time at the American Society of Nephrology's 39th Annual Meeting and Scientific Exposition are data on the initiation of PROCRIT® (Epoetin alfa) therapy 20,000 Units once every two weeks in patients with anemia related to chronic...
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Nov20
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According to Introgen Therapeutics, Inc. (Nasdaq: INGN)’s preclinical data on the NPRL2 tumor suppressor gene, systemic treatment using NPRL2 nanoparticles in combination with cisplatin resulted in a 90% tumor growth inhibition in human lung cancer cells compared to control treatments....
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Positive results from Somaxon Pharmaceuticals, Inc. (Nasdaq: SOMX)’s Phase 3 clinical trial that evaluated SILENOR™ (doxepin HCl) in elderly patients with primary sleep maintenance insomnia, have recently been announced. Clinical data revealed that SILENOR™ demonstrated a statistically significant improvement over...
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Nov19
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The poster presented by Celtic Pharmaceutical Holdings, L.P. (Celtic Pharma) and Neurobiological Technologies Inc. (Nasdaq: NTII) at the just concluded 11th Annual Meeting of the Society For Neuro-Oncology (SNO) in Orlando included the interim report of an open-label extension study...
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Shire plc (LON: SHP, Nasdaq: SHPGY) recently announced that a single once-daily morning dose of the investigational amphetamine compound SPD465 (extended release triple-bead mixed amphetamine salts) designed to reduce symptoms of Attention-Deficit/Hyperactivity Disorder (ADHD) in adults for up to 16...
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Nov18
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The USFDA has just approved Herceptin® of Genenetch, Inc. (NYSE:DNA) as part of a treatment regimen containing doxorubicin, cyclophosphamide and paclitaxel for the adjuvant treatment of HER2-positive node-positive breast cancer patients. Adjuvant therapy is given to women with early-stage (localized)...
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Nov17
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Positive results from a Phase III clinical trial of ferumoxytol as an intravenous (IV) iron replacement therapeutic has recently been announced by Advanced Magnetics (Nasdaq: AMAG) and presented at the American Society of Nephrology's Renal Week 2006 Annual Meeting in...
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A Phase 2 Study of Novalar Pharmaceuticals, Inc.’s local dental anesthetic reversal agent – NV-101- recently met its safety and efficacy endpoints in pediatric patients where the time to normal sensation was reduced by 55.6 %, a clinically and statistically...
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A division of Pfizer Inc. (NYSE: PFE) – Pfizer Animal Health- has recently agreed to acquire Embrex, Inc. (Nasdaq: EMBX), an international agricultural biotechnology company known for its Inovoject® vaccine-delivery systems. The terms of agreement include Pfizer acquiring (via a...
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According to new data presented at the annual meeting of the American Society of Regional Anesthesia and Pain Medicine, novel intranasal pain reliever of ROXRO PHARMA Inc. – ketorolac (ROX-888) - has been shown to be safe and effective in...
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A product of Vanda Pharmaceuticals Inc. (Nasdaq: VNDA), VEC-162 is a balanced melatonin receptor agonist for transient insomnia. The company’s Phase III clinical trail evaluating VEC-162 in transient insomnia yielded top line positive results. VEC-162 demonstrated statistically significant improvements at...
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USFDA-approved and available by prescription, WelChol® is the top-selling branded drug in the bile acid sequestrants (BAS) class. Now, a new data presented at the American Heart Association's (AHA) Scientific Sessions 2006 in Chicago demonstrated that WelChol® (colesevelam HCl), when...
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Nov16
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Analysis of new clinical data revealed that patients who have heart disease and chronic kidney disease who took Lipitor® (atorvastatin calcium) Tablets (80 mg) reduced their risk of heart attack and stroke by 32% compared with patients taking the 10...
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In the middle of the growing concern about the growing epidemic of counterfeit drugs, the National Associations of Boards of Pharmacy launched a new web site called Dangerous Pill and a series of podcasts to educate the public about this...
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Nov15
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Representatives from AIDS Healthcare Foundation (AHF) recently met with the CEO of the generic manufacturer CIPLA (BOM:500087), Dr.Y.K. Hamied in Mumbai (India) in order to discuss the concerns on the current high price and inaccessibility of CIPLA's new one-pill-a-day antiretroviral treatment...
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An investigational oral zonulin receptor antagonist being developed for treatment of Celiac Disease (CD), AT-1001 induced intestinal permeability in a double blind, placebo controlled study of CD patients. The findings have recently been presented at the XII International Celiac Disease...
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A biopharmaceutical company developing patient-specific, active immunotherapies for the treatment of cancer - Favrille, Inc. (Nasdaq: FVRL) – recently announced that the Data Monitoring Committee (DMC) have already completed its prospectively planned interim analysis of a secondary endpoint in the...
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Nov14
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Results from Roche’s two Phase III studies and one Phase II study revealed that treatment with the investigational agent tocilizumab (marketed as ACTEMRA™ in Japan for Castleman's Disease) was consistent in improving remission rates in patients with rheumatoid arthritis (RA)...
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Results from a three-year phase 3 clinical trial in which ruboxistaurin mesylate (proposed brand name Arxxant™, pronounced ark-ZONT) reduced the risk of sustained moderate vision loss by 40% vs. placebo in patients with moderate to severe non-proliferative diabetic retinopathy (DR)...
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In the recently concluded (November 10-15) 70th annual meeting of the American College of Rheumatology and the 41st annual meeting of the Association of Rheumatology Health Professionals in Washington, DC, Immunomedics, Inc. (Nasdaq: IMMU) has reported study data which showed...
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There has been documented concern about the cardiovascular safety of some pain relievers and arthritis treatments (1) in the past two years. Now, at the 70th annual meeting of the American College of Rheumatology (ACR), a new data that looked...
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Nov13
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Results of a randomized multinational study comparing the outcomes of kidney transplant patients undergoing induction therapy with Thymoglobulin® (Anti-thymocyte globulin [Rabbit]) with those receiving induction therapy with basiliximab have recently been published at the New England Journal of Medicine. …Rabbit...
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Xcytrin® (motexafin gadolinium) Injection may improve stereotactic radiosurgery treatment-planning by enhancing magnetic resonance imaging (MRI) and better defining the treatment field in patients with brain metastases from solid tumors. Such were the preliminary results of Pharmacyclics, Inc. (Nasdaq: PCYC)’s open-label...
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The USFDA has recently approved Boehringer Ingelheim Pharmaceuticals, Inc. (15251470)’s Mirapex® (pramipexole dihydrochloride) tablets for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS). RLS symptoms are typically described as an urge to move the legs accompanied by burning, creeping,...
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Results from Angiotech Pharmceuticals, Inc.’s first-in-man study for its Vascular Wrap™ have recently been announced. The trial produced evidence that the Vascular Wrap reduced the overall incidence of leg amputation and prolonged limb retention time for patients in the treatment...
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Nov 9
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In its recent financial update, Denmark-based Bavarian Nordic A/S (CPH: BAVA) reported that it is in continuous dialogue with the Department of Health and Human Services (HHS) officials on the company’s submitted proposal to supply the government with its Imvamune®...
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Filling the business headlines today is the 11 million bottles (or 383 lots) of Perrigo Co. (Nasadaq: PRGO)’s acetaminophen bottles being recalled due to metals fragments that contaminated some of the caplets in the said bottles. From NY Times: The...
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Anadys Pharmaceuticals, Inc. (Nasdaq: ANDS) went into a collaboration with Novartis Pharma (2856737) for a new 13-week pre-clinical toxicology study of ANA975 to assess safety and tolerability in animals. Being developed by Anadys in collaboration with Novartis, ANA975 is a...
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The U.S. Patent and Trademark Office (USPTO) have issued U.S. Patent No. 7,132,570 (the '570 patent) covering a novel polymorphic form of armodafinil to Cephalon, Inc. (Nasdaq: CEPH). Armodafinil is the active pharmaceutical ingredient in NUVIGIL™ (armodafinil) Tablets -- currently...
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A biotechnology company dedicated to the discovery and development of novel therapeutics for diabetes and related metabolic disorders - Metabolex, Inc. (205073) – has received its first European patent for metaglidasen (MBX-102), the company's lead drug candidate. The European patent...
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Infinity Pharmaceuticals, Inc. (Nasdaq: INFI) and MedImmune, Inc. (Nasdaq: MEDI) announced the preliminary results of an open-label Phase I clinical study of IPI-504 in patients with Gleevec®-resistant metastatic gastrointestinal stromal tumors (GIST). A proprietary small molecule inhibitor of Heat Shock...
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Results from a Phase 1 clinical trial of Cytogen Corporation (Nasdaq: CYTO)’s QUADRAMET® (samarium Sm-153 lexidronam injection) in combination with hormonal therapy and external beam radiation therapy in high-risk, clinically non-metastatic prostate cancer patients, demonstrated positive results. QUADRAMET® is Cytogen...
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Clinical data of Panacea Pharmaceuticals, Inc.’s novel and proprietary cancer biomarker were presented at the Molecular Targets and Cancer Therapeutics meeting currently being held in Prague, Czech Republic. The presentation will illustrate an in vitro assay that reliably predicts the response...
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Nov 8
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Nope you aren't lost and it's not a trick of the mouse but the trick of a redirect. I hope you still find me here at the PharmaGazette (this blog's spanking new name) so please update your URLs and link txt:...
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Nov 7
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Developer of stem cell therapeutics and a subsidiary of Elbit Medical Imaging Ltd. (EMI) (Nasdaq: EMITF) - Gamida Cell Ltd. - has reached an agreement under a Special Protocol Assessment (SPA) with the USFDA regarding the design of the global,...
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Abbott (NYSE: ABT) and Kos Pharmaceuticals, Inc. (Nasdaq: KOSP) has reached a definitive agreement that enables Abbott to acquire Kos for $78 per share in cash, for a total transaction value of $3.7 billion, net of cash currently held by...
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MIGENIX Inc. (TSE: MGI) has proven and demonstrated that using the oral alpha-glucosidase inhibitor, celgosivir (MX-3253), in combination with pegylated interferon and ribavirin is more beneficial compared to treatment with pegylated interferon and ribavirin alone in patients with chronic hepatitis...
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A specialty pharmaceutical company focused on oncology- Poniard Pharmaceuticals, Inc. (Nasdaq: PARD) – has announced the positive interim median overall survival data from the company’s ongoing Phase 2 clinical trial of picoplatin in small cell lung cancer (SCLC) patients. The...
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ImClone Systems Incorporated (Nasdaq: IMCL) and Bristol-Myers Squibb Company (NYSE: BMY) have recently announced the results of two randomized Phase III trials of ERBITUX® (cetuximab) in metastatic colorectal cancer patients. The said trials are the first large, randomized studies that...
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Nov 6
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Introgen Therapeutics, Inc. (Nasdaq: INGN) gained a worldwide exclusive license to a family of patent applications directed to combination therapy using ADVEXIN® with inhibitors of epidermal growth factor receptors (EGFr inhibitors), such as Erbitux™, Vectibix™, Tarceva™ and Iressa™. The said...
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Four researchers of Wyeth Pharmaceuticals (10944776), a division of Wyeth (NYSE: WYE) were honored at the Research & Development (R&D) Council of New Jersey 2006 Annual Thomas Alva Edison Patent Awards for a significant scientific breakthrough and revolutionary product innovation...
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Cytokinetics, Incorporated (Nasdaq: CYTK) will present data from a Phase Ib combination clinical trial of ispinesib and a non-clinical study of SB-743921 (both novel inhibitors of kinesin spindle protein (KSP)) at the 18th Annual EORTC-NCI-AACR Symposium on Molecular Targets and...
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New clinical data presented at the recent Sexual Medicine Society of North America (SMSNA) Fall meeting and published in the November issue of the International Journal of Clinical Practice revealed: LEVITRA® (vardenafil HCl), is effective at first dose with continued...
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Nov 5
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The World Health Organization (WHO) and its partners will officially launch the first ever International Medical Products Anti-counterfeiting Taskforce (IMPACT) on November 15, 2006 which will unveil the global plan to combat counterfeit medical products. At its first official meeting...
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One of the world's leading companies in dermatology, LEO Pharma, has been granted the exclusive worldwide rights to develop, manufacture, and commercialize a novel preclinical HDAC inhibitor - PXD118490 – for the treatment of psoriasis and other dermatological disorders. This...
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The US National Institutes of Health (NIH) has selected EvoGenix Ltd.(ASX: EGX) to collaborate in the development of antibody therapies against a new cancer target. Dr Frank Cuttitta, senior investigator and head of the Angiogenesis Core Facility at the US...
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A specialty pharmaceutical company focused on niche drug delivery technologies and products – Inyx, Inc. (OTC: IYXI) – has recently signed an agreement with Plethora Solutions Holdings plc (SEA: PLE) - an emerging U.K. specialty pharmaceutical company – for the...
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AstraZeneca (US) (NYSE: AZN), in its new efforts to help more people who have difficulty paying for their medicines, has changed its Patient Assistance Program. Beginning November 15th, a family of four earning $60,000 or less or individuals earnings $30,000...
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Diabets drug compnay, Oramed Pharmaceuticals, Inc. (OTC: ORMP), has recently signed a manufacturing agreement with one of the largest soft gel capsule manufacturers in the world, Swiss Caps AG. Under the terms of agreement: Swiss Caps AG will provide gel...
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Nov 4
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A wholly owned subsidiary of Ranbaxy Laboratories Limited (PINK: RBXLF, BOM: 500359) – Ranbaxy Pharmaceuticals Inc. (RPI, 13512105) - has received a USFDA tentative approval for the manufacture and marketing of Cetirizine Hydrochloride Syrup, 5 mg/5 ml. Indicated for the...
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A leading developer in the treatment of multiple sclerosis (MS), BioMS Medical Corp (TSE: MS) \, recently announced that the University of Alberta has received additional patents for the Company's synthetic peptide therapeutic, MBP8298, for the treatment of multiple sclerosis...
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A research-based, technology-driven Canadian biopharmaceutical company, Bioniche Life Sciences Inc. (TSE: BNC), has recently been granted three new patents for its core proprietary Mycobacterial Cell Wall-DNA Complex (MCC) and the related oligonucleotides. U.S. patent entitled "Hyaluronic acid in the treatment...
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The European Patent Office has issued patent number EP1534305B1 (TREATING CARTILAGE/BONE CONDITIONS WITH WATER-SOLUBLE STRONTIUM SALTS) has recently been issued to Osteologix, Inc. (OTC: OLGX). The said patent, expiring in 2024, covers the use of strontium malonate for use in...
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A collaborative study between Sapient Discovery, LLC and Lpath, Inc. that used Sapient Discovery's powerful computational platform to understand the binding properties of Lpath's humanized Sphingomab™ antibody to its target, sphingosine-1-phosphate (S1P) has been successfully completed, as announced by the...
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For the manufacture of its proprietary dengue vaccine for human clinical trials, InViragen has entered into an agreement with Shantha Biotechnics (Hyderabad, India) - the first Indian company to develop, manufacture and market a recombinant human healthcare product in India....
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Nov 3
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An all natural supplement that promotes hair regrowth - Nourkrin®- has been proven to stop thinning hair, strengthen existing hair and promote growth of dormant hair. 61.5 percent of study participants experienced hair growth using Nourkrin® and the participants' hair...
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A biopharmaceutical company specializing in the research and development of pharmaceutical products and technologies for the management of cancer - Lorus Therapeutics Inc. ("Lorus") (TSE: LOR) - presented the pharmacokinetics of GTI-2040 in patients with acute myeloid leukemia at the...
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Now it is official: CVS Corporation (NYSE: CVS) has entered into a merger agreement with pharmacy benefit management company Caremark Rx, Inc. (NYSE: CMX) in a stock deal valued at about $21 billion. This merger, which combines CVS' PBM, PharmaCare,...
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Nov 1
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China Pharma Holdings, Inc. (''China Pharma'') (OTC: CPHI) has finally received the Good Manufacturing Practice (GMP) certification and approval from the Chinese State Food and Drug Administration (SFDA) for the production of cephalosporin following the company’s completion of its facility...
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A new oral tablet for erectile dysfunction (ED) by Dong-A Pharmaceutical Co., Ltd. (SEO: 000640) -Zydena- was launched in Korea in December 2005 and since then has already exceeded more than 20% (by volume) of the Korean market because of its...
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The said trial also provided a hint of efficacy as disease stabilization and regression of lesions were observed at the 160 mg/m(2) and 267 mg/m(2) dose levels. 
