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Aug31
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Ranbaxy Laboratories Limited (Public, BOM: 500359) has been favored by a Norwegian court recently in its case against Pfizer (Public, NYSE: PFE) that involved two patents on atorvastatin in Norway.
Atorvastatin is a cholesterol-lowering drug marketed by Pfizer under the brand name Lipitor®.
The Oslo City Court favored Ranbaxy upon finding non-infringement of two of Pfizer's Norwegian patents (No. 177,566 and No. 180,199) covering particular intermediate compounds.
Last November 2005, the Norwegian Court found Ranbaxy's atorvastatin product not to infringe one of Pfizer's process patents (No. 309,322) but to infringe another of Pfizer's patents (No. 177,706) covering a particular intermediate compound.
Thus, Ranbaxy has appealed to the Norwegian Court of Appeals against the negative judgment on the one remaining intermediate compound patent.
"This is a most important decision for Ranbaxy, as it significantly validates our position regarding the atorvastatin patents," said Jay Deshmukh, Senior Vice President, Global Intellectual Property for RLL.
"We will continue to actively pursue all of our options in Norway and other markets in order to bring affordable atorvastatin to patients around the world."
Source: Ranbaxy Laboratories Limited
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Aug31
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Denmark-base biopharmaceutical firm Pharmexa A/S (PHARMX) has obtained approvals in France to start the Heptovax Phase II trials, with approvals from Spain and Germany still pending. The trials will assess GV1001's safety and efficacy in advanced hepatocellular carcinoma (liver cancer)....
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The European Commission has granted Exjade (deferasirox) for use in 25 European countries. Exjade is a single daily oral dose drug manufactured by Novartis AG (NOVN), indicated for patients with transfusional iron overload. Exjade is the first oral iron chelator...
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The USFDA has accepted a New Drug Application submitted by Hana Biosciences (HNAB), the North American partner of NovaDel Pharma (NVD) for Zensana™ (ondansetron HCl) Oral Spray. The NDA was filed under Section 505(b)(2) of the Food, Drug and Cosmetic...
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Millennium Pharmaceuticals, Inc. (MLNM) has initiated Phase I trials of MLN0415, an oral, highly selective, small molecule inhibitor of IKK2, which targets a major inflammatory pathway. The trial will enlist 72 healthy volunteers to assess the drug's safety, tolerability, pharmacokinetic...
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Innovator of new products and distributor of nutritional ingredients, Compound Solutions, have agreed to represent Hangzhou Zhongmeihuadong Pharmaceutical (HZH) in the distribution of CoQ10 across North America and Europe. CoQ10 is a powerful antioxidant and catalyst for ATP (energy production...
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Aug30
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Allos Therapeutics, Inc. (Nasdaq: ALTH) has initiated the pivotal multi-center Phase 2 study of its unique next generation antifolate PDX (pralatrexate) with vitamin B12 and folic acid supplementation in patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). The said...
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A biotechnology company developing chemokine-based therapies for the treatment of cancer, blood disorders and vascular diseases, Chemokine Therapeutics (TSE: CTI) has been granted by the United States Patent and Trademark Office a U.S. Patent 7,091,310 B2. The said patent is...
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MedImmune, Inc. (Nasdaq: MEDI) and Infinity Pharmaceuticals, Inc. have entered into an agreement for joint development and commercialization of novel small molecule cancer drugs targeting Heat Shock Protein 90 (Hsp90) and the Hedgehog cell-signaling pathway. Hsp90 and the Hedgehog pathway,...
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Paramount Acquisition Corp. (OTC BB: PMQCU.OB) (Paramount) and BioValve Technologies, Inc. (BioValve) have entered into a definitive agreement whereby Paramount will acquire a majority interest in the recently-formed medical technologies subsidiary of BioValve; Valeritas, LLC (Valeritas). Completion of the said...
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Genentech, Inc. (NYSE: DNA) and Biogen Idec, Inc. (Nasdaq: BIIB) recently announced the positive results of a Phase II study of Rituxan® (Rituximab) for relapsing-remitting multiple sclerosis (RRMS). RRMS, the most common form of MS (a chronic autoimmune disease in...
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SGX Pharmaceuticals, Inc. (Nasdaq: SGXP) has discontinued the Phase II/III clinical trial of Troxatyl™ as a third-line treatment for patients suffering from acute myelogenous leukemia (AML). The discontinuation of the said trial is based upon the recommendation of the study's...
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Aug29
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US pharmaceutical firm Mylan Laboratories (MYL) has agreed to acquire 71.5 % of the Hyderabad-based Matrix Laboratories (BOM:524794) for a total purchase price estimated at $736 million. By combining Matrix's active pharmaceutical ingredient (API) and drug development business with Mylan's...
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Endo Pharmaceuticals Holdings Inc. (ENDP) will stop sales of generic OxyContin by the end of the year after reaching a settlement with Purdue Frederick Co., P.F. Laboratories Inc., and Euro-Celtique S.A., over a long-running patent litigation claiming that Endo's oxycodone...
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Nabi Biopharmaceuticals (NABI) has obtained exclusive rights to the use of a novel hyperimmune immunoglobulin extraction technology developed by Montreal-based ProMetic Life Sciences, Inc. (PLI) in the production of its hyperimmune products. Nabi expects that using the technology will provide...
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StemCells, Inc. (STEM) has entered into a licence agreement with Canadian firm Stem Cell Therapeutics Corp. (TSX: SSS) to develop stem-cell-based therapeutics for neurological diseases. "This is a mutually advantageous deal that we believe advances the adult neural stem cell...
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Novogen Limited (Nasdaq: NVGN; ASX: NRT), has ended the 2005/06 financial year with solid cash reserves of $25.4 million and a USFDA clearance for the final phase of the company’s human clinical testing of its lead anti-cancer drug, phenoxodiol. Revenue...
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Aug28
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Dendreon Corporation (Nasdaq: DNDN) has submitted the clinical and non-clinical sections of the rolling submission of its USFDA Biologics License Application (BLA) of PROVENGE® (sipuleucel-T) for the treatment of asymptomatic patients with metastatic, androgen-independent (also known as hormone-refractory) prostate cancer....
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Shire plc (LON: SHP, NASDAQ: SHPGY) has recently submitted a new drug application (NDA) to the USFDA for its investigational compound guanfacine extended release (previously referred to as SPD503), which when approved will become the first once-daily selective alpha-2A-adrenoceptor agonist...
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Nanogen, Inc. (Nasdaq: NGEN) has been issued six patents by the U.S. Patent and Trademark Office (USPTO) for inventions related to diabetes and Alzheimer’s disease and their biomarkers. The 3 following patents are related to the use of mass spectrometry...
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Neurobiological Technologies, Inc. (Nasdaq: NTII) has completed its targeted U.S. site selection for its first global Phase III trial for Viprinex™ (Ancrod Injection) in acute ischemic stroke. Neurobiological Technologies, Inc.’s Ancrod Stroke Program (ASP) includes two double-blind, randomized, placebo-controlled clinical...
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According to a 6-year study whose results were recently published in the Journal of the American Medical Association, a less expensive form of heparin can be just as safe and effective than the newer low-molecular weight heparins for treating venous...
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Aug27
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Lpath, Inc. (LPTN.OB) recently received a Notice of Allowance from the US Patent and Trademark Office (USPTO) on an important patent covering the use of Sphingomab™ in the treatment of cancer. Sphingomab™ is Lpath Inc.’s monoclonal antibody against sphingosine-1-phosphate (S1P),...
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Corcept Therapeutics, Incorporated (Nasdaq: CORT) recently announced that the first of its three Phase 3 trials evaluating CORLUX® for treating the psychotic features of Psychotic Major Depression (PMD) yielded negative results. "There was an unusually high placebo response rate in...
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The publication of preclinical data demonstrating the potential clinical utility of N-Chlorotaurine (NCT) in the treatment of viral conjunctivitis has recently been announced by Acuity Pharmaceuticals, Inc. and Pathogenics, Inc. (PTGN.PK) Pathogenics is developing NCT for a variety of topical and...
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Germany-based pharmaceutical company, Boehringer Ingelheim (10922165) and the New York-based healthcare company (specializing in vitamins, minerals, nutrition products and herbs), IdeaSphere Inc. recently announced the sale of Boehringer Ingelheim's Natural Healthcare company and business Pharmaton SA (Lugano) to IdeaSphere, Inc....
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Aug26
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Mirapex® (pramipexole dihydrochloride) tablets, a dopamine agonist indicated for the treatment of Parkinson's disease (PD) has recently been shown in a study to improve depressive symptoms in Parkinson's disease patients as the established antidepressant sertraline. The said open-label, multicenter, randomized,...
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The European Commission has approved Keppra® as monotherapy in the treatment of partial onset seizures with or without secondary generalisation in patients from 16 years of age with newly diagnosed epilepsy. The approval is based on a positive controlled phase...
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MedImmune, Inc. (Nasdaq: MEDI) has filed an investigational new drug application (IND) with the USFDA for MT103 (also known as MEDI-538) for the treatment of patients with B-cell-derived non-Hodgkins lymphoma (NHL) not eligible for curative therapy. MT103, a recombinant single-chain bispecific...
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Initial studies made by researchers from the Universtiy of Manchester indicate that the HIV drug, lopinavir, is also effective against human papilloma virus (HPV), the virus that causes cervical cancer. Michael Carter, of the HIV organisation Aidsmap, said: "This latest...
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Mission Pharmacal (3799318) submitted a supplemental new drug application (sNDA) to the USFDA for a new indication of Tindamax® (tinidazole) as treatment of bacterial vaginosis (BV), the United States’ most common vaginal infection. Upon USFDA approval of the said sNDA,...
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Aug25
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The USFDA has approved the use of Keppra® (levetiracetam) as adjunctive therapy in the treatment of myoclonic seizures in adults and adolescents 12 years of age and older with juvenile myoclonic epilepsy (JME). UCB Group, Inc. (UCB)’s Keppra® is widely...
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Cell Therapeutics, Inc. (CTI) (Nasdaq: CTIC)’s Phase I study data of weekly XYOTAX™ given in combination with radiation for patients with esophageal or gastric cancer is published in the August edition of the American Journal of Clinical Oncology. In the...
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Mayne Pharma Limited’s proposed acquisition of the North American rights to SuperGen, Inc.'s Nipent® (pentostatin for injection) and SurfaceSafe™ (communicated on 22 June 2006) has now been completed, as announced by both companies. Mayne Pharma Limited (ASX: MYP) will pay...
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Stiefel Laboratories, Inc. has reached an exclusive worldwide licensing agreement with Italian companies, The Epitech Group s.r.l. and Innovet Italia s.r.l. The said agreement gave Stiefel Laboratories, Inc. the production and marketing rights for pharmaceutical and cosmetic products based on...
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Medarex, Inc. (Nasdaq: MEDX) and GenPat77 Pharmacogenetics AG, have entered into a collaborative agreement to fully develop human therapeutic antibody products. The collaborative agreement plans to utilize use Medarex's UltiMAb Human Antibody Development System® to generate antibodies to novel disease...
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Aug24
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ARIAD Pharmaceuticals, Inc. (ARIA) has been issued a U.S. patent covering its novel mTOR inhibitors, including its lead cancer product candidate, AP23573. AP23573 is a novel small-molecule inhibitor of the protein mTOR (mammalian Target Of Rapamycin), an enzyme that plays...
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As indicated in a previous entry, the USFDA finally approved the emergency contraceptive Plan B, commonly known as the "morning-after pill," available without a prescription to women 18 and older. Plan B is manufactured by Barr Pharmaceuticals, Inc (BRL). "While...
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A Wyeth division (NYSE: WYE), Wyeth Pharmaceuticals and Progenics Pharmaceuticals, Inc. (Nasdaq: PGNX) has recently initiated the Phase 2 clinical trial evaluating the once-daily dosing of oral methylnaltrexone. The said Phase 2 clinical trial is designed to identify the dose(s)...
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Neuren Pharmaceuticals (ASX: NEU)’ Phase 2 clinical trial of its lead compound, Glypromate® for the reduction of cognitive decline following cardiac surgery, yielded favorable results. Neuren's Phase 2a clinical trial designed to investigate the safety, tolerability and pharmacokinetics of a...
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These days, diabetics have to endure the pain and discomfort of insulin injections. But scientists are continuously looking for easier, more effective ways for diabetics for their insulin intake. Next month, Pfizer (NYSE: PFE) will release an insulin inhaler called...
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Aug23
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Entelos Inc (ENTL) and Novartis AG (NVS) will collaborate in the development of drugs for multiple disease areas. Under terms of the agreement, Novartis will provide R&D funding and Entelos will conduct biosimulation research using its PhysioLab® platforms that predict...
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Isotechnika Inc. (TSE:ISA) recently announced the promising results from its Phase I Trial of TAFA93. TAFA93 is a pro-drug of rapamycin, a novel small molecule mTOR inhibitor, a class of drugs currently used in the prevention of organ rejection in...
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The USFDA and GlaxoSmithKline (GSK) have recently notified healthcare professionals of the changes to the BOXED WARNING, WARNINGS and PRECAUTIONS sections of the prescribing information for Dexedrine® (dextroamphetamine sulfate). GlaxoSmithKline’s Dexedrine® (dextroamphetamine sulfate) is approved for the treatment of Attention-Deficit Hyperactivity...
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Altus Pharmaceuticals Inc. (NASDAQ: ALTU) has signed an agreement with Althea Technologies, Inc. (5777566) a contract manufacturing organization (CMO), to manufacture ALTU-238 for use in the planned Phase III clinical trials of that product candidate. ALTU-238 is being developed by Altus...
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A wholly-owned subsidiary of The Quigley Corporation (Nasdaq: QGLY), Quigley Pharma, has been granted Patent No. US 7,083,813 B2 for its application "Methods for the Treatment of Peripheral Neural and Vascular Ailments" filed in November of 2002. This particular patent...
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Aug22
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ATG003, Athenagen’s proprietary topical formulation of mecamylamine that has shown efficacy in animal models, is a possible alternative to current therapies for AMD (mostly requiring frequent needle injections directly in the eye). The said Phase 1 clinical trial is the...
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CoGenesys, Inc. and Vegenics, Ltd. have entered into a worldwide licensing agreement that provides Vegenics with rights to an intellectual property in the field of vascular endothelial growth factors (VEGF). The terms of agreement entitles CoGenesys to an upfront licensing...
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Bristol-Myers Squibb Company (NYSE: BMY) and Otsuka Pharmaceutical Co. (2579667), recently launched ABILIFY® DISCMELT™ (a pdf file) (aripiprazole) Orally Disintegrating Tablets, a new oral form of the antipsychotic medication ABILIFY® (aripiprazole) that rapidly disintegrates in the mouth. It has been shown...
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Acquired on August 9, 2006 by Caliper Life Sciences, Inc. (Nasdaq: CALP), Xenogen Biosciences, has entered into a target validation collaboration with Schering-Plough Corporation (NYSE: SGP), under which Xenogen Biosciences will utilize its proprietary Serial Phenotyping Compression Technology (SPCT) to...
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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. (Public, OTC: CHBP), has completed all required clinical trials for one of its new drugs, Nafamostate Mesilate, and is...
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Aug21
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Isolagen, Inc. (Amex: ILE) has recently acquired a 57% interest in Agera Laboratories, Inc., for $2,655,000 in cash plus an earn-out provision. In addition, Isolagen also obtained a six month option to increase its stake in Agera to 65% for...
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United Research Laboratories/Mutual Pharmaceutical Company recently filed an Abbreviated New Drug Application (ANDA) to the USFDA, seeking approval to market Mutual's guaifenesin extended-release tablets (600 mg and 1200 mg) Guaifenesin extended-release tablets (pdf file), currently marketed over-the-counter (OTC) by Adams Respiratory...
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Eli Lilly and Company (NYSE:LLY)’s investigational oral therapy being studied for treatment of diabetic retinopathy (DR), ruboxistaurin mesylate (proposed trade name Arxxant™, pronounced, ark-ZONT), received an approvable letter from the USFDA. The USFDA has requested submission of additional data to support...
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Aug20
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The makers of the blood thinner Plavix®, Bristol-Myers Squibb Co. (NYSE:BMY)and Sanofi-Aventis SA (NYSE:SNY), have filed an injunction against the Canadian drug maker, Apotex Corp., to stop it from selling a less expensive, generic version of Plavix® and to recall the products...
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Aug19
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Caraco Pharmaceutical Laboratories, Ltd. (Amex: CPD)’s Abbreviated New Drug Application (ANDA) for Baclofen Tablets has been granted final approval by the USFDA. Baclofen Tablet, a muscle relaxant and antispastic, is useful for the alleviation of signs and symptoms of spasticity...
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An ophthalmic-focused biopharmaceutical company, Sirion Therapeutics, Inc. has merged with Sytera, Inc., a biopharmaceutical firm based in La Jolla, California committed to discovering new treatments for dry AMD (age- related macular degeneration). The newly merged company will be called Sirion...
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Cytogen Corporation (Nasdaq: CYTO)’s SOLTAMOX™ (tamoxifen citrate, oral solution 10mg/5mL), the first liquid form of the hormonal breast cancer therapy tamoxifen, is currently being introduced in the and is available in pharmacies nationwide. SOLTAMOX™, USFDA approved in October 2005, is...
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Aug18
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Northwest Biotherapeutics, Inc. (OTC: NWBT) has taken a key step in initiating its Phase II clinical trial to evaluate DCVax®-Brain in patients with Glioblastoma multiforme, by awarding the clinical trial management contract to Synteract (Carlsbad, CA). The clinical trial designed...
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Iomai Corporation (Nasdaq: IOMI) has already initiated enrollment of participants in a Phase 2 trial designed to test its vaccine patch for travelers' diarrhea in volunteers traveling to sites in Mexico and Guatemala. This trial is designed to assess the...
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Transport Pharmaceuticals’ statistically significant Phase IIb clinical results of its first-generation drug/device combination product, SoloVir™ for herpes labialis (cold sores) has been published August 15, 2006 in the journal Clinical Infectious Diseases as a major article (entitled: Topical Iontophoretic Administration...
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Novartis (VTX: NOVN) is seeking European approval for Galvus (vildagliptin), a new once-daily oral drug for the treatment of type 2 diabetes. Clinical trials have demonstrated that the drug could effectively lower blood sugar, even among difficult to treat patients....
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Aug17
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ProEthic Pharmaceuticals, Inc. announced positive results from two Phase I trials for PRO-571, a drug candidate for the treatment of acute pain. PRO-571 is a rapid-release formulation of diclofenac potassium in tablet form, developed using the company's proprietal "Dynamic Buffering...
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Data analysis of ViroPharma Incorporated (Nasdaq: VPHM) and Wyeth (NYSE: WYE)’s ongoing Phase 1b study of HCV-796 (an investigational oral non-nucleoside hepatitis C virus (HCV) polymerase inhibitor) in combination with pegylated interferon, indicated that HCV-796 has achieved a "proof of...
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A leading global manufacturer and marketer of nutritional supplements, NBTY, Inc. (NYSE: NTY) has entered into a contract to acquire Zila Nutraceuticals, Inc. (a business unit of Zila, Inc., Nasdaq: ZILA), the manufacturer and marketer of the Ester-C® nutritional supplement...
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Intranasal Therapeutics, Inc (ITI), a specialty pharmaceutical company focused on developing nasally delivered pharmaceutical products, closed $39.1 million in its first round of venture financing. The Series A financing was led by SV Life Sciences, and included the following investors:...
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Dutch chemical group Akzo Nobel NV (AKZOY) plans to spin off its human and veterinarian pharmaceutical units as Organon BioSciences, and focus on coatings and chemicals instead. Akzo Nobel, which had already announced its intention to spin off Organon, with...
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Aug16
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VaxGen, Inc. (Public, OTC: VXGN)’s peer-reviewed data from the company's Phase I clinical trial of its candidate anthrax vaccine rPA102 were published in the journal Vaccine(1). The data which demonstrated a clear relationship between the rPA102 dose administration and the...
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Schering-Plough Corporation (NYSE: SGP) has entered into a global collaboration with Novartis AG (NYSE: NVS) for the development and commercialization of a once-daily inhaled fixed-dose combination therapy for the treatment of asthma and chronic obstructive pulmonary disease (COPD). The collaboration...
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REMICADE® was first approved in 1998 for the treatment of Crohn's disease, and since then has been used to treat over 770,000 patients worldwide suffering from gastroenterologic, rheumatologic and dermatologic inflammatory diseases. Now, the USFDA has extended its approval for...
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In June 2006, the USFDA has granted accelerated approval of PREZISTA™ (a protease inhibitor formerly known as TMC114). PREZISTA™ (darunavir) 300 mg tablets, co-administered with 100 mg ritonavir (PREZISTA/rtv) and with other antiretroviral agents, is indicated for the treatment of...
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The Transportation Safety Administration (TSA) on Sunday August 13, 2006 added a new rule that allows for the exemption of Bioponic Phytoceuticals, Inc.’s Flight Spray® from the recent established ban on passengers carrying liquids onto flights. The TSA ban on...
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Aug15
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Potentia Pharmaceuticals, Inc. has entered into an exclusive, worldwide licensing agreement with the University of Pennsylvania that provides broad rights to develop and commercialize University of Pennsylvania's Compstatin class of complement-inhibiting peptides for the treatment of ocular diseases. The said...
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There are two new quarterly publications from Analysts in Media that will be beneficial to Pharmaceutical and Healthcare Professionals (both practitioner and business people) as well as the patients and consumers. 1) Future Pharmaceuticals: a publication that provides senior-level decision-makers...
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What: eCommunication and Online Marketing Conference When: November 13-14, 2006-08-15 Where: Philadelphia, USA. The only annual Pharma gathering on interactive media, eCommunication and Online Marketing Conference is a unique platform for discussion and exchange, a venue that will enable you...
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PXD101, a small molecule histone deacetylase (HDAC) inhibitor, is under clinical trial for liver cancer and for mutiple myeloma in combination with Velcade®. Last week, CuraGen Corporation (Nasdaq: CRGN) and TopoTarget A/S (Public, CPH: TOPO) initiated the patient dosing of...
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Bioheart, Inc. has acquired an option to the worldwide exclusive rights to Tissue Genesis, Inc.'s adipose (fat) derived therapeutic cell technology which is currently being developed to treat heart attacks and congestive heart failure. Adipose derived cells are an abundant,...
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Aug14
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According to a new study conducted in the Intramural Research Program of the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) (a component of the National Institutes of Health) and published in the august 10 issue of the...
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The U.S. Patent and Trademark Office (USPTO) have issued a patent to the President and Fellows of Harvard College, the General Hospital Corporation and Organix, Inc. The patent, exclusively licensed to Boston Life Sciences, Inc. (Nasdaq: BLSI) under a worldwide...
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Aug13
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Founder of Cure HIV, Inc. and Global Humanceuticals, Inc., Dr. Roger Kenneth Hershline M.D., Ph.D., has applied for an international patent on his antiviral composition. Dr. Hershline received International Publication No. WO2006/050381 published on May 6, 2006 and was issued...
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Canadian pharmaceutical firm Medicure Inc. (TSE:MPH) has acquired the US rights to Aggrastat for US$19 million. Aggrastat, a drug indicated for the treatment of acute coronary syndrome, including angina and myocardial infarction, was developed by Merck, and whose US marketing...
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Encysive Pharmaceuticals (ENCY) has received marketing authorization for Thelin® (sitaxentan sodium) 100 mg tablets from the European Commission. Thelin is a once daily oral endothelin A receptor antagonist indicated for the treatment of patients with pulmonary arterial hypertension (PAH). The...
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Genzyme Corp. (Nasdaq: GENZ) has filed with the European authority to expand the CE mark for Synvisc® (hylan G-F 20) to include treatment of pain due to osteoarthritis (OA) of the ankle and shoulder. Approval of this new label will...
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Cell Therapeutics, Inc. (CTI) (Nasdaq: CTIC) reported an encouraging interim data of its randomized phase III trial of pixantrone in patients aggressive non-Hodgkin's lymphoma. The Data Monitoring Committee recommended that the study continue as planned while the company plans to...
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Aug12
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Quigley Pharma, Inc., a wholly-owned subsidiary of The Quigley Corporation (Nasdaq: QGLY), obtained positive results for its QR-443 compound for the treatment of Cachexia. Cachexia is a debilitating and life threatening muscle wasting condition characterized by loss of weight, muscle...
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Novartis’ two-year nationwide mass vaccination campaign in New Zealand based on the company's MeNZB® vaccine, which was developed specifically for that purpose, has been successfully concluded. Novartis (Public, NYSE:NVS) scientists, in collaboration with the New Zealand Ministry of Health with the...
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Abeille Pharmaceuticals, Inc. recently submitted its AB-1001 Phase III Pivotal Efficacy Study Protocol for review and comment by the USFDA under a Special Protocol Assessment (SPA). AB-1001, a transdermal patch for chemotherapy induced nausea and vomiting (CINV) is designed to...
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Anacor Pharmaceuticals(Anacor)’ lead compound, AN2690, is the first in a new class of antifungal agents that is being developed for onychomycosis, a fungal infection of the nail and nail bed. The company recently announced that its Phase 1 trial of...
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Aug11
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Genzyme’s Renagel®, the only phosphate binder available that does not contain either calcium or a metal, controls serum phosphorus in patients with Chronic Kidney Disease on hemodialysis. Recently, the American Kidney Fund and Genzyme Corp. launched a new program that...
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Advancis Pharmaceutical Corporation (Nasdaq: AVNC) announce positive trial results for its Amoxicillin PULSYS Phase III clinical trial for the treatment of adults and adolescents with pharyngitis/tonsillitis due to Group A streptococcal infections. Compared to the current treatment regimen requiring 500...
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According to Manhattan Research's study, "ePharma Physician® v6.0: The Future of Professional eMarketing", these are the top 10 pharma product websites visited by physicians: 1.Pfizer's Lipitor 2. Merck's Fosamax 3.Shire's Adderall XR 4.GlaxoSmithKline's Advair 5.Bristol-Myers Squibb and Sanofi-Aventis' Plavix 6.Johnson...
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MacuSight, Inc.’s Investigational New Drug (IND) application for its proprietary formulation of sirolimus (rapamycin) has been accepted by the USFDA. The company’s IND covers the compound's development as a treatment for wet age-related macular degeneration (wet AMD) and diabetic macular...
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The Bureau of Food and Drugs (BFAD), the Philippine drug regulatory body, has granted Epeius Biotechnologies an accelerated approval for the company's lead clinical product, Rexin-G™ for the treatment of all solid tumors. "With Rexin-G™, Epeius is advancing genetic medicine...
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Aug10
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According to a study headed by researchers from the University Of Maryland School Of Medicine, a medication used to treat mild to moderate Alzheimer's disease can be used to protect people against the toxic effects of nerve agents and certain...
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In order to bring its live-saving AIDS pill to more people in the world’s poorest countries, Gilead Sciences, Inc. (Public, Nasdaq:GILD) has offered to help generic drug makers in India to produce Truvada, a drug that combines the company’s best-selling...
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What: Seventh Annual Pharmaceutical Regulatory and Compliance Congress When: November, 8 - 10, 2006 Where: JW Marriott Hotel, Washington, DC A transformational learning and knowledge exchange on the year's top pharmaceutical regulatory and compliance issues in the field of medical...
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The report that Thai scientists were successful in making the generic version of the bird flu antiviral drug, Roche (RHHBY)’s Tamiflu, not for commercial purposes but for Thailand’s security really caught my attention. IPS News reported: ''It will not be...
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Aug 9
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The stockholders of NWH, Inc. (Nasdaq: NWIR) (NWH), the parent company of health care payer services organization, Electronic Network Systems, Inc. (ENS), has approved the company’s acquisition by Ingenix, Inc. (Ingenix). In 25 May 2006, NWH and Ingenix has entered...
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Radius, a privately held company, a leader in the discovery and development of a new generation of drug therapies for osteoporosis and women's health, has acquired exclusive worldwide rights from the University of Illinois to several new classes of estrogen...
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MicroIslet, Inc. (Amex: MII), a biotechnology company engaged in the research, development and commercialization of patented technologies in transplantation therapy for people with insulin-dependent diabetes, reported that that primate subjects in ongoing studies have continued to exhibit improved glycemic control...
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Following the successful completion of toxicology testing, Novogen Limited (NRT)'s investigational anti-inflammatory compound NV-52, is entering its second human clinical study. NV-52 is a novel compound developed by Novogen from its isoflavonoid technology platform to target inflammatory bowel disease. After the...
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TorreyPines Therapeutics, Inc. has initiated a Phase I clinical trial for NGX426, the company’s novel oral therapy intended for the treatment of migraine and chronic pain conditions such as neuropathic pain. The double-blind, placebo-controlled, single ascending dose Phase 1 trial...
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Aug 8
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BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) has recently received a Special Protocol Assessment (SPA) letter from the USFDA for the commencement of a pivotal clinical trial of the company's lead anti-cancer compound Fodosine™ (forodesine hydrochloride) in patients who have failed two...
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Corcept Therapeutics Incorporated (Nasdaq: CORT)’s Study 03 (a Phase 2 clinical trial) demonstrated with statistical significance that more patients treated with CORLUX® achieved a rapid and sustained reduction of the psychotic features of psychotic major depression (PMD) than did patients...
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In a study presented at the recent 47th Annual Meeting of the American Society of Pharmacognosy (Aug. 5-9, 2006, at Crystal Gateway Marriott Hotel in Arlington, Virginia), Bionovo, Inc. (Public, OTC: BNVI) reported the potential benefits of selective estrogen receptor...
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Following its approval in Estonia, Oxaliplatin, an anti-cancer drug manufactured by Australian pharmaceutical firm, Mayne Pharma Ltd (MYP), has received marketing approval in Portugal. The pharmaceutical company said the Portuguese licensing authority, Infarmed, issued the marketing approval under a mutual...
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Predix Pharmaceuticals (Predix) has begun with its Phase II clinical trials to evaluate the short-term efficacy and safety of PRX-08066, a serotonin 5-HT2B antagonist, in patients with pulmonary hypertension (PH) associated with chronic obstructive pulmonary disease (COPD). According to Michael...
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The USFDA has granted fast-track designation to NOV-002, a drug candidate from Novelos Therapeutics, Inc. (OTCBB: NVLT) for use in combination with first-line chemotherapy for the treatment of advanced non-small cell lung cancer (NSCLC). "Obtaining Fast Track for NOV-002 is...
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Aug 7
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Napo Pharmaceuticals, Inc. (Public, LON:NAPL) has recently received approval from the Drug Controller General of India (DCGI), to commence the Phase II trial of crofelemer, Napo's proprietary gastro-intestinal compound for the treatment of acute infectious diarrhea. The said Phase II trial...
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AEterna Zentaris, Inc. (Nasdaq: AEZS) has entered into a licensing and collaboration agreement with Nippon Kayaku for its fourth generation luteinizing hormone-releasing hormone (LHRH) antagonist, ozarelix (a pdf file). The terms of agreement include the following: Nippon Kayaku has exclusive...
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A clinical trial involving 366 patients has demonstrated that Dutasteride (marketed as Avodart or Duprost) may be effective in treating benign prostatic hyperplasia (BPH), an enlargement of the prostate gland that leads to frequent urination and a weak urine stream....
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Clinical trial data demonstrate that Strattera (atomoxetine) may be a feasible therapeutic for treating attention deficit/hyperactivity disorder (ADHD), particularly in adolescents. In comparison to Ritalin, a stimulant drug often prescribed to children with ADHD, Straterra is dosed once daily, has...
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According to a survey released by Bain & Company, a leading global business consulting firm, international pharmaceutical companies favor China over India for outsourcing drug prodcution. Among the issues raised were: intelectual property protection parallel trade or grey market imports...
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Aug 6
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What: 11th Annual Drug Delivery Technologies & Deal-Making Summit When: 25-27 September, 2006 Where: New Brunswick, New Jersey A leading industry-focused meeting on the business and new science of the pharmaceutical field, this conference and exposition annually attracts hundreds of...
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China Biopharmaceuticals Holdings, Inc. (Public,OTC: CHBP) is a leading Chinese pharmaceutical company focused on the development, manufacturing and distribution of innovative drugs in China. Last week, the company announced that it has submitted application for listing its common stock on...
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PDL BioPharma, Inc. (PDL) (Nasdaq: PDLI)’s double-blind, placebo-controlled, Phase 3 clinical study of terlipressin (a vasoactive peptide) did not meet its primary endpoint in the treatment of type 1 hepatorenal syndrome (HRS). Type 1 hepatorenal syndrome (HRS) is a life-threatening...
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Allos Therapeutics, Inc. (Nasdaq: ALTH) has reached agreement with the USFDA under the Special Protocol Assessment process (SPA) on the design of a pivotal Phase 2 trial of the company's novel, next generation antifolate PDX (pralatrexate) in patients with relapsed...
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Archemix Corp. and Nuvelo, Inc. (Nasdaq: NUVO) have expanded their collaboration agreement. Replacing the 50/50 collaboration, under the new agreement, Archemix will be responsible for the discovery of short-acting aptamers targeting the coagulation cascade for use in acute cardiovascular procedures...
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Toronto-based firm Amorfix Life Sciences Ltd. (AMF) collaborates with US biopharmaceutical company, Biogen Idec (BIIB), to develop and commercialize drugs for Amyotrophic Lateral Sclerosis, a neurodegenerative condition also known as Lou Gehrig's Disease. Biogen Idec will buy 289,187 Amorfix common...
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Aug 5
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Data published in the August 1 issue of Pediatrics revealed that lamotrigine (LAMICTAL®) is an effective add-on therapy for the treatment of Primary Generalized Tonic-Clonic (PGTC) seizures in a subgroup of children and adolescents. PGTC seizures (also know as "grand...
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ISTA Pharmaceuticals, Inc. (Nasdaq: ISTA) has licensed from Senju Pharmaceutical Co., Ltd. the exclusive North American rights to an eye drop formulation of bepotastine. Bepotastine, the third product candidate in-licensed by ISTA this year, is an investigational ophthalmic treatment for...
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Baxter Corporation (Canada)’s ADVATE® [Antihemophilic Factor (Recombinant), Plasma/Albumin Free Method (rAHF-PFM)] for the prevention and control of bleeding episodes in people with hemophilia A (classical hemophilia) has been approved by Health Canada. ADVATE®, developed by Baxter Corporation (Canada) (a subsidiary...
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Cerexa Inc.’s Phase 2 clinical trial of Ceftaroline for the treatment of complicated skin and skin structure infections (cSSSI) produced positive top-line results. This observer-blinded trial evaluated Ceftaroline versus standard therapy in 100 patients at 24 study sites worldwide. The...
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AEterna Zentaris Inc. (NASDAQ: AEZS) this week disclosed the positive headline data from its Phase 2 trial with Ozarelix (D-63153) for patients suffering from hormone-dependent inoperable prostate cancer. The study was able to define a tolerable dosage regimen of ozarelix...
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Transition Therapeutics Inc. (Public,TSE:TTH) has received clearance from the USFDA to initiate a Phase I clinical trial for its lead Alzheimer's drug product, AZD-103. AZD-103 (scyllo-cyclohexanehexol) is a compound that is a possible disease-modifying therapeutic drug candidate for the treatment...
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Aug 4
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Last week, the USFDA has issued a warning to consumers not to purchase or use high-strength hydrogen peroxide products. This warning pertains even to a product marketed as "35 Percent Food Grade Hydrogen Peroxide" for medicinal purposes. Hydrogen Peroxide, when...
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Betaferon® (interferon beta-1b), a drug against multiple sclerosis (MS) developed by Schering, AG (SCH), has been granted marketing authorization by Canadian regulators for an extension of its indication to include the treatment of patients with a first clinical event suggestive...
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Raptor Pharmaceuticals Corp. (OTC: RPTP)’s wholly-owned subsidiary, Raptor Pharmaceutical Inc., has signed a research collaboration agreement with Dr. William Mobley, Professor of Neurology and Neurological Sciences at the Stanford School of Medicine and Director, Neuroscience Institute at Stanford. Commenced August...
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GPC Biotech (GPC) has initiated Phase II trials for its drug candidate satraplatin, in combination with Tarceva® (erlotinib) to treat advanced non-small cell lung cancer (NSCLC) in patients who cannot undergo surgery and are 70 years or older. The trials...
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Dendreon Corporation (Nasdaq:DNDN) has completed the initial build-out of its New Jersey state-of-the art manufacturing facility that has the capacity to support clinical processes and future anticipated commercial needs for PROVENGE® (sipuleucel-T), Dendreon’s investigational active cellular immunotherapy for advanced prostate...
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The U.S. Food and Drug Administration has approved Keppra® (levetiracetam) injection 500mg/5mL (100mg/mL) for use as adjunct therapy in the treatment of partial-onset seizures in adults with epilepsy. "This U.S. approval closely follows the European approval of the IV formulation...
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Aug 3
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AstraZeneca (AZN) has entered into an exclusive global agreement with Pozen Inc (POZN) to co-develop fixed dose combinations of naproxen and esomeprazole for the treatment of chronic pain. Under the terms of the agreement, AstraZeneca will pay Pozen an upfront...
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CHDI, Inc and Edison Pharmaceuticals, Inc. are collaborating to develop analogs of CoQ(10) selectively targeted to reach the brain and address the mitochondrial component of Huntington's disease, a hereditary disease that leads to loss of intellectual faculties and uncontrolled movements....
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A Ranbaxy Laboratories Limited (RLL) subsidiary, OHM Laboratories Inc., received the coveted "Private Label Supplier of the Year Award" from AmerisourceBergen (NYSE:ABC) at the recently held (July 11-15, 2006) National Healthcare Conference & Exposition (NHCE) in Las Vegas, NV. NHCE...
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Alfacell Corporation (Nasdaq: ACEL)’s AC 03-636, one of the company's novel drug candidates from its proprietary ribonuclease (RNase) technology platform, demonstrated definitive antiviral activity in in vitro studies conducted by scientists at a major research institute for tropical diseases as...
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Chantix (varenicline), a new smoking cessation drug from Pfizer Inc (PFE), is now available in US pharmacies. Chantix received regulatory approval from the FDA in May this year. Those prescribed with Chantix will also be offered to participate in a...
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The Journal of Clinical Investigation (JCI) published a preclinical study suggesting that CVT-6883 significantly reduced elevated markers of inflammation, fibrosis and pulmonary injury in two separate in vivo models. CVT-6883 is CV Therapeutics, Inc. (Nasdaq: CVTX)’s investigational new drug (a...
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Aug 2
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The USFDA may approve a wider release of a contraceptive pill, the Plan B, also called "morning-after" pill , for sale without prescription to women aged 18 and older. The proposal came in a letter from the FDA to Barr...
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Schering AG,Germany (Public, NYSE: SHR)’s two recently completed clinical studies of sargramostim for the treatment of Crohn's disease resulted to the following conclusions: Phase III trial (n.o.v.e.l. 4 study) suggested a treatment benefit but fail to demonstrate superiority in the...
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Takeda Pharmaceutical Company Limited (Public, TYO:4502) and BioNumerik Pharmaceuticals, Inc. recently announced the results of two Phase III Trials for Tavocept™, an investigational new drug with potential for oncology and non-oncology indications that was originated and developed by BioNumerik. The...
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Roche (Public, OTC:RHHBY)recently announced that its large, international Phase III study (NO16966) that enrolled 2,035 previously untreated metastatic colorectal cancer patients revealed positive results, thereby meeting the following primary endpoints: The chemotherapy combination Xeloda® plus oxaliplatin (called XELOX) is as effective...
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The Japan Ministry of Health, Labor and Welfare (MHLW) has approved Schering-Plough Corporation (NYSE: SGP)’s TEMODAL® (temozolomide) Capsules for the treatment of malignant glioma. TEMODAL, marketed as TEMODAR® in the US, is already approved in 77 countries. This MHLW approval...
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Takeda Pharmaceuticals North America, Inc. (TPNA)’s New Drug Application (NDA) for Duetact™ (pioglitazone HCl and glimepiride) [pronounced "Duet Act"] has been approved by the USFDA for the treatment of type 2 diabetes. Duetact™ is a combination of ACTOS® (pioglitazone HCl)...
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Aug 1
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Abbott (NYSE: ABT)’s HUMIRA® (adalimumab) has been approved by the USFDA for reducing the signs and symptoms in patients with active ankylosing spondylitis (AS). AS is the third of six autoimmune diseases targeted for HUMIRA® therapy that has received USFDA...
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MedImmune, Inc.(Nasdaq: MEDI) has submitted to the USFDA a supplemental Biologics License Application (sBLA) for use of CAIV-T (cold adapted influenza vaccine, trivalent) in children age 12 to 59 months who do not have a history of wheezing or asthma....
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Synovics Pharmaceuticals, Inc. (OTCBB: SYVC)’s metformin Extended Release (XR) Tablets 500mg has been approved by the USFDA, whose therapeutically equivalent listed drug is Bristol-Myers Squibb Company (BMY)’s Glucophage® XR Extended-Release Tablets 500mg (a pdf file). Metformin, a member of the...
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GlaxosmithKline (GSK) has applied for marketing approvals to the US and European regulatory authorities for its enhanced affinity intranasal corticosteroid for the treatment of seasonal allergic rhinitis (SAR) and perennial allergic rhinitis (PAR). Allergic rhinitis is one of the most...
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Japanese firm Daiichi Pharmaceutical Co. has acquired development and marketing rights to CIMYM BioSciences Inc.'s nimotuzumab, an anti-EGFR humanized antibody, for an upfront fee of $US14.5 million, plus milestone payments and royalities. In July 2006, nimotuzumab was approved in India...
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