PharmaGazette: August 2006 Archives

Know More: Patents and Clinical Trials

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

Posted at 5:47 AM | Permalink | Comments

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).... Continue Reading

Posted at 4:33 AM | Permalink | Comments

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... Continue Reading

Posted at 3:31 AM | Permalink | Comments

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... Continue Reading

Posted at 2:27 AM | Permalink | Comments

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... Continue Reading

Posted at 1:24 AM | Permalink | Comments

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... Continue Reading

Posted at 12:17 AM | Permalink | Comments

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... Continue Reading

Posted at 11:08 PM | Permalink | Comments

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... Continue Reading

Posted at 11:01 PM | Permalink | Comments

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,... Continue Reading

Posted at 10:55 PM | Permalink | Comments

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... Continue Reading

Posted at 10:48 PM | Permalink | Comments

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... Continue Reading

Posted at 1:05 AM | Permalink | Comments

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... Continue Reading

Posted at 12:52 AM | Permalink | Comments

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... Continue Reading

Posted at 7:41 PM | Permalink | Comments

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... Continue Reading

Posted at 7:38 PM | Permalink | Comments

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... Continue Reading

Posted at 7:33 PM | Permalink | Comments

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... Continue Reading

Posted at 7:14 PM | Permalink | Comments

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... Continue Reading

Posted at 12:56 AM | Permalink | Comments

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.... Continue Reading

Posted at 6:51 PM | Permalink | Comments

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... Continue Reading

Posted at 6:43 PM | Permalink | Comments

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... Continue Reading

Posted at 6:34 PM | Permalink | Comments

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... Continue Reading

Posted at 6:27 PM | Permalink | Comments

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... Continue Reading

Posted at 6:16 PM | Permalink | Comments

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),... Continue Reading

Posted at 3:50 AM | Permalink | Comments

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... Continue Reading

Posted at 2:39 AM | Permalink | Comments

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... Continue Reading

Posted at 1:35 AM | Permalink | Comments

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.... Continue Reading

Posted at 12:19 AM | Permalink | Comments

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,... Continue Reading

Posted at 9:00 PM | Permalink | Comments

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... Continue Reading

Posted at 8:53 PM | Permalink | Comments

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... Continue Reading

Posted at 8:34 PM | Permalink | Comments

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... Continue Reading

Posted at 8:27 PM | Permalink | Comments

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,... Continue Reading

Posted at 12:42 AM | Permalink | Comments

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... Continue Reading

Posted at 4:52 AM | Permalink | Comments

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... Continue Reading

Posted at 3:45 AM | Permalink | Comments

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... Continue Reading

Posted at 2:36 AM | Permalink | Comments

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... Continue Reading

Posted at 1:28 AM | Permalink | Comments

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... Continue Reading

Posted at 12:23 AM | Permalink | Comments

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... Continue Reading

Posted at 7:18 PM | Permalink | Comments

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... Continue Reading

Posted at 7:14 PM | Permalink | Comments

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)... Continue Reading

Posted at 7:03 PM | Permalink | Comments

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... Continue Reading

Posted at 6:53 PM | Permalink | Comments

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... Continue Reading

Posted at 12:10 AM | Permalink | Comments

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... Continue Reading

Posted at 7:08 PM | Permalink | Comments

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... Continue Reading

Posted at 1:21 AM | Permalink | Comments

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... Continue Reading

Posted at 1:07 AM | Permalink | Comments

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... Continue Reading

Posted at 1:02 AM | Permalink | Comments

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... Continue Reading

Posted at 12:57 AM | Permalink | Comments

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... Continue Reading

Posted at 10:14 PM | Permalink | Comments

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... Continue Reading

Posted at 9:56 PM | Permalink | Comments

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... Continue Reading

Posted at 9:42 PM | Permalink | Comments

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... Continue Reading

Posted at 9:33 PM | Permalink | Comments

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... Continue Reading

Posted at 9:13 PM | Permalink | Comments

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... Continue Reading

Posted at 2:33 AM | Permalink | Comments

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... Continue Reading

Posted at 12:22 AM | Permalink | Comments

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... Continue Reading

Posted at 12:12 AM | Permalink | Comments

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... Continue Reading

Posted at 11:58 PM | Permalink | Comments

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... Continue Reading

Posted at 2:00 AM | Permalink | Comments

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... Continue Reading

Posted at 1:50 AM | Permalink | Comments

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... Continue Reading

Posted at 1:42 AM | Permalink | Comments

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... Continue Reading

Posted at 4:54 AM | Permalink | Comments

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... Continue Reading

Posted at 2:47 AM | Permalink | Comments

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... Continue Reading

Posted at 1:34 AM | Permalink | Comments

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.... Continue Reading

Posted at 12:26 AM | Permalink | Comments

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... Continue Reading

Posted at 7:18 PM | Permalink | Comments

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... Continue Reading

Posted at 4:18 AM | Permalink | Comments

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... Continue Reading

Posted at 2:54 AM | Permalink | Comments

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:... Continue Reading

Posted at 1:33 AM | Permalink | Comments

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... Continue Reading

Posted at 1:31 AM | Permalink | Comments

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... Continue Reading

Posted at 4:39 AM | Permalink | Comments

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...

Aug31	Ranbaxy Won Two Additional Norwegian Patents for Atorvastatin Gloria Gamat August 31, 2006 Know More: Patents and Clinical Trials 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 Posted at 5:47 AM \| Permalink \| Comments
Aug31	Pharmexa Receives Approval In France To Initiate Phase II Trial with GV1001 in Liver Cancer Gloria Gamat August 31, 2006 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).... Continue Reading Posted at 4:33 AM \| Permalink \| Comments
	European Commission Approves Novartis' Exjade Oral Iron Chelator Gloria Gamat August 31, 2006 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... Continue Reading Posted at 3:31 AM \| Permalink \| Comments
	USFDA Accepts Hana Biosciences' New Drug Application For Zensana Oral Spray Gloria Gamat August 31, 2006 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... Continue Reading Posted at 2:27 AM \| Permalink \| Comments
	Millenium Pharmaceuticals Initiates Phase I Trials for MLN0415 Drug Candidate Against Inflammatory Diseases Gloria Gamat August 31, 2006 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... Continue Reading Posted at 1:24 AM \| Permalink \| Comments
	Compound Solutions Entered CoQ10 Agreement with Premier Chinese Manufacturer, HZH Pharmaceutical Gloria Gamat August 31, 2006 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... Continue Reading Posted at 12:17 AM \| Permalink \| Comments
Aug30	Allos Therapeutics, Inc. Initiated Phase 2 Study of PDX (Pralatrexate) in Peripheral T-cell Lymphoma Patients Gloria Gamat August 30, 2006 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... Continue Reading Posted at 11:08 PM \| Permalink \| Comments
	Chemokine Therapeutics, Granted US Patent on Chemokine Analogs for the Treatment of Various Human Diseases Gloria Gamat August 30, 2006 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... Continue Reading Posted at 11:01 PM \| Permalink \| Comments
	MedImmune, Inc. and Infinity Pharmaceuticals, Inc. Entered Development and Worldwide Commercialization Agreement Announce of Novel Small Molecule Cancer Drugs Gloria Gamat August 30, 2006 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,... Continue Reading Posted at 10:55 PM \| Permalink \| Comments
	Paramount Acquisition Corp. Acquires Major Interest in BioValve Technologies, Inc.’s Valeritas, LLC Gloria Gamat August 30, 2006 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... Continue Reading Posted at 10:48 PM \| Permalink \| Comments
	Genentech and Biogen Idec, Inc.’s Rituxan® Passed Phase II Trial in Relapsing-Remitting Multiple Sclerosis (RRMS) Gloria Gamat August 30, 2006 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... Continue Reading Posted at 1:05 AM \| Permalink \| Comments
	SGX Pharmaceuticals, Inc.’s Phase II/III Clinical Trial of Troxatyl™ in Acute Myelogenous Leukemia, Discontinued Gloria Gamat August 30, 2006 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... Continue Reading Posted at 12:52 AM \| Permalink \| Comments
Aug29	Mylan Laboratories To Acquire Up to 71.5% of India-Based Matrix Laboratories Gloria Gamat August 29, 2006 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... Continue Reading Posted at 7:41 PM \| Permalink \| Comments
	Endo Pharmaceuticals Settles Patent Case, Will Cease Generic OxyContin Sales Gloria Gamat August 29, 2006 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... Continue Reading Posted at 7:38 PM \| Permalink \| Comments
	Nabi Biopharmaceuticals Acquires Exclusive Rights to Novel Plasma Fractionation Technology from ProMetic Life Sciences Gloria Gamat August 29, 2006 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... Continue Reading Posted at 7:33 PM \| Permalink \| Comments
	StemCells, Inc. Enters Licensing Agreement With Stem Cell Therapeutics Over Adult Neural Stem Cell Therapeutics Gloria Gamat August 29, 2006 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... Continue Reading Posted at 7:14 PM \| Permalink \| Comments
	Novogen, Ltd. Ends Financial Year with Solid Cash Reserves and USFDA Clearance for Phase III Human Trial of Phenoxodiol Gloria Gamat August 29, 2006 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... Continue Reading Posted at 12:56 AM \| Permalink \| Comments
Aug28	Dendreon Corp. Partially Completes Rolling USFDA BLA of PROVENGE® as Treatment for Advanced Prostate Cancer Patients Gloria Gamat August 28, 2006 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.... Continue Reading Posted at 6:51 PM \| Permalink \| Comments
	Shire plc Submitted Guanfacine Extended Release NDA for the Treatment of ADHD in Children and Teens Gloria Gamat August 28, 2006 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... Continue Reading Posted at 6:43 PM \| Permalink \| Comments
	Nanogen, Inc. Acquired 6 Patents for Detection and Use of Biomarkers Related to Diabetes and Alzheimer’s disease Gloria Gamat August 28, 2006 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... Continue Reading Posted at 6:34 PM \| Permalink \| Comments
	Neurobiological Technologies, Inc. Completes Targeted U.S. Site Selection for Its First Phase III Clinical Trial of Viprinex™ (Ancrod Injection) in Acute Ischemic Stroke Patients Gloria Gamat August 28, 2006 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... Continue Reading Posted at 6:27 PM \| Permalink \| Comments
	Study Shows Unfractionate Heparin Just As Effective as Low-Molecular Weight Heparin in the Treatmetn of Venous Thromboembolism Gloria Gamat August 28, 2006 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... Continue Reading Posted at 6:16 PM \| Permalink \| Comments
Aug27	Lpath, Inc. Received Allowance of Patent Claims for Anti-Cancer Drug, Sphingomab™ Gloria Gamat August 27, 2006 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),... Continue Reading Posted at 3:50 AM \| Permalink \| Comments
	Corcept Therapeutics, Inc.’s CORLUX®, Failed First of 3 Phase III Studies for Treating the Psychotic Features of Psychotic Major Depression Gloria Gamat August 27, 2006 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... Continue Reading Posted at 2:39 AM \| Permalink \| Comments
	Acuity Pharma, Inc. and Pathogenics, Inc. Announced Positive Preclinical Data of N-Chlorotaurine (NCT) in Viral Conjunctivitis (Pink Eye) Gloria Gamat August 27, 2006 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... Continue Reading Posted at 1:35 AM \| Permalink \| Comments
	IdeaSphere, Inc. Acquires Boehringer Ingelheim's Pharmaton SA (Lugano) Gloria Gamat August 27, 2006 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.... Continue Reading Posted at 12:19 AM \| Permalink \| Comments
Aug26	Boehringer Ingelheim Pharma, Inc.’s Mirapex® Showed Positive Results Against Depressive Symptoms in Parkinson's Disease Patients Gloria Gamat August 26, 2006 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,... Continue Reading Posted at 9:00 PM \| Permalink \| Comments
	Keppra® Granted European Approval As Monotherapy For Partial Onset Seizures in Patients with Epilepsy Gloria Gamat August 26, 2006 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... Continue Reading Posted at 8:53 PM \| Permalink \| Comments
	MedImmune Files Investigational New Drug Application for MT103 Against non-Hodgkins Lymphoma Gloria Gamat August 26, 2006 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... Continue Reading Posted at 8:34 PM \| Permalink \| Comments
	HIV Drug Lopinavir Also Effective Against Human Papilloma Virus (HPV) Gloria Gamat August 26, 2006 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... Continue Reading Posted at 8:27 PM \| Permalink \| Comments
	sNDA for Mission Pharmacal’s Tindamax® (Tinidazole) as Treatment of Bacterial Vaginosis (BV), Submitted to the USFDA Gloria Gamat August 26, 2006 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,... Continue Reading Posted at 12:42 AM \| Permalink \| Comments
Aug25	UCB Group, Inc.’s Keppra®, USFDA Approved as Adjunctive Therapy in the Treatment of Myoclonic Seizures in Juvenile Myoclonic Epilepsy Patients Gloria Gamat August 25, 2006 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... Continue Reading Posted at 4:52 AM \| Permalink \| Comments
	XYOTAX™ (Paclitaxel Poliglumex) + Concurrent Radiation Produces= Promising Tumor Responses in 91% of Esophageal or Gastric Cancer Patients Gloria Gamat August 25, 2006 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... Continue Reading Posted at 3:45 AM \| Permalink \| Comments
	Mayne Pharma Limited Completes Purchase of SuperGen Inc.'s North American Oncology Products Gloria Gamat August 25, 2006 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... Continue Reading Posted at 2:36 AM \| Permalink \| Comments
	Stiefel Laboratories, Inc. Bagged Licensing Agreement with Italian Companies Gloria Gamat August 25, 2006 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... Continue Reading Posted at 1:28 AM \| Permalink \| Comments
	Medarex and GenPat77 Entered Therapeutic Antibody Co-Development Agreement Gloria Gamat August 25, 2006 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... Continue Reading Posted at 12:23 AM \| Permalink \| Comments
Aug24	ARIAD Pharmaceuticals Obtains Patent For AP23573 mTOR Inhibitors and Its Use in Cancer Treatment and Restenosis Gloria Gamat August 24, 2006 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... Continue Reading Posted at 7:18 PM \| Permalink \| Comments
	FDA Approves Barr Pharmaceutical's Plan B Contraceptive for OTC Sale Gloria Gamat August 24, 2006 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... Continue Reading Posted at 7:14 PM \| Permalink \| Comments
	Wyeth and Progenics Pharmaceuticals Initiated Phase 2 Clinical Trial of Oral Methylnaltrexone Gloria Gamat August 24, 2006 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)... Continue Reading Posted at 7:03 PM \| Permalink \| Comments
	Neuren Pharmaceuticals’ Glypromate®, Passed Phase 2a Clinical Trial Gloria Gamat August 24, 2006 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... Continue Reading Posted at 6:53 PM \| Permalink \| Comments
	Now Insulin Inhaler, Tomorrow Insulin Pill Gloria Gamat August 24, 2006 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... Continue Reading Posted at 12:10 AM \| Permalink \| Comments
Aug23	Entelos Signs Research Collaboration with Novartis AG Gloria Gamat August 23, 2006 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... Continue Reading Posted at 7:08 PM \| Permalink \| Comments
	Isotechnika, Inc.’s TAFA93, Passed Phase 1a Clinical Trial Gloria Gamat August 23, 2006 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... Continue Reading Posted at 1:21 AM \| Permalink \| Comments
	Changes to Dexedrine®’s Boxed Warnings and Precautions, Announced by the USFDA and GlaxoSmithKLine Gloria Gamat August 23, 2006 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... Continue Reading Posted at 1:07 AM \| Permalink \| Comments
	Althea Technologies, To Manufacture Altus Pharmaceuticals’ ALTU-238 for Phase III Trial Gloria Gamat August 23, 2006 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... Continue Reading Posted at 1:02 AM \| Permalink \| Comments
	Quigley Pharma Received Second Patent Covering Peripheral Neural and Vascular Complaints for QR-333, Its Lead Investigational New Drug Formulated for Diabetic Neuropathy Gloria Gamat August 23, 2006 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... Continue Reading Posted at 12:57 AM \| Permalink \| Comments
Aug22	Athenagen, Inc. Initiated First Human Trial of Novel Anti-angiogenic Therapy (ATG003) for AMD Gloria Gamat August 22, 2006 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... Continue Reading Posted at 10:14 PM \| Permalink \| Comments
	CoGenesys, Inc. Entered Worldwide License Agreement with Vegenics Ltd. Gloria Gamat August 22, 2006 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... Continue Reading Posted at 9:56 PM \| Permalink \| Comments
	ABILIFY® DISCMELT™(aripiprazole): New Rapidly Disintegrating Oral Form of Antipsychotic Medication ABILIFY® (aripiprazole), Launched by Bristol-Myers Squib Co. and Otsuka Pharma Co. Gloria Gamat August 22, 2006 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... Continue Reading Posted at 9:42 PM \| Permalink \| Comments
	Xenogen Biosciences Entered Into a Target Validation Collaboration Agreement with Schering-Plough Gloria Gamat August 22, 2006 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... Continue Reading Posted at 9:33 PM \| Permalink \| Comments
	China Biopharmaceuticals Completed All Clinical Trials for Nafamostate Mesilate Gloria Gamat August 22, 2006 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... Continue Reading Posted at 9:13 PM \| Permalink \| Comments
Aug21	Isolagen Acquired 57% Interest in Agera Laboratories, Inc. Gloria Gamat August 21, 2006 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... Continue Reading Posted at 2:33 AM \| Permalink \| Comments
	United Research Laboratories/Mutual Pharmaceutical Company Filed USFDA ANDA for Guaifenesin Extended-Release Tablets, 600 mg and 1200 mg Gloria Gamat August 21, 2006 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... Continue Reading Posted at 12:22 AM \| Permalink \| Comments
	Eli Lilly & Co.’s NDA for Arxxant™ (ruboxistaurin mesylate) for the Treatment of Diabetic Retinopathy, Received USFDA Approvable Letter Gloria Gamat August 21, 2006 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... Continue Reading Posted at 12:12 AM \| Permalink \| Comments
Aug20	Bristol-Myers Squibb Co. and Sanofi-Aventis SA, Trying to Block Generic Plavix Gloria Gamat August 20, 2006 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... Continue Reading Posted at 11:58 PM \| Permalink \| Comments
Aug19	Caraco Pharma Lab Ltd.’s Baclofen Tablets, Received USFDA Final Approval Gloria Gamat August 19, 2006 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... Continue Reading Posted at 2:00 AM \| Permalink \| Comments
	Sirion Therapeutics, Inc. Merged With Sytera, Inc. Gloria Gamat August 19, 2006 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... Continue Reading Posted at 1:50 AM \| Permalink \| Comments
	SOLTAMOX™: First Oral Liquid Formulation of Tamoxifen for Breast Cancer Patients, Launched by Cytogen Corp. in the US Market Gloria Gamat August 19, 2006 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... Continue Reading Posted at 1:42 AM \| Permalink \| Comments
Aug18	Northwest Biotherapeutics’ Phase II Clinical Trial of its DCVax®-Brain in Patients with Brain Cancer, to be managed by Synteract Gloria Gamat August 18, 2006 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... Continue Reading Posted at 4:54 AM \| Permalink \| Comments
	Iomai Corp. Initiates Phase 2 Clinical Trial of Travelers' Diarrhea Gloria Gamat August 18, 2006 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... Continue Reading Posted at 2:47 AM \| Permalink \| Comments
	Transport Pharma's Drug/Device Combination Product for Herpes Labialis, SoloVir™, Passed Phase IIb Clinical Trial Gloria Gamat August 18, 2006 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... Continue Reading Posted at 1:34 AM \| Permalink \| Comments
	Novartis Seek European Approval for Diabetes Drug Galvus (Vildagliptin) Gloria Gamat August 18, 2006 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.... Continue Reading Posted at 12:26 AM \| Permalink \| Comments
Aug17	ProEthic Pharmaceuticals Announce Positive Phase I Trials For Rapid Release Diclofenac Gloria Gamat August 17, 2006 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... Continue Reading Posted at 7:18 PM \| Permalink \| Comments
	ViroPharma and Wyeth Achieved Proof of Concept Milestone for HCV-796 (Investigational Oral Non-nucleoside Hepatitis C Virus (HCV) Polymerase Inhibitor) Gloria Gamat August 17, 2006 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... Continue Reading Posted at 4:18 AM \| Permalink \| Comments
	NBTY, Inc. to Acquire Manufacturer and Marketer of Ester-C®: Zila Nutraceuticals, Inc. Gloria Gamat August 17, 2006 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... Continue Reading Posted at 2:54 AM \| Permalink \| Comments
	Intranasal Therapeutics Closes $39.1 Million Series A Venture Financing Gloria Gamat August 17, 2006 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:... Continue Reading Posted at 1:33 AM \| Permalink \| Comments
	Akzo Nobel to Spin-off Organon Biosciences, Shareholders to Vote on September 7 Gloria Gamat August 17, 2006 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... Continue Reading Posted at 1:31 AM \| Permalink \| Comments
Aug16	VaxGen, Inc. Published Results of its Phase I Clinical Trial of Anthrax Vaccine Candidate, rPA102 Gloria Gamat August 16, 2006 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... Continue Reading Posted at 4:39 AM \| Permalink \| Comments
	Schering-Plough and Novartis Collaborates to Develop Once-Daily Combination Therapy for Asthma and COPD Gloria Gamat August 16, 2006 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...

Pharmaceutical Industry discussion, review, analysis, news and information.