Drug Week articles from October 2001

Drug Week archives from October 2001

Protease Inhibitors Inhibit P-Glycoprotein Function.
October 5, 2001... 2001 OCT 5 - (NewsRx.com & NewsRx.net) -- by Michael Greer, senior medical writer - Drugs that interfere with the function of HIV protease may also inhibit the activity of the multidrug transporter P-glycoprotein, researchers in Italy say....

Lower Dose Of Mifepristone Effective When Used With Misoprostol.
October 5, 2001... 2001 OCT 5 - (NewsRx.com & NewsRx.net) -- A 100-milligram dose of mifepristone may be an effective alternative to larger doses of the drug when used with misoprostol for early pregnancy termination, according to the results of a recent...

New Drug Offers Hope To Bone Marrow Transplant Recipients.
October 5, 2001... 2001 OCT 5 - (NewsRx.com & NewsRx.net) -- Bone marrow transplantation (BMT) is used to improve the survival of leukemia patients who have a poor outlook following chemotherapy. However, the success of bone marrow transplantation is...

40% Of Patients Use Alternative Therapies But Don't Tell Their Doctors.
October 5, 2001... 2001 OCT 5 - (NewsRx.com & NewsRx.net) -- In a study of more than 200 patients with Parkinson disease, 40% used at least one type of alternative therapy, such as vitamins/herbs, massage and acupuncture. Over half of the patients failed to...

Finding Of Key Blood Sugar Controller Could Yield New Diabetes Drugs.
October 5, 2001... 2001 OCT 5 - (NewsRx.com & NewsRx.net) -- Dana-Farber Cancer Institute researchers have discovered the long-sought molecular "switch" that regulates the liver's production of glucose, the sugar that fuels the brain but which builds up...

Old Drug May Have New Treatment Potential.
October 5, 2001... 2001 OCT 5 - (NewsRx.com & NewsRx.net) -- An age-old drug may point to a brand new way to treat type 2 diabetes, according to scientists at Joslin Diabetes Center, Massachusetts, and the University of California in San Diego (UCSD). ...

Unique Medication Has Anti-Inflammatory Activity.
October 5, 2001... 2001 OCT 5 - (NewsRx.com & NewsRx.net) -- Summers Laboratories, Inc. has announced the purchase of Vanoxide-HC (benzoyl peroxide 5% and hydrocortisone 1/2%), a topical, water-based lotion for the treatment of acne, from Dermik Laboratories,...

Zyrtec-D Receives FDA Approval.
October 5, 2001... 2001 OCT 5 - (NewsRx.com & NewsRx.net) -- The U.S. Food and Drug Administration has approved Zyrtec-D 12 Hour (cetrizine HCl/pseudoephedrine HCl), an antihistamine with decongestant for the treatment of a broad range of allergies and nasal...

Enrollment In Pivotal Trial Completed.
October 5, 2001... 2001 OCT 5 - (NewsRx.com & NewsRx.net) -- NeoTherapeutics, Inc. (NEOT), has announced that 521 patients at 51 clinical sites around the United States have been enrolled in its double-blind, placebo-controlled pivotal study of Neotrofin in...

Sustained-Release Ranolazine Gets Patent Approval.
October 5, 2001... 2001 OCT 5 - (NewsRx.com & NewsRx.net) -- CV Therapeutics Inc. (CVTX), has received a Notice of Allowance from the U.S. Patent and Trademark Office for a method of using ranolazine sustained release (SR) formulations, including the...

First Injectable, Long-Acting Drug Submitted To FDA For Approval.
October 5, 2001... 2001 OCT 5 - (NewsRx.com & NewsRx.net) -- A new drug application for a long-acting injectable formulation of Risperdal (risperidone) has been filed with the U.S. Food and Drug Administration by Janssen Pharmaceutica Products, LP, and...

FDA Grants Fast Track Designation For Secretin Therapy.
October 5, 2001... 2001 OCT 5 - (NewsRx.com & NewsRx.net) -- Repligen Corporation announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for secretin for the treatment of pediatric autism. Under the FDA...

Novartis And Celgene In Final Phase Of FDA Approval For Dexmethylphenidate.
October 5, 2001... 2001 OCT 5 - (NewsRx.com & NewsRx.net) -- Novartis Pharmaceuticals Corp. and Celgene Corp. have received an approvable letter from the FDA for dexmethylphenidate HCl, a refined formulation of Ritalin (dl-methylphenidate). Dexmethylphenidate...

Orion Collaborates With Pharmacia On Antianxiety Drug.
October 5, 2001... 2001 OCT 5 - (NewsRx.com & NewsRx.net) -- Orion Corp. and Pharmacia Corp. have signed an agreement under which the two companies will collaborate in the development and commercialization of Orion Pharma's investigational new drug...

New Data Confirms Safety And Tolerability Of Pravachol.
October 5, 2001... 2001 OCT 5 - (NewsRx.com & NewsRx.net) -- Analysis from three landmark clinical trials provide further confirmation regarding the safety and tolerability profile of pravastatin. The results of the "Prospective Pravastatin Pooling...

NeoSan Acquires Nutrition Products From AstraZeneca.
October 5, 2001... 2001 OCT 5 - (NewsRx.com & NewsRx.net) -- aaiPharma Inc. (AAII) has acquired, through its business unit NeoSan Pharmaceuticals, a line of critical care injectable nutritional products from AstraZeneca AB, an affiliate of AstraZeneca PLC...

Lab-On-A-Chip Device Has Many Potential Uses.
October 5, 2001... 2001 OCT 5 - (NewsRx.com & NewsRx.net) -- Knoxville startup company QGENICS Biosciences is looking for big things from a miniaturized platform technology developed at Oak Ridge National Laboratory to quickly diagnose disease, analyze DNA,...

Immunoconjugate Enhances Chemotherapy Effectiveness.
October 5, 2001... 2001 OCT 5 - (NewsRx.com & NewsRx.net) -- CryoLife, Inc. announced that its wholly owned subsidiary, AuraZyme Pharmaceuticals, Inc., presented results of animal studies on its A-Z-CINN Linker for targeted delivery of anticancer chemotherapy...

Clinical Trials Of Obesity Drug Candidate To Be Initiated.
October 5, 2001... 2001 OCT 5 - (NewsRx.com & NewsRx.net) -- Karo Bio and Bristol-Myers Squibb (BMS) have jointly discovered a novel antiobesity drug candidate that targets the thyroid hormone receptor. BMS has now filed an Investigational New Drug (IND)...

Preclinical Studies Of CRL-5861 Are Encouraging.
October 5, 2001... 2001 OCT 5 - (NewsRx.com & NewsRx.net) -- CytRx Corporation announced results from experimental studies investigating the combination effect of its development-stage drug, CRL-5861 (purified poloxamer 188) with the anticancer agent...

Slow Drug Approval Process In Europe Puts Patients At Risk.
October 5, 2001... 2001 OCT 5 - (NewsRx.com & NewsRx.net) -- Barely a month after the European Union (EU) Commission unveiled plans to speed up the process for approving new medical treatments in Europe, a new report published August 30, 2001, says the...

Trial To Examine Ability Of Metoprolol Succinate To Reverse Cardiac Remodeling.
October 5, 2001... 2001 OCT 5 - (NewsRx.com & NewsRx.net) -- AstraZeneca has announced the initiation of a clinical trial to examine the ability of the beta-blocker Toprol-XL (metoprolol succinate) extended-release tablets to reverse the cardiac remodeling...

International Bureau Stands Behind Statin Safety.
October 5, 2001... 2001 OCT 5 - (NewsRx.com & NewsRx.net) -- On September 4, 2001, at the XXIII Congress of the European Society of Cardiology (ESC), held in Stockholm, Sweden, members of the International Lipid Information Bureau (ILIB) discussed and...

Marketing Clearance For Advicor Tablets Expected By Year End.
October 5, 2001... 2001 OCT 5 - (NewsRx.com & NewsRx.net) -- The U.S. Food and Drug Administration (FDA) has completed the satisfactory inspection of Kos Pharmaceuticals' primary manufacturing facility for Advicor (extended-release niacin/lovastatin)...

Prehospital Administration Of Clot-Buster Beneficial For Heart-Attack Patients.
October 5, 2001... 2001 OCT 5 - (NewsRx.com & NewsRx.net) -- A study presented September 2, 2001, at the European Society of Cardiology Congress appears to demonstrate the benefits of the clot-dissolving agent Retavase (reteplase) in the treatment of...

Drug Approved For Patients Suffering From Lennox-Gastaut Syndrome.
October 5, 2001... 2001 OCT 5 - (NewsRx.com & NewsRx.net) -- The Epilepsy Foundation welcomed the U.S. Food and Drug Administration (FDA) approval of topiramate (Topamax) as add-on therapy for seizures associated with Lennox-Gastaut syndrome (LGS), an advance...

Transdermal Testosterone Gel Looks Like Promising Therapy.
October 5, 2001... 2001 OCT 5 - (NewsRx.com & NewsRx.net) -- Cellegy Pharmaceuticals, Inc. (CLGY) announced that it has successfully completed a second Phase I/II clinical trial using Tostrelle, its transdermal testosterone gel product for the treatment of...

Merck KGaA Sells Stake In Pharmaceutical Resources For EUR400 Million+.
October 5, 2001... 2001 OCT 5 - (NewsRx.com & NewsRx.net) -- Merck KGaA has entered into binding agreements with a number of investors to sell its 43% stake in the U.S. generic drug manufacturer Pharmaceutical Resources Inc. (PRI) in a private placement for...

Neurogen Reports Second Quarter Losses.
October 5, 2001... 2001 OCT 5 - (NewsRx.com & NewsRx.net) -- Neurogen Corp. (NRGN) reported a second quarter loss of $5,689,000 or $0.33 per share for the three months ended June 30, 2001. This compares to a net loss of $2,542,000 or $0.16 per share for the...

OGS Submits New Drug Application For Vevesca (OGT 918).
October 5, 2001... 2001 OCT 5 - (NewsRx.com & NewsRx.net) -- Oxford GlycoSciences Plc (OGS, OGSI) has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Vevesca (OGT 918), its oral treatment in development for type 1...

Dr. Reddy's To Launch Famotidine 10-mg OTC In The U.S.
October 5, 2001... 2001 OCT 5 - (NewsRx.com & NewsRx.net) -- Dr. Reddy's Laboratories (RDY) is preparing to launch famotidine tablets 10 mg OTC immediately in the U.S. generic market following U.S. Food and Drug Administration (FDA) final approval of its...

Medarex And Genesto Collaborate To Develop Therapeutic Antibodies.
October 5, 2001... 2001 OCT 5 - (NewsRx.com & NewsRx.net) -- Medarex Inc. expects to use its UltiMAb Human Antibody Development System to generate antibodies to infectious disease targets provided by Genesto A/S, in a collaboration to develop fully human...

Class-Action Lawsuits Charge Pharmaceutical Companies With Illegally Inflating Prices.
October 5, 2001... 2001 OCT 5 - (NewsRx.com & NewsRx.net) -- New York City Patrolmen's Benevolent Association (PBA) President Patrick J. Lynch filed four federal class-action lawsuits in four states charging nine brand-name and generic pharmaceutical...

Preliminary Ruling Favors MorphoSys In Griffiths Patent Dispute With CAT.
October 5, 2001... 2001 OCT 5 - (NewsRx.com & NewsRx.net) -- A district court in Washington, DC, has issued a preliminary ruling in favor of MorphoSys AG (MOR), a German biotechnology company, in the dispute with Cambridge Antibody Technology (CAT) concerning...

BioReliance Will Produce Two Anticancer Drugs For MediGene.
October 5, 2001... 2001 OCT 5 - (NewsRx.com & NewsRx.net) -- BioReliance Corp. (BREL) has agreed to produce clinical supplies of herpes simplex virus-derived G207 and NV1020 for the biopharmaceutical company MediGene. These products are two of MediGene's...

Novartis Seeks To Extend ZOMETA Approval To U.S.
October 5, 2001... 2001 OCT 5 - (NewsRx.com & NewsRx.net) -- Novartis has submitted an application to the Food and Drug Administration (FDA), seeking marketing authorization for ZOMETA (zoledronic acid for injection) in the treatment of bone complications...

Repifermin Studied In Multiple Myeloma Patients.
October 5, 2001... 2001 OCT 5 - (NewsRx.com & NewsRx.net) -- Human Genome Sciences, Inc., announced September 4, 2001, that the company has initiated a Phase II clinical trial to examine the safety and preliminary efficacy of repifermin for the treatment of...

FDA Accepts Proposed Response Plan Regarding Xyrem NDA.
October 5, 2001... 2001 OCT 5 - (NewsRx.com & NewsRx.net) -- Orphan Medical Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted the company's plan for a complete response to the agency's Approvable Letter dated July 2, 2001,...

Quintiles, Novia Join To Develop Central Nervous System Compound.
October 5, 2001... 2001 OCT 5 - (NewsRx.com & NewsRx.net) -- Quintiles Transnational Corp. (QTRN) and Novia Pharmaceuticals Ltd. have formed an alliance to provide preclinical services for Novia's lead compound to treat central nervous system (CNS) disorders,...

New Legislation May Allow Health Plan Coverage Of Dietary Supplements.
October 5, 2001... 2001 OCT 5 - (NewsRx.com & NewsRx.net) -- At a time when the majority of Americans use dietary supplements to improve their health and well being, the U.S. Senate is taking some new steps to ensure that vitamins, minerals, herbs, and...

Evotec OAI Extends Combinatorial Chemistry Collaboration With Pharmacia Corp.
October 5, 2001... 2001 OCT 5 - (NewsRx.com & NewsRx.net) -- Evotec OAI, a Hamburg, Germany supplier of integrated drug discovery services, has signed a new four-year contract with Pharmacia Corp. (PHA) to extend an original agreement signed in February 1998....

IND Filed For IV Formulation Of Novel Anti-Inflammatory Drug.
October 5, 2001... 2001 OCT 5 - (NewsRx.com & NewsRx.net) -- AtheroGenics, Inc. has filed an investigational new drug (IND) application with the U.S. Food and Drug Administration (FDA) for AGIX-4207 I.V., a novel, intravenously administered drug for the...

Generic HCV Drug In The Pipeline.
October 5, 2001... 2001 OCT 5 - (NewsRx.com & NewsRx.net) -- Three Rivers Pharmaceuticals, LLC, a Pittsburgh-based, privately owned company, has filed an Abbreviated New Drug Application with the U.S. Food & Drug Administration (FDA) for permission to market...

European Union Grants Ribavirin Patent To ICN Pharmaceuticals.
October 5, 2001... 2001 OCT 5 - (NewsRx.com & NewsRx.net) -- The European Union has granted ICN Pharmaceuticals (ICN) a new patent covering the manufacture of the drug ribavirin for medical treatment of three families of viruses, including the virus...

New Drug Restores Bowel Function Sooner.
October 12, 2001... 2001 OCT 12 - (NewsRx.com & NewsRx.net) -- A team of researchers, led by anesthesiologists at Washington University School of Medicine in St. Louis, has found that an investigational drug helps patients recover bowel function more quickly...

Genetic Analysis May Not Be Sufficient For Drug-Resistance Testing.
October 12, 2001... 2001 OCT 12 - (NewsRx.com & NewsRx.net) -- by Michael Greer, senior medical writer - Tuberculosis gene analysis may not provide enough information to diagnose drug-resistant strains, researchers in South Africa warn. "The use of...

Capecitabine In Combination With Docetaxel Offers Superior Survival.
October 12, 2001... 2001 OCT 12 - (NewsRx.com & NewsRx.net) -- The U.S. Food and Drug Administration (FDA) has approved the oral cancer drug, Xeloda (capecitabine), in combination with Taxotere (docetaxel), given by infusion, for the treatment of metastatic...

New Generation Antidepressants Increase Risk Of Gastrointestinal Bleeding.
October 12, 2001... 2001 OCT 12 - (NewsRx.com & NewsRx.net) -- Some new generation antidepressants increase the risk of gastrointestional bleeding, researchers say. Canadian researchers monitored hospital admissions for gastrointestinal bleeding among...

Insulin Detemir Controls Blood Glucose Levels More Predictably.
October 12, 2001... 2001 OCT 12 - (NewsRx.com & NewsRx.net) -- New clinical trial data shows that the soluble basal insulin analogue, insulin detemir, provides more consistent control of blood glucose with less risk of hypoglycemic events compared to NPH...

Pulmonary Insulin Deemed Safe In Asthmatic Patients.
October 12, 2001... 2001 OCT 12 - (NewsRx.com & NewsRx.net) -- New data presented at the September (2001) European Association for the Study of Diabetes (EASD) demonstrated that the revolutionary AERx iDMS electronic pulmonary insulin system, which is...

Full Structure Of Key Protein May Lead To Next Generation Cancer Drugs.
October 12, 2001... 2001 OCT 12 - (NewsRx.com & NewsRx.net) -- After five years of transatlantic collaboration, researchers of Merck KGaA and the Massachusetts General Hospital (MGH) have solved, for the first time ever, the full structure of an integrin...

New Drug Treats Diarrhea Caused By Giardia intestinalis In Children.
October 12, 2001... 2001 OCT 12 - (NewsRx.com & NewsRx.net) -- A clinical trial found that a 3-day course of treatment with nitazoxanide pediatric suspension was as effective as a longer 5-day course of metronidazole suspension in treating diarrhea caused by...

Streptococcus pneumoniae Is Increasingly Resistant To Fluoroquinolones.
October 12, 2001... 2001 OCT 12 - (NewsRx.com & NewsRx.net) -- Streptococcus pneumoniae is the leading cause of community-acquired pneumonia, meningitis, and otitis media in the United States. Because of the emergence of antimicrobial resistance in...

Clopidogrel Bisulfate Reduces Risk of Heart Attack, Stroke and Death.
October 12, 2001... 2001 OCT 12 - (NewsRx.com & NewsRx.net) -- The U.S. Food and Drug Administration (FDA) has granted priority review to Sanofi-Synthelabo and Bristol-Myers Squibb Company for their supplemental new drug application (sNDA) for Plavix...

Few American Medical Students Get Training On Potential Drug Problems.
October 12, 2001... 2001 OCT 12 - (NewsRx.com & NewsRx.net) -- Only 16% of internal medicine clerkship programs in the United States include formal lectures about adverse drug events, and students typically have little exposure to information in the curriculum...

Study Favors Drug Over Surgery; Cost Savings of Over 25%.
October 12, 2001... 2001 OCT 12 - (NewsRx.com & NewsRx.net) -- Cellegy Pharmaceuticals, Inc. announced the results of a pharmacoeconomic study comparing the use of Rectogesic (nitroglycerin ointment) with surgery for anal fissures at the September 2001...

New Study Compares Two Leading Maintenance Treatments.
October 12, 2001... 2001 OCT 12 - (NewsRx.com & NewsRx.net) -- A new study is the first to compare the safety and efficacy of new Advair Diskus 100/50 (fluticasone propionate 100 mcg and salmeterol 50 mcg inhalation powder) twice daily with Singulair 10 mg...

Results From PRECEDENT Trial Presented At Sweden Conference.
October 12, 2001... 2001 OCT 12 - (NewsRx.com & NewsRx.net) -- Researchers from Scios Inc. presented data derived from the PRECEDENT (Prospective Randomized Evaluation of Cardiac Ectopy with Dobutamine or Nesiritide Therapy) trial at the 23rd Congress of the...

Trial Of Treatment For Quinacrine Fast-Tracked.
October 12, 2001... 2001 OCT 12 - (NewsRx.com & NewsRx.net) -- The United Kingdom Department of Health has asked the Medical Research Council (MRC) to fast-track the design of a clinical trial to evaluate the effectiveness of quinacrine (Mepacrine) as a...

Acurian Launches Drug Knowledge Center.
October 12, 2001... 2001 OCT 12 - (NewsRx.com & NewsRx.net) -- Acurian, a leader in accelerating the launch of clinical trials for pharmaceutical and biotechnology companies, has launched its Drug Knowledge Center (DKC), a set of comprehensive databases...

Generic Prozac 10-mg Tablet Tentatively Approved by FDA.
October 12, 2001... 2001 OCT 12 - (NewsRx.com & NewsRx.net) -- The U.S. Food and Drug Administration (FDA) has tentatively approved Barr Laboratories' application to manufacture and market fluoxetine hydrochloride tablets, USP 10 mg, the generic equivalent of...

Topiramate Fails To Demonstrate Efficacy In Trial.
October 12, 2001... 2001 OCT 12 - (NewsRx.com & NewsRx.net) -- The R.W. Johnson Pharmaceutical Research Institute (RWJPRI), a subsidiary of Johnson & Johnson, has completed evaluation of the results of three pivotal clinical trials conducted with topiramate in...

Data From Oral Insulin Studies Reported.
October 12, 2001... 2001 OCT 12 - (NewsRx.com & NewsRx.net) -- Emisphere Technologies, Inc. announced the results from three Phase I studies evaluating two of its proprietary drug delivery agents (carriers) for the oral delivery of insulin. The data,...

NovoRapid Insulin Approved For Pump Therapy In Europe.
October 12, 2001... 2001 OCT 12 - (NewsRx.com & NewsRx.net) -- Novo Nordisk A/S announced that the European Medicines Evaluation Agency (EMEA) approved the insulin analogue NovoRapid (insulin aspart [rDNA origin]) for continuous subcutaneous insulin infusion...

Bristol-Myers Squibb, ImClone To Co-Develop Cancer Therapies.
October 12, 2001... 2001 OCT 12 - (NewsRx.com & NewsRx.net) -- Drug maker Bristol-Myers Squibb Co. has agreed to co-develop and promote an experimental cancer drug being tested by ImClone Systems and to buy a sizable stake in the New York biotechnology...

Grants Aimed At Furthering Protein Production In Eggs.
October 12, 2001... 2001 OCT 12 - (NewsRx.com & NewsRx.net) -- Origen Therapeutics, Inc. recently announced that it has received two Phase I Small Business Innovation Research (SBIR) grants to support research ultimately directed at producing therapeutic...

Novel Hepatitis C Drug Target Discovered.
October 12, 2001... 2001 OCT 12 - (NewsRx.com & NewsRx.net) -- Myriad Genetics, Inc. has discovered a novel drug target for the treatment of human infection by the hepatitis C virus (HCV), and has initiated high-throughput screening with its ProTrap drug...

Orally Available Compound For Inflammatory Pain Relief Undergoes Testing.
October 12, 2001... 2001 OCT 12 - (NewsRx.com & NewsRx.net) -- Adolor Corporation announced that it has given the first doses of ADL 10-0116, an orally available peripherally restricted kappa opioid receptor agonist designed to relieve inflammatory pain, to...

Trial Initiated Against Antibody-Mediated Stroke And Deep-Vein Thrombosis.
October 12, 2001... 2001 OCT 12 - (NewsRx.com & NewsRx.net) -- La Jolla Pharmaceutical Company announced that it has filed an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) to begin a Phase I/II clinical trial of...

Cellomics Launches Multiparameter Cytotoxicity 1 Assay.
October 12, 2001... 2001 OCT 12 - (NewsRx.com & NewsRx.net) -- Cellomics Inc. has released the Multiparameter Cytotoxicity 1 Assay, including proprietary fluorescence reagents and the application software to quantify multiple hallmark indicators of toxicity in...

New Analysis Underscores Safety and Efficacy of Statins.
October 12, 2001... 2001 OCT 12 - (NewsRx.com & NewsRx.net) -- In the wake of concerns about the safety of cholesterol-lowering drugs belonging to the statin class, Novartis has conducted a rigorous analysis of data pooled from controlled clinical trials...

Enrollment Completed For Phase III Testing Of INS365 Ophthalmic.
October 12, 2001... 2001 OCT 12 - (NewsRx.com & NewsRx.net) -- Inspire Pharmaceuticals, Inc. announced the completion of patient enrollment in two Phase III clinical studies for INS365 Ophthalmic eye drops for the treatment of dry eye. The...

Successful Phase II Results Lead To Phase III Approval.
October 12, 2001... 2001 OCT 12 - (NewsRx.com & NewsRx.net) -- BioSpecifics Technologies Corp. announced the successful conclusion of Phase II for its drug Cordase for the treatment of Dupuytren disease. Dupuytren's disease is a genetically inherited...

New Non-Steroid Cream Could Provide Alternative Treatment For Children.
October 12, 2001... 2001 OCT 12 - (NewsRx.com & NewsRx.net) -- A new steroid-free approach to controlling the itching skin disease, eczema, in most children was outlined in September (2001), to the world's leading specialists at the International Symposium on...

Significant Improvement In Patients Treated With Topical Gel.
October 12, 2001... 2001 OCT 12 - (NewsRx.com & NewsRx.net) -- MacroChem Corporation announced that its investigational topical drug for erectile dysfunction (ED), Topiglan, achieved statistical significance in both total erectile-function score and...

Enzyme Replacement Therapy Effective And Safe For Women.
October 12, 2001... 2001 OCT 12 - (NewsRx.com & NewsRx.net) -- Transkaryotic Therapies, Inc. announced at a workshop held in conjunction with the 39th Annual Symposium of the Society for the Study of Inborn Errors of Metabolism in Prague, Czech Republic,...

Cellegy Files For Marketing Approval Of Rectogesic.
October 12, 2001... 2001 OCT 12 - (NewsRx.com & NewsRx.net) -- Cellegy Pharmaceuticals Inc. has submitted a Marketing Authorization Application (MAA) with the Medicines Control Agency (MCA) requesting approval of its product Rectogesic (nitroglycerin ointment)...

Multinational Pivotal Trial For Inhaleable Therapy Initiated.
October 12, 2001... 2001 OCT 12 - (NewsRx.com & NewsRx.net) -- This therapy utilizes the Inhance pulmonary delivery technology, a proprietary drug delivery solution from Inhale Therapeutic Systems, Inc., Aventis Behring's development partner. "We will be...

Phase I Study Of Topical Gel For Treatment Of Genital Warts Initiated.
October 12, 2001... 2001 OCT 12 - (NewsRx.com & NewsRx.net) -- Origenix Technologies, Inc. announced that an investigational new drug application (IND) has been filed with the U.S. Food and Drug Administration (FDA) for ORI-1001, a topical gel for the...

Feridex I.V. Supplemental New Drug Application Not Approvable by FDA.
October 12, 2001... 2001 OCT 12 - (NewsRx.com & NewsRx.net) -- The U.S. Food and Drug Administration (FDA) has determined that the supplemental New Drug Application (sNDA) submitted by Advanced Magnetics Inc. (AVM) for Feridex I.V. is not approvable. Feridex...

FDA Requests More Information From Aviron On FluMist.
October 12, 2001... 2001 OCT 12 - (NewsRx.com & NewsRx.net) -- Aviron has received a complete response letter from the U.S. Food and Drug Administration (FDA) requesting additional information and clarification regarding clinical and manufacturing data from...

Genta Receives Orphan Drug Designation For Three New Cancer Indications.
October 12, 2001... 2001 OCT 12 - (NewsRx.com & NewsRx.net) -- Genta Inc. (GNTA) has received notice from the U.S. Food and Drug Administration that Genasense, its lead anticancer compound, has been granted designation as an "Orphan Drug" for three additional...

Phase III Trials Of Natalizumab To Begin Soon.
October 12, 2001... 2001 OCT 12 - (NewsRx.com & NewsRx.net) -- Antegren (natalizumab), a humanized monoclonal antibody, demonstrated promising results on multiple endpoints in a Phase II study in multiple sclerosis (MS), according to data presented September...

FDA Accepts Orphan Medical's Proposed Response Plan On Xyrem NDA.
October 12, 2001... 2001 OCT 12 - (NewsRx.com & NewsRx.net) -- The U.S. Food and Drug Administration (FDA) has accepted Orphan Medical (ORPH) Inc.'s plan for a complete response to the agency's Approvable Letter dated July 2, 2001, regarding Xyrem (sodium...