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Sep27
Sanofi-Aventis U.S. LLC’s Dermik Laboratories Submitted USFDA Supplemental Premarket Approval Application (s-PMA) for Sculptra®

The dermatology business of sanofi-aventis U.S. LLC, Dermik Laboratories, has recently submitted a supplemental premarket approval application (s-PMA) to the USFDA for Sculptra® (injectable poly-L-lactic acid) for facial cosmetic use.

Sculptra®, sold under the trade name NEW-FILL™, was approved in Europe in 1999 to increase volume, particularly for the correction of skin depression, including skin creases, wrinkles, folds and scars.

Sculptra®, a synthetic, biocompatible, bioabsorbable material that is naturally degraded by the body over time, was approved in the in 2004 for restoration and/or correction of the signs of facial fat loss (lipoatrophy) in people with human immunodeficiency virus.

Source: PR Newswire

Sep27
Nastech Pharma Co. Inc. Initiated Clinical Development of Rapid Acting Diabetic Insulin Nasal Spray
Cardinal Health Agreed to Scale-Up and Manufacture Clinical Supplies for Bentley Pharmaceuticals, Inc.'s Intranasal Insulin Program
Sigma-Aldrich Corp. Reached Settlement with Enzo
ExonHit Therapeutics and Allergan, Inc. Extended Strategic Alliance
Serono's Oral Cladribine, Granted USFDA Fast Track Status for the Treatment of Multiple Sclerosis (MS)
Serono, To be Acquired by Merck KGaA
Debiopharm Group’s Debio-0513 (PTR-262) Received European Orphan Drug Status for Myasthenia Gravis (MG)
Sep25
Top 8 Medicinal Products in My Toddlers’ Cabinet
Chromos and Y's Theraputic Agreed on Cell Line Engineering Contract
ChemBridge Corporation and ChemBridge Research Laboratories, Inc. (CRL) Entered Into Strategic Alliance on Discovery Chemistry with AstraZeneca
MannKind Corp.’s Technosphere® Insulin System, Showed Safety and Efficacy in Phase III Clinical Trial in Type 2 Diabetes Patients
CoFactor®/ Uftoral® (UFT) Combination Showed Positive Results in Colorectal Cancer Model
Sep23
Itax (Itopride) Fails Phase III Clinical Trials, Axcan Pharma Shares Fall
Long-term Alendronate (Bisphosphonate) Use in Patients with Osteoporosis Do Not Increase Vertebral Microcracks
Sep22
Tranzyme Pharma Expands Clinical Program of Post-Operative Ileus Drug Candidate, TZP-101, to Include Patients with Gastroparesis
Sebivo (Telbivudine) Approved in Switzerland for Chronic Hepatitis B
Altana AG Sells Pharmaceutical Business to Nycomed
Hospira Agrees to Buy Mayne Pharma Limited for $2 Billion
Nucryst Pharmaceutical's NPI 32101 Drug Candidate Against Atopic Dermatitis Fails Phase II Clinical Trials
Sep21
Wal-Mart to Cut Prices On Almost 300 Generic Prescription Drugs, Drugstore chains Shares Falls
Angiotech Pharmaceuticals Presents Positive Preclinical Study On Vascular Wrap ™ Paclitaxel-Eluting Mesh for Inhibiting Neointimal Hyperplasia
BioMarin Completes Enrollment for Phase II Clinical Trials of 6R-BH4 for Treatment of Hypertension
Novogen's Investigational Cancer Drug Phenoxodiol Targets Prostate Cancer Protein
Five Wyeth Research Scientists: Honored by Science Spectrum Magazine
Fosrenol Approved in Germany, AnorMed Receives $3 Million Milestone Payment
Jury Favored Wyeth in Hormone Therapy Case v. Linda Reeves
Sep20
ZymoGenetics Reported the Positive Results of Phase 3 Trial Evaluating rhThrombin as a Potential Treatment for Surgical Bleeding
Schering-Plough’s NOXAFIL® (Posaconazole): USFDA-Approved for the Prevention of Invasive Fungal Infections (IFIs)
GlaxoSmithKline Submitted USFDA NDA of Tykerb® (Lapatinib Ditosylate) for Advanced Breast Cancer Treatment
Serono and Syntonix Pharmaceuticals, Inc Joined Forces to Pursue Development of a Long-Acting, Inhaleable FSH Therapy for the Treatment of Infertility
Cell Therapeutics Inc. and Novartis Entered Worldwide License and Co-Development Agreement to Develop and Commercialize XYOTAX™
Pfizer and TransTech Pharma Agreed to Develop and Commercialize RAGE (Receptor for Advanced Glycation End products) Modulators
Sep18
Somanta Pharmaceuticals Completed SEC Registration and Received Stock Trading Symbol
Pharmion Corporation and MethylGene, Inc. Initiated Phase II Clinical Trial of Proprietary HDAC Inhibitor MGCD0103 in B-Cell Lymphomas
Schering AG and AstraZeneca Entered Strategic Alliance to Develop SERDs: Novel Anti-Cancer Drug
GlaxoSmithKline’s DREAM Trial Revealed Avandia® (rosiglitazone maleate) Reduced Risk of Progression from Pre-Diabetes to Type 2 Diabetes by 62 Percent Relative to Placebo
Unimed Pharmaceuticals, Inc. Settled Pending AndroGel® Patent Litigation with Watson Pharmaceuticals, Inc. and Paddock Laboratories/Par Pharmaceutical Companies, Inc.
Sep17
Dutch Court Ruled in Favor of Pfizer, Inc. Upholding Basic Lipitor Patent and Preventing Launch of Ranbaxy Generic Version Before November 2011
Vical, Inc. Received Extended Patent Coverage for Vaxfectin™ Adjuvant to Conventional Vaccines
Bristol-Myers Squibb Company and Medivir AB Entered Worldwide Collaboration to Develop and Commercialize MIV-170 for the Treatment of HIV-1 Infection in Adults
Sep15
Transition Therapeutics Inc. and JDRF Partnered for the Development of Diabetes Regenerative Product GLP1-I.N.T.™
Cardiome Pharma Corp.’s Oral RSD1235 Passed Phase 2a Pilot Study
Radius and Karo Bio Entered Into Licensing Agreement for Novel SARM Compounds
VIRTUE, Largest Clinical Trial of Subcutaneous Immunoglobulin (Ig) Therapy: Launched and Now Open to Primary Immunodeficiency (IP) Patients Across the United States
Sep14
KV Pharmaceutical Co. Received USFDA ANDA Approval To Market Six Strengths of Diltiazem HCl ER Capsules (Generic Tiazac®)
BioMarin and Serono Announced Positive Clinical Trial Results of Phenoptin™ in PKU to be Presented at the 56th Annual Meeting of ASHG
Ortec International Inc. Announced Positive Results of Orcel® in Confirmatory Venous Leg Ulcer Trial
Neurocrine Biosciences, Inc.’s Orally Active GnRH Receptor Antagonist in Endometriosis (NBI-56418) Passed Follow-Up Phase II Study
Peter R. Dolan Left Bristol-Myers Squibb as CEO, James M. Cornelius Appointed by Board of Directors as Interim CEO
Sep13
Douglas Laboratories Canada: Acquired by Atrium Biotechnologies, Inc.
Positive Genotoxicity Studies of Somaxon Pharmaceuticals’ SILENOR™ May Lead to its USFDA NDA for the Treatment of Insomnia
Biomarin Pharmaceutical Inc. Announced Promising Preclinical Outcome of Phenylase™ (Enzyme Substitution Therapy For PKU)
Acuity Pharmaceuticals Announced the Positive Phase II Results for Bevasiranib in Wet AMD
Ranbaxy’s Ohm Laboratories, Inc. Received USFDA Approval to Manufacture and Market Loperamide Hydrochloride and Simethicone Tablets (Generic Imodium® Advanced)
Sep12
CIP-Tramadol Fails Phase III Clinical Trials, Cipher Pharma Stocks Plunges 24 Percent
Synta Pharmaceuticals Announces Positive Phase 2 Clinical Trial Results for STA-4783 in Metastatic Melanoma
Introgen Therapeutics, Inc. and Gendux AB’s ADVEXIN Therapy, Granted EU Orphan Designation
Abbott Submitted Both U.S. and E.U. Regulatory Applications for the Approval of HUMIRA® (Adalimumab) as Treatment for Crohn's Disease
Northwest Biotherapeutics, Inc., USFDA-Cleared to Proceed Lung Cancer Trial of DCVax®-LB Personalized Therapeutic Vaccine
Sep11
Jazz Pharmaceuticals Initiated Phase III Clinical Trial of Xyrem® (Sodium Oxybate) in Fibromyalgia Syndrome Patients
ExonHit Therapeutics S. A.’s RNA Splicing Microarray Patent Rights, Licensed to Merck & Co., Inc.
GTx, Inc. Entered Partnership Agreement with Ipsen for Acapodene®’s European Rights
Introgen Therapeutics, Inc.’s ADVEXIN Therapy (p53 tumor suppressor) Showing Potential in Breast Cancer Treatment
Nextrials, Inc.’s Co-Founder Will Discuss Benefits of Integrating Electronic Healthcare and Clinical Trial Data at ExL Pharma's Second Annual Merging Electronic Health Records (EHR) and Electronic Data Capture (EDC) Conference
Sep10
STEEPLE Study Revealed Superior Safety Profile of Sanofi-Aventis’ LOVENOX® (Enoxaparin Sodium Injection) Over Unfractionated Heparin (UFH) in Non-Emergent Percutaneous Coronary Intervention (PCI) Patients
Annual Merging Electronic Health Records (EHR) and Electronic Data Capture (EDC) Conference
Labopharm Inc. Presented at the Clinical Meeting of American Academy of Pain Management, the Safety Data from 3 U.S. Phase III Trials for Once-Daily Tramadol
Review Period for Shire plc’s MESAVANCE™ (mesalamine) NDA, Extended by USFDA
In Product Acquisition Agreement with Ligand Pharmaceuticals: Eisai, Inc. Gains Four Oncology-Related Products
EuroPharma Entered Exclusive Agreement with New Chapter for the Distribution of Vectomega® Into Health Food/Natural Product Retail Channel
Sep 9
Manufacture of OVATION Pharmaceuticals, Inc.’s Panhematin® (hemin for injection) at Cardinal Health, Inc.’s New Facility, Received USFDA Approvable Letter
Cordis Endovascular’s CYPHER SELECT™ Sirolimus- eluting Stent: First Drug-Eluting Stent Approved in Europe for Most Severe Form of Leg Arterial Disease
Pfizer’s Lipitor® Found More Effective Than Simvastatin® in Reducing Risk of Additional Heart Attacks in Patients Who Had a Recent Heart Attack
Lentigen Corporation Signed Second Collaborative Research Agreement with the University of Pennsylvania
Sep 8
SkyePharma and Mundipharma Entered Exclusive Licence Agreement for European Marketing and Distribution of Flutiform™
U.S. Court of Appeals favored Mylan Laboratories, Inc. in Oxybutynin Patent Litigation
Watson Pharmaceuticals’ Generic Seasonale®, USFDA Approved
FDA Advisory Committee Gives Negative Review on Genta Incorporated's Genasense® for Treatment of Chronic Lymphocytic Leukemia
Dynavax and AstraZeneca to Co-Develop TLR-9 Agonists for Asthma and COPD
Sep 7
Claris LifeSciences to Expand in Europe, Ties up with STADA Arzneimittel Subsidiaries
Pfizer Won Norvasc Patent Against Synthon Pharmaceuticals
Tentative Approval For Clobetasol Propionate Foam (Generic Olux® Foam, 0.05%) Granted to Perrigo
Sabinsa Corp.’s Ocufors™, Approved for Indian Market and Manufacturing
Debiopharm and Salix Pharmaceuticals Signed SANVAR® IR (Immediate Release Formulation) License Agreement
Sep 6
Anthera Pharmaceuticals Acquires Rights to Anti-Inflammatory Drug Portfolio Developed By Eli Lilly and Shionogi
ZymoGenetics Reports Positive Phase 3 Clinical Trial Results of Recombinant Thrombin
EpiCept's LidoPAIN SP Analgesic Patch Fails European Phase III Trial
Cenestra Health Releases High-Purity Omega-3 Fatty Acid Supplement
Rheumatoid Arthritis Drugs May Be More Efficient If Delivered Into the CNS
Sep 5
Sanofi pasteur Started Shipment of Fluzone®, Influenza Virus Vaccine
Plavix® Patent Infringement Case’s Preliminary Injunction, Ordered Apotex to Stop Sales of Generic Plavix®
Sep 4
Emergent BioSolutions Awarded Two NIAID Grants to Support Development of Anthrax Immune Globulin (AIG) Therapeutic Product
Exelixis, Inc. Submitted USFDA IND for Novel Anticancer Compound, XL228
Velcura Therapeutics, Inc., Awarded NIA SBIR Grant for More Research on Human Bone Formation Processes
Vanda Pharmaceuticals, Inc. Successfully Completed Enrollment of Volunteers for its Iloperidone and VEC-162 Phase III Trials for Treatment of Schizophrenia and Insomnia, Respectively
Mylan Lab Inc.’s Fluoxetine Capsules, USP, Granted USFDA Tentative Approval
Sep 3
Lentigen Corp. and Dharmacon, Inc. Joint Forces to Develop Custom Lentiviral Reagents for RNAi Research
Nastech Pharma Co. Inc. Received Development Grant for siRNA Therapeutics for the Prevention and Treatment of Influenza
Purdue Pharma L.P. and Teva Pharmaceuticals Agreed to End OxyContin® Patent Lawsuit
Sep 2
Emergent BioSolutions, Inc.’s BioThrax® (Anthrax Vaccine Adsorbed), Certified by U.S. Department of Homeland Security As An Approved Product For Homeland Security
Sep 1
Sinovac Biotech Annouces Positive Phase I Trials of H5N1 Influenza Vaccine, Prepares for Mass Production

« August 2006 | Main | October 2006 »

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