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Oct31
Shire plc’s ADHD Patch, DAYTRANA™ (methylphenidate transdermal system): Provided Individualized Symptom Management

Shire plc’s Attention Deficit Hyperactivity Disorder (ADHD) patch, DAYTRANA™ (methylphenidate transdermal system), significantly reduced the symptoms of ADHD in children aged 6 to 12 years, even when the ADHD patch is taken off earlier than the recommended nine hours.

Being able to remove the patch earlier than the recommended nine-hour wear time enables physicians to manage the potential for late-day side effects, such as lack of appetite or difficulty sleeping.

Such were the phase IIIb clinical trial results recently reported by Shire Plc (LON: SHP, Nasdaq: SHPGY) at the 53rd Annual Meeting of the American Academy of Child and Adolescent Psychiatry (AACAP) in San Diego, California.

Timothy E. Wilens, M.D., Clinical and Research Program in Pediatric Psychopharmacology at Massachusetts General Hospital and Associate Professor of Psychiatry at Harvard Medical School, explained:

"The patch's delivery system offers physicians individualized control of their patients' ADHD symptoms, adding an important dimension to the treatment of ADHD, since a child's schedule often varies between school day and weekend.

Because it is a patch, if a child sleeps late on the weekend and the patch is applied later than on a school day, it can still be removed at the usual time. That way, the child receives the benefit of their long-acting ADHD medication for a shorter duration of effect, as well as managing the potential for late-day side effects.

The physician, in consultation with the parent, can determine the appropriate patch wear time, up to the recommended nine hours."

DAYTRANA™ is the first and only patch medication approved by the USFDA for the treatment of the symptoms of pediatric ADHD and is available in four dosage strengths -- 10 mg, 15 mg, 20 mg and 30 mg -- all designed for once-daily use.

Find more details from the press release.

Oct31
Pharmasset Commenced Phase 1 Study of R7128 for Hepatitis C Virus
Oct30
Dendreon’s PROVENGE® Demonstrated Prostate Cancer Survival in Phase 3 Studies
Telbivudine (TYZEKA™) Data from Idenix’s GLOBE Study, Presented at AASLD Annual Meeting
Schering –Plough’s INTRON® and REBETOL® Retreatment Study Results, Presented at AASLD Annual Meeting
Oct29
NicOx’s Naproxcinod Sucessfully Passed Osteoarthritis Phase 3 Trial
Strattera®, Effective in Treating ADHD Symptoms in Children and Adolescents with ADHD and Reading Disorders, New Study Says
European Patent Office Supports Validity of Pfizer's Lipitor® Patent
Oct28
Wyeth: One of the U.S. EPA's Best Workplaces for Commuters
New Drug for the Treatment of Chronic Hepatitis B Patients: Idenix Pharma, Inc.'s TYZEKA™ (telbivudine), USFDA-Approved
Laureate Pharma Extended its PROSTASCINT® Manufacture Agreement with Cytogen Corp.
Auxilium Pharmaceuticals, Inc.'s Injectable Enzyme against Peyronie's Disease: AA4500, Passed Phase II Studies
Oct27
Javelin Pharmaceuticals: Frost & Sullivan’s Entrepreneurial Company of the Year for Intranasal Therapeutics
Genmab A/S Initiated Combination Clinical Study of HuMax-EGFr™ With Chemo-Radiation
Treatment Response to Mesalamine = Rapid Mucosal Healing in Moderately Active Ulcerative Colitis (UC) Patients, According to Combined Data Analysis
New Nexium® Formulation: NEXIUM® For Delayed-Release Oral Suspension, Approved by the USFDA
Clinical Data Demonstrating Additive Anti-Fibrotic Combination Effects of Actimmune® and Pirfenidone, Presented by InterMune, Inc. at CHEST 2006
U.S. District Court Granted Ortho-McNeil Neurologics, Inc.’s Request for Preliminary Injunction for TOPAMAX®
D-Pharm Ltd. Granted DP-b99 Exclusive License to Yungjin Pharmaceutical Company Ltd. For Korean Acute Stroke Market
Oct26
Stiefel Laboratories, Inc. Bought Connetics Corporation
BrainCells and Organon Entered Collaboration for Discovery and Development of CNS Drugs
Oct25
Somaxon Pharmaceuticals' SILENOR™ Passed Phase 3 Transient Insomnia Clinical Trial
DelSite Presented Clinical Data on Influenza Nasal Powder Vaccine
Novartis’ Zelnorm® Demonstrated Relief of Multiple Symptoms of Dysmotility-Type Dyspepsia
AMITIZA™ (lubiprostone) Demonstrated Efficacy Within 24 and 48 Hours of Treatment
VIVUS' Obesity Pill, Qnexa™ Demonstrated Positive Phase 2 Clinical Data
Prasugrel Achieved Faster Onset and Higher Levels of Platelet Inhibition than Clopidogrel in a New Study
U.S. Appeals Court Denied Ranbaxy’s Petition for Rehearing of Main Patent in Lipitor Case
Abbott's HUMIRA® (Adalimumab) Induced Clinical Remission in Infliximab-Intolerant/Unresponsive Crohn's Disease Patients, Phase III Data Says
Oct24
Schering-Plough’s NOXAFIL® (Posaconazole), USFDA-approved for the Treatment of Oropharyngeal Candidiasis (OPC)
SkinMedica’s Desonate™ (Desonide) Gel 0.05% USFDA-approved for the Treatment of Atopic Dermatitis
USFDA Approved Expanded Indication of Berlex, Inc.’s Betaseron®
New Purdue Biochip Used in Studying Living Cells: A Tool to Speedy Drug Development
Oct21
Roche is No. 3 in Science Magazine's list of Top 20 Employers in the Biotech and Pharmaceutical Industry
PharmaNova Granted Exclusive U.S. License to Depomed for the Use of Extended Release Gabapentin against Hot Flashes
ELAPRASE™ (idulsulfase) Received Positive Opinion From European Regulatory Agency
Tm Bioscience Amended License Agreement with Sirius Genomics
Novocell, Inc. is Creating Insulin-producing Pancreatic Endocrine Cells from Human Embryonic Stem Cells
Indication of Centocor, Inc.'s REMICADE®, Now Expanded by the USFDA for Ulcerative Colitis
PTC Therapeutics Awarded USFDA Orphan Products Development Grant for the Development of PTC124 in Duchenne Muscular Dystrophy
U.S. District Court Granted Mylan a Motion to Dismiss the '909 Patent in the Amlodipine Besylate Litigation
Oct20
Cheaper Generics are More Likely to Attract Large Share of Prescription Drug Sales
Medicines for Malaria Venture, Genzyme Corporation and the Broad Institute Expanded Collaboration For the Discovery of New Malaria Drugs
Oct19
Mutual Pharmaceutical Company Filed Counter Suit Against Adams Respiratory Therapeutics on Guaifenesin Case
Genzyme Corp. and AnorMED Inc. Agreed on Acquisition Terms
Sanofi- Aventis' Allegra® (fexofenadine hydrochloride) Oral Suspension, USFDA-approved for Treatment of Seasonal Allergy Symptoms and Chronic Idiopathic Urticaria
Sanofi Aventis' Taxotere® (docetaxel) Injection Concentrate, USFDA-approved for the Treatment of Patients With Head and Neck Cancer
Merck's JANUVIA™, USFDA Approved for Type 2 Diabetes
Endo Pharmaceuticals Responded to the Lidoderm® Issue
Lexicon Genetics Initiated Preclinical Development of LX2931 for Autoimmune Diseases
Oct18
Diffusion Pharmaceuticals Completed USFDA-Required Toxicology Studies in Support of TSC Phase I Trials and Closed $1.5 Million Private Placement
Genta Incorporated’s Genasense® Received Australian Orphan Drug Designation for Advanced Melanoma Patients
ARICEPT® (donepezil HCl tablets), USFDA-Approved for Full Spectrum Alzheimer’s Disease
OncoMed Pharmaceuticals Granted USPTO Patent for Identifying Therapeutics Targeting Cancer Stem Cells
Austrian Patent Office Ruled in Favor of Pfizer On Lipitor Basic Patent
Serono and Newron Pharma Entered Into Global Development and Commercialization Agreement for Safinamide
Foamix, Ltd. and Taro Pharmaceutical Industries Ltd Entered Into License Agreement for the Development and Commercialization of Foamix's PerFoam™ 1% for the Treatment of Head Lice
TyRx Pharma, Inc. Submitted Premarket Application for PIVIT™ CRM: Novel Mesh Pouch Containing Rifampin and Minocycline Designed to Hold and Reduce Bacterial Colonization of a Pacemaker or ICD Pulse Generator
Neurochem Submitted Complete Response in Lieu of USFDA’s Approvable Letter for KIACTA™
Oct17
Human Genome Sciences Reported Positive Interim Quality-of-Life Data From Phase 2B Trial of Albuferon™ with Ribavirin in Treatment-Naïve Hepatitis C Patients
Medarex and PharmAthene’s Anthrax Therapeutic Valortim™, Passed Phase I Clinical Trial
Nabi Biopharmaceuticals’ PhosLo® EPICK Study Revealed Positive Results
Neuren's NNZ-2591, Proved Effective At Memory Loss Reversal
PDL BioPharma Presented Physician Survey Results on Heart Attack Treatment
Oct16
Genta, Inc. Initiated Phase 1 trial of Antisense Drug, G4460, in Advanced Cancer Patients
CHEM Rx Announced Acquisition Strategy
Bayer Appointed Independent Investigator for Review of Trasylol® Study Issues
Isolagen, Inc and the USFDA Has Agreed on Phase III Protocol Design for Isolagen™ Therapy (IT)
New River Pharmaceuticals, Inc. and USFDA Conducted End-of-Phase II Meeting on NRP290 (Product Candidate for Acute Pain)
Oct15
Morphotek Inc Receives $40 Million in Series D Financing Round
Clinical Data on Selected Cethromycin Trials Presented by Advanced Life Sciences at IDSA Annual Meeting
Innocoll, Inc. Receives FDA Approval for CollaGUARD™ Collagen-Based Advanced
Newly Published Data Show Efficacy and Safety of Spracor's Lunesta in Elderly Patients with Insomnia
USAMRMC Extended Lexicon Genetics' Grant for Spinal Muscular Atrophy (SMA) Research Program
Peregrine Receives Regulatory Approval in India for New Cotara® Brain Cancer Clinical Trial
FDA Grants Orphan Drug Designation For Agennix's Talactoferrin Alfa In Renal Cell Carcinoma
FDA Approves AstraZeneca's NEXIUM® for the Treatment of Zollinger-Ellison Syndrome
New Sleeping Pill Rozerem Unlikely to Lead to Dependence or Abuse
Bellicum Pharmaceuticals Entered into Commercial Licensing of ARIAD's ARGENT™ Cell-Signaling Regulation Technology for Development of New Cancer Therapies
"Humanized" Antibodies May Prevent and Treat Bird Flu
FDA Grants Tentative Approval to Teva Pharmaceutical's Generic Risperdal
Roche Seeks European Marketing Authorization for Herceptin Plus Hormonal Therapy for Advanced HER2-Positive Breast Cancer
Endo Pharmaceuticals Acquires RxKinetix for $20 Million, Gains Rights to RK-0202 Oral Rinse for Oral Mucositis
FDA Approves Aricept® For Treatment of Severe Alzheimer's Disease
Indevus Submits New Drug Application for SANCTURA XR Once Daily Drug For Overactive Bladders
Alfred Mann Institute Established at the Technion-Israel Institute of Technology , Technion Receives $100 Million
BioAlliance Pharma Receives French Marketing Authorization for Its first Product Loramyc® for the Treatment of Oropharyngeal Candidiasis
Oct14
PharmAthene, Inc. Got $1 Million Congressional Appropriation for Continued Development of Anthrax Therapeutic Valortim™
Modified Inteleukin-1 Receptor Antagonist May Offer Prolonged Osteoarthritis Relief
LifeCycle Pharma Entered Into Three Distinct Strategic Collaboration Agreements With Global Pharmaceutical Companies
Psychostimulant Methamphetamine May Reduce Stroke Damage
More Than 90% of Pliva Shares Tendered to Barr Pharmaceuticals for $2.5 Billion
Prozac Increases Bone Mass, May Treat Osteoporosis
Clinical Studies Show Rotigotine Patch Appears to Be a Safe Treatment for Early-Stage Parkinson's Disease
FDA Approves Colon Cancer Drug Avastin for Treatment of Non-Small Cell Lung Cancer
Antipsychotic Drugs Found Ineffective For Treating Psychotic Symptoms in Alzheimer's Disease
Ambrilla Licenses HIV/AIDA Protease Inhibitor Drug Candidate to Merck for $17 Million Plus $215 Million Milestone Fees
Oct13
Cephalon, Inc.'s FENTORA™ (fentanyl buccal tablet) for Breakthrough Pain in Patients with Chronic Low Back Pain, Passed Phase III Clinical Trial
Amarin Corporation plc, Granted USPTO Patent Approval for Miraxion in Huntington's Disease
GlaxoSmithKLine Submitted Supplemental New Drug Application for Advair Diskus® in COPD
Novartis Launched 'GALIANT' Study Comparing the Investigational Drug Galvus® and a Leading Class of Oral Anti-Diabetic Medicines (TZDs)
CV Therapeutics, Inc. Terminated Co-Promotion of ACEON® (perindopril erbumine) Tablets with Solvay Pharmaceuticals, Inc.
Oct11
Schering-Plough Files Patent Infringement Lawsuit Against GeoPharma Inc Over Generic Version of Clarinex(R)
EU Grants Marketing Approval To Schering-Plough's Suboxone Sublingual Tablets for the Treatment of Opioid Addiction
Theravance Announce Positive Phase III Trials on Telavancin for MRSA Infections
Oct10
Dyanavax Shares Rose Following Publication of Pilot Study On the Efficacy of Tolamba Ragweed Allergy Vaccine
Wyeth Submits NDA and MAA for mTOR Inhibitor Torisel for the Treatment of Advanced Renal Cell Carcinoma
Edison Pharmaceuticals Collaborate With Brazil's Institute of Vision To Develop Mitochondrial Therapies for Leber's Disease
deCode Pharmaceuticals Suspends Phase III Trial of Heart Attack Drug DG031 Due to Formulation Issues
GW Pharmaceuticals Announce Positive Phase II Trials of Sativex Oromucosal Spray for Multiple Sclerosis
Oct 9
Out of The Storm Debris

« September 2006 | Main | November 2006 »

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