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Feb28
Abbott’s HUMIRA® (Adalimumab), USFDA-Approved for Crohn's Disease Treatment
The USFDA granted marketing approval to Abbott (NYSE: ABT) for HUMIRA® (adalimumab) with the following new indications:
  • treatment for reducing the signs and symptoms and inducing and maintaining clinical remission in adults with moderately to severely active Crohn's disease who have had an inadequate response to conventional therapy
  • humira.jpgreducing the signs and symptoms and inducing clinical remission in these patients if they have also lost response to or are intolerant to infliximab - the only other approved biologic for treatment of Crohn's disease

Crohn's disease (the fourth USFDA approval in immune-mediated diseases for HUMIRA®) is a serious chronic, inflammatory disease of the gastrointestinal (GI) with no medical or surgical cure and only a few options for patients with this chronic condition.

HUMIRA® - the only fully human monoclonal antibody approved for the treatment of rheumatoid arthritis (RA), psoriatic arthritis (PsA), and ankylosing spondylitis (AS) in the U.S. and Europe (in addition to Crohn’s disease in the U.S.) - works by blocking TNF-alpha, a protein that when produced in excess, plays a central role in the inflammatory responses of many immune-mediated diseases.

Find more details from the press release.

Feb28
Unit Dose Budesonide (UDB): MAP Pharma’s Pediatric Asthma Drug Candidate, Passed Phase 2 Clinical Trial
Albuferon® + Ribavirin, Passed Phase 2b Clinical Trial in Treatment-Naïve Genotype 1 Chronic Hepatitis C (HCV) Patients
Feb27
Survey Reveals Reason for Allergic Rhinitis Patients to Discontinue Treatment of Existing Nasal Sprays
Eli Lilly’s Cymbalta®, USFDA-Approved for the Treatment of Generalized Anxiety Disorder in Adults
Feb26
Interesting Finds: Pharma-related Blog Posts 2
Feb25
Avastin® + Chemotherapy Passed International Phase III Study in Advanced Lung Cancer Patients
Idenix Pharma’s SEBIVO® (telbivudine) Received EU Positive Opinion as New Treatment for Chronic Hepatitis B Patients
First Digital Insulin Pen with Memory, Launched by Eli Lilly
TorreyPines Therapeutics and Eisai Co., Ltd. Extended Collaboration Agreement on Alzheimer's Disease
Feb22
Shire plc Will Acquire New River Pharmaceuticals for $64 per Share
Auxilium Pharma’s AA4500 Passed Phase III Clinical Trial for the Treatment of Dupuytren's Contracture
GPC Biotech’s Satraplatin Expanded Rapid Access protocol (SPERA) Program, Launched in the U.S.
Harvard Developed Novel TB Spray Vaccine
Feb20
Interesting Finds: Pharma-Related Blog Posts
Merck Stops Lobbying of Mandatory HPV Vaccine Use
HIV Drug Darunavir (Prezista™), Granted EU Conditional Marketing Approval
Feb18
ZymoGenetics' BLA for Recombinant Human Thrombin (rhThrombin), Accepted for Review by the USFDA
Spectrum Pharma Has Completed Filing of NDA of Satraplatin for Hormone Refractory Prostate Cancer
Florida Policy Roundtable is Urging State Lawmakers to Re-think Mandatory HPV Vaccination
Feb16
Favrille Agreed with Berlex to Use FavId® in Combination With Leukine® (sargramostim) in B-Cell Non-Hodgkin's Lymphoma
Peregrine Pharmaceuticals’ Bavituximab Passed Phase Ib Clinical Trial in Chronic Hepatitis C Virus (HCV) Infection
Organon and Pharmacopeia Agreed on New Collaboration
Ingenuity Systems Agreed to Expand and Extend Merck Licensing Agreement
Feb15
About Lorenzo's Oil
Feb14
Pfizer’s Novel HIV/AIDS Drug Maraviroc, Under Accelerated Review in US and EU Regulatory Agencies
GSK Access Offers Free Prescription Medicines to Eligible Medicare Part D-Enrolled Patients
Feb13
Nexavar® Passed Phase III Clinical Trial in Primary Liver Cancer Patients
ViroPharma’s Maribavir, Granted USFDA Orphan Drug Designation for Cytomegalovirus Viremia and Disease Indication
Anesiva’s New Drug Application (NDA) of Zingo™ for Reduction of Needle Insertion-Painin Children, Accepted by the USFDA
Corautus Genetics and VIA Pharmaceuticals Agreed on a Merger
Lupin’s Sertraline, Approved by the USFDA
Sanofi-aventis’ sNDA of Lovenox® (Enoxaparin Sodium Injection) for Acute Heart Attack Under USFDA Priority Review
Pfizer’s Sutent® (sunitinib malate) USFDA-Approved to Include New First-Line Advanced Kidney Cancer Data in Product Label
Feb11
ImmuneRegen's Viprovex™ Demonstrated Potential in Treatment of Avian Influenza and Spanish Flu
2007 Shingo Prize for Excellence in Manufacturing Goes to Two Baxter Int’l. Facilities
Pharmacokinetics of KADIAN® (morphine sulfate extended-release), Not Significantly Affected by Alcohol Consumption
Alphanate, New Product USFDA-Approved for von Willebrand Disease
Ranbaxy Signed New R&D Agreement with GlaxoSmithKline
Feb 7
WEHI and Genentech Collaboration, To Develop New Cancer Drugs
BioCryst’s Fodosine™, Granted EMEA Orphan Drug Status for Cutaneous T-cell Lymphoma (CTCL)
AXM Shengyang Acquires Yuhuatang
ImClone and Bristol-Myer Squibb’s ERBITUX ®, under Japanese PMDA Evaluation for Treatment of Advanced Colorectal Cancer
elbion NV and Wyeth to Develop New Treatments for Schizophrenia
Feb 6
Cervical Cancer Vaccination: A Mandate in Texas State
Wyeth Pharmaceuticals and Nautilus Biotech Collaborates for Development of Hemophilia Therapies
Feb 5
Majority Stake in Beijing Boran Pharmaceutical, Acquired by China Health Holding
CSL Behring and Bayer Healthcare Agreed to Extend Agreement for Supply of Helixate® Recombinant Coagulation Factor
China’s Aida Pharmaceuticals won Etimicin Sulfate Patent Lawsuit
Feb 4
Genentech’s Raptiva® (efalizumab) Passed Phase IV Study in Moderate-to-Severe Hand and Foot Psoriasis Patients
New Dosing Recommendations for RAPAMUNE® (sirolimus) in High Immunologic Risk Renal Transplant Patients, Approved by the USFDA
Anacor Signed Worldwide Exclusive License Agreement with Schering-Plough for New Topical Anti-Fungal, AN2690
Pfizer Agreed to Acquire BioRexis Pharmaceutical
Acquisition of Arrow Therapeutics Broadens AstraZeneca’s Anti-Infective Portfolio
Feb 2
MediVas Collaborates With Merck in Area of Biologics
USFDA Accepted Pharmion’s IND for Oral Azacitidine (Vidaza®)
AstraZeneca and Palatin Technologies Collaborates to Discover, Develop and Commercialise Small Molecule Obesity Compounds
Institute of Materia Medica and TB Alliance Will Develop Improved TB Drugs
Feb 1
Patent for Heat Shock Protein (Hsp) Fusion for Flu Treatment, Awarded to Nventa Biopharma
Laureate Pharma in Manufacturing Agreement with Trubion Pharmaceuticals

« January 2007 | Main | March 2007 »

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