« December 2006 | Main | February 2007 »

Jan31
Novo Nordisk’s NovoLog® (insulin aspart [rDNA origin] injection), FDA-Approved for Use in Pregnant Women with Type 1 Diabetes

NovoLog®, a product of Novo Nordisk A/S (NYSE: NVO) is a safe and effective treatment for pregnant women with Type 1 diabetes and their unborn children.

This fact has been further validated by the recent USFDA approval of NovoLog® (insulin aspart [rDNA origin] injection) for pregnancy Category B rating.

The Pregnancy Category B rating for NovoLog® indicates that adequate studies in pregnant women with Type 1 diabetes have demonstrated that NovoLog® does not increase risk to the unborn baby.

novolog.gif

Previously classified under Category C rating, NovoLog® is a rapid-acting form of insulin for the treatment of people with diabetes mellitus for the control of hyperglycemia.

Offering convenient mealtime dosing and should be administered 5 to 10 minutes before a meal, NovoLog® enters the bloodstream quickly and begins working within minutes to lower blood glucose.

Find more details from the press release.

[Photo Credit: Novo Nordisk-U.S.]

Jan31
Alfacell Corp.’s ONCONASE®, Received U.S. Orphan Drug Designation for the Treatment of Malignant Mesothelioma
Spatially Offset Raman Spectroscopy: Novel Non-Invasive Method of Detection of Counterfeit Drugs
Debiopharm Entered Into R&D and Commercialisation Agreement with Kirin for Debio-0719
The USFDA is Too Slow to Approve New Drugs and Devices, New Physician Survey Finds
iCardiac Technologies Signed Cardiac Safety Alliance With Pfizer
Jan30
Pharmion Corp.’s Vidaza® (azacitidine for injection), USFDA-Approved for I.V. Administration
Berlex, Inc.’s YAZ®, USFDA-Approved for New Indication: Treatment of Acne
Jan29
Copegus® Tablet 200 mg, Approved as Combination Therapy to Chronic Hepatitis C Drug Pegasys®
Bayer Schering Pharma AG’s Oral Fludara®, Approved in Japan
Jan28
Sanofi pasteur’s New Pediatric Combination Vaccine (Pentacel®): Recommended for Licensure by USFDA Advisory Committee
NF-kB Inhibitors: New Class of Drugs Potentially Anti-Alzheimer’s Disease
Topical Eutectic Mixture, Found Safe and Effective Against Premature Ejaculation
Jan27
Beta Blockers: Not The Best First-line Treatment of HIgh Blood Pressure
Small Molecule Now, Diabetes and Obesity Pill Tomorrow
Jan25
MediVas Signed Collaboration Agreement With Pfizer
Roche’s ACTEMRA™ (tocilizumab) Passed Phase III Study in Rheumatoid Arthritis Patients
Medarex and Compugen Collaborates to Develop Antibody-Based Therapeutics
Jan24
Pharmion Submitted EU Marketing Authorization Application for Thalidomide Pharmion® for Untreated Multiple Myeloma
Wyeth Pharmaceuticals Received USFDA Approvable Letter for Pristiq™ (desvenlafaxine succinate) as Treatment for Adult Major Depressive Disorder (MDD) Patients
Ortho Biotech Submitted USFDA sNDA for DOXIL® as Combination to VELCADE® for Treatment of Relapsed/Refractory Multiple Myeloma
Jan23
SQ109: Sequella, Inc.’s TB Drug Candidate, Received USFDA Fast Track Status
Bioponic Phytoceuticals’ Curecumin™ Product Potentially Effective Against Alzheimer's Disease (AD)
Cell Genesys, Inc.’s GVAX® Immunotherapy Passed Follow-Up Phase 2 Clinical Trial for Pancreatic Cancer
International Phase III Study Revealed That XELOX (Xeloda® + oxaliplatin) Equals FOLFOX in Overall Patient Survival From Advanced Colorectal Cancer
Prilosec OTC: As Effective as Prescription Drugs for Heartburn and Acid Reflux Disease
Jan21
BioMS Medical Corp. Received USFDA Clearance to Commence Phase III Multiple Sclerosis Trial
New Imaging Compounds for Detection of Neurodegenerative Diseases To be Developed by Bayer Schering Pharma
Generic METAGLIP™ Tablets, Launched by Barr Labs
Jan20
Barr Labs Received USFDA Tentative Approval for Generic KYTRIL® (granisetron hydrochloride) Tablets, 1mg (base)
TAXUS® Stent System Expiration Date Extended to 18 Months by USFDA
H. Lundbeck A/S’ Cipralex® (escitalopram), Approved in Europe for Treatment of OCD (Obsessive Compulsive Disorder)
Carrington Laboratories Entered Supply and Trademark Agreement with Veterinary Products Laboratories for Acemannan Immunostimulant™
Jan19
Archemix and Merck KGaA Collaborates on Development and Marketing of Aptamer-Based Cancer Therapeutics
Cepheid and bioMerieux Agreed to Develop and Market Sepsis and MRSA Products
Metabolex, Inc.’s MBX-102/JNJ-39659100 (metaglidasen) Reduced Inflammation in Preclinical Diabetes Models
VioQuest Pharma’s VQD-001 ((sodium stibogluconate) Granted USFDA Orphan Drug Designation for the Treatment of Cutaneous Form Leishmaniasis
Sirion Therapeutics Acquired U.S. License of Virgan® (ganciclovir gel), Opthalmic Anti-viral
Jan18
Green Tea is Source Of Potential Potent and Safe Antibacterial
Jan17
Denderon Corp.’s BLA for PROVENGE® under USFDA Priority Review Status for the Treatment of Asymptomatic, Metastatic, Androgen-Independent Prostate Cancer
XTL and DOV Pharmaceuticals, Agreed on Worldwide Rights to Bicifadine
Merck Serono’s Phase III Diet Study of Phenoptin for Phenylketonuria Yielded Positive Results
Watson Pharma’s Silodosin Passed Phase III Clinical Trials for Treatment of Benign Prostatic Hyperplasia
Jan16
Merger with Genentech, Approved by Stockholders of Tanox, Inc.
Lux Biosciences Received USFDA Orphan Drug Designation for Ophthalmic Indications of ISA247
Long Term Dose-dependent Use of Genzyme Corp.’s Cerezyme® (imiglucerase for injection), Improve Bone Mineral Density in Type 1 Gaucher Disease Patients
Jan15
Canadian Marketing Rights to Xyrem®, Signed By Jazz Pharmaceuticals With Valeant Pharmaceuticals
Peregrine Pharmaceuticals Established Chinese Subsidiary
Jan14
ERBITUX® Passed Phase III Study as First-Line Treatment of Metastatic Colorectal Cancer
Jan13
AMDL is Producing Antibiotic Levofloxacin in China
Wyeth and Solvay Pharmaceuticals Agreed on Additional Neuroscience Collaboration
Bristol-Myers Squibb and AstraZeneca Entered Into Worldwide Collaboration For the Development and Commercialization of Diabetes Compounds
Warning from National Association of Boards of Pharmacy: Beware of Continued Dangers of Counterfeit Prescription Drugs
First and Only Enzyme Replacement Therapy for Hunter Syndrome: Approved by the European Commission
Jan11
Neurocrine Biosciences’ Orally Active GnRH Receptor Antagonist in Endometriosis, Passed Second Phase II Clinical Trial
Provectus’ Anti-Cancer Agent (PV-10) Received USFDA Orphan Drug Designation for the Treatment of Metastatic Melanoma
Horizon Therapeutics’ Special Protocol Assessment (SPA) Phase 3 Trial Program of GI-Friendly Prescription NSAID, Approved by the USFDA
QIAGEN and Pathway Diagnostics In Agreement to Address Pharma’s Biomarker Development Needs
Genentech, Made it Once More to FORTUNE’s ‘100 Best Companies To Work For’
PTC Therapeutics Entered Into a Strategic Drug Discovery Collaboration with Pfizer
Jan 9
Hypnion’s Novel Sleep Drug – HY10275 – Passed Phase II Clinical Trial
Pfizer Animal Health’s Slentrol™: First USFDA-Approved Anti-Obesity Drug for Dogs
Serono S.A.’s Majority Share, Acquired by Merck KGaA
Helix BioPharma Corp. Signed L-DOS47 Manufacturing Aagreement with BioVectra dcl
ActiveSight Entered Multi-Target Crystallography Service Agreement With Lexicon Pharmaceuticals
Provid Signed Agreement to Acquire Tripos Discovery Research
Jan 8
Genentech’s Pertuzumab in Combination with Gemcitabine Passed Phase II Trial for Advanced Ovarian Cancer
Anthera Received USFDA Approval to Initiate A-002 Phase 2 'PLASMA' Trial in Patients with Coronary Atherosclerosis
Roche and Synosis Therapeutics Entered Partnership to Explore Potential of Five Central Nervous System-Targeted Compounds
US$4.8 Million Biodefense Research Contract Awarded to Affinium Pharmaceuticals by United States Department of Defense/DTRA
Schering-Plough and OraSure Technologies Sealed Agreement for Development and Promotion of Rapid Point-Of-Care Oral Hepatitis C Test
Exclusive Worldwide License Rights to Develop and Commercialize Promising Phase II Spinal Cord Injury Drug, Cethrin®, Acquired by Boston Life Sciences
Elusys Therapeutics, Inc. Sealed Collaborative Research and License Agreement with Pfizer
AVEO Pharma, Inc. Acquired Kirin’s Clinical Stage Anti-Cancer Compound, KRN951
HHS Granted $102.6 M Fund to BioCryst Pharma, Inc. To Further Develop New Influenza Antiviral Drug, Peramivir
D-Pharm Successfully Completed Phase IIb Trial of its Neuroprotective Compound (DP-b99) in Acute Stroke Patients
USFDA Accepted Spectrum Pharma’s IND for Ozarelix and Approved BPH (Benign Prostate Hypertrophy) Phase 2b Protocol
AspenBio Pharma Submitted Investigational New Animal Drug Application (INADA) to the USFDA’s Center for Veterinary Medicine for StayBred™
Genaera Corp.’s Restructuring Terminates EVIZON ™ Clinical Program to Pursue Anti-Obesity Research
MacroGenics and JDRF Sealed Partnership to Support Pivotal Phase II/III Clinical Trial of Anti-CD3 Monoclonal Antibody for Children and Adults with Recent-Onset Type 1 Diabetes
Medarex Received Milestone Payment from ImClone Systems for IMC-3G3 (Fully Human Antibody for the Treatment of Cancer)
Exelixis and Genentech Entered Co-development Agreement for Small Molecule Oncology Compound
Jan 7
Daiichi Sankyo, Inc. Submitted WelChol Supplemental New Drug Application (NDA) for Type 2 Diabetes Mellitus Treatment
Lupin Pharmaceuticals’ Generic ZOLOFT® Received USFDA Tentative Approval
BYETTA® (exenatide) Injection, USFDA-Approved for Expanded Combination Use
Biomira Initiated Phase II Clinical Trial of PX-12 in Advanced Pancreatic Cancer Patients
Sigma-Aldrich Awarded Pfizer Non-Exclusive Worldwide License to Use ddRNAi in Research Programs
Graceway Pharmaceuticals, LLC Has Completed Acquisition of 3M Pharmaceuticals Business
Eli Lilly’s Reaction on the NY Times Zyprexa® Article
Jan 3
Viragen Inc. Granted Multiferon®’s Exclusive Marketing Rights in Australia and New Zealand to Orphan Australia
Sontra Medical Corporation is Closing Down
ThromboGenics and BioInvent Received 2 Million € EU Grant for ANGIOSTOP Anti-Angiogenesis Programme
Multiple Myeloma Research Consortium (MMRC) and Keryx Biopharmaceuticals Initiated Multi-Center Combination Study for the Treatment of Multiple Myeloma
Jan 2
Threshold Pharmaceuticals’ Glufosfamide Showing Promising Results in (Ongoing) Phase 2 Clinical Trial for Treatment of Pancreatic Cancer
Stiefel Laboratories, Inc.’s Acquisition of Connetics Corporation, Completed
Nuvo Research, Inc. Received USFDA Approvable Letter for Pennsaid® (Potential New Treatment for Osteoarthritis of the Knee)
Boca Pharmacal’s Generic Pamine® and Pamine® Forte Tablets, Approved by the USFDA
First Generic Versions of Ondansetron Tablets, Orally Disintegrating Tablets and Oral Solution, USFDA Approved
Jan 1
Pharmaceutical Business Round-up: What We Missed During the Holidays
Happy New Year

« December 2006 | Main | February 2007 »

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