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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
The USFDA has granted orphan-drug designation in the United States for the Alfacell Corporation (Nasdaq: ACEL)’s lead drug candidate, ONCONASE® (ranpirnase), for treatment of malignant mesothelioma. Currently being evaluated in a confirmatory Phase IIIb clinical trial in unresectable malignant mesothelioma... Continue Reading
Spatially Offset Raman Spectroscopy: Novel Non-Invasive Method of Detection of Counterfeit Drugs
UK Scientists (Pavel Matousek and Charlotte Eliasson), as described in a report scheduled for the March 1 issue of ACS' Analytical Chemistry, have developed a new form of Raman spectroscopy (a mainstay tool for identifying molecules) which can probe deep... Continue Reading
Debiopharm Entered Into R&D and Commercialisation Agreement with Kirin for Debio-0719
A global independent biopharmaceutical development company specialising in oncology and serious medical conditions, The Debiopharm Group, is investigating under preclinical development a highly potent inhibitor of lysophosphatidic acid (LPA) signalling, Debio-0719. Discovered by Kirin in a screen for small molecule... Continue Reading
The USFDA is Too Slow to Approve New Drugs and Devices, New Physician Survey Finds
According to a survey of orthopedic surgeons recently released, the federal Food and Drug Administration (FDA) is too slow to approve new drugs and medical devices: over three-quarters, 76%, believe FDA's approval process is too slow60% believe FDA hinders their... Continue Reading
iCardiac Technologies Signed Cardiac Safety Alliance With Pfizer
iCardiac Technologies, Inc. has entered into a multi-year research alliance with Pfizer Inc. (NYSE: PFE) for the development and validation of advanced ECG-based cardiac safety biomarkers utilizing the COMPAS technology platform. The COMPAS technology was developed at the University of... Continue Reading
Jan30
Pharmion Corp.’s Vidaza® (azacitidine for injection), USFDA-Approved for I.V. Administration
Pharmion Corporation (Nasdaq: PHRM) has received USFDA approval for the intravenous (IV) administration of its DNA demethylating agent Vidaza® (azacitidine for injection). The said approval allows Vidaza® to be administered intravenously over a period of 10 to 40 minutes in... Continue Reading
Berlex, Inc.’s YAZ®, USFDA-Approved for New Indication: Treatment of Acne
A product of Berlex, Inc.(996344), YAZ® (3 mg drospirenone/20 mcg ethinyl estradiol), has recently been approved by the USFDA for the treatment of moderate acne vulgaris in women who opts to use oral contraceptive for birth control. The said approval... Continue Reading
Jan29
Copegus® Tablet 200 mg, Approved as Combination Therapy to Chronic Hepatitis C Drug Pegasys®
Chugai Pharmaceutical Co., Ltd. (TYO:4519)’s antiviral agent ribavirin (trade name: Copegus® tablet 200 mg) has recently been approved for combination therapy with the chronic hepatitis C treatment drug Pegasys® (peginterferon alfa-2a, genetic recombinant) (trade names: Pegasys® S.C. Injection 90 mcg... Continue Reading
Bayer Schering Pharma AG’s Oral Fludara®, Approved in Japan
Bayer Schering Pharma AG’s oral Fludara® for low-grade non-Hodgkin’s lymphoma and mantle cell lymphoma has been approved for marketing in Japan. The oral formulation of Fludara® provides simpler, easier outpatient chemotherapy out to improve the quality of life of the... Continue Reading
Jan28
Sanofi pasteur’s New Pediatric Combination Vaccine (Pentacel®): Recommended for Licensure by USFDA Advisory Committee
The vaccines business of the sanofi-aventis Group (NYSE: SNY; EPA: SAN) – Sanofi Pasteur (8788819) - has been vetoed by an advisory committee to the USFDA for the safety and efficacy of the company’s pentavelant combination vaccine for pediatric patients.... Continue Reading
NF-kB Inhibitors: New Class of Drugs Potentially Anti-Alzheimer’s Disease
Appearing in Neuroscience Letters is an article (co-authored by Drs. Daniel Paris and Michael Mullan) announcing the discovery of a new class of drugs that lower the production of the main pathological proteins (beta amyloid plaques) causing Alzheimer’s disease. According... Continue Reading
Topical Eutectic Mixture, Found Safe and Effective Against Premature Ejaculation
The TEMPE (Topical Eutectic Mixture for Premature Ejaculation) spray has been found effective in delaying ejaculation for an extra four minutes. Such were the findings of researchers from the UK and Netherlands in a study of 54 men with premature... Continue Reading
Jan27
Beta Blockers: Not The Best First-line Treatment of HIgh Blood Pressure
According to a new Cochrane Review, beta blocker drugs (commonly used to initially lower blood pressure) is not as good as reducing death or the severity of the disease as opposed to other classes of drugs: thiazides, calcium channel blockers... Continue Reading
Small Molecule Now, Diabetes and Obesity Pill Tomorrow
Jiayu Liao, Assistant Professor of Bioenginering at the University of California, Riverside, has been instrumental in the discovery of a small molecule that will lead to the development of an obesity and diabetes pill. The molecule, dubbed as Boc5 (discovered... Continue Reading
Jan25
MediVas Signed Collaboration Agreement With Pfizer
Developer of novel drug delivery platforms – MediVas, LLC – has signed a collaborative research agreement with Pfizer (NYSE: PFE) that will focus on the research and development of advanced delivery methods for proprietary Pfizer compounds for the treatment of... Continue Reading
Roche’s ACTEMRA™ (tocilizumab) Passed Phase III Study in Rheumatoid Arthritis Patients
OPTION (TOcilizumab Pivotal Trial in Methotrexate Inadequate respONders) trial is the first international Phase III study of Roche’s ACTEMRA™ outside of Japan. Results of which as announced by Roche, has shown that the study has successfully met its primary endpoint... Continue Reading
Medarex and Compugen Collaborates to Develop Antibody-Based Therapeutics
For the development of novel monoclonal antibody-based therapeutics for oncology and autoimmune diseases, Medarex, Inc. (Nasdaq: MEDX) and Compugen Ltd. (TLV: CGEN) have entered into a collaborative agreement. The terms of agreement include: Medarex and Compugen will share discovery, development... Continue Reading
Jan24
Pharmion Submitted EU Marketing Authorization Application for Thalidomide Pharmion® for Untreated Multiple Myeloma
Pharmion Corporation (Nasdaq: PHRM) has submitted a marketing authorization application (MAA) to the European Medicines Agency (EMEA) for Thalidomide Pharmion® for the treatment of untreated multiple myeloma in the European Union.Multiple myeloma (also known as myeloma or plasma cell myeloma)... Continue Reading
Wyeth Pharmaceuticals Received USFDA Approvable Letter for Pristiq™ (desvenlafaxine succinate) as Treatment for Adult Major Depressive Disorder (MDD) Patients
The USFDA has recently granted an approvable letter to Wyeth Pharmaceuticals’ Pristiq™ (desvenlafaxine succinate), a serotonin-norepinephrine reuptake inhibitor (SNRI) under investigation as a treatment for adult patients with major depressive disorder (MDD). FDA’s approvable letter subjected Pristiq’s approval on several... Continue Reading
Ortho Biotech Submitted USFDA sNDA for DOXIL® as Combination to VELCADE® for Treatment of Relapsed/Refractory Multiple Myeloma
The USFDA has accepted Ortho Biotech Products, L.P.(4336966)’s Supplemental New Drug Application (sNDA) for DOXIL® (doxorubicin HCl liposome injection) as combination therapy with VELCADE® (bortezomib) for injection to treat multiple myeloma patients who have received at least one prior therapy.... Continue Reading
Jan23
SQ109: Sequella, Inc.’s TB Drug Candidate, Received USFDA Fast Track Status
A clinical-stage biopharmaceutical company focused on commercializing improved treatment paradigms for diseases of epidemic potential – Sequella, Inc. – has just received Fast Track Designation from the USFDA for SQ109. Currently undergoing Phase 1 clinical trial on US IND (investigational... Continue Reading
Bioponic Phytoceuticals’ Curecumin™ Product Potentially Effective Against Alzheimer's Disease (AD)
Curcumin, an active compound in turmeric, has been known for its anti-inflammatory and anti-oxidant properties. Researchers from UCLA/VA found that curcumin may help the immune system clear the brain of the amyloid beta plaques found in Alzheimer's disease patients. The... Continue Reading
Cell Genesys, Inc.’s GVAX® Immunotherapy Passed Follow-Up Phase 2 Clinical Trial for Pancreatic Cancer
Follow-up data from a Phase 2 clinical trial of Cell Genesys, Inc. (Nasdaq: CEGE)’s GVAX® immunotherapy for pancreatic cancer in 60 patients with operable pancreatic cancer who received the immunotherapy after surgical resection of their tumor and adjuvant radiation and... Continue Reading
International Phase III Study Revealed That XELOX (Xeloda® + oxaliplatin) Equals FOLFOX in Overall Patient Survival From Advanced Colorectal Cancer
Clinical data (from an international phase III study: NO16966) presented at the American Society of Clinical Oncology Gastrointestinal Symposium (ASCO GI) in Orlando, Florida suggest that XELOX (Xeloda® + oxaliplatin) is an effective alternative to the current standard treatment for... Continue Reading
Prilosec OTC: As Effective as Prescription Drugs for Heartburn and Acid Reflux Disease
Analysis from Consumer Reports Best Buy Drugs (a public education project of Consumers Union) reported that a widely available nonprescription drug - Prilosec OTC – is as effective a treatment for heartburn and acid reflux disease as its prescription counterparts... Continue Reading
Jan21
BioMS Medical Corp. Received USFDA Clearance to Commence Phase III Multiple Sclerosis Trial
A leading developer of products for the treatment of multiple sclerosis (MS) – BioMS Medical Corporation (TSE: MS) has been granted clearance by the USFDA of its Investigational New Drug Application (IND) for the initiation of a pivotal phase III... Continue Reading
New Imaging Compounds for Detection of Neurodegenerative Diseases To be Developed by Bayer Schering Pharma
To develop novel imaging compounds for the detection of neurodegenerative diseases (Alzheimer's disease, Parkinson's disease and other disorders also associated with neuroinflammation such as multiple sclerosis), Bayer Schering Pharma AG (OTC: SHRGY) has signed a license and option agreement with... Continue Reading
Generic METAGLIP™ Tablets, Launched by Barr Labs
A subsidiary of Barr Pharmaceuticals, Inc. (NYSE: BRL) – Barr Laboratories, Inc. has launched a generic version of METAGLIP™ (Glipizide and Metformin HCl) Tablets, 2.5/250 mg, 2.5/500 mg and 5/500 mg. METAGLIP™ is a product of Bristol-Myers Squibb Company (NYSE:... Continue Reading
Jan20
Barr Labs Received USFDA Tentative Approval for Generic KYTRIL® (granisetron hydrochloride) Tablets, 1mg (base)
Barr Laboratories, Inc., a subsidiary of Barr Pharmaceuticals, Inc. (NYSE: BRL) has been granted tentative approval by the USFDA for its generic version of Roche Laboratories, Inc.'s KYTRIL® (granisetron hydrochloride) Tablets, 1mg (base). KYTRIL (granisetron hydrochloride) Tablets, 1mg (base) is... Continue Reading
TAXUS® Stent System Expiration Date Extended to 18 Months by USFDA
The current shelf-life of Boston Scientific Corporation (NYSE: BSX)’s TAXUS® Express (2)™ paclitaxel-eluting coronary stent system in the United States is 12 months. The USFDA has just granted the approval to extend that shelf-life to 18 months based on data... Continue Reading
H. Lundbeck A/S’ Cipralex® (escitalopram), Approved in Europe for Treatment of OCD (Obsessive Compulsive Disorder)
Based on H. Lundbeck A/S (CPH: LUN)' two pivotal studies that have shown Cipralex® to be effective and well-tolerated in the treatment of OCD (Obsessive Compulsive Disorder), the product has recently been approved in Europe for such indication. The 10th... Continue Reading
Carrington Laboratories Entered Supply and Trademark Agreement with Veterinary Products Laboratories for Acemannan Immunostimulant™
Carrington Laboratories, Inc., (Nasdaq: CARN) have agreed with Veterinary Products Laboratories (a division of Farnam Companies, Inc.; 9325468) for a supply and trademark agreement for Acemannan Immunostimulant™. Acemannan Immunostimulant™ is a biologic injectable treatment for fibrosarcoma, a form of soft... Continue Reading
Jan19
Archemix and Merck KGaA Collaborates on Development and Marketing of Aptamer-Based Cancer Therapeutics
Archemix Corp. (13113958) has signed a multi-year, multi-target agreement with Merck KGaA (Darmstadt, Germany; FRA: MRK) but focused on discovery, development, and commercialization of first-in-class aptamer-based therapeutics for cancer treatment. The terms of agreement include the following: Archemix will receive... Continue Reading
Cepheid and bioMerieux Agreed to Develop and Market Sepsis and MRSA Products
Cepheid (Nasdaq: CPHD) and bioMerieux (EPA: BIM) recently announced their strategic partnership for the development and commercialization of a novel line of sepsis test products on the GeneXpert platform. Both companies will jointly develop the products, Cepheid will be in... Continue Reading
Metabolex, Inc.’s MBX-102/JNJ-39659100 (metaglidasen) Reduced Inflammation in Preclinical Diabetes Models
Preclinical studies of Metabolex, Inc.’s MBX-102/JNJ-39659100 (metaglidasen) demonstrated that the company's lead insulin sensitizer potently reduces inflammation in mouse and rat models of diabetes. Both mice and rats treated with either active compound demonstrated substantially reduced inflammation and macrophage infiltration... Continue Reading
VioQuest Pharma’s VQD-001 ((sodium stibogluconate) Granted USFDA Orphan Drug Designation for the Treatment of Cutaneous Form Leishmaniasis
In partnership with the U.S. Army, VioQuest Pharmaceuticals, Inc. (OTC: VQPH) has received USFDA orphan drug designation for VQD-001 (sodium stibogluconate), a treatment for the cutaneous form of leishmaniasis. VQD-001's development and regulatory filing process for a New Drug Application... Continue Reading
Sirion Therapeutics Acquired U.S. License of Virgan® (ganciclovir gel), Opthalmic Anti-viral
Sirion Therapeutics, Inc. has entered into an exclusive licensing agreement with Laboratories Thea (France) for the U.S. rights to develop and market a topical ophthalmic gel containing ganciclovir for the treatment of certain viral and superficial eye infections. Marketed by... Continue Reading
Jan18
Green Tea is Source Of Potential Potent and Safe Antibacterial
The beneficial effects of green tea have been known for ages. The biological activity of cathechins (up to 200 mg/cup of green tea) is what explains green tea’s antioxidant activity. For centuries the antibacterial activity of green tea has been... Continue Reading
Jan17
Denderon Corp.’s BLA for PROVENGE® under USFDA Priority Review Status for the Treatment of Asymptomatic, Metastatic, Androgen-Independent Prostate Cancer
Dendreon Corporation (Nasdaq: DNDN)’s Biologics License Application (BLA) for PROVENGE® (sipuleucel-T) has been accepted and assigned priority review status by the USFDA. PROVENGE® (sipuleucel-T) is Dendreon Corp.’s investigational active cellular immunotherapy for the treatment of asymptomatic, metastatic, androgen-independent (also known... Continue Reading
XTL and DOV Pharmaceuticals, Agreed on Worldwide Rights to Bicifadine
XTL Biopharmaceuticals Ltd. (Nasdaq: XTLB, LON: XTL) signed an agreement with DOV Pharmaceutical, Inc. (OTC: DOVP) to in-license the worldwide rights for Bicifadine. Bicifadine is a serotonin and norepinephrine reuptake inhibitor (SNRI) that XTL intends to develop for the treatment... Continue Reading
Merck Serono’s Phase III Diet Study of Phenoptin for Phenylketonuria Yielded Positive Results
Phenoptin™ (sapropterin dihydrochloride) is an investigational oral small molecule, being developed by Merck Serono (NYSE: SRA, VTX: SEO) in partnership with BioMarin Pharmaceutical (Nasdaq: BMRN), for the treatment of patients with phenylketonuria (PKU), who have elevated phenylalanine (Phe) levels. A genetic... Continue Reading
Watson Pharma’s Silodosin Passed Phase III Clinical Trials for Treatment of Benign Prostatic Hyperplasia
Two Phase III clinical trials of Watson Pharmaceuticals, Inc. (NYSE: WPI)’s Silodosin yielded top-line positive results. Kissei Pharmaceutical Co., Ltd. originally developed Silodosin in Japan and licensed to Watson for the US, Canada and Mexico markets. Silodosin, a novel, highly... Continue Reading
Jan16
Merger with Genentech, Approved by Stockholders of Tanox, Inc.
Stockholders of Tanox, Inc. (Nasdaq: TNOX) have voted in favour of the merger agreement with Genentech, Inc. (NYSE: DNA) that will make Tanox its wholly owned subsidiary. Approximately 34.2 million shares of common stock were voted at the special meeting... Continue Reading
Lux Biosciences Received USFDA Orphan Drug Designation for Ophthalmic Indications of ISA247
Lux Biosciences – a partner of Isotechnika Inc. (TSE: ISA) – has received orphan drug designation from the USFDA for its product ISA247 (LX211) for the treatment of non-infectious posterior, intermediate and pan-uveitis. Uveitis is an autoimmune disease characterized by... Continue Reading
Long Term Dose-dependent Use of Genzyme Corp.’s Cerezyme® (imiglucerase for injection), Improve Bone Mineral Density in Type 1 Gaucher Disease Patients
The long term dose-dependent use of Genzyme Corporation (Nasdaq: GENZ)’s Cerezyme® (imiglucerase for injection) has been found to significantly improve bone mineral density in patients with Type 1 Gaucher disease. Gaucher disease is a condition wherein patients suffering from it... Continue Reading
Jan15
Canadian Marketing Rights to Xyrem®, Signed By Jazz Pharmaceuticals With Valeant Pharmaceuticals
Jazz Pharmaceuticals, Inc. (15809101) has signed a licensing agreement that entitles Canadian marketing rights for Xyrem® (sodium oxybate) to Valeant Pharmaceuticals International (NYSE: VRX). Cataplexy is a condition characterized by sudden loss of muscle tome associated with narcolepsy. Xyrem® is... Continue Reading
Peregrine Pharmaceuticals Established Chinese Subsidiary
A clinical stage biopharmaceutical company developing targeted therapeutics for cancer and hepatitis C virus infection treatments - Peregrine Pharmaceuticals, Inc. (Nasdaq: PPHM) – has recently established its wholly foreign-owned enterprise (WFOE) in China. Located in Beijing, the new subsidiary is... Continue Reading
Jan14
ERBITUX® Passed Phase III Study as First-Line Treatment of Metastatic Colorectal Cancer
The study – known as CRYSTAL (1) Study – which recruited more than 1,000 patients worldwide, is the Phase III study of ImClone Systems Inc. (Nasdaq: IMCL) and Bristol-Myers Squibb Company (NYSE: BMY)’s ERBITUX® (cetuximab) plus FOLFIRI (an irinotecan- based... Continue Reading
Jan13
AMDL is Producing Antibiotic Levofloxacin in China
Part of the top selling class of drugs in China, the antibiotic levofloxacin is used to treat bacterial infections including pneumonia, urinary tract, kidney and skin infection. AMDL, Inc. (Amex: ADL)’s Chinese subsidiary -Jade Pharmaceutical Inc. – has commenced the production... Continue Reading
Wyeth and Solvay Pharmaceuticals Agreed on Additional Neuroscience Collaboration
Previously, in April 2004, Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE) and Solvay Pharmaceutical B.V. have previously entered into co-development and co-commercialization agreements for bifeprunox and other neuroscience compounds. The said old collaboration has already resulted to a New... Continue Reading
Bristol-Myers Squibb and AstraZeneca Entered Into Worldwide Collaboration For the Development and Commercialization of Diabetes Compounds
Bristol-Myers Squibb Company (NYSE: BMY) and AstraZeneca (NYSE: AZN) recently announced their collaboration to develop and commercialize two investigational compounds (both discovered by Bristol-Myers Squibb) for the treatment of Type 2 diabetes. Saxagliptin: a dipeptidyl peptidase-4 (DPP-4) inhibitor, currently in Phase... Continue Reading
Warning from National Association of Boards of Pharmacy: Beware of Continued Dangers of Counterfeit Prescription Drugs
The National Association of Boards of Pharmacy (NABP) continuously warns the public not only about counterfeit drugs in the United States but also worldwide. According to a 2006 World Health Organization report, the current prevalence of counterfeit medicines can range... Continue Reading
First and Only Enzyme Replacement Therapy for Hunter Syndrome: Approved by the European Commission
The use of Elaprase® (idursulfase) for the long-term treatment of Hunter Syndrome patients has been granted marketing authorization by the European Commission. Marketed by Shire Human Genetics Therapies, idursulfase is the first and only enzyme replacement treatment Hunter syndrome (Mucopolysaccharidosis... Continue Reading
Jan11
Neurocrine Biosciences’ Orally Active GnRH Receptor Antagonist in Endometriosis, Passed Second Phase II Clinical Trial
Surgery and medical treatments are currently available for women with endometriosis (an approximate 6 million in the U.S.). Surgery, however, is an option to many of these women and medical therapies (such as the injectable GnRH agonist leuprolide or injectable... Continue Reading
Provectus’ Anti-Cancer Agent (PV-10) Received USFDA Orphan Drug Designation for the Treatment of Metastatic Melanoma
Provectus Pharmaceuticals, Inc. (OTC: PVCT)’s leading anti-cancer agent - PV-10 - has received orphan drug designation from the USFDA for the treatment of metastatic melanoma. An injectable formulation of Rose Bengal (also known as Provecta™) for the ablation of metastatic... Continue Reading
Horizon Therapeutics’ Special Protocol Assessment (SPA) Phase 3 Trial Program of GI-Friendly Prescription NSAID, Approved by the USFDA
A Special Protocol Assessment for the Phase 3 trial program of HZT-501, Horizon Therapeutics, Inc.’s "GI-friendly" prescription NSAID for mild-to-moderate pain relief has just been approved by the USFDA. An SPA agreement means that if the trial data turned positive... Continue Reading
QIAGEN and Pathway Diagnostics In Agreement to Address Pharma’s Biomarker Development Needs
QIAGEN N.V. (Nasdaq: QGEN) is the leading provider of molecular diagnostics products and the world's premier supplier of solutions for preanalytical sample preparation. Pathway Diagnostics Corporation (Malibu, CA) is pharmaceutical industry’s pioneer in biomarker development and testing services. The two... Continue Reading
Genentech, Made it Once More to FORTUNE’s ‘100 Best Companies To Work For’
For the 9th consecutive year, Genentech (NYSE: DNA) has again been named as one FORTUNE’s ‘100 Best Companies to Work For’, this year ranking number 2 on the list (just behind GOOGLE!).The complete list of companies will appear in the... Continue Reading
PTC Therapeutics Entered Into a Strategic Drug Discovery Collaboration with Pfizer
PTC Therapeutics, Inc. (PTC, 705606) has entered into an exclusive research collaboration and licensing agreement with Pfizer Inc. (NYSE:PFE) for the development of pharmaceuticals through the application of PTC's GEMS (Gene Expression Modulation by Small-Molecules) technology. The terms of agreement... Continue Reading
Jan 9
Hypnion’s Novel Sleep Drug – HY10275 – Passed Phase II Clinical Trial
Both primary and secondary endpoints in the Hypnion’s initial Phase II clinical trial evaluating HY10275 at doses of 1 mg and 3 mg in adults with transient insomnia have been reached. HY10275 is a proprietary compound discovered and developed by... Continue Reading
Pfizer Animal Health’s Slentrol™: First USFDA-Approved Anti-Obesity Drug for Dogs
The USFDA has just approved Pfizer Animal Health’s Slentrol™ for the safe and effective management of canine obesity, making it the first and only veterinary-approved obesity drug for dogs in the United States. According to Claudia A. Kirk, DVM, PhD,... Continue Reading
Serono S.A.’s Majority Share, Acquired by Merck KGaA
Merck KGaA (FRA: MRK) has closed the share purchase agreement signed with the Bertarelli family on September 21, 2006, and now holds the majority of the capital as well as the voting rights of Serono S.A. (NYSE: SRA). Serono is... Continue Reading
Helix BioPharma Corp. Signed L-DOS47 Manufacturing Aagreement with BioVectra dcl
Helix BioPharma Corp. (TSE: HBP) recently signed an agreement with BioVectra, a division of Diagnostic Chemicals Limited (BioVectra dcl), for the manufacture of L-DOS47 bulk drug product for human clinical testing. L-DOS47 combines Helix's proprietary DOS47 new drug candidate with... Continue Reading
ActiveSight Entered Multi-Target Crystallography Service Agreement With Lexicon Pharmaceuticals
ActiveSight has signed an expanded crystallography services agreement with Lexicon Pharmaceuticals, the medicinal chemistry division of Lexicon Genetics Incorporated (Nasdaq: LEXG). The agreement covers co-crystallography services for multiple proprietary targets of Lexicon Pharmaceuticals and is the third agreement between the... Continue Reading
Provid Signed Agreement to Acquire Tripos Discovery Research
Provid Pharmaceuticals Inc. has signed a definitive agreement for the acquisition of Tripos Discovery Research (TDR), the UK-based drug discovery division of Tripos, Inc. (Nasdaq: TRPS). According to Gary Olson, President and Chief Scientific Officer of Provid: "The mission of... Continue Reading
Jan 8
Genentech’s Pertuzumab in Combination with Gemcitabine Passed Phase II Trial for Advanced Ovarian Cancer
Genentech, Inc. (NYSE: DNA) has recently announced the encouraging results from a randomized Phase II study comparing pertuzumab plus gemcitabine to gemcitabine alone in women with platinum-resistant ovarian, primary peritoneal, or fallopian tube cancer. Formerly known as Omnitarg, Pertuzumab or... Continue Reading
Anthera Received USFDA Approval to Initiate A-002 Phase 2 'PLASMA' Trial in Patients with Coronary Atherosclerosis
The USFDA has approved Anthera Pharmaceuticals, Inc.’s Investigational New Drug (IND) application for its lead cardiovascular compound A-002. The said approval enables the company to proceed with its multi-center phase 2 clinical trial (PLASMA -- Phospholipase Levels And Serological Markers... Continue Reading
Roche and Synosis Therapeutics Entered Partnership to Explore Potential of Five Central Nervous System-Targeted Compounds
Roche (OTC:RHHBY)and Synosis Therapeutics have agreed on a new partnership that could lead to the development of treatments for schizophrenia, cognitive disorders, Parkinson's, drug dependency and pain. The collaboration will focus on five drug candidates that Synosis will acquire from... Continue Reading
US$4.8 Million Biodefense Research Contract Awarded to Affinium Pharmaceuticals by United States Department of Defense/DTRA
Affinium Pharmaceuticals, Inc. has just bagged a two-year US$4.8 million research contract with the Defense Threat Reduction Agency (DTRA) (an agency of the United States Department of Defense (DoD)) to fund preclinical studies of selected compounds from Affinium's fatty acid... Continue Reading
Schering-Plough and OraSure Technologies Sealed Agreement for Development and Promotion of Rapid Point-Of-Care Oral Hepatitis C Test
Schering-Plough Corporation (NYSE: SGP) and OraSure Technologies, Inc. (Nasdaq: OSUR) have agreed to collaborate on the development and promotion of a rapid oral test for the detection of antibodies to the hepatitis C virus (HCV) utilizing OraSure Technologies' OraQuick® technology... Continue Reading
Exclusive Worldwide License Rights to Develop and Commercialize Promising Phase II Spinal Cord Injury Drug, Cethrin®, Acquired by Boston Life Sciences
A biotechnology company focused on diagnostic and therapeutic products for central nervous system disorders – Boston Life Sciences, Inc. (Nasdaq: BLSI) - has entered into an exclusive, worldwide license with BioAxone Therapeutic Inc. (Montreal, Canada) to develop and commercialize Cethrin®... Continue Reading
Elusys Therapeutics, Inc. Sealed Collaborative Research and License Agreement with Pfizer
A biotechnology company developing targeted anti-infective antibodies to fight life-threatening infections - Elusys Therapeutics, Inc. (16140337) - has entered into an exclusive collaborative research and license agreement with Pfizer Inc. (NYSE: PFE) for the development of new therapeutics for select... Continue Reading
AVEO Pharma, Inc. Acquired Kirin’s Clinical Stage Anti-Cancer Compound, KRN951
A biopharmaceutical company focused on the discovery and development of novel cancer medicines - AVEO Pharmaceuticals, Inc. (8917542) - has acquired an exclusive license to develop and commercialize Kirin Brewery Co. (OTC: KNBWY)'s highly potent and selective, once-a-day, oral VEGF... Continue Reading
HHS Granted $102.6 M Fund to BioCryst Pharma, Inc. To Further Develop New Influenza Antiviral Drug, Peramivir
The U.S. Department of Health and Human Services (HHS) has awarded a $102.6 million, four-year contract to BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) for advanced development of their influenza antiviral drug, peramivir. Peramivir, a member of the neuraminidase inhibitor class of... Continue Reading
D-Pharm Successfully Completed Phase IIb Trial of its Neuroprotective Compound (DP-b99) in Acute Stroke Patients
D-Pharm’s DP-b99 is a unique neuroprotective drug that addresses an array of damaging processes occurring in the brains of stroke patients. As recently announced by D-Pharm (691243), the Phase IIb trial of the neuroprotective compound has been successfully completed. A... Continue Reading
USFDA Accepted Spectrum Pharma’s IND for Ozarelix and Approved BPH (Benign Prostate Hypertrophy) Phase 2b Protocol
The USFDA has accepted Spectrum Pharmaceuticals, Inc. (Nasdaq: SPPI)’s Investigational New Drug (IND) application for ozarelix in Benign Prostate Hypertrophy (BPH) and has approved the protocol for the Phase 2b study of ozarelix for the treatment of BPH. UT Southwestern... Continue Reading
AspenBio Pharma Submitted Investigational New Animal Drug Application (INADA) to the USFDA’s Center for Veterinary Medicine for StayBred™
An emerging bio-pharmaceutical company dedicated to the development of novel drugs and diagnostics for animals and humans - AspenBio Pharma, Inc. (OTC Bulletin Board: APNB) – has recently filed an Investigational New Animal Drug Application (INADA) to the USFDA’s Center... Continue Reading
Genaera Corp.’s Restructuring Terminates EVIZON ™ Clinical Program to Pursue Anti-Obesity Research
After a comprehensive review of the company’s development portfolio and external marketing conditions, the board of Directors and management of Genaera Corporation (Nasdaq: GENR) decided that it is in the company’s best interest to terminate the EVIZON™ (squalamine lactate) clinical... Continue Reading
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
MacroGenics, Inc. (5036640, a Maryland-based biotechnology company) and the world’s leading charitable funder of type 1 diabetes research – Juvenile Diabetes Research Foundation (JDRF) – have formed a partnership in order to support a pivotal multinational Phase II/III clinical trial... Continue Reading
Medarex Received Milestone Payment from ImClone Systems for IMC-3G3 (Fully Human Antibody for the Treatment of Cancer)
Medarex, Inc. (Nasdaq: MEDX) has received a milestone payment from its licensing partner, ImClone Systems Incorporated (Nasdaq: IMCL), after an Investigational New Drug (IND) application to the USFDA for IMC-3G3 has been accepted. IMC-3G3, a fully human antibody that targets... Continue Reading
Exelixis and Genentech Entered Co-development Agreement for Small Molecule Oncology Compound
Exelixis, Inc. (Nasdaq: EXEL) entered into an agreement with Genentech, Inc. (NYSE:DNA) for the worldwide co-development of XL518, a small-molecule inhibitor of MEK. MEK, also known as mitogen activated protein kinase (MAPK) kinase, is a key component of the RAS/RAF/MEK/ERK... Continue Reading
Jan 7
Daiichi Sankyo, Inc. Submitted WelChol Supplemental New Drug Application (NDA) for Type 2 Diabetes Mellitus Treatment
Daiichi Sankyo, Inc. has filed a supplemental New Drug Application (sNDA) to the USFDA for WelChol® for the improvement of glycemic control in patients with type 2 diabetes mellitus. Once approved, WelChol® will become the first LDL cholesterol lowering medication... Continue Reading
Lupin Pharmaceuticals’ Generic ZOLOFT® Received USFDA Tentative Approval
The USFDA has recently granted tentative approval to Lupin Pharmaceuticals, Inc.’s Abbreviated New Drug Application (ANDA) for Sertraline Hydrochloride Tablets, 25mg, 50mg and 100mg, the generic version of Pfizer (NYSE:PFE)’s ZOLOFT®. ZOLOFT® tablets are indicated for the treatment of majaor... Continue Reading
BYETTA® (exenatide) Injection, USFDA-Approved for Expanded Combination Use
A product of Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN) and Eli Lilly and Company (NYSE: LLY), BYETTA® (exenatide) injection has been approved by the USFDA as an add-on therapy to improve blood sugar control in people with type 2 diabetes who... Continue Reading
Biomira Initiated Phase II Clinical Trial of PX-12 in Advanced Pancreatic Cancer Patients
Biomira Inc. (Nasdaq: BIOM), a biotechnology company specializing in the development of innovative therapeutic products for the treatment of cancer has opened a Phase II Clinical trial of PX-12 for advanced pancreatic cancer patients. PX-12 is Biomira’s proprietary small molecule... Continue Reading
Sigma-Aldrich Awarded Pfizer Non-Exclusive Worldwide License to Use ddRNAi in Research Programs
A leading $1.7 billion Life Science and High Technology company - Sigma-Aldrich (Nasdaq: SIAL) – has granted Pfizer (NYSE:PFE) a worldwide non-exclusive research license to utilize DNA-directed RNAi (ddRNAi) technology. Licensed exclusively by Sigma- Aldrich from Benitec Limited of Australia, applications... Continue Reading
Graceway Pharmaceuticals, LLC Has Completed Acquisition of 3M Pharmaceuticals Business
The previously announced acquisition of the pharmaceutical business of 3M (NYSE: MMM) in the United States, Puerto Rico, Canada and Latin America by Graceway Pharmaceuticals, LLC (a portfolio company of GTCR Golder Rauner, LLC, 14092026) have already been completed. Among... Continue Reading
Eli Lilly’s Reaction on the NY Times Zyprexa® Article
Eli Lilly and Company (NYSE: LLY)’s Zyprexa® (olanzapine) is indicated in the United States for the short- and long-term treatment of schizophrenia, acute mixed and manic episodes of bipolar I disorder, and maintenance treatment of bipolar disorder. Zyprexa® was first... Continue Reading
Jan 3
Viragen Inc. Granted Multiferon®’s Exclusive Marketing Rights in Australia and New Zealand to Orphan Australia
Viragen, Inc. (Amex: VRA) together with its majority-owned subsidiary, Viragen International, Inc. (OTC: VGNI) have recently completed a license agreement that bestows exclusive rights to Orphan Australia to market, sell and distribute Multiferon® (multi-subtype, human alpha interferon) in Australia and... Continue Reading
Sontra Medical Corporation is Closing Down
As recently announced by the company, Sontra Medical Corporation (Nasdaq: SONT) will cease its operations because it has been unable to raise additional capital and also failed to complete a possible merger or a financing transaction that would have raised... Continue Reading
ThromboGenics and BioInvent Received 2 Million € EU Grant for ANGIOSTOP Anti-Angiogenesis Programme
ThromboGenics NV (EBR: THR) and BioInvent International AB (STO: BINV) have recently been awarded by the European Union with a 2 million € grant to jointly develop a new class of anti-angiogenesis agents which are based on antibodies against Placental... Continue Reading
Multiple Myeloma Research Consortium (MMRC) and Keryx Biopharmaceuticals Initiated Multi-Center Combination Study for the Treatment of Multiple Myeloma
The Multiple Myeloma Research Consortium (MMRC) and Keryx Biopharmaceuticals (Nasdaq: KERX) have recently initiated a multi-center Phase I clinical program designed to explore the safety and efficacy of KRX-0401 (Perifosine) in combination with Revlimid (Lenalidomide) and Dexamethasone in Patients with... Continue Reading
Jan 2
Threshold Pharmaceuticals’ Glufosfamide Showing Promising Results in (Ongoing) Phase 2 Clinical Trial for Treatment of Pancreatic Cancer
Top-line results from the Phase 2 clinical trial of glufosfamide in combination with gemcitabine for the treatment of advanced pancreatic cancer have recently been announced by Threshold Pharmaceuticals, Inc. (Nasdaq: THLD). 21% of patients in the clinical trial had a... Continue Reading
Stiefel Laboratories, Inc.’s Acquisition of Connetics Corporation, Completed
Effective close of trading last December 28, 2006, shares of Palo Alto, California- based Connetics Corporation will cease to be listed in the NASDAQ Stock Market in lieu of its being acquired by Stiefel Laboratories, Inc.(8068636), the world's largest dermatology-specialized... Continue Reading
Nuvo Research, Inc. Received USFDA Approvable Letter for Pennsaid® (Potential New Treatment for Osteoarthritis of the Knee)
Pennsaid® (1.5% w/w diclofenac sodium solution) is a topical non-steroidal anti-inflammatory (NSAID) developed by Nuvo Research Inc. (TSE: NRI) for use as a treatment of osteoarthritis (OA) of the knee. Based on Nuvo's skin-penetrating technology, Pennsaid® allows diclofenac to be... Continue Reading
Boca Pharmacal’s Generic Pamine® and Pamine® Forte Tablets, Approved by the USFDA
Boca Pharmacal, Inc. has been granted USFDA final approval for its Abbreviated New Drug Application (ANDA) to market the company’s generic version of Kenwood Therapeutics Pamine® (Methscopolamine Bromide) Tablets, 2.5 mg and Pamine® Forte (Methscopolamine Bromide) Tablets 5 mg. The... Continue Reading
First Generic Versions of Ondansetron Tablets, Orally Disintegrating Tablets and Oral Solution, USFDA Approved
Zofran (Ondansetron) Tablets, Orally Disintegrating Tablets and Oral Solution are indicated for the prevention of nausea and vomiting associated with surgery, radiotherapy and cancer chemotherapy. The USFDA has just recently approved the first generic versions of Zofran (Ondansetron) Tablets, Orally... Continue Reading
Jan 1
Pharmaceutical Business Round-up: What We Missed During the Holidays
The Christmas season was a good time to get away from the blogosphere and do something else like (most especially) spending time with one's family. That's exactly what i did and I truly thank the big wigs of Know More... Continue Reading
Happy New Year
Welcome back. I truly hope that the holiday season has rejuvenated each and everyone of us. Though I feel bloated and a bit over-rested (at least from the business blogging and anything pharma department) I'm just too eager to go... Continue Reading

« December 2006 | Main | February 2007 »

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