PharmaGazette: March 2006 Archives

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Mar30	Potential Market for Novel Allergy Medications Gloria Gamat March 30, 2006 Know More: First, I wanna thank a long time friend and colleague, Ruth Schaffer* (now a "colleague" in the science blogosphere) for guest blogging here at The PharmVoice.* I myself am dependent on Claritin to relieve me of my itchy symptoms and am fairly satisifed with the results. My son uses Fenistil drops and so far, it works. But according to the results of a survey released last week by The Asthma and Allergy Foundation of America (AAFA), 31% are not satisfied with their current allergy prescription 60% are interested in finding a new drug 55% said that their current medication does not relieve their allergy symptoms for a long enough period of time 44% said their medication doesn't provide quick enough relief So many numbers. All it boils down to is the fact that a significant number of allergy sufferers are not satisfied with their medications, whether oral or nasal. A lucrative market for pharmaceutical companies, I say, including manufacturers of generic allergy medications. Ruth Schaffer writes at The Biotech Weblog, Allergizer and Let's Visit Asia. Posted at 7:33 PM \| Permalink \| Comments
Mar30	Anthrim(TM), Anthrax Antibody Therapeutic, Passes Phase 1 Human Clinical Trial Gloria Gamat March 30, 2006 AnthrimTM , ElusysTherapeutics Inc.'s fast-tracked anthrax antibody therapeutic has successfully passed its human clinical trial designed to determine its safety and tolerability in healthy volunteers, when administered with or without the antibiotic Ciprofloxacin®. "The Anthim Phase 1 study, AH-101, has... Continue Reading Posted at 5:22 AM \| Permalink \| Comments
	Big Pharma Bad Gloria Gamat March 30, 2006 First of all, I wanna thank a colleague at B5media, Dr. Hsien-Hsien Lei for agreeing to guest blog here at The PharmVoice: Of all the evil in the world, pharmaceutical companies rank amongst the worst. Agree or... Continue Reading Posted at 2:37 AM \| Permalink \| Comments
Mar29	Calypte Biomed Corp’s Rapid HIV Test Kits, Approved in Kenya Gloria Gamat March 29, 2006 Calypte Biomedical Corporation’s rapid tests for HIV: Calypte Aware™ HIV-1/2 BSP (blood) and Aware™ HIV-1/2 OMT (oral fluid) has been issued a Kenyan National Public Health Laboratory Services (NPHLS) notification of registration and approval. These HIV test kits are... Continue Reading Posted at 1:00 AM \| Permalink \| Comments
	Ranbaxy Lab Ltd. Acquires Allen S.p.A., a GSK-Italy Division Gloria Gamat March 29, 2006 Ranbaxy Laboratories Limited is among the top ten generic pharmaceutical companies and ’s largest pharmaceutical company. Recently, the company announced its acquisition of the unbranded generic business of Allen S.p.A. (a division of GlaxoSmithKline (GSK) Italy through Ranbaxy’s Italian subsidiary... Continue Reading Posted at 12:59 AM \| Permalink \| Comments
Mar28	Santarus Inc.’s ZEGERID® with Magnesium Hydroxide Chewable Tablets Received USFDA NDA Approval Gloria Gamat March 28, 2006 Santarus Inc. is a specialty pharmaceutical company focused on therapies for gastrointestinal diseases and disorders. Yesterday the company received a USFDA approval for its New Drug application (NDA) of its product ZEGERID® with Magnesium Hydroxide (omeprazole/sodium bicarbonate/magnesium hydroxide) Chewable Tablets... Continue Reading Posted at 12:57 AM \| Permalink \| Comments
	Cymbalta® Significantly Reduces Core Anxiety Symptoms of Generalized Anxiety Disorder, Study Says Gloria Gamat March 28, 2006 In a study of some 500 patients, the safety and efficacy of the antidepressant Cymbalta® on the core anxiety symptoms in patients with generalized anxiety disorder was evaluated. Findings of the said study showed that Cymbalta® significantly reduced core anxiety... Continue Reading Posted at 12:30 AM \| Permalink \| Comments
	Additional Doses of Risperdal® Now Available By Prescription Gloria Gamat March 28, 2006 Risperdal® is one of the most prescribed antipsychotic drug and Risperdal® M-TAB® is its fast dissolving form. Now, two additional doses (3 mg and 4 mg) of Risperdal® (risperidone) is now available for prescription to schizophrenia or bipolar mania patients.... Continue Reading Posted at 12:18 AM \| Permalink \| Comments
Mar26	Ranexa™, Now Available in U.S. Pharmacies Gloria Gamat March 26, 2006 CV Therapeutic Inc.’s Ranexa™ is now available in pharmacies and is now being promoted to cardiology specialists in the United States. Ranexa™ (ranolazine extended-release tablets) is approved as second-line treatment for chronic angina and has antianginal and anti-ischemic effects that... Continue Reading Posted at 11:53 PM \| Permalink \| Comments
	Upcoming Conference: Strategic Pharmaceutical Marketing Gloria Gamat March 26, 2006 What: Strategic Pharmaceutical Marketing:Practical Tools and Techniques for Creative and Compliant Marketing in a Complex Regulatory Environment When: March 30-31, 2006 Where: Princeton Marriott Hotel & Conference Center at Forrestal, Princeton, NJ ... Continue Reading Posted at 11:28 PM \| Permalink \| Comments
	Avicena Group Inc.’s HD-02, Designated Orphan Drug for HD by USFDA Gloria Gamat March 26, 2006 HD-02, the Avicena Group Inc.’s proprietary drug candidate for the treatment of Huntington's disease (HD) recently received a USFDA orphan drug designation. In the journal Neurology, the company published the positive results of its Phase I/II data for HD-02. The... Continue Reading Posted at 8:54 PM \| Permalink \| Comments
	PXD101 and Velcade® (bortezomib), Into Phase Ib/II Clinical Trial for Multiple Myeloma (MM) Gloria Gamat March 26, 2006 Multiple myeloma is a deadly form of blood cancer, characterized by excessive numbers of abnormal plasma cells in the bone marrow and the overproduction of abnormal immunoglobulins. Recently, CuraGen Corporation and TopoTarget A/S initiated the patient dosing in... Continue Reading Posted at 8:26 PM \| Permalink \| Comments
Mar23	Levitra® Found Effective against ED in Hypertensive Men Gloria Gamat March 23, 2006 Along with diabetes and high cholesterol, hypertension is one of the major risk factor that affects erectile dysfunction (ED), affecting 29.4 million men in the alone. Moreover, many blood-pressure-lowering medications (beta-blockers and diuretics) may adversely affect erectile function. Levitra®... Continue Reading Posted at 11:07 PM \| Permalink \| Comments
	Raloxifene: Osteoporosis Drug, Now on Phase II Clinical Trial for Prostate Cancer Gloria Gamat March 23, 2006 Raloxifene is a drug commonly used to treat osteoporosis has been recently to be a potential treatment against prostate cancer by researchers at Cedars-Sinai Medical Center . Since Raloxifene is a drug already on the market, researchers were able to... Continue Reading Posted at 10:18 PM \| Permalink \| Comments
	Patent Case Settlement on Plavix® Gloria Gamat March 23, 2006 The makers of Plavix®, Sanofi-Aventis and Bristol-Myers Squibb have tentatively settled a patent dispute on the drug. Plavix®, an anti-clotting agent is the world’s second-best selling drug have been settled to be generically manufactured by Apotex, a Canadian generic drug... Continue Reading Posted at 2:32 AM \| Permalink \| Comments
Mar22	Helix BioMedix, Inc. and Grant Industries’ Granactive™ Acne Solution, Passes Human Panel Test Gloria Gamat March 22, 2006 The collaboration between Helix BioMedix, Inc. (developer of bioactive peptides) and Grant Industries (private developer,manufacturer and marketer of cosmetic, textile, and performance specialty chemicals resulted to an acne blend for use in over-the-counter acne products: acne solution Granactive™, a combination... Continue Reading Posted at 3:03 AM \| Permalink \| Comments
	Schering-Plough and PTC Therapeutics Collaborating on Development of PTC's Preclinical Hepatitis C Compounds Gloria Gamat March 22, 2006 On March 20, Schering-Plough Corporation and PTC Therapeutics, Inc. announced their collaboration and licensing agreement for the development of PTC's preclinical compounds for the oral treatment of hepatitis C virus (HCV) infection and other viral diseases. "The goal of this... Continue Reading Posted at 2:45 AM \| Permalink \| Comments
	Eli Lilly & Co. and Biosite® Inc. Enters Collaboration on Clinical Trial Using Tailored Xigris® Therapy Gloria Gamat March 22, 2006 Eli Lilly & Company and Biosite® Incorporated announced their collaboration on a clinical trial employing a tailored therapy strategy for Lilly's severe sepsis drug, Xigris® (drotrecogin alfa [activated]). The trial will investigate the use of a multipurpose biomarker (Protein C)... Continue Reading Posted at 1:35 AM \| Permalink \| Comments
	Monsanto’s Posilac® bST, FDA Approved for Manufacture in Augusta Gloria Gamat March 22, 2006 Monsanto Company’s Posilac® has been FDA approved for its full production at the company’s Augusta, facilities. Posilac® bST (bovine somatotropin) is a milk production enhancer that serves as an important tool to help dairy producers improve the efficiency and profitability... Continue Reading Posted at 1:03 AM \| Permalink \| Comments
	Sunesis Pharma Inc.’s SNS-595 Enters Phase II Clinical Trial for Small Lung Cancer Gloria Gamat March 22, 2006 The Phase II clinical trial of Sunesis Pharmaceuticals, Inc.’s SNS-595 just started. The clinical trial will examine the safety and efficacy of SNS-595 as a second-line agent in patients with small cell lung cancer who have failed first-line therapy. SNS-595... Continue Reading Posted at 12:37 AM \| Permalink \| Comments
Mar21	Medidur™, Novel Treatment for DME, DSMB Recommended to Continue Phase 3 Clinical Trial Gloria Gamat March 21, 2006 Alimera Sciences Inc. and pSivida Limited’s Medidur™ is a tiny, injectable device to deliver fluocinolone acetonide (a corticosteroid) to the retina as a treatment for diabetic macular edema (DME) has just been recommended by the Data Safety Monitoring Board (DSMB)... Continue Reading Posted at 1:44 AM \| Permalink \| Comments
	Despite Vioxx®, Merck is Venturing into Pain Drugs Gloria Gamat March 21, 2006 It was a big blow to Merck & Company when Vioxx® was withdrawn from the market due to increased risk of heart attack. Not in the attempt to replace Vioxx® but in identifying pain as one of the nine medical... Continue Reading Posted at 1:15 AM \| Permalink \| Comments
Mar20	Topical Meeting Driven by Pandemic Threat Gloria Gamat March 20, 2006 What: Vaccine Production: Potential Engineering Approaches to a Pandemic When: April 10-11, 2006 Where: Case Western Reserve University , Severance Hall, Cleveland, Ohio. A meeting organized by The National Academy of Engineering, the Institute of Medicine, and... Continue Reading Posted at 3:42 AM \| Permalink \| Comments
	DelSite’s GelVac® system, Novel Avian Flu Vaccine to be presented at the World Vaccine Conference Gloria Gamat March 20, 2006 With the daily treat of an avian flu pandemic as suggested by the world’s health experts, the unique GelVac® system, developed by DelSite Biotechnologies (a subsidiary of Carrington Laboratories) could be the solution to deliver more vaccines to more people,... Continue Reading Posted at 3:23 AM \| Permalink \| Comments
	Senate Supports Prescription Drug Bargaining Gloria Gamat March 20, 2006 On Wednesday the (U.S.) Senate gave approval granting the federal government the power to bargain with pharmaceutical manufacturers for lower prices under the Medicare Prescription Drug Program. Since January 1 of this year, Medicare began offering drug benefits to seniors... Continue Reading Posted at 2:53 AM \| Permalink \| Comments
Mar17	Phase 3 Clinical Trial of Oral Temsirolimus in Women with Metastatic Breast Cancer, Terminated by Wyeth due to IDMC Review Gloria Gamat March 17, 2006 HORIZON is the phase 3 clinical trial program of Wyeth's investigational drug temsirolimus oral tablets in combination with letrozole (Femaraâ) (a currently approved breast cancer therapy) for first-line use in postmenopausal women with hormone-receptor positive metastatic breast cancer. Wyeth Pharmaceuticals... Continue Reading Posted at 11:15 PM \| Permalink \| Comments
	Yaz®: First Oral Contraceptive to Offer Drospirenone in a 24-day, Active-Pill Regimen, FDA Approved Gloria Gamat March 17, 2006 Schering AG, Germany’s U.S. affiliate Berlex, Inc. just announced the USFDA approval of Yaz® (3 mg drospirenone/20 mcg ethinyl estradiol), a new monophasic oral contraceptive (OC) and the first pill to combine 20 mcg of ethinyl estradiol with the innovative... Continue Reading Posted at 10:48 PM \| Permalink \| Comments
	Extended-Cycle Oral Contraceptive SEASONIQUE™: No Additional Clinical Data Required for Approval, Says Barr Pharma Inc. Gloria Gamat March 17, 2006 Duramed Pharmaceuticals, Inc.'s New Drug Application (NDA) for SEASONIQUE™ (levonorgestrel/ethinyl estradiol tablets 0.15 mg/0.03 mg and ethinyl estradiol tablets 0.01 mg) extended-cycle oral contraceptive, doesn’t need additional clinical data for USFDA approval as announced by Barr Pharmaceuticals, Inc. which will... Continue Reading Posted at 10:26 PM \| Permalink \| Comments
	Cholesterol-Lowering Atorvastatin, Effective MS Therapy Gloria Gamat March 17, 2006 The cholesterol-lowering drug, atorvastatin has been found to be an effective therapy for preventing the progression and reversing the severity of multiple sclerosis (MS) according to Scientists at the University of California , San Francisco and Stanford University Medical Center... Continue Reading Posted at 3:36 AM \| Permalink \| Comments
	EntreMed Inc., Made Strong by New 2ME2 Patent Gloria Gamat March 17, 2006 EntreMed, Inc. has been granted a U.S. Patent No. 7,012,070 covering methods of treatment for a broad range of indications with its lead clinical-stage compound, 2-methoxyestradiol (2ME2). Patent No. 7,012,070 which is entitled “Estrogenic Compounds as Anti-Mitotic Agents,” includes claims... Continue Reading Posted at 1:21 AM \| Permalink \| Comments
	Advexin® Passes Phase I/II Clinical Trial in Advanced Esophageal Cancer Patients Gloria Gamat March 17, 2006 Intratumoral administration of multiple Advexin® doses in advanced esophageal cancer patients has shown to be safe, feasible and clinically active; giving Introgen Therapeutics, Inc. enough reason to announce the publication of the positive data from the said Phase I/II clinical... Continue Reading Posted at 12:59 AM \| Permalink \| Comments
Mar16	Warning to Patients on Plavix® Medication Gloria Gamat March 16, 2006 Recent media reports on Plavix® may be misinterpreted by patients with coronary stents and other conditions*, causing these patients to inappropriately stop taking the anti-clotting drug clopidogrel (Plavix®). In any case, patients taking Plavix® for any reason must discuss the... Continue Reading Posted at 10:31 PM \| Permalink \| Comments
	Old Generic Drug, New Weapon against Pandemic Gloria Gamat March 16, 2006 Amantadine (1-aminoadamantane, sold as Symmetrel®) is a generic drug for treatment of seasonal flu that has been created in the 1970s. Today, it might become the new weapon along with Tamiflu in the onset of a pandemic. Research evidence is... Continue Reading Posted at 2:50 AM \| Permalink \| Comments
	Nastech Pharma Inc. & Novo Nordisk A/S, In Agreement Gloria Gamat March 16, 2006 A leader in developing therapeutics using advanced molecular biology-based drug delivery technologies, Nastech Pharmaceuticals Company Inc. announced yesterday that it has entered into a multi-compound, feasibility study agreement with Novo Nordisk A/S with respect to certain Novo Nordisk therapeutic compounds.... Continue Reading Posted at 12:21 AM \| Permalink \| Comments
Mar15	Oxytrex™ Shows Promise for Further Development, Says Pain Therapeutics Gloria Gamat March 15, 2006 Oxytrex™ is an investigational drug, a strong opioid painkiller with minimal physical dependence intended for patients with severe chronic pain. Pain Therapeutics today announced that it will present results from prior Phase III studies evaluating the safety, efficacy and minimal... Continue Reading Posted at 10:19 PM \| Permalink \| Comments
	Phenoptin™ Showed Positive Results from Phase 3 Clinical Study Gloria Gamat March 15, 2006 Phenylketonuria (PKU) is a genetic disorder that is characterized by an inability of the body to utilize the essential amino acid, phenylalanine. Phenoptin™ (sapropterin dihydrochloride) is an investigational oral small molecule for the treatment of phenylketonuria (PKU). Today, BioMarin Pharmaceutical... Continue Reading Posted at 9:59 PM \| Permalink \| Comments
	Provenge®, Novel Vaccine for Prostate Cancer: The Market Awaits Gloria Gamat March 15, 2006 Prostate cancer is the third most common cancer in the world. Diosynth Biotechnology has been awarded by Dendreon with a long –term contract to supply its novel vaccine for prostate cancer in anticipation of the USFDA approval. The novel vaccine... Continue Reading Posted at 9:21 PM \| Permalink \| Comments
	Wanted: Guest Bloggers Gloria Gamat March 15, 2006 Do you think you can blog here at The PharmVoice? If you think you can, Know More Media is welcoming guest bloggers (maximum of 5 bloggers, not necessarily 1 entry per blogger) on this blog for the duration 27 March to... Continue Reading Posted at 8:41 PM \| Permalink \| Comments
Mar13	ZoMaxx™ Drug-Eluting Coronary Stent’s First Human Clinical Trial Showed Positive Results Gloria Gamat March 13, 2006 ZoMaxx™, Abbott’s investigational Drug-Eluting Coronary Stent System demonstrated 100% procedural success, no major adverse cardiac events and minimal late lumen loss (vessel diameter loss) in the first human clinical trial (4-month period) conducted to evaluate the safety and performance of... Continue Reading Posted at 10:14 PM \| Permalink \| Comments
	Abbott to Market FREESTYLE® FREEDOM™ Blood Glucose Monitoring System, FDA Granted Clearance Gloria Gamat March 13, 2006 The USFDA granted a 510K clearance to Abbott Diabetes Care to market the company’s FreeStyle® Freedom™ blood glucose monitoring system for consumer use. FreeStyle® Freedom™ requires the smallest blood sample size (0.3 micro liter) among all blood glucose monitoring product... Continue Reading Posted at 9:15 PM \| Permalink \| Comments
	Plavix®’s Safety in Question Gloria Gamat March 13, 2006 A major clinical study found that the drug Plavix®, may cause dangerous bleeding in patients who take it along with aspirin to prevent heart attack. The results of the study which will be published in the New England Journal of Medicine... Continue Reading Posted at 8:43 PM \| Permalink \| Comments
	Drug Delivery Partnerships 2006 Gloria Gamat March 13, 2006 What: Drug Delivery Partnerships 2006 One of Europe 's leading meetings that bring together decision makers working in the field of drug delivery. The meeting provides executives from pharmaceutical, biotech, drug delivery and specialty pharma companies to network and strike... Continue Reading Posted at 2:25 AM \| Permalink \| Comments
	Dentonin® Passes Phase 2 Clinical Trial Gloria Gamat March 13, 2006 Dentonin® or AC-100 is a novel synthetic peptide derived from an endogenous human protein produced by bone and dental cells that can stimulate the formation of new dentin (the hard tissue of teeth that protects the tooth pulp and supports... Continue Reading Posted at 12:48 AM \| Permalink \| Comments
	Ranexa® Shipments Ongoing Gloria Gamat March 13, 2006 Ranexa™ (ranolazine extended-release tablets) was approved by USDA for marketing on January 27, 2005 and is now being shipped to pharmaceutical wholesalers. CV Therapeutics, the drug’s manufacturer is anticipating that Ranexa™ will be available in pharmacies by the end of... Continue Reading Posted at 12:24 AM \| Permalink \| Comments
	DAYTRANA, ADHD Transdermal Patch, Under FDA Class I Resubmission Gloria Gamat March 13, 2006 DAYTRANA (methylphenidate transdermal system (MTS)) is an investigational transdermal patch formulation for methylphenidate designed for once-daily use to treat attention deficit hyperactivity disorder (ADHD) in children aged 6 to 12 years. In December 2005, it received an NDA approvable letter... Continue Reading Posted at 12:04 AM \| Permalink \| Comments
Mar12	USDA Grants Approvable Letter to NPS Pharma Inc. for PREOS® NDA Gloria Gamat March 12, 2006 The USFDA deemed NPS Pharmaceuticals, Inc’s NDA (new drug application) for PREOS® (parathyroid hormone [rDNA origin] for injection) approvable. PREOS® is a recombinant human parathyroid hormone (PTH) that reduces the risk of first and subsequent vertebral fractures in post-menopausal women.... Continue Reading Posted at 11:46 PM \| Permalink \| Comments
Mar11	Phase 2 Clinical Trial of Corgentech’s ALGRX 4975 Showed Significant Decreased Pain from Tendonitis Gloria Gamat March 11, 2006 The Phase 2 clinical trial of ALGRX 4975 is showing positive results according to Corgentech Inc. ALGRX 4975 is one of three non-opioid pain management drug candidates the company is developing for pain relief of patients with elbow tendonitis. Corgentech... Continue Reading Posted at 2:44 AM \| Permalink \| Comments
Mar10	U.S. is World Leader in Important New Drugs Introduction, Study Says Gloria Gamat March 10, 2006 According to a study led by a Duke University economist, the U.S. pharmaceutical industry has become the world leader in introducing important new drugs since 1993. U.S. firms introduced 48 percent of first-in-class or novel drugs, 52 percent of biotech... Continue Reading Posted at 11:44 PM \| Permalink \| Comments
	Iomai Corp. Received Second Installation of NIH Fund for IS Patch against Flu Gloria Gamat March 10, 2006 Biopharmaceutical company, Iomai Corp. received a $1.4 Million award from the National Institutes of Health (NIH) for the continued development of its immunostimulant (IS) needle-free patch to extend the availability of existing stocks of influenza vaccine in the case of... Continue Reading Posted at 11:34 PM \| Permalink \| Comments
	Cardium Therapeutics, Inc. Acquired InnerCool Therapies, Inc. Gloria Gamat March 10, 2006 InnerCool Therapies, Inc., a San Diego-based medical technology company focused on the emerging field of therapeutic hypothermia has been recently acquired by Cardium Therapeutics, Inc. InnerCool Therapies, Inc. is a developer, manufacturer and marketer of endovascular, catheter-based therapeutic systems designed... Continue Reading Posted at 3:08 AM \| Permalink \| Comments
	BioCryst Pharma, Inc. Enters Peramivir Phase I Clinical Trial Gloria Gamat March 10, 2006 BioCryst Pharmaceuticals, Inc. entered into phase I clinical trial of Peramivir, the company's lead influenza neuraminidase inhibitor, to determine the pharmacokinetics and safety of single and multiple doses of an intravenous (IV) formulation of the drug in healthy volunteers. This... Continue Reading Posted at 2:23 AM \| Permalink \| Comments
	Novel Nicotine Addiction Vaccine NicVAX® Received US FDA Fast Tract Designation Gloria Gamat March 10, 2006 NicVAX® (Nicotine Conjugate Vaccine), Nabi Biopharmaceutical’s novel, innovative and proprietary investigational vaccine under development to treat nicotine addiction and prevent smoking relapse has received Fast Track Designation from the U.S. FDA. Fast Track regulations facilitate the development of products that... Continue Reading Posted at 1:14 AM \| Permalink \| Comments
	APP Received Two Tentative USFDA Approvals for Ondansetron Injection, Generic Zofran® Gloria Gamat March 10, 2006 The American Pharmaceutical Partners, Inc. received two tentative approvals from the U.S. FDA for its Abbreviated New Drug Applications (ANDAs) for Ondansetron Injection, USP (single-dose and multiple-dose vials), GlaxoSmithKline's Zofran® Injection’s generic version. APP expects to receive the final approval... Continue Reading Posted at 12:35 AM \| Permalink \| Comments
Mar 9	Remicade®, First EU approved Biologic Treatment for Ulcerative Colitis (UC) Gloria Gamat March 9, 2006 The European Commisions granted approval to Remicade® (infliximab) as treatment of moderately to severely active ulcerative colitis (UC) in patients who had inadequate response to conventional therapy (including corticosteroids and 6-MP or AZA) or who are intolerant to or have... Continue Reading Posted at 11:39 PM \| Permalink \| Comments
	Bristol-Myers Squibb Co., to build U.S. Manufacturing Facility Gloria Gamat March 9, 2006 During its March 7 regular meeting, the Bristol-Myers Squibb Company’s Board of Directors approved a capital expenditure in the amount of $660 million for the construction of a large-scale multi-product bulk biologics manufacturing facility in the . Pharmaceuticals President... Continue Reading Posted at 2:31 AM \| Permalink \| Comments
	Erbitux®, First and Only FDA Approved Treatment for Head and Neck Cancer Gloria Gamat March 9, 2006 The US FDA approval of Erbitux® (Cetuximab) (an IgG1 monoclonal antibody, for use in the treatment of squamous cell carcinoma of the head and neck) was recently announced by ImClone Systems Incorporated and Bristol-Myers Squibb Company. The first and... Continue Reading Posted at 2:12 AM \| Permalink \| Comments
Mar 8	Perrigo Co. Bagged FDA Approval to Manufacture and Market Generic Loprox® Gloria Gamat March 8, 2006 As announced earlier, the US FDA gave Perrigo Company approval to manufacture and market Ciclopirox Olamine Cream USP 0.77%, the generic version of Medicis Pharmaceutical manufactured Loprox® Cream 0.77%, an anti-fungal medication indicated for the topical treatment of skin infections:... Continue Reading Posted at 3:24 AM \| Permalink \| Comments
Mar 7	Twinject®, 2 dose-Epinephrine against Anaphylaxis Gloria Gamat March 7, 2006 Anaphylaxis is a severe, life-threatening systemic allergic reaction. Verus Pharmaceuticals, Inc., announced study results supporting the potential need for two doses of epinephrine to treat anaphylaxis. The study, “Factors Affecting the Use of Automatic Epinephrine Injectors”, was presented today as... Continue Reading Posted at 11:30 PM \| Permalink \| Comments
	Miraxion®, Potential Anti-Melancholic Depression Drug Says Amarin Corp plc Gloria Gamat March 7, 2006 The most severe form among depressive disorders is melancholic depression. It is more prevalent among hospitalized depression patients than among those in the community. Affected persons lack pleasure in almost all activities and do not react to pleasurable stimulation. They... Continue Reading Posted at 11:13 PM \| Permalink \| Comments
	Baxter HealthCare Corp Enters Phase II Adult Stem Cell Trial in U.S. CMI Patients Gloria Gamat March 7, 2006 CMI (chronic myocardial ischemia) is a severe form of coronary artery disease. It is a serious heart condition that involves narrowing of coronary arteries which results in limited blood flow to the heart and is affecting hundreds of thousands of... Continue Reading Posted at 10:21 PM \| Permalink \| Comments
	Doctors Warned Not to Base Prescription Solely on Drug Promo Brochures Gloria Gamat March 7, 2006 A study recently published in the open access journal BMC Family Practice found that promotional brochures produced by pharmaceutical companies to promote drugs to doctors don’t always present accurate data. Eventhough small differences were found, authors of the study still... Continue Reading Posted at 8:59 PM \| Permalink \| Comments
	Generic Flonase Make it to the Market Gloria Gamat March 7, 2006 Fluticasone propionate nasal spray, manufactured by Roxane Laboratories of Columbus, OH, is the first generic version of the brand name drug Flonase approved by FDA. Flonase is an anti-inflammatory nasal spray used to treat the nasal symptoms of indoor and... Continue Reading Posted at 8:31 PM \| Permalink \| Comments
	Novartis Seeks Approval for Exforge®, a 2-in-1 Blood Pressure-Lowering Tablet Gloria Gamat March 7, 2006 Two of the leading blood pressure-lowering tablets: amlodipine and valsartan; have been combined by Novartis in one tablet called Exforge® which has been shown in clinical trials (involving more than 5,000 patients) to provide powerful blood pressure control with excellent... Continue Reading Posted at 8:03 PM \| Permalink \| Comments
	New DNA Recognition Method Offers New Drug Design Gloria Gamat March 7, 2006 Scientists from Barcelona and Birmingham have discovered a new way that drugs can attach themselves to DNA which led to the discovery of a synthetic drug agent that targets and binds to the centre of a 3-way junction in the... Continue Reading Posted at 7:29 PM \| Permalink \| Comments
	Collaboration Against Infectious Diseases Gloria Gamat March 7, 2006 With the aim of discovering novel therapeutics for infectious diseases, Graffinity announced its second collaboration with Mutabilis. These days, the anti-infective market is facing serious challenges due to the growing resistance by infective microorganisms to almost all available products that... Continue Reading Posted at 12:17 AM \| Permalink \| Comments
Mar 6	End Essential Drug Tariffs, Save Lives Gloria Gamat March 6, 2006 The Word Health Organization reported in 2005 that many countries burdened with such diseases as HIV/AIDS, tuberculosis and malaria are still imposing tariffs on imports of medicines and medical devices. On Monday, trade officials said that the US, Switzerland and... Continue Reading Posted at 9:04 PM \| Permalink \| Comments
	Botox® Cosmetic, More Efficient and Longer Lasting than Dysport® Gloria Gamat March 6, 2006 At the recommended dosage, Botox Cosmetic (botulinum toxin type A) also known as VISTABEL or VISTABEX in Europe proved to be more efficient and tolerable in treating moderate to severe glabellar lines (the vertical frowns between the brows) compared to... Continue Reading Posted at 8:48 PM \| Permalink \| Comments
	Cowen & Co. 26th Annual Health Care Conference Gloria Gamat March 6, 2006 What: Cowen & Co. 26th Annual Health Care Conference When: Monday, March 6th, at 2:20 pm ET Where:Province Town Meeting Room,3rd floor, Boston Marriott Copley Place ChemGenex Pharmaceuticals is a pharmaceutical development company dedicated to improving the lives of... Continue Reading Posted at 12:48 AM \| Permalink \| Comments
	FDA Guidelines to Expedite Development of Seasonal and Pandemic Flu Vaccines Gloria Gamat March 6, 2006 On March 2, 2006, the FDA issued recommendations to aid manufacturers in developing seasonal and pandemic influenza vaccines in connection to its commitment to expedite the development and availability of safe and effective vaccines needed to protect against influenza in... Continue Reading Posted at 12:29 AM \| Permalink \| Comments
Mar 4	EMEA Disapproved EU Marketing of Atryn Gloria Gamat March 4, 2006 The potential of transgenic animals and plants for the cheap and efficient production of biopharmaceuticals is huge, leading to sales of more than $12bn (€10bn) by 2012 according to the market research firm Kalorama. GTC Biotherapeutics gave birth to... Continue Reading Posted at 12:01 AM \| Permalink \| Comments
	UCB’s New Treatment for Crohn’s Disease, CIMZIA: BLA Submitted to FDA Gloria Gamat March 4, 2006 Crohn's disease, a chronic and debilitating inflammatory disease of the gastrointestinal tract, affects nearly one million patients worldwide and an estimated 500,000 people in the United States. UCB, a global biopharmaceutical company, announced on 2nd March 2006 the submission... Continue Reading Posted at 12:00 AM \| Permalink \| Comments
	Emsam: First Transdermal Patch for Depression Approved by FDA Gloria Gamat March 4, 2006 Emsam, the first transdermal patch for treating major depression was approved by FDA on Feruary 28, 2006. Emsam is a once a day patch that works by delivering selegiline, a monoamine oxidase inhibitor (MAOI) through the skin and into... Continue Reading Posted at 12:00 AM \| Permalink \| Comments
Mar 3	Experimental Drug Reverses Key Cognitive Deficits in Alzheimer's Gloria Gamat March 3, 2006 Animal studies successfully revealed that a new drug that enhances the activity of a key brain cell receptor involved in Alzheimer's disease (AD) is capable of reversing learning and memory deficits. The new drug is called AF267B. In an article... Continue Reading Posted at 12:01 AM \| Permalink \| Comments
	Rituxan, Cancer Drug to Treat Rheumatoid Arthritis Gloria Gamat March 3, 2006 Rituxan is one cancer drug that is more precise and less toxic than previous chemotherapy compounds. It is the world’s best selling cancer drug that recently won FDA approval to be used for treating another disease, this time rheumatoid... Continue Reading Posted at 12:00 AM \| Permalink \| Comments
	Arthritis Drug Celebrex, Linked to Heart Attack Gloria Gamat March 3, 2006 Celebrex is an arthritis drug whose safety is now in question after studies linked it to higher risk of heart attack. Like Vioxx (which was taken off the market last year) Celebrex is a Cox-2 inhibitor, which has fewer... Continue Reading Posted at 12:00 AM \| Permalink \| Comments
Mar 2	A Pandemic Flu Collaboration Between Novartis and Alnylam Gloria Gamat March 2, 2006 In the hope to develop an RNAi based therapeutic for flu, Swiss Pharma giants Novartis and Alnylam are in collaboration. This is in response to the projected shortage of vaccines against the influenza virus on the onset of the feared... Continue Reading Posted at 1:52 AM \| Permalink \| Comments
	Resveratrol: Anti-aging Wine Compound Gloria Gamat March 2, 2006 There is a growing focus of research in the development of a drug that will prolong life span and delay the onset of age-related diseases. This has become a challenge to both biotech and pharmaceutical industry. A natural compound... Continue Reading Posted at 12:00 AM \| Permalink \| Comments
	RotaTeq Vaccine, Mandatory for Babies Gloria Gamat March 2, 2006 RotaTeq is the brand name of the new rotavirus vaccine manufactured by Merck. A meeting of the Advisory Committee on Immunization Practices (the federal panel that sets vaccination policy in the ) approved the recommendation for the universal use of... Continue Reading Posted at 12:00 AM \| Permalink \| Comments
	New Novartis Drug for Paget’s Disease Gloria Gamat March 2, 2006 Novartis announced on February 24 that it has received the approval letter from the US FDA for for zoledronic acid (5mg infusion), which is under review for the treatment of Paget's disease of the bone. Paget’s disease of the... Continue Reading Posted at 12:00 AM \| Permalink \| Comments
	Research Produced Powerful Tool for Drug Discovery Gloria Gamat March 2, 2006 Florida State University 's National High Magnetic Field Laboratory and Scripps Florida researchers have developed and evaluated a robust new system for analyzing the binding mechanism of drugs to proteins: a novel work that will speed up the delivery... Continue Reading Posted at 12:00 AM \| Permalink \| Comments
Mar 1	ReactArray Solo: Aid to Drug Patent Protection Gloria Gamat March 1, 2006 Before a pharmaceutical company can bring a novel drug to the market, it should first accomplish the task of producing and identifying the diversity of crystal forms or polymorphs of the new drugs in development. Normally that is a time... Continue Reading Posted at 7:00 PM \| Permalink \| Comments
	Sudafed 24, Found More Effective Than Expensive Drugs Against Allergic Rhinitis Gloria Gamat March 1, 2006 Sudafed 24 Hour is 240 mg of pseudoephedrine hydrochloride (Sudafed 24 Hour) is an over-the counter drug while prescription-only Singulair is 10 mg montelukast sodium, about four times more expensive. Scientists at the University of Chicago recently reported that... Continue Reading Posted at 6:41 PM \| Permalink \| Comments
	Potential Drug to Cure All TB Forms, Underway Gloria Gamat March 1, 2006 Researchers of Johns Hopkins Medical School reported their results at the 2006 American Society of Microbiology Biodefense Research Meeting that an experimental tuberculosis drug, a compound tagged as FAS20013 may be effective against multi drug-resistant forms of tuberculosis as well... Continue Reading Posted at 6:29 PM \| Permalink \| Comments
	Introductory Post Gloria Gamat March 1, 2006 First of all, I am a chemist and a single mom recently turned problogger. In the past 8 years I've been working on agricultural research but I cannot forget that the first two years of my working experience was spent... Continue Reading Posted at 5:44 PM \| Permalink \| Comments

« January 2006 | Main | April 2006 »

Mar30	Potential Market for Novel Allergy Medications Gloria Gamat March 30, 2006 Know More: First, I wanna thank a long time friend and colleague, Ruth Schaffer* (now a "colleague" in the science blogosphere) for guest blogging here at The PharmVoice.* I myself am dependent on Claritin to relieve me of my itchy symptoms and am fairly satisifed with the results. My son uses Fenistil drops and so far, it works. But according to the results of a survey released last week by The Asthma and Allergy Foundation of America (AAFA), 31% are not satisfied with their current allergy prescription 60% are interested in finding a new drug 55% said that their current medication does not relieve their allergy symptoms for a long enough period of time 44% said their medication doesn't provide quick enough relief So many numbers. All it boils down to is the fact that a significant number of allergy sufferers are not satisfied with their medications, whether oral or nasal. A lucrative market for pharmaceutical companies, I say, including manufacturers of generic allergy medications. Ruth Schaffer writes at The Biotech Weblog, Allergizer and Let's Visit Asia. Posted at 7:33 PM \| Permalink \| Comments
Mar30	Anthrim(TM), Anthrax Antibody Therapeutic, Passes Phase 1 Human Clinical Trial Gloria Gamat March 30, 2006 AnthrimTM , ElusysTherapeutics Inc.'s fast-tracked anthrax antibody therapeutic has successfully passed its human clinical trial designed to determine its safety and tolerability in healthy volunteers, when administered with or without the antibiotic Ciprofloxacin®. "The Anthim Phase 1 study, AH-101, has... Continue Reading Posted at 5:22 AM \| Permalink \| Comments
	Big Pharma Bad Gloria Gamat March 30, 2006 First of all, I wanna thank a colleague at B5media, Dr. Hsien-Hsien Lei for agreeing to guest blog here at The PharmVoice: Of all the evil in the world, pharmaceutical companies rank amongst the worst. Agree or... Continue Reading Posted at 2:37 AM \| Permalink \| Comments
Mar29	Calypte Biomed Corp’s Rapid HIV Test Kits, Approved in Kenya Gloria Gamat March 29, 2006 Calypte Biomedical Corporation’s rapid tests for HIV: Calypte Aware™ HIV-1/2 BSP (blood) and Aware™ HIV-1/2 OMT (oral fluid) has been issued a Kenyan National Public Health Laboratory Services (NPHLS) notification of registration and approval. These HIV test kits are... Continue Reading Posted at 1:00 AM \| Permalink \| Comments
	Ranbaxy Lab Ltd. Acquires Allen S.p.A., a GSK-Italy Division Gloria Gamat March 29, 2006 Ranbaxy Laboratories Limited is among the top ten generic pharmaceutical companies and ’s largest pharmaceutical company. Recently, the company announced its acquisition of the unbranded generic business of Allen S.p.A. (a division of GlaxoSmithKline (GSK) Italy through Ranbaxy’s Italian subsidiary... Continue Reading Posted at 12:59 AM \| Permalink \| Comments
Mar28	Santarus Inc.’s ZEGERID® with Magnesium Hydroxide Chewable Tablets Received USFDA NDA Approval Gloria Gamat March 28, 2006 Santarus Inc. is a specialty pharmaceutical company focused on therapies for gastrointestinal diseases and disorders. Yesterday the company received a USFDA approval for its New Drug application (NDA) of its product ZEGERID® with Magnesium Hydroxide (omeprazole/sodium bicarbonate/magnesium hydroxide) Chewable Tablets... Continue Reading Posted at 12:57 AM \| Permalink \| Comments
	Cymbalta® Significantly Reduces Core Anxiety Symptoms of Generalized Anxiety Disorder, Study Says Gloria Gamat March 28, 2006 In a study of some 500 patients, the safety and efficacy of the antidepressant Cymbalta® on the core anxiety symptoms in patients with generalized anxiety disorder was evaluated. Findings of the said study showed that Cymbalta® significantly reduced core anxiety... Continue Reading Posted at 12:30 AM \| Permalink \| Comments
	Additional Doses of Risperdal® Now Available By Prescription Gloria Gamat March 28, 2006 Risperdal® is one of the most prescribed antipsychotic drug and Risperdal® M-TAB® is its fast dissolving form. Now, two additional doses (3 mg and 4 mg) of Risperdal® (risperidone) is now available for prescription to schizophrenia or bipolar mania patients.... Continue Reading Posted at 12:18 AM \| Permalink \| Comments
Mar26	Ranexa™, Now Available in U.S. Pharmacies Gloria Gamat March 26, 2006 CV Therapeutic Inc.’s Ranexa™ is now available in pharmacies and is now being promoted to cardiology specialists in the United States. Ranexa™ (ranolazine extended-release tablets) is approved as second-line treatment for chronic angina and has antianginal and anti-ischemic effects that... Continue Reading Posted at 11:53 PM \| Permalink \| Comments
	Upcoming Conference: Strategic Pharmaceutical Marketing Gloria Gamat March 26, 2006 What: Strategic Pharmaceutical Marketing:Practical Tools and Techniques for Creative and Compliant Marketing in a Complex Regulatory Environment When: March 30-31, 2006 Where: Princeton Marriott Hotel & Conference Center at Forrestal, Princeton, NJ ... Continue Reading Posted at 11:28 PM \| Permalink \| Comments
	Avicena Group Inc.’s HD-02, Designated Orphan Drug for HD by USFDA Gloria Gamat March 26, 2006 HD-02, the Avicena Group Inc.’s proprietary drug candidate for the treatment of Huntington's disease (HD) recently received a USFDA orphan drug designation. In the journal Neurology, the company published the positive results of its Phase I/II data for HD-02. The... Continue Reading Posted at 8:54 PM \| Permalink \| Comments
	PXD101 and Velcade® (bortezomib), Into Phase Ib/II Clinical Trial for Multiple Myeloma (MM) Gloria Gamat March 26, 2006 Multiple myeloma is a deadly form of blood cancer, characterized by excessive numbers of abnormal plasma cells in the bone marrow and the overproduction of abnormal immunoglobulins. Recently, CuraGen Corporation and TopoTarget A/S initiated the patient dosing in... Continue Reading Posted at 8:26 PM \| Permalink \| Comments
Mar23	Levitra® Found Effective against ED in Hypertensive Men Gloria Gamat March 23, 2006 Along with diabetes and high cholesterol, hypertension is one of the major risk factor that affects erectile dysfunction (ED), affecting 29.4 million men in the alone. Moreover, many blood-pressure-lowering medications (beta-blockers and diuretics) may adversely affect erectile function. Levitra®... Continue Reading Posted at 11:07 PM \| Permalink \| Comments
	Raloxifene: Osteoporosis Drug, Now on Phase II Clinical Trial for Prostate Cancer Gloria Gamat March 23, 2006 Raloxifene is a drug commonly used to treat osteoporosis has been recently to be a potential treatment against prostate cancer by researchers at Cedars-Sinai Medical Center . Since Raloxifene is a drug already on the market, researchers were able to... Continue Reading Posted at 10:18 PM \| Permalink \| Comments
	Patent Case Settlement on Plavix® Gloria Gamat March 23, 2006 The makers of Plavix®, Sanofi-Aventis and Bristol-Myers Squibb have tentatively settled a patent dispute on the drug. Plavix®, an anti-clotting agent is the world’s second-best selling drug have been settled to be generically manufactured by Apotex, a Canadian generic drug... Continue Reading Posted at 2:32 AM \| Permalink \| Comments
Mar22	Helix BioMedix, Inc. and Grant Industries’ Granactive™ Acne Solution, Passes Human Panel Test Gloria Gamat March 22, 2006 The collaboration between Helix BioMedix, Inc. (developer of bioactive peptides) and Grant Industries (private developer,manufacturer and marketer of cosmetic, textile, and performance specialty chemicals resulted to an acne blend for use in over-the-counter acne products: acne solution Granactive™, a combination... Continue Reading Posted at 3:03 AM \| Permalink \| Comments
	Schering-Plough and PTC Therapeutics Collaborating on Development of PTC's Preclinical Hepatitis C Compounds Gloria Gamat March 22, 2006 On March 20, Schering-Plough Corporation and PTC Therapeutics, Inc. announced their collaboration and licensing agreement for the development of PTC's preclinical compounds for the oral treatment of hepatitis C virus (HCV) infection and other viral diseases. "The goal of this... Continue Reading Posted at 2:45 AM \| Permalink \| Comments
	Eli Lilly & Co. and Biosite® Inc. Enters Collaboration on Clinical Trial Using Tailored Xigris® Therapy Gloria Gamat March 22, 2006 Eli Lilly & Company and Biosite® Incorporated announced their collaboration on a clinical trial employing a tailored therapy strategy for Lilly's severe sepsis drug, Xigris® (drotrecogin alfa [activated]). The trial will investigate the use of a multipurpose biomarker (Protein C)... Continue Reading Posted at 1:35 AM \| Permalink \| Comments
	Monsanto’s Posilac® bST, FDA Approved for Manufacture in Augusta Gloria Gamat March 22, 2006 Monsanto Company’s Posilac® has been FDA approved for its full production at the company’s Augusta, facilities. Posilac® bST (bovine somatotropin) is a milk production enhancer that serves as an important tool to help dairy producers improve the efficiency and profitability... Continue Reading Posted at 1:03 AM \| Permalink \| Comments
	Sunesis Pharma Inc.’s SNS-595 Enters Phase II Clinical Trial for Small Lung Cancer Gloria Gamat March 22, 2006 The Phase II clinical trial of Sunesis Pharmaceuticals, Inc.’s SNS-595 just started. The clinical trial will examine the safety and efficacy of SNS-595 as a second-line agent in patients with small cell lung cancer who have failed first-line therapy. SNS-595... Continue Reading Posted at 12:37 AM \| Permalink \| Comments
Mar21	Medidur™, Novel Treatment for DME, DSMB Recommended to Continue Phase 3 Clinical Trial Gloria Gamat March 21, 2006 Alimera Sciences Inc. and pSivida Limited’s Medidur™ is a tiny, injectable device to deliver fluocinolone acetonide (a corticosteroid) to the retina as a treatment for diabetic macular edema (DME) has just been recommended by the Data Safety Monitoring Board (DSMB)... Continue Reading Posted at 1:44 AM \| Permalink \| Comments
	Despite Vioxx®, Merck is Venturing into Pain Drugs Gloria Gamat March 21, 2006 It was a big blow to Merck & Company when Vioxx® was withdrawn from the market due to increased risk of heart attack. Not in the attempt to replace Vioxx® but in identifying pain as one of the nine medical... Continue Reading Posted at 1:15 AM \| Permalink \| Comments
Mar20	Topical Meeting Driven by Pandemic Threat Gloria Gamat March 20, 2006 What: Vaccine Production: Potential Engineering Approaches to a Pandemic When: April 10-11, 2006 Where: Case Western Reserve University , Severance Hall, Cleveland, Ohio. A meeting organized by The National Academy of Engineering, the Institute of Medicine, and... Continue Reading Posted at 3:42 AM \| Permalink \| Comments
	DelSite’s GelVac® system, Novel Avian Flu Vaccine to be presented at the World Vaccine Conference Gloria Gamat March 20, 2006 With the daily treat of an avian flu pandemic as suggested by the world’s health experts, the unique GelVac® system, developed by DelSite Biotechnologies (a subsidiary of Carrington Laboratories) could be the solution to deliver more vaccines to more people,... Continue Reading Posted at 3:23 AM \| Permalink \| Comments
	Senate Supports Prescription Drug Bargaining Gloria Gamat March 20, 2006 On Wednesday the (U.S.) Senate gave approval granting the federal government the power to bargain with pharmaceutical manufacturers for lower prices under the Medicare Prescription Drug Program. Since January 1 of this year, Medicare began offering drug benefits to seniors... Continue Reading Posted at 2:53 AM \| Permalink \| Comments
Mar17	Phase 3 Clinical Trial of Oral Temsirolimus in Women with Metastatic Breast Cancer, Terminated by Wyeth due to IDMC Review Gloria Gamat March 17, 2006 HORIZON is the phase 3 clinical trial program of Wyeth's investigational drug temsirolimus oral tablets in combination with letrozole (Femaraâ) (a currently approved breast cancer therapy) for first-line use in postmenopausal women with hormone-receptor positive metastatic breast cancer. Wyeth Pharmaceuticals... Continue Reading Posted at 11:15 PM \| Permalink \| Comments
	Yaz®: First Oral Contraceptive to Offer Drospirenone in a 24-day, Active-Pill Regimen, FDA Approved Gloria Gamat March 17, 2006 Schering AG, Germany’s U.S. affiliate Berlex, Inc. just announced the USFDA approval of Yaz® (3 mg drospirenone/20 mcg ethinyl estradiol), a new monophasic oral contraceptive (OC) and the first pill to combine 20 mcg of ethinyl estradiol with the innovative... Continue Reading Posted at 10:48 PM \| Permalink \| Comments
	Extended-Cycle Oral Contraceptive SEASONIQUE™: No Additional Clinical Data Required for Approval, Says Barr Pharma Inc. Gloria Gamat March 17, 2006 Duramed Pharmaceuticals, Inc.'s New Drug Application (NDA) for SEASONIQUE™ (levonorgestrel/ethinyl estradiol tablets 0.15 mg/0.03 mg and ethinyl estradiol tablets 0.01 mg) extended-cycle oral contraceptive, doesn’t need additional clinical data for USFDA approval as announced by Barr Pharmaceuticals, Inc. which will... Continue Reading Posted at 10:26 PM \| Permalink \| Comments
	Cholesterol-Lowering Atorvastatin, Effective MS Therapy Gloria Gamat March 17, 2006 The cholesterol-lowering drug, atorvastatin has been found to be an effective therapy for preventing the progression and reversing the severity of multiple sclerosis (MS) according to Scientists at the University of California , San Francisco and Stanford University Medical Center... Continue Reading Posted at 3:36 AM \| Permalink \| Comments
	EntreMed Inc., Made Strong by New 2ME2 Patent Gloria Gamat March 17, 2006 EntreMed, Inc. has been granted a U.S. Patent No. 7,012,070 covering methods of treatment for a broad range of indications with its lead clinical-stage compound, 2-methoxyestradiol (2ME2). Patent No. 7,012,070 which is entitled “Estrogenic Compounds as Anti-Mitotic Agents,” includes claims... Continue Reading Posted at 1:21 AM \| Permalink \| Comments
	Advexin® Passes Phase I/II Clinical Trial in Advanced Esophageal Cancer Patients Gloria Gamat March 17, 2006 Intratumoral administration of multiple Advexin® doses in advanced esophageal cancer patients has shown to be safe, feasible and clinically active; giving Introgen Therapeutics, Inc. enough reason to announce the publication of the positive data from the said Phase I/II clinical... Continue Reading Posted at 12:59 AM \| Permalink \| Comments
Mar16	Warning to Patients on Plavix® Medication Gloria Gamat March 16, 2006 Recent media reports on Plavix® may be misinterpreted by patients with coronary stents and other conditions*, causing these patients to inappropriately stop taking the anti-clotting drug clopidogrel (Plavix®). In any case, patients taking Plavix® for any reason must discuss the... Continue Reading Posted at 10:31 PM \| Permalink \| Comments
	Old Generic Drug, New Weapon against Pandemic Gloria Gamat March 16, 2006 Amantadine (1-aminoadamantane, sold as Symmetrel®) is a generic drug for treatment of seasonal flu that has been created in the 1970s. Today, it might become the new weapon along with Tamiflu in the onset of a pandemic. Research evidence is... Continue Reading Posted at 2:50 AM \| Permalink \| Comments
	Nastech Pharma Inc. & Novo Nordisk A/S, In Agreement Gloria Gamat March 16, 2006 A leader in developing therapeutics using advanced molecular biology-based drug delivery technologies, Nastech Pharmaceuticals Company Inc. announced yesterday that it has entered into a multi-compound, feasibility study agreement with Novo Nordisk A/S with respect to certain Novo Nordisk therapeutic compounds.... Continue Reading Posted at 12:21 AM \| Permalink \| Comments
Mar15	Oxytrex™ Shows Promise for Further Development, Says Pain Therapeutics Gloria Gamat March 15, 2006 Oxytrex™ is an investigational drug, a strong opioid painkiller with minimal physical dependence intended for patients with severe chronic pain. Pain Therapeutics today announced that it will present results from prior Phase III studies evaluating the safety, efficacy and minimal... Continue Reading Posted at 10:19 PM \| Permalink \| Comments
	Phenoptin™ Showed Positive Results from Phase 3 Clinical Study Gloria Gamat March 15, 2006 Phenylketonuria (PKU) is a genetic disorder that is characterized by an inability of the body to utilize the essential amino acid, phenylalanine. Phenoptin™ (sapropterin dihydrochloride) is an investigational oral small molecule for the treatment of phenylketonuria (PKU). Today, BioMarin Pharmaceutical... Continue Reading Posted at 9:59 PM \| Permalink \| Comments
	Provenge®, Novel Vaccine for Prostate Cancer: The Market Awaits Gloria Gamat March 15, 2006 Prostate cancer is the third most common cancer in the world. Diosynth Biotechnology has been awarded by Dendreon with a long –term contract to supply its novel vaccine for prostate cancer in anticipation of the USFDA approval. The novel vaccine... Continue Reading Posted at 9:21 PM \| Permalink \| Comments
	Wanted: Guest Bloggers Gloria Gamat March 15, 2006 Do you think you can blog here at The PharmVoice? If you think you can, Know More Media is welcoming guest bloggers (maximum of 5 bloggers, not necessarily 1 entry per blogger) on this blog for the duration 27 March to... Continue Reading Posted at 8:41 PM \| Permalink \| Comments
Mar13	ZoMaxx™ Drug-Eluting Coronary Stent’s First Human Clinical Trial Showed Positive Results Gloria Gamat March 13, 2006 ZoMaxx™, Abbott’s investigational Drug-Eluting Coronary Stent System demonstrated 100% procedural success, no major adverse cardiac events and minimal late lumen loss (vessel diameter loss) in the first human clinical trial (4-month period) conducted to evaluate the safety and performance of... Continue Reading Posted at 10:14 PM \| Permalink \| Comments
	Abbott to Market FREESTYLE® FREEDOM™ Blood Glucose Monitoring System, FDA Granted Clearance Gloria Gamat March 13, 2006 The USFDA granted a 510K clearance to Abbott Diabetes Care to market the company’s FreeStyle® Freedom™ blood glucose monitoring system for consumer use. FreeStyle® Freedom™ requires the smallest blood sample size (0.3 micro liter) among all blood glucose monitoring product... Continue Reading Posted at 9:15 PM \| Permalink \| Comments
	Plavix®’s Safety in Question Gloria Gamat March 13, 2006 A major clinical study found that the drug Plavix®, may cause dangerous bleeding in patients who take it along with aspirin to prevent heart attack. The results of the study which will be published in the New England Journal of Medicine... Continue Reading Posted at 8:43 PM \| Permalink \| Comments
	Drug Delivery Partnerships 2006 Gloria Gamat March 13, 2006 What: Drug Delivery Partnerships 2006 One of Europe 's leading meetings that bring together decision makers working in the field of drug delivery. The meeting provides executives from pharmaceutical, biotech, drug delivery and specialty pharma companies to network and strike... Continue Reading Posted at 2:25 AM \| Permalink \| Comments
	Dentonin® Passes Phase 2 Clinical Trial Gloria Gamat March 13, 2006 Dentonin® or AC-100 is a novel synthetic peptide derived from an endogenous human protein produced by bone and dental cells that can stimulate the formation of new dentin (the hard tissue of teeth that protects the tooth pulp and supports... Continue Reading Posted at 12:48 AM \| Permalink \| Comments
	Ranexa® Shipments Ongoing Gloria Gamat March 13, 2006 Ranexa™ (ranolazine extended-release tablets) was approved by USDA for marketing on January 27, 2005 and is now being shipped to pharmaceutical wholesalers. CV Therapeutics, the drug’s manufacturer is anticipating that Ranexa™ will be available in pharmacies by the end of... Continue Reading Posted at 12:24 AM \| Permalink \| Comments
	DAYTRANA, ADHD Transdermal Patch, Under FDA Class I Resubmission Gloria Gamat March 13, 2006 DAYTRANA (methylphenidate transdermal system (MTS)) is an investigational transdermal patch formulation for methylphenidate designed for once-daily use to treat attention deficit hyperactivity disorder (ADHD) in children aged 6 to 12 years. In December 2005, it received an NDA approvable letter... Continue Reading Posted at 12:04 AM \| Permalink \| Comments
Mar12	USDA Grants Approvable Letter to NPS Pharma Inc. for PREOS® NDA Gloria Gamat March 12, 2006 The USFDA deemed NPS Pharmaceuticals, Inc’s NDA (new drug application) for PREOS® (parathyroid hormone [rDNA origin] for injection) approvable. PREOS® is a recombinant human parathyroid hormone (PTH) that reduces the risk of first and subsequent vertebral fractures in post-menopausal women.... Continue Reading Posted at 11:46 PM \| Permalink \| Comments
Mar11	Phase 2 Clinical Trial of Corgentech’s ALGRX 4975 Showed Significant Decreased Pain from Tendonitis Gloria Gamat March 11, 2006 The Phase 2 clinical trial of ALGRX 4975 is showing positive results according to Corgentech Inc. ALGRX 4975 is one of three non-opioid pain management drug candidates the company is developing for pain relief of patients with elbow tendonitis. Corgentech... Continue Reading Posted at 2:44 AM \| Permalink \| Comments
Mar10	U.S. is World Leader in Important New Drugs Introduction, Study Says Gloria Gamat March 10, 2006 According to a study led by a Duke University economist, the U.S. pharmaceutical industry has become the world leader in introducing important new drugs since 1993. U.S. firms introduced 48 percent of first-in-class or novel drugs, 52 percent of biotech... Continue Reading Posted at 11:44 PM \| Permalink \| Comments
	Iomai Corp. Received Second Installation of NIH Fund for IS Patch against Flu Gloria Gamat March 10, 2006 Biopharmaceutical company, Iomai Corp. received a $1.4 Million award from the National Institutes of Health (NIH) for the continued development of its immunostimulant (IS) needle-free patch to extend the availability of existing stocks of influenza vaccine in the case of... Continue Reading Posted at 11:34 PM \| Permalink \| Comments
	Cardium Therapeutics, Inc. Acquired InnerCool Therapies, Inc. Gloria Gamat March 10, 2006 InnerCool Therapies, Inc., a San Diego-based medical technology company focused on the emerging field of therapeutic hypothermia has been recently acquired by Cardium Therapeutics, Inc. InnerCool Therapies, Inc. is a developer, manufacturer and marketer of endovascular, catheter-based therapeutic systems designed... Continue Reading Posted at 3:08 AM \| Permalink \| Comments
	BioCryst Pharma, Inc. Enters Peramivir Phase I Clinical Trial Gloria Gamat March 10, 2006 BioCryst Pharmaceuticals, Inc. entered into phase I clinical trial of Peramivir, the company's lead influenza neuraminidase inhibitor, to determine the pharmacokinetics and safety of single and multiple doses of an intravenous (IV) formulation of the drug in healthy volunteers. This... Continue Reading Posted at 2:23 AM \| Permalink \| Comments
	Novel Nicotine Addiction Vaccine NicVAX® Received US FDA Fast Tract Designation Gloria Gamat March 10, 2006 NicVAX® (Nicotine Conjugate Vaccine), Nabi Biopharmaceutical’s novel, innovative and proprietary investigational vaccine under development to treat nicotine addiction and prevent smoking relapse has received Fast Track Designation from the U.S. FDA. Fast Track regulations facilitate the development of products that... Continue Reading Posted at 1:14 AM \| Permalink \| Comments
	APP Received Two Tentative USFDA Approvals for Ondansetron Injection, Generic Zofran® Gloria Gamat March 10, 2006 The American Pharmaceutical Partners, Inc. received two tentative approvals from the U.S. FDA for its Abbreviated New Drug Applications (ANDAs) for Ondansetron Injection, USP (single-dose and multiple-dose vials), GlaxoSmithKline's Zofran® Injection’s generic version. APP expects to receive the final approval... Continue Reading Posted at 12:35 AM \| Permalink \| Comments
Mar 9	Remicade®, First EU approved Biologic Treatment for Ulcerative Colitis (UC) Gloria Gamat March 9, 2006 The European Commisions granted approval to Remicade® (infliximab) as treatment of moderately to severely active ulcerative colitis (UC) in patients who had inadequate response to conventional therapy (including corticosteroids and 6-MP or AZA) or who are intolerant to or have... Continue Reading Posted at 11:39 PM \| Permalink \| Comments
	Bristol-Myers Squibb Co., to build U.S. Manufacturing Facility Gloria Gamat March 9, 2006 During its March 7 regular meeting, the Bristol-Myers Squibb Company’s Board of Directors approved a capital expenditure in the amount of $660 million for the construction of a large-scale multi-product bulk biologics manufacturing facility in the . Pharmaceuticals President... Continue Reading Posted at 2:31 AM \| Permalink \| Comments
	Erbitux®, First and Only FDA Approved Treatment for Head and Neck Cancer Gloria Gamat March 9, 2006 The US FDA approval of Erbitux® (Cetuximab) (an IgG1 monoclonal antibody, for use in the treatment of squamous cell carcinoma of the head and neck) was recently announced by ImClone Systems Incorporated and Bristol-Myers Squibb Company. The first and... Continue Reading Posted at 2:12 AM \| Permalink \| Comments
Mar 8	Perrigo Co. Bagged FDA Approval to Manufacture and Market Generic Loprox® Gloria Gamat March 8, 2006 As announced earlier, the US FDA gave Perrigo Company approval to manufacture and market Ciclopirox Olamine Cream USP 0.77%, the generic version of Medicis Pharmaceutical manufactured Loprox® Cream 0.77%, an anti-fungal medication indicated for the topical treatment of skin infections:... Continue Reading Posted at 3:24 AM \| Permalink \| Comments
Mar 7	Twinject®, 2 dose-Epinephrine against Anaphylaxis Gloria Gamat March 7, 2006 Anaphylaxis is a severe, life-threatening systemic allergic reaction. Verus Pharmaceuticals, Inc., announced study results supporting the potential need for two doses of epinephrine to treat anaphylaxis. The study, “Factors Affecting the Use of Automatic Epinephrine Injectors”, was presented today as... Continue Reading Posted at 11:30 PM \| Permalink \| Comments
	Miraxion®, Potential Anti-Melancholic Depression Drug Says Amarin Corp plc Gloria Gamat March 7, 2006 The most severe form among depressive disorders is melancholic depression. It is more prevalent among hospitalized depression patients than among those in the community. Affected persons lack pleasure in almost all activities and do not react to pleasurable stimulation. They... Continue Reading Posted at 11:13 PM \| Permalink \| Comments
	Baxter HealthCare Corp Enters Phase II Adult Stem Cell Trial in U.S. CMI Patients Gloria Gamat March 7, 2006 CMI (chronic myocardial ischemia) is a severe form of coronary artery disease. It is a serious heart condition that involves narrowing of coronary arteries which results in limited blood flow to the heart and is affecting hundreds of thousands of... Continue Reading Posted at 10:21 PM \| Permalink \| Comments
	Doctors Warned Not to Base Prescription Solely on Drug Promo Brochures Gloria Gamat March 7, 2006 A study recently published in the open access journal BMC Family Practice found that promotional brochures produced by pharmaceutical companies to promote drugs to doctors don’t always present accurate data. Eventhough small differences were found, authors of the study still... Continue Reading Posted at 8:59 PM \| Permalink \| Comments
	Generic Flonase Make it to the Market Gloria Gamat March 7, 2006 Fluticasone propionate nasal spray, manufactured by Roxane Laboratories of Columbus, OH, is the first generic version of the brand name drug Flonase approved by FDA. Flonase is an anti-inflammatory nasal spray used to treat the nasal symptoms of indoor and... Continue Reading Posted at 8:31 PM \| Permalink \| Comments
	Novartis Seeks Approval for Exforge®, a 2-in-1 Blood Pressure-Lowering Tablet Gloria Gamat March 7, 2006 Two of the leading blood pressure-lowering tablets: amlodipine and valsartan; have been combined by Novartis in one tablet called Exforge® which has been shown in clinical trials (involving more than 5,000 patients) to provide powerful blood pressure control with excellent... Continue Reading Posted at 8:03 PM \| Permalink \| Comments
	New DNA Recognition Method Offers New Drug Design Gloria Gamat March 7, 2006 Scientists from Barcelona and Birmingham have discovered a new way that drugs can attach themselves to DNA which led to the discovery of a synthetic drug agent that targets and binds to the centre of a 3-way junction in the... Continue Reading Posted at 7:29 PM \| Permalink \| Comments
	Collaboration Against Infectious Diseases Gloria Gamat March 7, 2006 With the aim of discovering novel therapeutics for infectious diseases, Graffinity announced its second collaboration with Mutabilis. These days, the anti-infective market is facing serious challenges due to the growing resistance by infective microorganisms to almost all available products that... Continue Reading Posted at 12:17 AM \| Permalink \| Comments
Mar 6	End Essential Drug Tariffs, Save Lives Gloria Gamat March 6, 2006 The Word Health Organization reported in 2005 that many countries burdened with such diseases as HIV/AIDS, tuberculosis and malaria are still imposing tariffs on imports of medicines and medical devices. On Monday, trade officials said that the US, Switzerland and... Continue Reading Posted at 9:04 PM \| Permalink \| Comments
	Botox® Cosmetic, More Efficient and Longer Lasting than Dysport® Gloria Gamat March 6, 2006 At the recommended dosage, Botox Cosmetic (botulinum toxin type A) also known as VISTABEL or VISTABEX in Europe proved to be more efficient and tolerable in treating moderate to severe glabellar lines (the vertical frowns between the brows) compared to... Continue Reading Posted at 8:48 PM \| Permalink \| Comments
	Cowen & Co. 26th Annual Health Care Conference Gloria Gamat March 6, 2006 What: Cowen & Co. 26th Annual Health Care Conference When: Monday, March 6th, at 2:20 pm ET Where:Province Town Meeting Room,3rd floor, Boston Marriott Copley Place ChemGenex Pharmaceuticals is a pharmaceutical development company dedicated to improving the lives of... Continue Reading Posted at 12:48 AM \| Permalink \| Comments
	FDA Guidelines to Expedite Development of Seasonal and Pandemic Flu Vaccines Gloria Gamat March 6, 2006 On March 2, 2006, the FDA issued recommendations to aid manufacturers in developing seasonal and pandemic influenza vaccines in connection to its commitment to expedite the development and availability of safe and effective vaccines needed to protect against influenza in... Continue Reading Posted at 12:29 AM \| Permalink \| Comments
Mar 4	EMEA Disapproved EU Marketing of Atryn Gloria Gamat March 4, 2006 The potential of transgenic animals and plants for the cheap and efficient production of biopharmaceuticals is huge, leading to sales of more than $12bn (€10bn) by 2012 according to the market research firm Kalorama. GTC Biotherapeutics gave birth to... Continue Reading Posted at 12:01 AM \| Permalink \| Comments
	UCB’s New Treatment for Crohn’s Disease, CIMZIA: BLA Submitted to FDA Gloria Gamat March 4, 2006 Crohn's disease, a chronic and debilitating inflammatory disease of the gastrointestinal tract, affects nearly one million patients worldwide and an estimated 500,000 people in the United States. UCB, a global biopharmaceutical company, announced on 2nd March 2006 the submission... Continue Reading Posted at 12:00 AM \| Permalink \| Comments
	Emsam: First Transdermal Patch for Depression Approved by FDA Gloria Gamat March 4, 2006 Emsam, the first transdermal patch for treating major depression was approved by FDA on Feruary 28, 2006. Emsam is a once a day patch that works by delivering selegiline, a monoamine oxidase inhibitor (MAOI) through the skin and into... Continue Reading Posted at 12:00 AM \| Permalink \| Comments
Mar 3	Experimental Drug Reverses Key Cognitive Deficits in Alzheimer's Gloria Gamat March 3, 2006 Animal studies successfully revealed that a new drug that enhances the activity of a key brain cell receptor involved in Alzheimer's disease (AD) is capable of reversing learning and memory deficits. The new drug is called AF267B. In an article... Continue Reading Posted at 12:01 AM \| Permalink \| Comments
	Rituxan, Cancer Drug to Treat Rheumatoid Arthritis Gloria Gamat March 3, 2006 Rituxan is one cancer drug that is more precise and less toxic than previous chemotherapy compounds. It is the world’s best selling cancer drug that recently won FDA approval to be used for treating another disease, this time rheumatoid... Continue Reading Posted at 12:00 AM \| Permalink \| Comments
	Arthritis Drug Celebrex, Linked to Heart Attack Gloria Gamat March 3, 2006 Celebrex is an arthritis drug whose safety is now in question after studies linked it to higher risk of heart attack. Like Vioxx (which was taken off the market last year) Celebrex is a Cox-2 inhibitor, which has fewer... Continue Reading Posted at 12:00 AM \| Permalink \| Comments
Mar 2	A Pandemic Flu Collaboration Between Novartis and Alnylam Gloria Gamat March 2, 2006 In the hope to develop an RNAi based therapeutic for flu, Swiss Pharma giants Novartis and Alnylam are in collaboration. This is in response to the projected shortage of vaccines against the influenza virus on the onset of the feared... Continue Reading Posted at 1:52 AM \| Permalink \| Comments
	Resveratrol: Anti-aging Wine Compound Gloria Gamat March 2, 2006 There is a growing focus of research in the development of a drug that will prolong life span and delay the onset of age-related diseases. This has become a challenge to both biotech and pharmaceutical industry. A natural compound... Continue Reading Posted at 12:00 AM \| Permalink \| Comments
	RotaTeq Vaccine, Mandatory for Babies Gloria Gamat March 2, 2006 RotaTeq is the brand name of the new rotavirus vaccine manufactured by Merck. A meeting of the Advisory Committee on Immunization Practices (the federal panel that sets vaccination policy in the ) approved the recommendation for the universal use of... Continue Reading Posted at 12:00 AM \| Permalink \| Comments
	New Novartis Drug for Paget’s Disease Gloria Gamat March 2, 2006 Novartis announced on February 24 that it has received the approval letter from the US FDA for for zoledronic acid (5mg infusion), which is under review for the treatment of Paget's disease of the bone. Paget’s disease of the... Continue Reading Posted at 12:00 AM \| Permalink \| Comments
	Research Produced Powerful Tool for Drug Discovery Gloria Gamat March 2, 2006 Florida State University 's National High Magnetic Field Laboratory and Scripps Florida researchers have developed and evaluated a robust new system for analyzing the binding mechanism of drugs to proteins: a novel work that will speed up the delivery... Continue Reading Posted at 12:00 AM \| Permalink \| Comments
Mar 1	ReactArray Solo: Aid to Drug Patent Protection Gloria Gamat March 1, 2006 Before a pharmaceutical company can bring a novel drug to the market, it should first accomplish the task of producing and identifying the diversity of crystal forms or polymorphs of the new drugs in development. Normally that is a time... Continue Reading Posted at 7:00 PM \| Permalink \| Comments
	Sudafed 24, Found More Effective Than Expensive Drugs Against Allergic Rhinitis Gloria Gamat March 1, 2006 Sudafed 24 Hour is 240 mg of pseudoephedrine hydrochloride (Sudafed 24 Hour) is an over-the counter drug while prescription-only Singulair is 10 mg montelukast sodium, about four times more expensive. Scientists at the University of Chicago recently reported that... Continue Reading Posted at 6:41 PM \| Permalink \| Comments
	Potential Drug to Cure All TB Forms, Underway Gloria Gamat March 1, 2006 Researchers of Johns Hopkins Medical School reported their results at the 2006 American Society of Microbiology Biodefense Research Meeting that an experimental tuberculosis drug, a compound tagged as FAS20013 may be effective against multi drug-resistant forms of tuberculosis as well... Continue Reading Posted at 6:29 PM \| Permalink \| Comments
	Introductory Post Gloria Gamat March 1, 2006 First of all, I am a chemist and a single mom recently turned problogger. In the past 8 years I've been working on agricultural research but I cannot forget that the first two years of my working experience was spent... Continue Reading Posted at 5:44 PM \| Permalink \| Comments

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