PharmaGazette: February 2007 Archives

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Feb28	Abbott’s HUMIRA® (Adalimumab), USFDA-Approved for Crohn's Disease Treatment Gloria Gamat February 28, 2007 Know More: Drug Regulations & Approval Abbott, Antibodies, Crohn's The USFDA granted marketing approval to Abbott (NYSE: ABT) for HUMIRA® (adalimumab) with the following new indications: treatment for reducing the signs and symptoms and inducing and maintaining clinical remission in adults with moderately to severely active Crohn's disease who have had an inadequate response to conventional therapy reducing the signs and symptoms and inducing clinical remission in these patients if they have also lost response to or are intolerant to infliximab - the only other approved biologic for treatment of Crohn's disease Crohn's disease (the fourth USFDA approval in immune-mediated diseases for HUMIRA®) is a serious chronic, inflammatory disease of the gastrointestinal (GI) with no medical or surgical cure and only a few options for patients with this chronic condition. HUMIRA® - the only fully human monoclonal antibody approved for the treatment of rheumatoid arthritis (RA), psoriatic arthritis (PsA), and ankylosing spondylitis (AS) in the U.S. and Europe (in addition to Crohn’s disease in the U.S.) - works by blocking TNF-alpha, a protein that when produced in excess, plays a central role in the inflammatory responses of many immune-mediated diseases. Find more details from the press release. Posted at 9:04 PM \| Permalink \| Comments
Feb28	Unit Dose Budesonide (UDB): MAP Pharma’s Pediatric Asthma Drug Candidate, Passed Phase 2 Clinical Trial Gloria Gamat February 28, 2007 MAP Pharmaceuticals, Inc.’s drug candidate - Unit Dose Budesonide (UDB) - is a proprietary nebulized formulation of budesonide for treatment of pediatric asthma. In a U.S. based Phase 2 clinical trial UDB met its primary efficacy endpoints. The primary endpoints... Continue Reading Posted at 7:48 PM \| Permalink \| Comments
	Albuferon® + Ribavirin, Passed Phase 2b Clinical Trial in Treatment-Naïve Genotype 1 Chronic Hepatitis C (HCV) Patients Gloria Gamat February 28, 2007 Human Genome Sciences (Nasdaq: HGSI) recently announced the positive results of its Phase 2b clinical trial of Albuferon® (albinterferon alfa-2b) in combination with ribavirin in patients with genotype 1 chronic hepatitis C (HCV) who are naive to interferon alpha-based treatment... Continue Reading Posted at 6:48 PM \| Permalink \| Comments
Feb27	Survey Reveals Reason for Allergic Rhinitis Patients to Discontinue Treatment of Existing Nasal Sprays Gloria Gamat February 27, 2007 According to a survey of more than 1,500 allergic rhinitis sufferers, the main reason for their discontinuing use of prescription nasal spray is the device and formulation-related attributes of the treatment. The reasons for stopping prescribed nasal spray treatment are... Continue Reading Posted at 7:21 PM \| Permalink \| Comments
	Eli Lilly’s Cymbalta®, USFDA-Approved for the Treatment of Generalized Anxiety Disorder in Adults Gloria Gamat February 27, 2007 The antidepressant Cymbalta® (duloxetine HCl) – a product of Eli Lilly and Company (NYSE: LLY) – has recently been approved by the USFDA for the treatment of generalized anxiety disorder (GAD) in adults (ages 18 and above). The approval came... Continue Reading Posted at 6:06 PM \| Permalink \| Comments
Feb26	Interesting Finds: Pharma-related Blog Posts 2 Gloria Gamat February 26, 2007 If you liked the first one, here are some more:Can aspirin be an aid to conception and prevent miscarriage?: Straight From The Doc.Steroid-free Astelin for seasonal pollen allergies: AllergizerMassachussets will offer free carvical cancer vaccine: Cancer CommentaryAnti-obesity soya could help... Continue Reading Posted at 9:12 PM \| Permalink \| Comments
Feb25	Avastin® + Chemotherapy Passed International Phase III Study in Advanced Lung Cancer Patients Gloria Gamat February 25, 2007 A Roche-sponsored international Phase III study evaluating two different doses of Genentech’s Avastin® (bevacizumab) in combination with gemcitabine and cisplatin chemotherapy met the primary endpoint of prolonging progression-free survival (PFS) in patients with previously untreated, advanced non-squamous, non-small cell lung... Continue Reading Posted at 11:15 PM \| Permalink \| Comments
	Idenix Pharma’s SEBIVO® (telbivudine) Received EU Positive Opinion as New Treatment for Chronic Hepatitis B Patients Gloria Gamat February 25, 2007 The European Medicines Agency's (EMEA) Committee for Medicinal Products for Human Use (CHMP) has recommended approval and granting of marketing authorization of SEBIVO® (telbivudine). SEBIVO® (telbivudine) is a once-a-day tablet (taken with or without food) for the treatment of chronic... Continue Reading Posted at 10:10 PM \| Permalink \| Comments
	First Digital Insulin Pen with Memory, Launched by Eli Lilly Gloria Gamat February 25, 2007 Eli Lilly and Co. (NYSE: LLY) has recently launched the very first insulin pen with memory - HumaPen® MEMOIR™ - to help simplify the daily management of diabetes. MEMOIR is designed to meet the needs of people with diabetes who take... Continue Reading Posted at 9:13 PM \| Permalink \| Comments
	TorreyPines Therapeutics and Eisai Co., Ltd. Extended Collaboration Agreement on Alzheimer's Disease Gloria Gamat February 25, 2007 Since February 2005, TorreyPines Therapeutics, Inc. (Nasdaq: TPTX) and Eisai Co., Ltd. (TYO: 4523) have been in exclusive collaborative agreement focused on discovery of novel, small molecules for the treatment of Alzheimer's disease. The two companies have recently agreed to... Continue Reading Posted at 8:04 PM \| Permalink \| Comments
Feb22	Shire plc Will Acquire New River Pharmaceuticals for $64 per Share Gloria Gamat February 22, 2007 New River Pharmaceuticals Inc. (Nasdaq: NRPH) has signed a definitive agreement with Shire plc (LON: SHP, Nasdaq: SHPGY, TSE: SHQ).Under the agreement, Shire plc has agreed to acquire New River for $64.00 in cash for each share of NRPH common... Continue Reading Posted at 11:25 PM \| Permalink \| Comments
	Auxilium Pharma’s AA4500 Passed Phase III Clinical Trial for the Treatment of Dupuytren's Contracture Gloria Gamat February 22, 2007 Auxilium Pharmaceuticals, Inc. (Nasdaq: AUXL)’s lead development product AA4500 passed its early Phase III study in the treatment of Dupuytren's contracture. Dupuytren's contracture is a disabling and recurring hand condition characterized by contracting of joints, impairing patients' ability to straighten... Continue Reading Posted at 10:22 PM \| Permalink \| Comments
	GPC Biotech’s Satraplatin Expanded Rapid Access protocol (SPERA) Program, Launched in the U.S. Gloria Gamat February 22, 2007 GPC Biotech AG (FRA: GPC; Nasdaq: GPCB) has recently launched the Satraplatin Expanded Rapid Access protocol (SPERA) in the U.S. Expanded Access Programs (EAPs) are intended to give patients access to investigational drugs to treat serious or life-threatening diseases or... Continue Reading Posted at 9:17 PM \| Permalink \| Comments
	Harvard Developed Novel TB Spray Vaccine Gloria Gamat February 22, 2007 Harvard University bioengineers and public health researchers have been able to develop a novel spraying method in tuberculosis (TB) vaccine delivery. This new needle-free process of TB vaccine delivery offers a better, cheaper approach in future TB vaccination that will... Continue Reading Posted at 8:08 PM \| Permalink \| Comments
Feb20	Interesting Finds: Pharma-Related Blog Posts Gloria Gamat February 20, 2007 It’s not everyday that the science/health/medical blogosphere talk about drugs and medications all the same time. Check out what I found today: At The Biotech Weblog: FDA Approves the First Drug for Obese Dogs At Cancer Commentary: Lung and Colorectal... Continue Reading Posted at 9:38 PM \| Permalink \| Comments
	Merck Stops Lobbying of Mandatory HPV Vaccine Use Gloria Gamat February 20, 2007 Merck (NYSE: MRK) has decided to stop its campaign for the mandate of HPV vaccine (Gardasil) use because, (according to Rick Haupt, director of medical affairs for Merck's vaccine division) the focus had shifted to the campaign rather than to... Continue Reading Posted at 8:45 PM \| Permalink \| Comments
	HIV Drug Darunavir (Prezista™), Granted EU Conditional Marketing Approval Gloria Gamat February 20, 2007 The European Union has granted conditional marketing authorization to Tibotec Pharmaceutical Ltd.’s new protease inhibitor (PI) darunavir (boosted with ritonivir; trade name Prezista™) as a new treatment in combination with Roche’s fusion inhibitor – FUZEON - for patients that are... Continue Reading Posted at 7:10 PM \| Permalink \| Comments
Feb18	ZymoGenetics' BLA for Recombinant Human Thrombin (rhThrombin), Accepted for Review by the USFDA Gloria Gamat February 18, 2007 The Biologics License Application (BLA) of ZymoGenetics, Inc. (Nasdaq: ZGEN) for recombinant human thrombin (rhThrombin) has been accepted by the USFDA. A recombinant form of human thrombin that is not derived from animal or human blood, rhThrombin is being developed... Continue Reading Posted at 9:07 PM \| Permalink \| Comments
	Spectrum Pharma Has Completed Filing of NDA of Satraplatin for Hormone Refractory Prostate Cancer Gloria Gamat February 18, 2007 Spectrum Pharmaceuticals, Inc. (Nasdaq: SPPI) has recently completed submission of its New Drug Application (NDA) to the USFDA for satraplatin. Satraplatin is Spectrum Pharma’s lead drug candidate for the treatment of hormone refractory prostate cancer (HRPC) in patients who have... Continue Reading Posted at 8:09 PM \| Permalink \| Comments
	Florida Policy Roundtable is Urging State Lawmakers to Re-think Mandatory HPV Vaccination Gloria Gamat February 18, 2007 Texas State was the first to agree to the mandatory HPV vaccination of 11-12 year old girls. However, the Florida Policy Roundtable is continuing its campaign to stop such legislation to protect civil rights and the safety of children. According... Continue Reading Posted at 6:51 PM \| Permalink \| Comments
Feb16	Favrille Agreed with Berlex to Use FavId® in Combination With Leukine® (sargramostim) in B-Cell Non-Hodgkin's Lymphoma Gloria Gamat February 16, 2007 Favrille, Inc. (Nasdaq: FVRL) has entered into an agreement with Berlex, Inc. (996344) in order to study the use of Favrille's active immunotherapy, FavId® (Id/KLH), in combination with Berlex's growth factor Leukine® (sargramostim, GM-CSF) in patients with B-cell non-Hodgkin's lymphoma... Continue Reading Posted at 10:52 PM \| Permalink \| Comments
	Peregrine Pharmaceuticals’ Bavituximab Passed Phase Ib Clinical Trial in Chronic Hepatitis C Virus (HCV) Infection Gloria Gamat February 16, 2007 Peregrine Pharmaceuticals, Inc. (Nasdaq: PPHM) has recently reported the top-line results of the company’s Phase lb study of its targeted immunotherapy bavituximab in patients with chronic HCV infection. The results indicate that Peregrine's novel immunotherapeutic drug was generally safe and... Continue Reading Posted at 9:34 PM \| Permalink \| Comments
	Organon and Pharmacopeia Agreed on New Collaboration Gloria Gamat February 16, 2007 Pharmacopeia Drug Discovery Inc. (Nasdaq: PCOP) and Organon (15977549) have entered into a new alliance for the discovery, development and commercialization of therapeutic indications in neuroscience and immunology. The terms of agreement include the following: Pharmacopeia will receive an up-front... Continue Reading Posted at 8:47 PM \| Permalink \| Comments
	Ingenuity Systems Agreed to Expand and Extend Merck Licensing Agreement Gloria Gamat February 16, 2007 Ingenuity Systems, Inc. (5138514) has sealed a multi-year agreement with Merck (NYSE: MRK). With the said agreement, Merck can extend and expand its access to Ingenuity Pathways Analysis (IPA) software. Ingenuity Pathways Analysis is a software application that enables researchers... Continue Reading Posted at 7:58 PM \| Permalink \| Comments
Feb15	About Lorenzo's Oil Gloria Gamat February 15, 2007 The movie Lorenzo's oil was completed in 1992. I was still a struggling college student at the time and for some reason missed the showing of this movie.Last night, I happen to watch it for the first time, thanks to... Continue Reading Posted at 7:33 PM \| Permalink \| Comments
Feb14	Pfizer’s Novel HIV/AIDS Drug Maraviroc, Under Accelerated Review in US and EU Regulatory Agencies Gloria Gamat February 14, 2007 Pfizer (NYSE: PFE)’s marketing authorization applications for maraviroc in the United States and Europe will receive accelerated reviews. Once approved, maraviroc will become the first in a new class of HIV/AIDS drugs called CCR5 antagonists that work by blocking viral... Continue Reading Posted at 9:24 PM \| Permalink \| Comments
	GSK Access Offers Free Prescription Medicines to Eligible Medicare Part D-Enrolled Patients Gloria Gamat February 14, 2007 GSK Access is the newly launched website by GlaxoSmithKline (NYSE: GSK) – a new patient assistance program for low income Medicare Part D patients. Patients can log on to GSK Access or call 1-866-475-3678 to get information on prescription medicines... Continue Reading Posted at 8:10 PM \| Permalink \| Comments
Feb13	Nexavar® Passed Phase III Clinical Trial in Primary Liver Cancer Patients Gloria Gamat February 13, 2007 The Phase 3 clinical trial of Nexavar® (sorafenib) tablets in patients with advanced hepatocellular carcinoma (HCC) or primary liver cancer, has met its primary endpoint. Clinical data demonstrated that treatment with Nexavar® (sorafenib) tablets has significantly extended overall survival (OS)... Continue Reading Posted at 11:37 PM \| Permalink \| Comments
	ViroPharma’s Maribavir, Granted USFDA Orphan Drug Designation for Cytomegalovirus Viremia and Disease Indication Gloria Gamat February 13, 2007 The USFDA has granted Orphan Drug Designation to ViroPharma Incorporated (Nasdaq: VPHM)’s maribavir for the prevention of cytomegalovirus (CMV) viremia and disease in the populations at-risk. Orphan drug designation entitles ViroPharma to seven years of market exclusivity in the United... Continue Reading Posted at 5:32 AM \| Permalink \| Comments
	Anesiva’s New Drug Application (NDA) of Zingo™ for Reduction of Needle Insertion-Painin Children, Accepted by the USFDA Gloria Gamat February 13, 2007 The USFDA has accepted the New Drug Application (NDA)/Common Technical Document (eCTD) submitted by Anesiva, Inc. (Nasdaq: ANSV) for the marketing clearance of Zingo™ for the treatment of pain associated with intravenous cannulation and venipuncture procedures in children. Zingo™ is... Continue Reading Posted at 4:43 AM \| Permalink \| Comments
	Corautus Genetics and VIA Pharmaceuticals Agreed on a Merger Gloria Gamat February 13, 2007 Corautus Genetics Inc. (Nasdaq: VEGF) - formerly known as GenStar Therapeutics Corporation and Urogen Corp. - is a development stage company dedicated to the development of innovative life sciences products. Headquartered in San Francisco, California, VIA Pharmaceuticals, Inc. is a... Continue Reading Posted at 3:30 AM \| Permalink \| Comments
	Lupin’s Sertraline, Approved by the USFDA Gloria Gamat February 13, 2007 The USFDA has granted final approval for Lupin Pharmaceuticals, Inc.’s Abbreviated New Drug Application (ANDA) for Sertraline Hydrochloride Tablets, 25mg, 50mg and 100mg. The company’s Sertraline Tablets are the AB-rated generic equivalent of Pfizer's Zoloft® Tablets that are indicated for... Continue Reading Posted at 2:34 AM \| Permalink \| Comments
	Sanofi-aventis’ sNDA of Lovenox® (Enoxaparin Sodium Injection) for Acute Heart Attack Under USFDA Priority Review Gloria Gamat February 13, 2007 The Supplemental New Drug Application (sNDA) of Sanofi-aventis (NYSE: SNY) for its anticoagualant - Lovenox® (enoxaparin sodium injection) has been accepted by the USFDA and placed at priority review status for the treatment of patients with acute ST-segment elevation myocardial... Continue Reading Posted at 1:30 AM \| Permalink \| Comments
	Pfizer’s Sutent® (sunitinib malate) USFDA-Approved to Include New First-Line Advanced Kidney Cancer Data in Product Label Gloria Gamat February 13, 2007 The USFDA has approved inclusion of first-line treatment of advanced renal cell carcinoma (RCC) in the label of Pfizer (NYSE: PFE)’s Sutent® (sunitinib malate), following large Phase 3 clinical data that demonstrated prolonged progression-free survival.Advanced renal cell carcinoma (RCC) is... Continue Reading Posted at 12:39 AM \| Permalink \| Comments
Feb11	ImmuneRegen's Viprovex™ Demonstrated Potential in Treatment of Avian Influenza and Spanish Flu Gloria Gamat February 11, 2007 Based on the company’s animal studies, ImmuneRegen BioSciences’ Viprovex™ has demonstrated potential for treating potentially resurgent Spanish Flu (H1N1), Avian Flu (H5N1) and other infectious diseases. Viprovex™ is the trade name used in referring to formulations of Homspera for potential... Continue Reading Posted at 10:42 PM \| Permalink \| Comments
	2007 Shingo Prize for Excellence in Manufacturing Goes to Two Baxter Int’l. Facilities Gloria Gamat February 11, 2007 The following Baxter International Inc. (NYSE: BAX) manufacturing facilities are being awarded the 2007 Shingo Prize for Excellence in Manufacturing: North Cove facility in Marion, North CarolinaCuernavaca facility in Morelos, Mexico…the Shingo Prize for Excellence in Manufacturing has honored businesses... Continue Reading Posted at 9:33 PM \| Permalink \| Comments
	Pharmacokinetics of KADIAN® (morphine sulfate extended-release), Not Significantly Affected by Alcohol Consumption Gloria Gamat February 11, 2007 Clinical data from the Phase IV study of Alpharma, Inc. (NYSE: ALO)’s KADIAN® (morphine sulfate extended-release) demonstrated that the long-acting opiod’s pharmacokinetics is not significantly affected by alcohol consumption. KADIAN® (morphine sulfate extended-release) Capsules are an extended- release formulation of... Continue Reading Posted at 8:33 PM \| Permalink \| Comments
	Alphanate, New Product USFDA-Approved for von Willebrand Disease Gloria Gamat February 11, 2007 Manufactured by Grifols Biologicals, Inc. (MCE: GRF), Antihemophilic Factor/von Willebrand Factor Complex (Human) – Alphanate – has recently been approved by the USFDA for patients undergoing surgery or invasive procedures with von Willebrand disease (vWD), when the hormone desmopressin is either... Continue Reading Posted at 7:32 PM \| Permalink \| Comments
	Ranbaxy Signed New R&D Agreement with GlaxoSmithKline Gloria Gamat February 11, 2007 In modification and expansion of their 2003 strategic alliance, Ranbaxy Laboratories (BOM:500359) and GlaxoSmithKline (NYSE: GSK) have signed a new multiyear R&D agreement, providing Ranbaxy with an expanded drug development responsibilities and more financial opportunities. The terms of agreement include: Ranbaxy... Continue Reading Posted at 6:42 PM \| Permalink \| Comments
Feb 7	WEHI and Genentech Collaboration, To Develop New Cancer Drugs Gloria Gamat February 7, 2007 For the development, manufacture and commercialization of a new class of broad spectrum cancer therapeutics, the Walter and Eliza Hall Institute of Medical Research (WEHI) has entered into an exclusive global collaboration agreement with Genentech, Inc. (NYSE: DNA). With the... Continue Reading Posted at 11:26 PM \| Permalink \| Comments
	BioCryst’s Fodosine™, Granted EMEA Orphan Drug Status for Cutaneous T-cell Lymphoma (CTCL) Gloria Gamat February 7, 2007 BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX)’s Fodosine™ has been granted by the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMEA) an orphan drug status for the treatment of cutaneous T-cell lymphoma (CTCL). BioCryst’s leading oncology candidate, Fodosine™... Continue Reading Posted at 10:27 PM \| Permalink \| Comments
	AXM Shengyang Acquires Yuhuatang Gloria Gamat February 7, 2007 The wholly-owned subsidiary of AXM Pharma Inc. (OTC: AXMP) - AXM Shengyang – has entered into an Acquisition Restructure and Technology Transfer Agreement with Beijing Yuhuatang Biological Sci-Tech Development Co., Ltd. (Yuhuatang) - a leading Chinese research institute. The terms... Continue Reading Posted at 9:39 PM \| Permalink \| Comments
	ImClone and Bristol-Myer Squibb’s ERBITUX ®, under Japanese PMDA Evaluation for Treatment of Advanced Colorectal Cancer Gloria Gamat February 7, 2007 ImClone Systems (Nasdaq: IMCL) and Bristol-Myers Squibb Company (NYSE: BMY) have submitted its application to the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) for the use of ERBITUX® (Cetuximab) in the treatment of advanced colorectal cancer patients. The said application... Continue Reading Posted at 8:30 PM \| Permalink \| Comments
	elbion NV and Wyeth to Develop New Treatments for Schizophrenia Gloria Gamat February 7, 2007 elbion NV has entered into a research and license agreement with Wyeth Pharmaceuticals (10944776) on its phosphodiesterase 10 (PDE10) program for CNS disorders, focusing initially on schizophrenia. The terms of agreement include: elbion will get an upfront payment, milestones and... Continue Reading Posted at 7:19 PM \| Permalink \| Comments
Feb 6	Cervical Cancer Vaccination: A Mandate in Texas State Gloria Gamat February 6, 2007 Schoolgirls in Texas must be vaccinated against the cervical cancer-causing HPV (human papillomavirus), as a mandate ordered by Texas Gov. Rick Perry. Merck's cervical cancer vaccine, Gardasil has been approved in June 2006 and is recommended for girls as early... Continue Reading Posted at 7:03 PM \| Permalink \| Comments
	Wyeth Pharmaceuticals and Nautilus Biotech Collaborates for Development of Hemophilia Therapies Gloria Gamat February 6, 2007 Wyeth Pharmaceuticals (10944776), a division of Wyeth (NYSE: WYE), and Nautilus Biotech (Evry, France) have signed a research collaboration and license agreement for the discovery and development of novel recombinant Factor IX proteins for the treatment of hemophilia B. The... Continue Reading Posted at 6:19 PM \| Permalink \| Comments
Feb 5	Majority Stake in Beijing Boran Pharmaceutical, Acquired by China Health Holding Gloria Gamat February 5, 2007 China Health Holding, Inc. (OTC: CHHH) is a development stage company focused on becoming a leading developer, manufacturer, marketer and distributor of pharmaceutical drugs and dietary supplements in China and worldwide. The company has recently executed a definitive agreement for... Continue Reading Posted at 10:31 PM \| Permalink \| Comments
	CSL Behring and Bayer Healthcare Agreed to Extend Agreement for Supply of Helixate® Recombinant Coagulation Factor Gloria Gamat February 5, 2007 CSL Behring (5950871) has agreed with Bayer Healthcare (16159456) for the continuation of supply and distribution of Helixate® recombinant coagulation Factor VIII- an important therapy for hemophilia A treatment. Under the extended contract: Bayer will continue to supply Helixate® recombinant... Continue Reading Posted at 9:20 PM \| Permalink \| Comments
	China’s Aida Pharmaceuticals won Etimicin Sulfate Patent Lawsuit Gloria Gamat February 5, 2007 Aida Pharmaceuticals, Inc. (OTC Bulletin Board: AIDA) is one of mainland China's leading pharmaceutical companies who patented the transfusion form of Etimicin Sulfate – an antibiotic. The company has recently won an infringement lawsuit against four counterfeit drug suppliers of... Continue Reading Posted at 8:34 PM \| Permalink \| Comments
Feb 4	Genentech’s Raptiva® (efalizumab) Passed Phase IV Study in Moderate-to-Severe Hand and Foot Psoriasis Patients Gloria Gamat February 4, 2007 Patients with chronic moderate-to-severe plaque psoriasis involving the hands and Feet are a uniquely challenged subpopulation of psoriasis patients. Phase IV study of Genentech (NYSE: DNA)’s Raptiva® (efalizumab) in this particular population yielded positive results - a first randomized clinical... Continue Reading Posted at 11:19 PM \| Permalink \| Comments
	New Dosing Recommendations for RAPAMUNE® (sirolimus) in High Immunologic Risk Renal Transplant Patients, Approved by the USFDA Gloria Gamat February 4, 2007 Wyeth Pharmaceuticals’ immunosuppressant drug RAPAMUNE® (sirolimus) has been approved by the USFDA of its new dosing recommendations. RAPAMUNE® is the first and only kidney transplant therapeutic with dosing recommendations specifically for the treatment of high immunologic risk renal transplant recipients.... Continue Reading Posted at 10:29 PM \| Permalink \| Comments
	Anacor Signed Worldwide Exclusive License Agreement with Schering-Plough for New Topical Anti-Fungal, AN2690 Gloria Gamat February 4, 2007 A privately held pharmaceutical company – Anacor Pharmaceuticals (14194587) – has recently entered into an exclusive, worldwide agreement with Schering-Plough Corporation (NYSE: SGP) for the development and commercialization of AN2690. AN2690 is Anacor Pharmaceuticals’ topical anti-fungal therapy under Phase II clinical trials... Continue Reading Posted at 9:18 PM \| Permalink \| Comments
	Pfizer Agreed to Acquire BioRexis Pharmaceutical Gloria Gamat February 4, 2007 BioRexis Pharmaceutical Corporation is a privately-held biopharmaceutical company with a number of diabetes candidates and a novel technology platform for developing new protein drug candidates. Not disclosing the financial terms of agreement, Pfizer, Inc. (NYSE: PFE) is going to acquire BioRexis.... Continue Reading Posted at 8:15 PM \| Permalink \| Comments
	Acquisition of Arrow Therapeutics Broadens AstraZeneca’s Anti-Infective Portfolio Gloria Gamat February 4, 2007 Arrow Therapeutics Ltd. (11137618) is a privately owned UK biotechnology company focused on the discovery and development of anti-viral therapies. Recently, AstraZeneca (LON: AZN) announced its agreement to acquire Arrow Therapeutics, purchasing the company’s total share capital for US$150 Million... Continue Reading Posted at 7:05 PM \| Permalink \| Comments
Feb 2	MediVas Collaborates With Merck in Area of Biologics Gloria Gamat February 2, 2007 A developer of novel drug delivery – MediVas, LLC – has recently signed an exclusive technology evaluation and exclusive option agreements with Merck & Co., Inc. (NYSE: MRK) focused on several orally available biologics delivered using MediVas' proprietary polymer delivery system.... Continue Reading Posted at 11:24 PM \| Permalink \| Comments
	USFDA Accepted Pharmion’s IND for Oral Azacitidine (Vidaza®) Gloria Gamat February 2, 2007 Submitted in December 2006, Pharmion Corporation (Nasdaq: PHRM) Investigational New Drug (IND) application for the Company's oral formulation of azacitidine is now active following its acceptance by the USFDA. The parenteral formulation of azacitidine - Vidaza® (azacitidine for injection) -... Continue Reading Posted at 10:31 PM \| Permalink \| Comments
	AstraZeneca and Palatin Technologies Collaborates to Discover, Develop and Commercialise Small Molecule Obesity Compounds Gloria Gamat February 2, 2007 An exclusive global licensing and research collaboration agreement between AstraZeneca (NYSE: AZN) and Palatin Technologies (AMEX:PTN) has recently been established for the discovery, development and commercialization of small molecule compounds targeting melanocortin receptors. The collaboration will be based from Palatin’s... Continue Reading Posted at 9:33 PM \| Permalink \| Comments
	Institute of Materia Medica and TB Alliance Will Develop Improved TB Drugs Gloria Gamat February 2, 2007 A member of the Chinese Academy of Medical Sciences, The Institute of Materia Media (IMM) have entered into a joint research partnership with the Global Alliance for TB Drug Development (TB Alliance) to develop promising, novel anti-tuberculosis drugs. The said... Continue Reading Posted at 8:44 PM \| Permalink \| Comments
Feb 1	Patent for Heat Shock Protein (Hsp) Fusion for Flu Treatment, Awarded to Nventa Biopharma Gloria Gamat February 1, 2007 The U.S. Patent and Trademark Office (USPTO) have issued Patent Number 7,157,089 to Nventa Biopharmaceuticals Corporation (TSE: NVN). The said patent covers compositions of fusion proteins comprised of an influenza antigen fused to a heat shock protein (Hsp), as well... Continue Reading Posted at 8:12 PM \| Permalink \| Comments
	Laureate Pharma in Manufacturing Agreement with Trubion Pharmaceuticals Gloria Gamat February 1, 2007 Laureate Pharma, Inc. (11061029) has entered into an agreement for the manufacture of Trubion Pharmaceuticals, Inc. (Nasdaq: TRBN)'s TRU-016. TRU-016, a novel protein for the treatment of non-Hodgkin's lymphoma (NHL) and chronic lymphocytic leukemia (CLL), is designed to target CD37,... Continue Reading Posted at 7:31 PM \| Permalink \| Comments

« January 2007 | Main | March 2007 »

Feb28	Abbott’s HUMIRA® (Adalimumab), USFDA-Approved for Crohn's Disease Treatment Gloria Gamat February 28, 2007 Know More: Drug Regulations & Approval Abbott, Antibodies, Crohn's The USFDA granted marketing approval to Abbott (NYSE: ABT) for HUMIRA® (adalimumab) with the following new indications: treatment for reducing the signs and symptoms and inducing and maintaining clinical remission in adults with moderately to severely active Crohn's disease who have had an inadequate response to conventional therapy reducing the signs and symptoms and inducing clinical remission in these patients if they have also lost response to or are intolerant to infliximab - the only other approved biologic for treatment of Crohn's disease Crohn's disease (the fourth USFDA approval in immune-mediated diseases for HUMIRA®) is a serious chronic, inflammatory disease of the gastrointestinal (GI) with no medical or surgical cure and only a few options for patients with this chronic condition. HUMIRA® - the only fully human monoclonal antibody approved for the treatment of rheumatoid arthritis (RA), psoriatic arthritis (PsA), and ankylosing spondylitis (AS) in the U.S. and Europe (in addition to Crohn’s disease in the U.S.) - works by blocking TNF-alpha, a protein that when produced in excess, plays a central role in the inflammatory responses of many immune-mediated diseases. Find more details from the press release. Posted at 9:04 PM \| Permalink \| Comments
Feb28	Unit Dose Budesonide (UDB): MAP Pharma’s Pediatric Asthma Drug Candidate, Passed Phase 2 Clinical Trial Gloria Gamat February 28, 2007 MAP Pharmaceuticals, Inc.’s drug candidate - Unit Dose Budesonide (UDB) - is a proprietary nebulized formulation of budesonide for treatment of pediatric asthma. In a U.S. based Phase 2 clinical trial UDB met its primary efficacy endpoints. The primary endpoints... Continue Reading Posted at 7:48 PM \| Permalink \| Comments
	Albuferon® + Ribavirin, Passed Phase 2b Clinical Trial in Treatment-Naïve Genotype 1 Chronic Hepatitis C (HCV) Patients Gloria Gamat February 28, 2007 Human Genome Sciences (Nasdaq: HGSI) recently announced the positive results of its Phase 2b clinical trial of Albuferon® (albinterferon alfa-2b) in combination with ribavirin in patients with genotype 1 chronic hepatitis C (HCV) who are naive to interferon alpha-based treatment... Continue Reading Posted at 6:48 PM \| Permalink \| Comments
Feb27	Survey Reveals Reason for Allergic Rhinitis Patients to Discontinue Treatment of Existing Nasal Sprays Gloria Gamat February 27, 2007 According to a survey of more than 1,500 allergic rhinitis sufferers, the main reason for their discontinuing use of prescription nasal spray is the device and formulation-related attributes of the treatment. The reasons for stopping prescribed nasal spray treatment are... Continue Reading Posted at 7:21 PM \| Permalink \| Comments
	Eli Lilly’s Cymbalta®, USFDA-Approved for the Treatment of Generalized Anxiety Disorder in Adults Gloria Gamat February 27, 2007 The antidepressant Cymbalta® (duloxetine HCl) – a product of Eli Lilly and Company (NYSE: LLY) – has recently been approved by the USFDA for the treatment of generalized anxiety disorder (GAD) in adults (ages 18 and above). The approval came... Continue Reading Posted at 6:06 PM \| Permalink \| Comments
Feb26	Interesting Finds: Pharma-related Blog Posts 2 Gloria Gamat February 26, 2007 If you liked the first one, here are some more:Can aspirin be an aid to conception and prevent miscarriage?: Straight From The Doc.Steroid-free Astelin for seasonal pollen allergies: AllergizerMassachussets will offer free carvical cancer vaccine: Cancer CommentaryAnti-obesity soya could help... Continue Reading Posted at 9:12 PM \| Permalink \| Comments
Feb25	Avastin® + Chemotherapy Passed International Phase III Study in Advanced Lung Cancer Patients Gloria Gamat February 25, 2007 A Roche-sponsored international Phase III study evaluating two different doses of Genentech’s Avastin® (bevacizumab) in combination with gemcitabine and cisplatin chemotherapy met the primary endpoint of prolonging progression-free survival (PFS) in patients with previously untreated, advanced non-squamous, non-small cell lung... Continue Reading Posted at 11:15 PM \| Permalink \| Comments
	Idenix Pharma’s SEBIVO® (telbivudine) Received EU Positive Opinion as New Treatment for Chronic Hepatitis B Patients Gloria Gamat February 25, 2007 The European Medicines Agency's (EMEA) Committee for Medicinal Products for Human Use (CHMP) has recommended approval and granting of marketing authorization of SEBIVO® (telbivudine). SEBIVO® (telbivudine) is a once-a-day tablet (taken with or without food) for the treatment of chronic... Continue Reading Posted at 10:10 PM \| Permalink \| Comments
	First Digital Insulin Pen with Memory, Launched by Eli Lilly Gloria Gamat February 25, 2007 Eli Lilly and Co. (NYSE: LLY) has recently launched the very first insulin pen with memory - HumaPen® MEMOIR™ - to help simplify the daily management of diabetes. MEMOIR is designed to meet the needs of people with diabetes who take... Continue Reading Posted at 9:13 PM \| Permalink \| Comments
	TorreyPines Therapeutics and Eisai Co., Ltd. Extended Collaboration Agreement on Alzheimer's Disease Gloria Gamat February 25, 2007 Since February 2005, TorreyPines Therapeutics, Inc. (Nasdaq: TPTX) and Eisai Co., Ltd. (TYO: 4523) have been in exclusive collaborative agreement focused on discovery of novel, small molecules for the treatment of Alzheimer's disease. The two companies have recently agreed to... Continue Reading Posted at 8:04 PM \| Permalink \| Comments
Feb22	Shire plc Will Acquire New River Pharmaceuticals for $64 per Share Gloria Gamat February 22, 2007 New River Pharmaceuticals Inc. (Nasdaq: NRPH) has signed a definitive agreement with Shire plc (LON: SHP, Nasdaq: SHPGY, TSE: SHQ).Under the agreement, Shire plc has agreed to acquire New River for $64.00 in cash for each share of NRPH common... Continue Reading Posted at 11:25 PM \| Permalink \| Comments
	Auxilium Pharma’s AA4500 Passed Phase III Clinical Trial for the Treatment of Dupuytren's Contracture Gloria Gamat February 22, 2007 Auxilium Pharmaceuticals, Inc. (Nasdaq: AUXL)’s lead development product AA4500 passed its early Phase III study in the treatment of Dupuytren's contracture. Dupuytren's contracture is a disabling and recurring hand condition characterized by contracting of joints, impairing patients' ability to straighten... Continue Reading Posted at 10:22 PM \| Permalink \| Comments
	GPC Biotech’s Satraplatin Expanded Rapid Access protocol (SPERA) Program, Launched in the U.S. Gloria Gamat February 22, 2007 GPC Biotech AG (FRA: GPC; Nasdaq: GPCB) has recently launched the Satraplatin Expanded Rapid Access protocol (SPERA) in the U.S. Expanded Access Programs (EAPs) are intended to give patients access to investigational drugs to treat serious or life-threatening diseases or... Continue Reading Posted at 9:17 PM \| Permalink \| Comments
	Harvard Developed Novel TB Spray Vaccine Gloria Gamat February 22, 2007 Harvard University bioengineers and public health researchers have been able to develop a novel spraying method in tuberculosis (TB) vaccine delivery. This new needle-free process of TB vaccine delivery offers a better, cheaper approach in future TB vaccination that will... Continue Reading Posted at 8:08 PM \| Permalink \| Comments
Feb20	Interesting Finds: Pharma-Related Blog Posts Gloria Gamat February 20, 2007 It’s not everyday that the science/health/medical blogosphere talk about drugs and medications all the same time. Check out what I found today: At The Biotech Weblog: FDA Approves the First Drug for Obese Dogs At Cancer Commentary: Lung and Colorectal... Continue Reading Posted at 9:38 PM \| Permalink \| Comments
	Merck Stops Lobbying of Mandatory HPV Vaccine Use Gloria Gamat February 20, 2007 Merck (NYSE: MRK) has decided to stop its campaign for the mandate of HPV vaccine (Gardasil) use because, (according to Rick Haupt, director of medical affairs for Merck's vaccine division) the focus had shifted to the campaign rather than to... Continue Reading Posted at 8:45 PM \| Permalink \| Comments
	HIV Drug Darunavir (Prezista™), Granted EU Conditional Marketing Approval Gloria Gamat February 20, 2007 The European Union has granted conditional marketing authorization to Tibotec Pharmaceutical Ltd.’s new protease inhibitor (PI) darunavir (boosted with ritonivir; trade name Prezista™) as a new treatment in combination with Roche’s fusion inhibitor – FUZEON - for patients that are... Continue Reading Posted at 7:10 PM \| Permalink \| Comments
Feb18	ZymoGenetics' BLA for Recombinant Human Thrombin (rhThrombin), Accepted for Review by the USFDA Gloria Gamat February 18, 2007 The Biologics License Application (BLA) of ZymoGenetics, Inc. (Nasdaq: ZGEN) for recombinant human thrombin (rhThrombin) has been accepted by the USFDA. A recombinant form of human thrombin that is not derived from animal or human blood, rhThrombin is being developed... Continue Reading Posted at 9:07 PM \| Permalink \| Comments
	Spectrum Pharma Has Completed Filing of NDA of Satraplatin for Hormone Refractory Prostate Cancer Gloria Gamat February 18, 2007 Spectrum Pharmaceuticals, Inc. (Nasdaq: SPPI) has recently completed submission of its New Drug Application (NDA) to the USFDA for satraplatin. Satraplatin is Spectrum Pharma’s lead drug candidate for the treatment of hormone refractory prostate cancer (HRPC) in patients who have... Continue Reading Posted at 8:09 PM \| Permalink \| Comments
	Florida Policy Roundtable is Urging State Lawmakers to Re-think Mandatory HPV Vaccination Gloria Gamat February 18, 2007 Texas State was the first to agree to the mandatory HPV vaccination of 11-12 year old girls. However, the Florida Policy Roundtable is continuing its campaign to stop such legislation to protect civil rights and the safety of children. According... Continue Reading Posted at 6:51 PM \| Permalink \| Comments
Feb16	Favrille Agreed with Berlex to Use FavId® in Combination With Leukine® (sargramostim) in B-Cell Non-Hodgkin's Lymphoma Gloria Gamat February 16, 2007 Favrille, Inc. (Nasdaq: FVRL) has entered into an agreement with Berlex, Inc. (996344) in order to study the use of Favrille's active immunotherapy, FavId® (Id/KLH), in combination with Berlex's growth factor Leukine® (sargramostim, GM-CSF) in patients with B-cell non-Hodgkin's lymphoma... Continue Reading Posted at 10:52 PM \| Permalink \| Comments
	Peregrine Pharmaceuticals’ Bavituximab Passed Phase Ib Clinical Trial in Chronic Hepatitis C Virus (HCV) Infection Gloria Gamat February 16, 2007 Peregrine Pharmaceuticals, Inc. (Nasdaq: PPHM) has recently reported the top-line results of the company’s Phase lb study of its targeted immunotherapy bavituximab in patients with chronic HCV infection. The results indicate that Peregrine's novel immunotherapeutic drug was generally safe and... Continue Reading Posted at 9:34 PM \| Permalink \| Comments
	Organon and Pharmacopeia Agreed on New Collaboration Gloria Gamat February 16, 2007 Pharmacopeia Drug Discovery Inc. (Nasdaq: PCOP) and Organon (15977549) have entered into a new alliance for the discovery, development and commercialization of therapeutic indications in neuroscience and immunology. The terms of agreement include the following: Pharmacopeia will receive an up-front... Continue Reading Posted at 8:47 PM \| Permalink \| Comments
	Ingenuity Systems Agreed to Expand and Extend Merck Licensing Agreement Gloria Gamat February 16, 2007 Ingenuity Systems, Inc. (5138514) has sealed a multi-year agreement with Merck (NYSE: MRK). With the said agreement, Merck can extend and expand its access to Ingenuity Pathways Analysis (IPA) software. Ingenuity Pathways Analysis is a software application that enables researchers... Continue Reading Posted at 7:58 PM \| Permalink \| Comments
Feb15	About Lorenzo's Oil Gloria Gamat February 15, 2007 The movie Lorenzo's oil was completed in 1992. I was still a struggling college student at the time and for some reason missed the showing of this movie.Last night, I happen to watch it for the first time, thanks to... Continue Reading Posted at 7:33 PM \| Permalink \| Comments
Feb14	Pfizer’s Novel HIV/AIDS Drug Maraviroc, Under Accelerated Review in US and EU Regulatory Agencies Gloria Gamat February 14, 2007 Pfizer (NYSE: PFE)’s marketing authorization applications for maraviroc in the United States and Europe will receive accelerated reviews. Once approved, maraviroc will become the first in a new class of HIV/AIDS drugs called CCR5 antagonists that work by blocking viral... Continue Reading Posted at 9:24 PM \| Permalink \| Comments
	GSK Access Offers Free Prescription Medicines to Eligible Medicare Part D-Enrolled Patients Gloria Gamat February 14, 2007 GSK Access is the newly launched website by GlaxoSmithKline (NYSE: GSK) – a new patient assistance program for low income Medicare Part D patients. Patients can log on to GSK Access or call 1-866-475-3678 to get information on prescription medicines... Continue Reading Posted at 8:10 PM \| Permalink \| Comments
Feb13	Nexavar® Passed Phase III Clinical Trial in Primary Liver Cancer Patients Gloria Gamat February 13, 2007 The Phase 3 clinical trial of Nexavar® (sorafenib) tablets in patients with advanced hepatocellular carcinoma (HCC) or primary liver cancer, has met its primary endpoint. Clinical data demonstrated that treatment with Nexavar® (sorafenib) tablets has significantly extended overall survival (OS)... Continue Reading Posted at 11:37 PM \| Permalink \| Comments
	ViroPharma’s Maribavir, Granted USFDA Orphan Drug Designation for Cytomegalovirus Viremia and Disease Indication Gloria Gamat February 13, 2007 The USFDA has granted Orphan Drug Designation to ViroPharma Incorporated (Nasdaq: VPHM)’s maribavir for the prevention of cytomegalovirus (CMV) viremia and disease in the populations at-risk. Orphan drug designation entitles ViroPharma to seven years of market exclusivity in the United... Continue Reading Posted at 5:32 AM \| Permalink \| Comments
	Anesiva’s New Drug Application (NDA) of Zingo™ for Reduction of Needle Insertion-Painin Children, Accepted by the USFDA Gloria Gamat February 13, 2007 The USFDA has accepted the New Drug Application (NDA)/Common Technical Document (eCTD) submitted by Anesiva, Inc. (Nasdaq: ANSV) for the marketing clearance of Zingo™ for the treatment of pain associated with intravenous cannulation and venipuncture procedures in children. Zingo™ is... Continue Reading Posted at 4:43 AM \| Permalink \| Comments
	Corautus Genetics and VIA Pharmaceuticals Agreed on a Merger Gloria Gamat February 13, 2007 Corautus Genetics Inc. (Nasdaq: VEGF) - formerly known as GenStar Therapeutics Corporation and Urogen Corp. - is a development stage company dedicated to the development of innovative life sciences products. Headquartered in San Francisco, California, VIA Pharmaceuticals, Inc. is a... Continue Reading Posted at 3:30 AM \| Permalink \| Comments
	Lupin’s Sertraline, Approved by the USFDA Gloria Gamat February 13, 2007 The USFDA has granted final approval for Lupin Pharmaceuticals, Inc.’s Abbreviated New Drug Application (ANDA) for Sertraline Hydrochloride Tablets, 25mg, 50mg and 100mg. The company’s Sertraline Tablets are the AB-rated generic equivalent of Pfizer's Zoloft® Tablets that are indicated for... Continue Reading Posted at 2:34 AM \| Permalink \| Comments
	Sanofi-aventis’ sNDA of Lovenox® (Enoxaparin Sodium Injection) for Acute Heart Attack Under USFDA Priority Review Gloria Gamat February 13, 2007 The Supplemental New Drug Application (sNDA) of Sanofi-aventis (NYSE: SNY) for its anticoagualant - Lovenox® (enoxaparin sodium injection) has been accepted by the USFDA and placed at priority review status for the treatment of patients with acute ST-segment elevation myocardial... Continue Reading Posted at 1:30 AM \| Permalink \| Comments
	Pfizer’s Sutent® (sunitinib malate) USFDA-Approved to Include New First-Line Advanced Kidney Cancer Data in Product Label Gloria Gamat February 13, 2007 The USFDA has approved inclusion of first-line treatment of advanced renal cell carcinoma (RCC) in the label of Pfizer (NYSE: PFE)’s Sutent® (sunitinib malate), following large Phase 3 clinical data that demonstrated prolonged progression-free survival.Advanced renal cell carcinoma (RCC) is... Continue Reading Posted at 12:39 AM \| Permalink \| Comments
Feb11	ImmuneRegen's Viprovex™ Demonstrated Potential in Treatment of Avian Influenza and Spanish Flu Gloria Gamat February 11, 2007 Based on the company’s animal studies, ImmuneRegen BioSciences’ Viprovex™ has demonstrated potential for treating potentially resurgent Spanish Flu (H1N1), Avian Flu (H5N1) and other infectious diseases. Viprovex™ is the trade name used in referring to formulations of Homspera for potential... Continue Reading Posted at 10:42 PM \| Permalink \| Comments
	2007 Shingo Prize for Excellence in Manufacturing Goes to Two Baxter Int’l. Facilities Gloria Gamat February 11, 2007 The following Baxter International Inc. (NYSE: BAX) manufacturing facilities are being awarded the 2007 Shingo Prize for Excellence in Manufacturing: North Cove facility in Marion, North CarolinaCuernavaca facility in Morelos, Mexico…the Shingo Prize for Excellence in Manufacturing has honored businesses... Continue Reading Posted at 9:33 PM \| Permalink \| Comments
	Pharmacokinetics of KADIAN® (morphine sulfate extended-release), Not Significantly Affected by Alcohol Consumption Gloria Gamat February 11, 2007 Clinical data from the Phase IV study of Alpharma, Inc. (NYSE: ALO)’s KADIAN® (morphine sulfate extended-release) demonstrated that the long-acting opiod’s pharmacokinetics is not significantly affected by alcohol consumption. KADIAN® (morphine sulfate extended-release) Capsules are an extended- release formulation of... Continue Reading Posted at 8:33 PM \| Permalink \| Comments
	Alphanate, New Product USFDA-Approved for von Willebrand Disease Gloria Gamat February 11, 2007 Manufactured by Grifols Biologicals, Inc. (MCE: GRF), Antihemophilic Factor/von Willebrand Factor Complex (Human) – Alphanate – has recently been approved by the USFDA for patients undergoing surgery or invasive procedures with von Willebrand disease (vWD), when the hormone desmopressin is either... Continue Reading Posted at 7:32 PM \| Permalink \| Comments
	Ranbaxy Signed New R&D Agreement with GlaxoSmithKline Gloria Gamat February 11, 2007 In modification and expansion of their 2003 strategic alliance, Ranbaxy Laboratories (BOM:500359) and GlaxoSmithKline (NYSE: GSK) have signed a new multiyear R&D agreement, providing Ranbaxy with an expanded drug development responsibilities and more financial opportunities. The terms of agreement include: Ranbaxy... Continue Reading Posted at 6:42 PM \| Permalink \| Comments
Feb 7	WEHI and Genentech Collaboration, To Develop New Cancer Drugs Gloria Gamat February 7, 2007 For the development, manufacture and commercialization of a new class of broad spectrum cancer therapeutics, the Walter and Eliza Hall Institute of Medical Research (WEHI) has entered into an exclusive global collaboration agreement with Genentech, Inc. (NYSE: DNA). With the... Continue Reading Posted at 11:26 PM \| Permalink \| Comments
	BioCryst’s Fodosine™, Granted EMEA Orphan Drug Status for Cutaneous T-cell Lymphoma (CTCL) Gloria Gamat February 7, 2007 BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX)’s Fodosine™ has been granted by the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMEA) an orphan drug status for the treatment of cutaneous T-cell lymphoma (CTCL). BioCryst’s leading oncology candidate, Fodosine™... Continue Reading Posted at 10:27 PM \| Permalink \| Comments
	AXM Shengyang Acquires Yuhuatang Gloria Gamat February 7, 2007 The wholly-owned subsidiary of AXM Pharma Inc. (OTC: AXMP) - AXM Shengyang – has entered into an Acquisition Restructure and Technology Transfer Agreement with Beijing Yuhuatang Biological Sci-Tech Development Co., Ltd. (Yuhuatang) - a leading Chinese research institute. The terms... Continue Reading Posted at 9:39 PM \| Permalink \| Comments
	ImClone and Bristol-Myer Squibb’s ERBITUX ®, under Japanese PMDA Evaluation for Treatment of Advanced Colorectal Cancer Gloria Gamat February 7, 2007 ImClone Systems (Nasdaq: IMCL) and Bristol-Myers Squibb Company (NYSE: BMY) have submitted its application to the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) for the use of ERBITUX® (Cetuximab) in the treatment of advanced colorectal cancer patients. The said application... Continue Reading Posted at 8:30 PM \| Permalink \| Comments
	elbion NV and Wyeth to Develop New Treatments for Schizophrenia Gloria Gamat February 7, 2007 elbion NV has entered into a research and license agreement with Wyeth Pharmaceuticals (10944776) on its phosphodiesterase 10 (PDE10) program for CNS disorders, focusing initially on schizophrenia. The terms of agreement include: elbion will get an upfront payment, milestones and... Continue Reading Posted at 7:19 PM \| Permalink \| Comments
Feb 6	Cervical Cancer Vaccination: A Mandate in Texas State Gloria Gamat February 6, 2007 Schoolgirls in Texas must be vaccinated against the cervical cancer-causing HPV (human papillomavirus), as a mandate ordered by Texas Gov. Rick Perry. Merck's cervical cancer vaccine, Gardasil has been approved in June 2006 and is recommended for girls as early... Continue Reading Posted at 7:03 PM \| Permalink \| Comments
	Wyeth Pharmaceuticals and Nautilus Biotech Collaborates for Development of Hemophilia Therapies Gloria Gamat February 6, 2007 Wyeth Pharmaceuticals (10944776), a division of Wyeth (NYSE: WYE), and Nautilus Biotech (Evry, France) have signed a research collaboration and license agreement for the discovery and development of novel recombinant Factor IX proteins for the treatment of hemophilia B. The... Continue Reading Posted at 6:19 PM \| Permalink \| Comments
Feb 5	Majority Stake in Beijing Boran Pharmaceutical, Acquired by China Health Holding Gloria Gamat February 5, 2007 China Health Holding, Inc. (OTC: CHHH) is a development stage company focused on becoming a leading developer, manufacturer, marketer and distributor of pharmaceutical drugs and dietary supplements in China and worldwide. The company has recently executed a definitive agreement for... Continue Reading Posted at 10:31 PM \| Permalink \| Comments
	CSL Behring and Bayer Healthcare Agreed to Extend Agreement for Supply of Helixate® Recombinant Coagulation Factor Gloria Gamat February 5, 2007 CSL Behring (5950871) has agreed with Bayer Healthcare (16159456) for the continuation of supply and distribution of Helixate® recombinant coagulation Factor VIII- an important therapy for hemophilia A treatment. Under the extended contract: Bayer will continue to supply Helixate® recombinant... Continue Reading Posted at 9:20 PM \| Permalink \| Comments
	China’s Aida Pharmaceuticals won Etimicin Sulfate Patent Lawsuit Gloria Gamat February 5, 2007 Aida Pharmaceuticals, Inc. (OTC Bulletin Board: AIDA) is one of mainland China's leading pharmaceutical companies who patented the transfusion form of Etimicin Sulfate – an antibiotic. The company has recently won an infringement lawsuit against four counterfeit drug suppliers of... Continue Reading Posted at 8:34 PM \| Permalink \| Comments
Feb 4	Genentech’s Raptiva® (efalizumab) Passed Phase IV Study in Moderate-to-Severe Hand and Foot Psoriasis Patients Gloria Gamat February 4, 2007 Patients with chronic moderate-to-severe plaque psoriasis involving the hands and Feet are a uniquely challenged subpopulation of psoriasis patients. Phase IV study of Genentech (NYSE: DNA)’s Raptiva® (efalizumab) in this particular population yielded positive results - a first randomized clinical... Continue Reading Posted at 11:19 PM \| Permalink \| Comments
	New Dosing Recommendations for RAPAMUNE® (sirolimus) in High Immunologic Risk Renal Transplant Patients, Approved by the USFDA Gloria Gamat February 4, 2007 Wyeth Pharmaceuticals’ immunosuppressant drug RAPAMUNE® (sirolimus) has been approved by the USFDA of its new dosing recommendations. RAPAMUNE® is the first and only kidney transplant therapeutic with dosing recommendations specifically for the treatment of high immunologic risk renal transplant recipients.... Continue Reading Posted at 10:29 PM \| Permalink \| Comments
	Anacor Signed Worldwide Exclusive License Agreement with Schering-Plough for New Topical Anti-Fungal, AN2690 Gloria Gamat February 4, 2007 A privately held pharmaceutical company – Anacor Pharmaceuticals (14194587) – has recently entered into an exclusive, worldwide agreement with Schering-Plough Corporation (NYSE: SGP) for the development and commercialization of AN2690. AN2690 is Anacor Pharmaceuticals’ topical anti-fungal therapy under Phase II clinical trials... Continue Reading Posted at 9:18 PM \| Permalink \| Comments
	Pfizer Agreed to Acquire BioRexis Pharmaceutical Gloria Gamat February 4, 2007 BioRexis Pharmaceutical Corporation is a privately-held biopharmaceutical company with a number of diabetes candidates and a novel technology platform for developing new protein drug candidates. Not disclosing the financial terms of agreement, Pfizer, Inc. (NYSE: PFE) is going to acquire BioRexis.... Continue Reading Posted at 8:15 PM \| Permalink \| Comments
	Acquisition of Arrow Therapeutics Broadens AstraZeneca’s Anti-Infective Portfolio Gloria Gamat February 4, 2007 Arrow Therapeutics Ltd. (11137618) is a privately owned UK biotechnology company focused on the discovery and development of anti-viral therapies. Recently, AstraZeneca (LON: AZN) announced its agreement to acquire Arrow Therapeutics, purchasing the company’s total share capital for US$150 Million... Continue Reading Posted at 7:05 PM \| Permalink \| Comments
Feb 2	MediVas Collaborates With Merck in Area of Biologics Gloria Gamat February 2, 2007 A developer of novel drug delivery – MediVas, LLC – has recently signed an exclusive technology evaluation and exclusive option agreements with Merck & Co., Inc. (NYSE: MRK) focused on several orally available biologics delivered using MediVas' proprietary polymer delivery system.... Continue Reading Posted at 11:24 PM \| Permalink \| Comments
	USFDA Accepted Pharmion’s IND for Oral Azacitidine (Vidaza®) Gloria Gamat February 2, 2007 Submitted in December 2006, Pharmion Corporation (Nasdaq: PHRM) Investigational New Drug (IND) application for the Company's oral formulation of azacitidine is now active following its acceptance by the USFDA. The parenteral formulation of azacitidine - Vidaza® (azacitidine for injection) -... Continue Reading Posted at 10:31 PM \| Permalink \| Comments
	AstraZeneca and Palatin Technologies Collaborates to Discover, Develop and Commercialise Small Molecule Obesity Compounds Gloria Gamat February 2, 2007 An exclusive global licensing and research collaboration agreement between AstraZeneca (NYSE: AZN) and Palatin Technologies (AMEX:PTN) has recently been established for the discovery, development and commercialization of small molecule compounds targeting melanocortin receptors. The collaboration will be based from Palatin’s... Continue Reading Posted at 9:33 PM \| Permalink \| Comments
	Institute of Materia Medica and TB Alliance Will Develop Improved TB Drugs Gloria Gamat February 2, 2007 A member of the Chinese Academy of Medical Sciences, The Institute of Materia Media (IMM) have entered into a joint research partnership with the Global Alliance for TB Drug Development (TB Alliance) to develop promising, novel anti-tuberculosis drugs. The said... Continue Reading Posted at 8:44 PM \| Permalink \| Comments
Feb 1	Patent for Heat Shock Protein (Hsp) Fusion for Flu Treatment, Awarded to Nventa Biopharma Gloria Gamat February 1, 2007 The U.S. Patent and Trademark Office (USPTO) have issued Patent Number 7,157,089 to Nventa Biopharmaceuticals Corporation (TSE: NVN). The said patent covers compositions of fusion proteins comprised of an influenza antigen fused to a heat shock protein (Hsp), as well... Continue Reading Posted at 8:12 PM \| Permalink \| Comments
	Laureate Pharma in Manufacturing Agreement with Trubion Pharmaceuticals Gloria Gamat February 1, 2007 Laureate Pharma, Inc. (11061029) has entered into an agreement for the manufacture of Trubion Pharmaceuticals, Inc. (Nasdaq: TRBN)'s TRU-016. TRU-016, a novel protein for the treatment of non-Hodgkin's lymphoma (NHL) and chronic lymphocytic leukemia (CLL), is designed to target CD37,... Continue Reading Posted at 7:31 PM \| Permalink \| Comments

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