Biopharmaceutical News and Research

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arGEN-X to develop its SIMPLE Antibody engine with completed EUR 12.5M Series A equity financing

arGEN-X BV, a biopharmaceutical company focused on the discovery and development of human antibodies using its proprietary SIMPLE Antibody(TM) platform, today announced the successful second closing of its Series A equity financing round. The Company raised an additional EUR 3.0 million (~USD 4.5 million) from two leading life science investors, Credit Agricole Private Equity and VIB (the prestigious Flemish research institute).

3 Dec 2009

European Phase III clinical trial of budesonide MMX completes patient enrollment

Santarus, Inc., a specialty biopharmaceutical company, today announced that its collaboration partner, Cosmo Technologies Ltd., a subsidiary of Cosmo Pharmaceuticals SpA (SIX: COPN), has completed enrollment of 514 patients in the European Phase III clinical trial to evaluate budesonide MMX® administered over eight weeks for the induction of remission of mild or moderate active ulcerative colitis.

3 Dec 2009

Aspen Brook Consulting announces 2010 Bioprocess Management Summit

Aspen Brook Consulting, Inc., announces the 2010 Bioprocess Management Summit. This event, occurring February 24th-26th, 2010 at The Canyons Hotel and Conference Center in Park City UT, has been designed as a forum where members of the bioprocess community gather annually to share their knowledge and experience in an effort to address challenges facing the biopharmaceutical industry.

2 Dec 2009

FDA approves revised clinical trial protocol for CytRx' arimoclomol

CytRx Corporation, a biopharmaceutical company, is permitted to re-enter the clinic with its orally administered molecular chaperone drug candidate arimoclomol as a therapeutic treatment for amyotrophic lateral sclerosis (ALS or Lou Gehrig’s disease), following the U.S. Food and Drug Administration’s (FDA) acceptance of a revised clinical trial protocol.

2 Dec 2009

FDA grants Fast Track designation for AEterna Zentaris' perifosine

AEterna Zentaris Inc., a global biopharmaceutical company focused on endocrine therapy and oncology, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the Company's PI3K/Akt pathway inhibitor compound, perifosine (KRX-0401), for the treatment of relapsed/refractory multiple myeloma.

2 Dec 2009

Shire settles ADDERALL XR authorized generic version supply litigation

Shire plc, the global specialty biopharmaceutical company, announces that it has settled the litigation with Teva Pharmaceuticals USA, Inc. ("Teva") over Shire's supply to Teva of an authorized generic version of ADDERALL XR. Shire has been supplying Teva with authorized generic ADDERALL XR since April 1, 2009.

2 Dec 2009

Sinovac Biotech receives fourth purchase order for its H1N1 vaccine from Chinese government

Sinovac Biotech Ltd., a leading provider of biopharmaceutical products in China, announced today that it has received its fourth purchase order for its H1N1 vaccine, PANFLU.1(TM), from China's Ministry of Industry and Information Technology for the national purchase plan.

2 Dec 2009

University of Texas M.D. Anderson Cancer Center and Stemline Therapeutics enter into research collaboration

Stemline Therapeutics, Inc., a private clinical stage biopharmaceutical company and leading developer of oncology compounds directed to cancer stem cells, today announced that The University of Texas M.D. Anderson Cancer Center (Houston, TX) and Stemline have entered into a research collaboration.

2 Dec 2009

Future likely to witness improved therapies and novel drugs to treat lifestyle disorders

Increasing genomic knowledge will lead to the development of improved therapies to treat lifestyle disorders. In the near future, the European lifestyle disorders therapeutics market is set to witness enhanced therapies and novel drugs to treat such conditions and reduce the risk of co-morbidities.

2 Dec 2009

FDA approves Schering-Plough's New Drug Application for ZEGERID OTC capsules

Santarus, Inc., a specialty biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has approved Schering-Plough HealthCare Products, Inc.’s, New Drug Application (NDA) for ZEGERID OTC™ Capsules (omeprazole/sodium bicarbonate) with a dosage strength of 20 mg of omeprazole for over-the-counter (OTC) treatment of frequent heartburn.

2 Dec 2009

DiaMedica to acquire all issued and outstanding shares of Sanomune

DiaMedica Inc. (TSX VENTURE:DMA)("Diamedica"), a biopharmaceutical company that has discovered and is developing a novel approach to treating diabetes, announces it has entered into a non-binding letter of intent to acquire all of the issued and outstanding shares of Sanomune Inc.

2 Dec 2009

Acceleron Pharma announces study results of its ACE-011 and ACE-536 blood forming agents

Acceleron Pharma, Inc., a biopharmaceutical company developing novel therapeutics that modulate the growth of cells and tissues including red blood cells, bone, muscle, fat, and the vasculature, today announced that results from preclinical and clinical studies of two, novel blood forming agents, ACE-011 and ACE-536, will be presented at the 51st Annual Meeting of the American Society of Hematology at the Ernest N. Morial Convention Center in New Orleans, Louisiana.

1 Dec 2009

Positive data from Provectus Pharmaceuticals' psoriasis and atopic dermatitis trials

Provectus Pharmaceuticals, Inc., a development-stage oncology and dermatology biopharmaceutical company, announced preliminary data for the company’s PH-10 Phase 2 clinical trial for Psoriasis as well as for its Phase 2 clinical trial for Atopic Dermatitis.

1 Dec 2009

Bayer Schering Pharma to develop new BiTE antibody for treatment of solid tumors

Micromet, Inc., a biopharmaceutical company developing novel, proprietary antibodies for the treatment of cancer, inflammation and autoimmune diseases today announced that Bayer Schering Pharma AG has exercised its option under the option, collaboration and license agreement entered into on January 12, 2009 to develop a new BiTE antibody for the treatment of solid tumors.

1 Dec 2009

Novartis Pharma extends Emisphere Technologies' Convertible Promissory Note maturity date

Emisphere Technologies, Inc., a biopharmaceutical company that focuses on a unique and improved delivery of pharmaceutical compounds and nutritional supplements using its Eligen® Technology, today announced that Novartis Pharma AG has agreed to extend the maturity date of Emisphere’s Convertible Promissory Note (the “Note”) to February 26, 2010.

1 Dec 2009

Intelliject announces an exclusive license with sanofi-aventis for epinephrine auto-injector

Intelliject, Inc. today announced an exclusive license with sanofi-aventis U.S. for a novel epinephrine auto-injector, in the U.S. and Canada territory. Under the license, sanofi-aventis U.S. shall be responsible for manufacturing and commercialization.

1 Dec 2009

Kiadis Pharma commences enrollment in multinational ATIR study

Biopharmaceutical company Kiadis Pharma announces today that the first patients have been enrolled in its multinational registration clinical trial with ATIR(TM). The study is designed to show reduction in transplant related mortality (TRM) after one year following an allogeneic stem cell transplantation with a mismatched (haplo-identical) donor in blood cancer patients eligible for an allogeneic stem cell transplantation but without having a matched donor available.

30 Nov 2009

Micromet to present new results from its blinatumomab study at the ASH meeting

Micromet, Inc., a biopharmaceutical company developing novel, proprietary antibodies for the treatment of cancer, inflammation and autoimmune diseases, today announced that it will present new results from its clinical studies with blinatumomab at the 51st annual meeting of the American Society of Hematology from December 5-8, 2009 in New Orleans, Louisiana.

30 Nov 2009

ALS research collaboration receives philanthropic funding

Three prominent philanthropic organizations – The Angel Fund, The ALS Therapy Alliance and Project ALS -- dedicated to finding a treatment for amyotrophic lateral sclerosis (ALS) have financed a new collaboration between one of the world’s leading ALS researchers and RXi Pharmaceuticals Corporation, a biopharmaceutical company pursuing the development and commercialization of proprietary therapeutics based on RNA interference (RNAi).

30 Nov 2009

Clinical data on ImmunoGen's TAP compounds to be presented at the 51st ASH meeting

ImmunoGen, Inc., a biopharmaceutical company that develops targeted anticancer therapeutics, announced today that presentations of clinical data for three product candidates employing its Targeted Antibody Payload (TAP) technology will be made at the 51st American Society of Hematology (ASH) Annual Meeting and Exposition to be held in New Orleans, LA, on December 5-8, 2009.

25 Nov 2009

Biopharmaceutical News and Research

arGEN-X to develop its SIMPLE Antibody engine with completed EUR 12.5M Series A equity financing

European Phase III clinical trial of budesonide MMX completes patient enrollment

Aspen Brook Consulting announces 2010 Bioprocess Management Summit

FDA approves revised clinical trial protocol for CytRx' arimoclomol

FDA grants Fast Track designation for AEterna Zentaris' perifosine

Shire settles ADDERALL XR authorized generic version supply litigation

Sinovac Biotech receives fourth purchase order for its H1N1 vaccine from Chinese government

University of Texas M.D. Anderson Cancer Center and Stemline Therapeutics enter into research collaboration

Future likely to witness improved therapies and novel drugs to treat lifestyle disorders

FDA approves Schering-Plough's New Drug Application for ZEGERID OTC capsules

DiaMedica to acquire all issued and outstanding shares of Sanomune

Acceleron Pharma announces study results of its ACE-011 and ACE-536 blood forming agents

Positive data from Provectus Pharmaceuticals' psoriasis and atopic dermatitis trials

Bayer Schering Pharma to develop new BiTE antibody for treatment of solid tumors

Novartis Pharma extends Emisphere Technologies' Convertible Promissory Note maturity date

Intelliject announces an exclusive license with sanofi-aventis for epinephrine auto-injector

Kiadis Pharma commences enrollment in multinational ATIR study

Micromet to present new results from its blinatumomab study at the ASH meeting

ALS research collaboration receives philanthropic funding

Clinical data on ImmunoGen's TAP compounds to be presented at the 51st ASH meeting

Biotechnology eBook

Expanding research and clinical options for children with cancer

Examining how pain could play a direct protective role in the gut

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