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Repligen acquires BioFlash

Repligen Corporation announced today that it has acquired the assets of BioFlash Partners, LLC, (BioFlash) including a technology platform for the production of pre-packed, "plug and play" chromatography columns. This patented technology enables economical production of chromatography columns in a format that is ready for use in the production of a broad range of biopharmaceuticals including monoclonal antibodies, vaccines and recombinant proteins.

4 Mar 2010

Lemelson-MIT Collegiate Student Prizes awarded to inventive students nationwide

A scientific "Renaissance man" whose work spans the fields of mathematics, linguistics, biotechnology and polymer physics, Erez Lieberman-Aiden, graduate student at the Harvard-MIT Division of Health Sciences and Technology, has been named the winner of the prestigious $30,000 Lemelson-MIT Student Prize. Lieberman-Aiden, one of four 2010 $30,000 Lemelson-MIT Collegiate Student Prize winners announced today, was selected for the breadth and depth of his innovations.

4 Mar 2010

CPEX Pharmaceuticals' fourth-quarter 2009 revenues up 23%

CPEX Pharmaceuticals, Inc. today reported financial results for the fourth quarter and year ended December 31, 2009. For the quarter CPEX reported revenues of $5.2 million and a net loss of $498,000. For the year CPEX reported revenues of $18.7 million and a net loss of $3.0 million.

3 Mar 2010

Spectral Diagnostics receives FDA IDE approval for Toraymyxin

BioMS Medical Corp. today reported that Spectral Diagnostics has received Investigational Device Exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) for Toraymyxin(TM). Spectral Diagnostics and BioMS have entered into a services agreement whereby BioMS will assist Spectral, as required, in its commercialization of Toraymyxin(TM), a therapeutic hemoperfusion device for the treatment of severe sepsis. This approval permits Spectral to initiate its planned pivotal trial for Toraymyxin(TM) in the United States.

3 Mar 2010

Seattle Genetics generates $110M through ADC technology license agreements

Seattle Genetics, Inc. announced today that it has achieved a milestone under its antibody-drug conjugate (ADC) collaboration with Genentech, Inc., a wholly owned member of the Roche Group.

3 Mar 2010

Astellas commences unsolicited tender offer to acquire common shares of OSI for $52.00 per share

OSI Pharmaceuticals, Inc. today confirmed that Astellas Pharma Inc. has commenced an unsolicited tender offer to acquire all outstanding common shares of OSI for $52.00 per share in cash.

3 Mar 2010

Baxter Healthcare's IIPV product recall of HomeChoice peritoneal dialysis cyclers classified as Class I recall

Baxter Healthcare Corporation announced today that the U.S. Food and Drug Administration (FDA) has classified Baxter’s recent Urgent Product Recall regarding Increased Intraperitoneal Volume (IIPV), or overfill of the abdominal cavity, associated with HomeChoice and HomeChoice Pro peritoneal dialysis cyclers as a Class I recall.

From Baxter International Inc. 3 Mar 2010

Biomagnetics Diagnostics announces accelerated delivery timetable for integrated optical biosensor

Biomagnetics Diagnostics Corp., a developer of revolutionary diagnostic systems and technology for HIV, hepatitis, tuberculosis and malaria detection, today announced its accelerated timetable for delivery of the world's first handheld, integrated optical biosensor.

3 Mar 2010

Solasia Pharma K.K. signs License and Supply Agreement with Kyowa Hakko Kirin to market SP-01

Solasia Pharma K.K. (http://www.solasia.co.jp), a developer of Western oncology pharmaceuticals in-licensed for commercialization in Asian markets, announced today the signing of a License and Supply Agreement with Kyowa Hakko Kirin that provides Kyowa Hakko Kirin with an exclusive right to market and sell SP-01 (extended release transdermal granisetron patch; brand name: Sancuso®) in Taiwan, Hong Kong, Singapore and Malaysia.

3 Mar 2010

NPS Pharmaceuticals sells royalty rights from sales of REGPARA to DRI Capital's fund

NPS Pharmaceuticals, Inc. today announced the sale of its royalty rights from sales of REGPARA® (cinacalcet HCl) to a fund managed by DRI Capital, Inc., (Fund) for $38.4 million. Royalties in excess of cumulative royalties of $96 million or 2.5 times the upfront purchase price have been retained by NPS.

3 Mar 2010

EMA accepts the filing of Lux Biosciences' MAA for Luveniq

Lux Biosciences, Inc. today announced that the European Medicines Agency has accepted the filing of the company’s Marketing Authorization Application (MAA) for the company’s lead product, Luveniq™ (LX211; oral voclosporin) for the treatment of noninfectious uveitis involving the intermediate or posterior segments of the eye.

3 Mar 2010

Advanced Cell Technology’s MA09-hRPE cells for treatment of SMD: FDA grants orphan drug designation

Advanced Cell Technology, Inc., a biotechnology company applying cellular technology in the field of regenerative medicine, announced today that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation for the company’s MA09-hRPE cells for use in the treatment of Stargardt’s Macular Dystrophy (SMD). As a result, the company is eligible to receive a number of benefits, including tax credits, access to grant funding for clinical trials, accelerated FDA approval and allowance for marketing exclusivity after drug approval for a period of as long as seven years.

3 Mar 2010

ImmunoCellular Therapeutics receives Notice of Allowance on ICT-69 monoclonal antibody

ImmunoCellular Therapeutics, Ltd., a biotechnology company that is developing immune based therapies for the treatment of various forms of cancer, announced today it received a Notice of Allowance on monoclonal antibody ICT-69 which targets multiple myeloma and ovarian cancers. The antibody has demonstrated high specificity to these cancers by targeting a novel cell surface antigen.

2 Mar 2010

Generic Hyzaar and Cozaar litigation: Court of Appeals rules in favor of Teva Pharmaceutical Industries

Teva Pharmaceutical Industries Ltd. announced today that the U.S. Court of Appeals for the District of Columbia Circuit has ruled in Teva’s favor by overturning a July 31, 2009, district court decision which held that Teva forfeited 180-day marketing exclusivity for its generic versions of Merck's antihypertensive agents Hyzaar® (hydrochlorothiazide; losartan potassium) and Cozaar® (losartan potassium).

2 Mar 2010

Affymetrix introduces GeneAtlas System for processing arrays and characterizing changes in gene expression

Affymetrix, Inc. today announced the launch of the GeneAtlas™ System, a complete, personal solution for processing Affymetrix arrays and characterizing changes in gene expression in a variety of research applications.

2 Mar 2010

National Cancer Institute awards PDS Biotechnology $1.28M phase 2 SBIR contract

PDS Biotechnology Corporation today announced that the company has been awarded a $1.28M phase 2 SBIR contract by the National Cancer Institute division of the US National Institutes of Health. The contract provides funding to complete studies required to file an Investigational New Drug Application (IND) with the FDA for the company's lead human papillomavirus (HPV)-cancer product late in 2010.

2 Mar 2010

InterMune seeks European marketing approval for pirfenidone

InterMune, Inc. today announced that it has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) seeking approval to market pirfenidone for the treatment of patients with idiopathic pulmonary fibrosis (IPF) in the European Union (EU). Currently, there are no EMA-approved treatments for IPF in the EU.

2 Mar 2010

ArQule reports net loss of $36,136,000 for 2009

ArQule, Inc. today announced its financial results for the year and for the fourth quarter ended December 31, 2009.

2 Mar 2010

Pre-clinical study of Cardio3 BioSciences' proprietary C-Cath catheter announced

Cardio3 BioSciences, a leading Belgian biotechnology company specialising in cell-based therapies for the treatment of cardiovascular diseases, announced today promising results in a pre-clinical study of its proprietary C-Cath(R) catheter which is under development to administer a range of bio-therapeutics to the heart. C-Cath is designed to take into account organ tissue structure and properties to maximize patients' safety, improve performance and increase user confidence during the injection procedure.

2 Mar 2010

Intercell AG's revenues for full year 2009 increase 10.6%

Today, the biotech-vaccine company Intercell AG announced its financial results for Q4 and the preliminary results for the full financial year 2009, and presented an update on the Company's development programs.

2 Mar 2010

Biotechnology News and Research

Repligen acquires BioFlash

Lemelson-MIT Collegiate Student Prizes awarded to inventive students nationwide

CPEX Pharmaceuticals' fourth-quarter 2009 revenues up 23%

Spectral Diagnostics receives FDA IDE approval for Toraymyxin

Seattle Genetics generates $110M through ADC technology license agreements

Astellas commences unsolicited tender offer to acquire common shares of OSI for $52.00 per share

Baxter Healthcare's IIPV product recall of HomeChoice peritoneal dialysis cyclers classified as Class I recall

Biomagnetics Diagnostics announces accelerated delivery timetable for integrated optical biosensor

Solasia Pharma K.K. signs License and Supply Agreement with Kyowa Hakko Kirin to market SP-01

NPS Pharmaceuticals sells royalty rights from sales of REGPARA to DRI Capital's fund

EMA accepts the filing of Lux Biosciences' MAA for Luveniq

Advanced Cell Technology’s MA09-hRPE cells for treatment of SMD: FDA grants orphan drug designation

ImmunoCellular Therapeutics receives Notice of Allowance on ICT-69 monoclonal antibody

Generic Hyzaar and Cozaar litigation: Court of Appeals rules in favor of Teva Pharmaceutical Industries

Affymetrix introduces GeneAtlas System for processing arrays and characterizing changes in gene expression

National Cancer Institute awards PDS Biotechnology $1.28M phase 2 SBIR contract

InterMune seeks European marketing approval for pirfenidone

ArQule reports net loss of $36,136,000 for 2009

Pre-clinical study of Cardio3 BioSciences' proprietary C-Cath catheter announced

Intercell AG's revenues for full year 2009 increase 10.6%

Industry Focus eBook - Biotechnology (4th edition) eBook

Designing fluidic architecture for scalable diagnostic platforms

Evaluating new approaches for rare disease genomics

Expanding access to NMR with the Fourier 80 Duo

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