Biotechnology News and Research

RSS

FDA extends Acorda Therapeutics' Fampridine-SR PDUFA goal date

Acorda Therapeutics, Inc. (Nasdaq: ACOR) today announced that the U.S. Food and Drug Administration (FDA) has extended the PDUFA goal date for its review of the New Drug Application (NDA) for Fampridine-SR to January 22, 2010. The original Prescription Drug User Fee Act (PDUFA) date for this priority review application was October 22, 2009.

22 Oct 2009

PacificGMP selected by ArmaGen Technologies to produce its proprietary protein for a Phase 1 clinical trial

PacificGMP, the leader in single-use bioprocessing for development and manufacturing for its client partners, announced that ArmaGen Technologies has selected it to produce its proprietary protein for a Phase 1 clinical trial.

22 Oct 2009

Sartorius reports financial results for the third quarter of 2009

Today Sartorius, a leading international process and laboratory technology provider, reported its nine-month results for 2009. Third-quarter business of both Group divisions showed a highly divergent pattern of development, similar to that in the previous quarters.

From Sartorius 22 Oct 2009

Biocare Medical on the 2009 Inc. 5000 list of the fastest-growing private companies in the nation

Inc. magazine has ranked Biocare Medical No. 2984 on the 2009 Inc. 5000 list of the fastest-growing private companies in the nation. The company's sales growth was 93.1% from 2005-2008.

22 Oct 2009

LANL and international researchers propose new genome sequence strategies

A team of geneticists at Los Alamos National Laboratory, together with a consortium of international researchers, has recently proposed a set of standards designed to elucidate the quality of publicly available genetic sequencing information.

22 Oct 2009

Ohio ranks fourth in bioscience industry

While other states jockeyed for position on Business Facilities Magazine's second-annual Biotechnology Strength Report, Ohio defended its ranking as best in the Midwest and No. 4 in the nation for its strengths in the bioscience industry.

22 Oct 2009

Cephalon announces receipt of a Paragraph IV Certification Notice Letter regarding ANDA

Cephalon, Inc. (Nasdaq: CEPH) today announced receipt of a Paragraph IV Certification Notice Letter on October 20, 2009 regarding an Abbreviated New Drug Application (ANDA) submitted to the U.S. Food and Drug Administration (FDA) by Teva Pharmaceuticals USA, Inc. requesting approval to market and sell a generic version of the 50 mg, 100 mg, 150 mg, 200 mg and 250 mg strengths of NUVIGIL® (armodafinil) Tablets [C-IV].

22 Oct 2009

France Biotech announces its 5th Bioethics Forum

France Biotech, the French association of life science businesses and their partners (www.france-biotech.org) today announced that its 5th Bioethics Forum (organized in collaboration with the Eurobiomed cluster) will take place on Friday, December 11th, at the Musée du Carre d’Art venue in Nîmes.

22 Oct 2009

BioStorage Technologies expands its operations in Europe, opens new facility in Germany

BioStorage Technologies, Inc., a worldwide provider of long- and short-term storage of biomaterials, sample management and cold chain logistics, will expand its European operations with the opening of a new 16,140 square foot (1,499 sq meters) full-service biorepository in Frankfurt, Germany.

22 Oct 2009

OSI Pharmaceuticals reports total revenues of $111 million for the third quarter of 2009

OSI Pharmaceuticals, Inc. announced today its financial results for the Company’s third quarter ended September 30, 2009. The Company reported total revenues from continuing operations of $111 million for the third quarter of 2009 compared to revenues of $95 million for the third quarter of 2008, an 18% increase over the prior year period.

22 Oct 2009

Illumina announces 2010 roadmap for Infinium whole-genome genotyping platform

At the 59th annual meeting of the American Society of Human Genetics, Illumina, Inc. today announced its 2010 roadmap for the Infinium whole-genome genotyping platform, offering products capable of analyzing up to five million (5M) variants per sample.

From Illumina, Inc. 22 Oct 2009

EMEA informs Antigenics on a negative opinion for Oncophage MAA

Antigenics Inc. today announced that the Committee for Medicinal Products for Human Use (CHMP), of the European Medicines Agency (EMEA), has verbally informed the Company at an oral meeting to anticipate a negative opinion on the marketing authorization application (MAA) for Oncophage (vitespen) in early-stage, localized renal cell carcinoma (kidney cancer).

21 Oct 2009

Lux Biosciences to present on LX211 at 2009 AAO annual conference

Lux Biosciences, Inc., a privately held biotechnology company focused on the development and commercialization of therapies for serious ophthalmic diseases, today announced that the company’s experimental drug LX211 (LUVENIQ; oral voclosporin) will be featured in several presentations at the 2009 American Academy of Ophthalmology annual conference and American Uveitis Society meeting being held October 24-26 in San Francisco.

21 Oct 2009

Northwest Biotherapeutics announces long-term data from Phase I and Phase I/II clinical trials of DCVax-Brain

Northwest Biotherapeutics, Inc. today announced further long-term follow-up data, for the period from January through September 2009, from its prior Phase I and Phase I/II clinical trials conducted at UCLA with DCVax®-Brain in patients with Glioblastoma multiforme ("GBM"). GBM is the most rapid and lethal type of brain cancer. During the update period, only one of the twenty patients treated with DCVax®-Brain (in addition to standard of care) died, and that patient had survived for nearly 7 years (80.5 months).

21 Oct 2009

Novavax, Xcellerex enter into collaboration to accelerate the development of Novavax's 2009 H1N1 vaccine

Novavax, Inc. and Xcellerex, Inc. have entered into a strategic collaboration to accelerate the development of Novavax's vaccine manufacturing process to commercial scale and begin immediate production of Novavax's novel 2009 H1N1 influenza vaccine for potential commercial sale.

21 Oct 2009

Applied Biosystems announces the commercial availability of SOLiD 3 Plus System

Applied Biosystems, part of Life Technologies Corporation today announced the commercial availability of the SOLiD™ 3 Plus System, an enhanced next-generation genomic analysis platform designed to allow researchers to move one step closer to performing mainstream sequencing of personal genomes for clinical research and personalized medicine.

21 Oct 2009

BioWa, NKT Therapeutics sign licensing agreement

BioWa, Inc. (BioWa) and NKT Therapeutics, Inc. (NKTT), announced today that they have entered into an agreement which provides NKTT with access to BioWa's patented POTELLIGENT(®) Technology platform for the development of antibody-dependent cellular cytotoxicity (ADCC) enhanced antibodies.

21 Oct 2009

ICON reports its financial results for the third quarter ended September 30, 2009

ICON, a global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries, today reported its financial results for its third quarter ended September 30, 2009.

21 Oct 2009

Genzyme commences patient enrollment in Genz-112638 phase 3 trials

Genzyme Corporation today announced that the company has begun enrollment in the first of two global, multi-center, phase 3 trials of Genz-112638, a potential new oral therapy for Gaucher disease type 1. The two multi-national, multi-center trials are being conducted to evaluate the safety and efficacy of the small molecule.

21 Oct 2009

Autobiography of a cardiologist "Doctor of the Heart" published

Doctor of the Heart: My Life in Medicine is the autobiography of Isadore Rosenfeld, MD, world-renowned cardiologist, best-selling author, and popular television commentator. Published by Mary Ann Liebert, Inc., Dr. Rosenfeld's book is a remarkable account of his long and extraordinary career (www.liebertpub.com/heart).

21 Oct 2009

Biotechnology News and Research

FDA extends Acorda Therapeutics' Fampridine-SR PDUFA goal date

PacificGMP selected by ArmaGen Technologies to produce its proprietary protein for a Phase 1 clinical trial

Sartorius reports financial results for the third quarter of 2009

Biocare Medical on the 2009 Inc. 5000 list of the fastest-growing private companies in the nation

LANL and international researchers propose new genome sequence strategies

Ohio ranks fourth in bioscience industry

Cephalon announces receipt of a Paragraph IV Certification Notice Letter regarding ANDA

France Biotech announces its 5th Bioethics Forum

BioStorage Technologies expands its operations in Europe, opens new facility in Germany

OSI Pharmaceuticals reports total revenues of $111 million for the third quarter of 2009

Illumina announces 2010 roadmap for Infinium whole-genome genotyping platform

EMEA informs Antigenics on a negative opinion for Oncophage MAA

Lux Biosciences to present on LX211 at 2009 AAO annual conference

Northwest Biotherapeutics announces long-term data from Phase I and Phase I/II clinical trials of DCVax-Brain

Novavax, Xcellerex enter into collaboration to accelerate the development of Novavax's 2009 H1N1 vaccine

Applied Biosystems announces the commercial availability of SOLiD 3 Plus System

BioWa, NKT Therapeutics sign licensing agreement

ICON reports its financial results for the third quarter ended September 30, 2009

Genzyme commences patient enrollment in Genz-112638 phase 3 trials

Autobiography of a cardiologist "Doctor of the Heart" published

Biotechnology eBook

Achieving and maintaining ISO/IEC 27001 and BS 10012 certifications

Expanding research and clinical options for children with cancer

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

Latest News