Biopharmaceutical News and Research

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FDA designates Synageva's sebelipase alfa as Breakthrough Therapy for early onset LAL Deficiency

Synageva BioPharma Corp., a biopharmaceutical company developing therapeutic products for rare diseases, today announced that the U.S. Food and Drug Administration granted Breakthrough Therapy designation to sebelipase alfa for the treatment of early onset lysosomal acid lipase deficiency, also known as Wolman disease.

20 May 2013

Shire's scientific data on treatments for psychiatric disorders to be presented at APA meeting

Shire plc, the global specialty biopharmaceutical company, announces that it will present scientific data in 7 poster presentations at the American Psychiatric Association 166th Annual Meeting in San Francisco, May 18-22.

20 May 2013

ElsaLys Biotech announces first round of financing from Transgene and Sofimac Partners

ElsaLys Biotech, which specializes in the development of therapeutic monoclonal antibodies, announces a first round of financing of 2.1M€ from the biopharmaceutical company Transgene and the investment fund Sofimac Partners.

20 May 2013

BioLineRx signs ATM sales agency agreement with Stifel

BioLineRx Ltd., a biopharmaceutical development company, announced today that it has entered into an at-the-market sales agency agreement with Stifel.

18 May 2013

Soligenix starts first clinical study for development of SGX203 for pediatric Crohn's disease

Soligenix, Inc., a clinical stage biopharmaceutical company focused on developing products to treat inflammatory diseases and biodefense countermeasures where there remains an unmet medical need, announced today that it has initiated the first clinical study for development of SGX203 (oral beclomethasone 17,21-dipropionate or oral BDP) for the treatment of pediatric Crohn's disease.

15 May 2013

Tokai Pharmaceuticals raises $35.5M in Series E financing

Tokai Pharmaceuticals, Inc., a biopharmaceutical company focused on developing new treatments for prostate cancer, today announced that the company raised $35.5 million in a Series E financing based on encouraging clinical progress and investor support for galeterone (TOK-001), Tokai's lead prostate cancer drug candidate.

15 May 2013

UIC's Center for Clinical and Translational Science selects six research projects for new pilot grants

The University of Illinois at Chicago's Center for Clinical and Translational Science has selected six research projects to receive pilot grants in 2013.

15 May 2013

CMC Biologics, RuiYi to develop a cell line for RYI-008

CMC Biologics today announced the execution of an agreement with RuiYi Inc. to develop a cell line for RYI-008, a novel anti-IL-6 monoclonal antibody.

14 May 2013

Synageva BioPharma reports study results of sebelipase alfa in adults with late onset LAL Deficiency

Synageva BioPharma Corp., a biopharmaceutical company developing therapeutic products for rare diseases, today reported 12-month results from an ongoing extension study with sebelipase alfa in adults with late onset Lysosomal Acid Lipase Deficiency.

9 May 2013

Phase 1b clinical study data of EBI-005 for treatment of dry eye disease presented at ARVO meeting

Eleven Biotherapeutics, a biopharmaceutical company designing and engineering novel and differentiated protein-based biotherapeutics for ocular diseases, announced today the presentation of data for EBI-005, the first IL-1 (Interleukin-1) signaling inhibitor designed for topical ocular administration, at the Association for Research in Vision and Ophthalmology 2013 Annual Meeting in Seattle, Washington.

9 May 2013

New VLP vaccine candidate produced for H7N9 virus

Medicago Inc., a biopharmaceutical company focused on developing highly effective and competitive vaccines based on proprietary manufacturing technologies and Virus-Like Particles, today announced that it has successfully produced a new VLP vaccine candidate for the H7N9 virus that is responsible for the current influenza outbreak in China.

8 May 2013

Targacept reports net loss of $8.1 million in first quarter 2013

Targacept, Inc., a clinical-stage biopharmaceutical company developing novel NNR Therapeutics™, today reported its financial results for the first quarter ended March 31, 2013.

7 May 2013

Aptiv Solutions participates in 'Practice Adaptive Clinical Trials’ conference at Tokyo University

Aptiv Solutions, a biopharmaceutical and medical device development services company and pioneer in adaptive clinical trial design, simulation and execution, announces its participation in a prestigious conference on adaptive clinical trials, held at the University of Tokyo on May 10th 2013.

7 May 2013

New Process Analytical Technology for pharmaceutical and chemical manufacturing industries

Process Analytical Technology (PAT) is quickly becoming an integral component in the pharmaceutical and chemical manufacturing industries. Utilizing a low latency network of powerful chemometric instruments, multivariate data analysis software, process control tools, and a central SQL database, PAT provides pharmaceutical and biopharmaceutical companies an edge over their competitors.

From Thermo Fisher Scientific Inc. 7 May 2013

Aeras receives grant to support the development of vaccines against TB, HIV and malaria

Aeras, a nonprofit biotech advancing TB vaccines for the world, the University of Oxford and Okairos, a biopharmaceutical company specializing in T-cell vaccines, today announced a $2.9 million grant to Aeras in support of a collaboration among the three parties to support the development of vaccines against tuberculosis, HIV and malaria.

7 May 2013

Alimera announces availability of ILUVIEN in U.K. for chronic DME treatment

Alimera Sciences, Inc., a biopharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals, today announced that ILUVIEN®, the first sustained release pharmaceutical product for the treatment of chronic diabetic macular edema, is now available in the United Kingdom.

29 Apr 2013

BioLineRx starts enrollment in Phase I/II trial of BL-8020 for treatment of HCV

BioLineRx, a biopharmaceutical development company, announced today enrollment of the first patient in a Phase I/II trial for BL-8020, an orally available, interferon-free treatment for the Hepatitis C virus.

29 Apr 2013

Transgene announces pre-clinical data of TG1050 for treatment of chronic hepatitis B infection

Transgene SA, a biopharmaceutical company that develops targeted immunotherapy products to treat major unmet medical needs in cancer and chronic infectious diseases, announced pre-clinical data obtained with its novel immunotherapeutic, TG1050, to treat chronic hepatitis B infection.

29 Apr 2013

Thermo Fisher Scientific brings several innovations in bioprocessing technologies and systems

Thermo Fisher Scientific Inc., the world leader in serving science, today debuted several innovations in bioprocessing technologies and systems that address the evolving requirements of drug discovery and production for global biopharmaceutical and pharmaceutical manufacturers.

From Thermo Fisher Scientific Inc. 26 Apr 2013

CytRx reaches agreement with FDA for aldoxorubicin Phase 3 trial for treatment of soft tissue sarcomas

CytRx Corporation, a biopharmaceutical research and development company specializing in oncology, announced today that it has reached an agreement with the U.S. Food and Drug Administration under a special protocol assessment for a global pivotal Phase 3 trial with aldoxorubicin as a treatment for patients with soft tissue sarcomas who have relapsed or were refractory following prior treatment with chemotherapy.

24 Apr 2013

Biopharmaceutical News and Research

FDA designates Synageva's sebelipase alfa as Breakthrough Therapy for early onset LAL Deficiency

Shire's scientific data on treatments for psychiatric disorders to be presented at APA meeting

ElsaLys Biotech announces first round of financing from Transgene and Sofimac Partners

BioLineRx signs ATM sales agency agreement with Stifel

Soligenix starts first clinical study for development of SGX203 for pediatric Crohn's disease

Tokai Pharmaceuticals raises $35.5M in Series E financing

UIC's Center for Clinical and Translational Science selects six research projects for new pilot grants

CMC Biologics, RuiYi to develop a cell line for RYI-008

Synageva BioPharma reports study results of sebelipase alfa in adults with late onset LAL Deficiency

Phase 1b clinical study data of EBI-005 for treatment of dry eye disease presented at ARVO meeting

New VLP vaccine candidate produced for H7N9 virus

Targacept reports net loss of $8.1 million in first quarter 2013

Aptiv Solutions participates in 'Practice Adaptive Clinical Trials’ conference at Tokyo University

New Process Analytical Technology for pharmaceutical and chemical manufacturing industries

Aeras receives grant to support the development of vaccines against TB, HIV and malaria

Alimera announces availability of ILUVIEN in U.K. for chronic DME treatment

BioLineRx starts enrollment in Phase I/II trial of BL-8020 for treatment of HCV

Transgene announces pre-clinical data of TG1050 for treatment of chronic hepatitis B infection

Thermo Fisher Scientific brings several innovations in bioprocessing technologies and systems

CytRx reaches agreement with FDA for aldoxorubicin Phase 3 trial for treatment of soft tissue sarcomas

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