Manufacturing News and Research

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Manufacturing is the production of products across all industries, on a large-scale, using machinery.

IGI Laboratories submits second abbreviated new drug application to FDA

IGI Laboratories, a New Jersey based formulation and manufacturing company, today announced that it has submitted its second abbreviated new drug application to the US FDA.

10 Jan 2011

Enobia Pharma completes ENB-0040 Phase II study in juveniles with hypophosphatasia

Enobia Pharma, today announced that it has successfully completed a Phase II study of ENB-0040, a bone targeted enzyme replacement therapy being investigated in juveniles with hypophosphatasia, a serious, rare metabolic bone disorder.

10 Jan 2011

Bonso reports $0.27 million net income for half year ended September 30, 2010

Bonso Electronics International, Inc. today reported its financial results for the six-month period ended September 30, 2010.

10 Jan 2011

Emergent BioSolutions estimates total revenue of $285 to $288 million for 2010

Emergent BioSolutions Inc. announced today preliminary, unaudited financial results for 2010 and guidance for 2011.

10 Jan 2011

Civitas receives $20 million Series A financing

Civitas Therapeutics, Inc., a privately held biopharmaceutical company focused on developing transformative pulmonary delivery therapies, announced today that it has secured a $20 million Series A financing from founding investor, Longitude Capital, along with co-lead Canaan Partners. The proceeds of the financing will be primarily used to advance Civitas' lead program for treating patients with Parkinson's disease through clinical proof-of-concept.

10 Jan 2011

AMT enters agreement with Consortium for clinical development of novel gene therapy to treat Sanfilippo B

Amsterdam Molecular Therapeutics, a leader in human gene therapy, announced today that it has entered into an agreement with Institut Pasteur, Paris, France, and a group of French research institutes (together the "Consortium") to support clinical development of a novel gene therapy to treat Sanfilippo B.

10 Jan 2011

New lab-on-a-chip technology detects protein in blood less than 30 minutes

While most blood tests require shipping a vial of blood to a laboratory for analysis and waiting several days for the results, a new device invented by a team of engineers and students at the University of Rhode Island uses just a pinprick of blood in a portable device that provides results in less than 30 minutes.

10 Jan 2011

Dendreon provides U.S. commercialization and European strategy updates for PROVENGE

Dendreon Corporation today announced several updates regarding the U.S. commercialization of PROVENGE® (sipuleucel-T), the European strategy for PROVENGE, and progress on its pipeline.

7 Jan 2011

Cell Medica enters EBV-associated cancer research collaboration with CAGT and Baylor College of Medicine

Cell Medica, a leading cellular therapeutics company which develops, manufactures and markets cellular immunotherapy products for the treatment of infectious disease and cancer, is pleased to announce an exclusive license agreement and research collaboration with the Center for Cell and Gene Therapy (CAGT), Baylor College of Medicine (Houston, Texas), for the commercialization of an innovative cell-based treatment for cancers associated with the oncogenic Epstein Barr virus (EBV).

7 Jan 2011

Intrexon Corporation, ZIOPHARM enter partnership to develop, commercialize DNA-based therapeutics

ZIOPHARM Oncology, a small molecule late-stage oncology drug development company, and Intrexon Corporation, a next generation synthetic biology company, announced today a global exclusive channel partnership in oncology where ZIOPHARM will develop and commercialize DNA-based therapeutics using Intrexon's UltraVector Technology.

7 Jan 2011

Spirogen, Genentech enter multi-year ADC research collaboration and license agreement

Spirogen Ltd. a leading oncology-focused company developing DNA sequence targeted agents, announced a multi-year research collaboration and license agreement with Genentech, a member of the Roche Group.

7 Jan 2011

Seattle Genetics enters ADC collaboration agreement with Pfizer

Seattle Genetics, announced today that it has entered into a collaboration agreement with Pfizer under which Pfizer will pay an upfront fee of $8 million for rights to utilize Seattle Genetics' antibody-drug conjugate technology with antibodies to a single oncology target.

7 Jan 2011

Opexa completes meetings with FDA regarding planned development program for Tovaxin

Opexa Therapeutics, Inc., a leading cell therapy company developing Tovaxin for multiple sclerosis, today announced the successful completion of two separate meetings with the U.S. Food and Drug Administration regarding the Company's planned development program for Tovaxin.

6 Jan 2011

Novel AAV gene therapy offers various advantages

A new, simplified method for producing large amounts of viral vector cassettes capable of shuttling genes into host cells will help advance the promising field of gene therapy as applications move into large animal studies and human clinical trials.

6 Jan 2011

Transposagen, CDI enter license agreement for iPS cell line production

Transposagen Biopharmaceuticals, a leader in genetic modification technology, announced today that it has entered into a non-exclusive license agreement with Cellular Dynamics International, the world's largest producer of human induced pluripotent stem cell lines and tissue cells for drug discovery and safety.

6 Jan 2011

DJO Incorporated announces acquisition of Elastic Therapy

DJO Incorporated, a global provider of medical device solutions for musculoskeletal health, vascular health and pain management, today announced the acquisition of Elastic Therapy, Inc. The acquisition closed yesterday, January 4, 2011.

6 Jan 2011

ImmunGene, Cephalon Australia collaborate to advance new class of protein therapeutics

ImmunGene, Inc., a privately held drug development company focused on targeted antibody therapeutics, announced today it has entered into a collaboration in which Cephalon Australia (a wholly owned subsidiary of Cephalon, Inc.) will apply ImmunGene's interferon payload technology to up to six of its new drug targets for cancers.

5 Jan 2011

Invacare comments on FDA warning letter over bed manufacturing facility inspection

Today Invacare Corporation commented on an FDA warning letter related to an inspection of the Company's bed manufacturing facility in Sanford, Florida. The warning letter takes issue with Invacare's compliance with the FDA's Quality System Regulation, specifically related to Invacare's ability to establish and maintain adequate procedures to analyze processes and operations and to document actions taken on product complaints.

5 Jan 2011

Dongsheng obtains exclusive sales rights of Thymosin Alpha 1 Injection in China

Dongsheng Pharmaceutical International Co., Ltd. announced today that it has obtained the exclusive sales rights of Thymosin Alpha 1 Injection in 19 provinces in China from Shanghai Biochemistry Pharmaceutical Co. I.

5 Jan 2011

Bioniche Life Sciences announces completion of Australian Offer and raises gross proceeds of A$12.5 million

Bioniche Life Sciences In., a research-based, technology-driven Canadian biopharmaceutical company, today announced that it has successfully completed its Australian Offer of 8.6 million CHESS Depositary Instruments at A$1.45 per CDI, raising gross proceeds of A$12.5 million.

4 Jan 2011

Manufacturing News and Research

Further Reading

IGI Laboratories submits second abbreviated new drug application to FDA

Enobia Pharma completes ENB-0040 Phase II study in juveniles with hypophosphatasia

Bonso reports $0.27 million net income for half year ended September 30, 2010

Emergent BioSolutions estimates total revenue of $285 to $288 million for 2010

Civitas receives $20 million Series A financing

AMT enters agreement with Consortium for clinical development of novel gene therapy to treat Sanfilippo B

New lab-on-a-chip technology detects protein in blood less than 30 minutes

Dendreon provides U.S. commercialization and European strategy updates for PROVENGE

Cell Medica enters EBV-associated cancer research collaboration with CAGT and Baylor College of Medicine

Intrexon Corporation, ZIOPHARM enter partnership to develop, commercialize DNA-based therapeutics

Spirogen, Genentech enter multi-year ADC research collaboration and license agreement

Seattle Genetics enters ADC collaboration agreement with Pfizer

Opexa completes meetings with FDA regarding planned development program for Tovaxin

Novel AAV gene therapy offers various advantages

Transposagen, CDI enter license agreement for iPS cell line production

DJO Incorporated announces acquisition of Elastic Therapy

ImmunGene, Cephalon Australia collaborate to advance new class of protein therapeutics

Invacare comments on FDA warning letter over bed manufacturing facility inspection

Dongsheng obtains exclusive sales rights of Thymosin Alpha 1 Injection in China

Bioniche Life Sciences announces completion of Australian Offer and raises gross proceeds of A$12.5 million

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