Manufacturing News and Research

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

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

Star Scientific develops moist snuff tobacco product with low carcinogenic levels

Star Scientific, Inc. reports that it has successfully developed a moist snuff tobacco product that has extremely low levels of carcinogens -- much lower than any snuff products currently in the marketplace. This new product has levels of tobacco-specific nitrosamines (TSNAs) -- recognized by scientists worldwide as one of the most powerful cancer-causing agents in tobacco leaf and smoke -- below 20 parts per billion (nanograms-per-gram moist weight, as used) in initial testing.

4 Jan 2011

Embryome Sciences announces $4M equity financing, changes name to ReCyte Therapeutics

BioTime, Inc. today announced a $4 million equity financing by its subsidiary, Embryome Sciences, Inc. Concurrent with the financing, Embryome Sciences will be renamed ReCyte Therapeutics, Inc. and will develop therapeutic products for cardiovascular and blood diseases. The new equity financing is being led by a $2.5 million investment by private investors and a $1.5 million investment from BioTime that valued ReCyte Therapeutics at a post money valuation of $60 million on a fully diluted basis.

4 Jan 2011

Stryker acquires Boston Scientific's Neurovascular business

Boston Scientific Corporation today announced that it has completed the sale of its Neurovascular business to Stryker Corporation.

From Stryker 3 Jan 2011

FDA clears ACT's IND to treat AMD using hESC derived RPE cells

Advanced Cell Technology, Inc., a leader in the field of regenerative medicine, announced today that the US Food and Drug Administration (FDA) has cleared the Company's Investigational New Drug (IND) application to treat Dry Age-Related Macular Degeneration (AMD) using retinal pigment epithelial (RPE) cells derived from human embryonic stem cells (hESCs).

3 Jan 2011

CEL-SCI initiates Multikine Phase III trail for head and neck cancer

CEL-SCI Corporation announced today that it has commenced its Phase III clinical trial for Multikine®, the Company's flagship immunotherapy. CEL-SCI has now completed all of the manufacturing and regulatory requirements to begin enrollment of the study.

29 Dec 2010

Chindex announces joint venture deal with Fosun Pharma

Chindex International, a leading independent American provider of Western healthcare products and services in the People's Republic of China, and Shanghai Fosun Pharmaceutical, a leading manufacturer and distributor of western and Chinese medicine and devices in China, today announced the formation of the previously-proposed joint venture to independently operate certain combined medical device businesses, including Chindex's Medical Products division.

28 Dec 2010

ACT, Roslin Cells collaborate to establish hESC line bank using single-ceblastomere technique

Advanced Cell Technology, a leader in the field of regenerative medicine, announced today that it has entered into a Memorandum of Understanding with Roslin Cells LTD of Scotland, in which the two companies contemplate a definitive collaboration agreement in the near future.

28 Dec 2010

Alimera receives FDA CRL for ILUVIEN NDA

pSivida Corp., a leader in developing sustained release, drug delivery products for treatment of back-of-the-eye diseases, including the investigational drug ILUVIEN® for the treatment of Diabetic Macular Edema (DME), today announced that Alimera Sciences, Inc, pSivida's collaborative partner, received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for ILUVIEN. The FDA issued the CRL to communicate its decision that the NDA cannot be approved in its present form.

24 Dec 2010

Manufacturing News and Research

Further Reading

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

Star Scientific develops moist snuff tobacco product with low carcinogenic levels

Embryome Sciences announces $4M equity financing, changes name to ReCyte Therapeutics

Stryker acquires Boston Scientific's Neurovascular business

FDA clears ACT's IND to treat AMD using hESC derived RPE cells

CEL-SCI initiates Multikine Phase III trail for head and neck cancer

Chindex announces joint venture deal with Fosun Pharma

ACT, Roslin Cells collaborate to establish hESC line bank using single-ceblastomere technique

Alimera receives FDA CRL for ILUVIEN NDA

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