Manufacturing News and Research

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

New York Times examines India's growing influence on global drug industry

"India's drug industry — on track to grow about 13 percent this year, to just over $24 billion — was once notorious for making cheap knockoffs of Western medicines and selling them in developing countries. But India, seasoned in the basics of medicine making, is now starting to take on a more mainstream role in the global drug industry, as a result of recent strengthening of patent law here and cost pressures on name-brand drug makers in the West," the New York Times writes.

8 Jul 2010

SurModics licenses biodegradable polymer implant technology to Clinuvel

SurModics, Inc., a leading provider of drug delivery and surface modification technologies to the healthcare industry, announced today that it has entered into a license agreement with Clinuvel Pharmaceuticals Limited of Melbourne, Australia. Under the agreement, the Company's SurModics Pharmaceuticals unit has licensed certain of its biodegradable polymer implant technology to Clinuvel for the treatment of sun-induced skin disorders. Terms of the agreement were not disclosed.

8 Jul 2010

Millipore launches new ProRes-S media for downstream purification of monoclonal antibodies, proteins

Millipore Corporation, a leading provider of technologies, tools and services for the global life science industry, today announced the launch of its new ProRes-S media. With the addition of ProRes-S media, Millipore's purification suite now provides a complete solution for the downstream purification of monoclonal antibodies and proteins. Developed jointly with The Dow Chemical Company, ProRes-S media offers biopharmaceutical manufacturers greater flexibility and increased throughput in a smaller manufacturing footprint.

8 Jul 2010

Oramed Pharmaceuticals signs MSA with sanofi-aventis

Oramed Pharmaceuticals Inc., a developer of oral delivery systems, today announced that Oramed entered into a Manufacturing Supply Agreement with sanofi-aventis. According to the MSA, sanofi-aventis will supply Oramed with specified quantities of recombinant human insulin to be used by Oramed for its clinical trials in the USA.

8 Jul 2010

Apicore files DMF for Fondaparinux Sodium API with U.S. FDA

Apicore LLC announced today that they filed a drug master file (DMF) for Fondaparinux Sodium active pharmaceutical ingredient (API) with the U.S. Food and Drug Administration (FDA) on June 28, 2010.

7 Jul 2010

FDA approves Glassia for treating Alpha 1 deficiency

Kamada, today announced that the United States Food and Drug Administration has approved Glassia (Alpha 1 Proteinase inhibitor, also known as Alpha-1-Antitrypsin) for the treatment of Alpha 1 deficiency. GlassiaM is now the first and only liquid Alpha- 1-Proteinase Inhibitor worldwide available liquid, ready to use, Alpha- 1-Proteinase Inhibitor on the market.

7 Jul 2010

BioNeutral, KRP complete manufacturing and distribution agreement

BioNeutral Group Inc., a specialty chemical technology-based life science company, announced today that it completed an agreement with Keystone Research and Pharmaceuticals for its proprietary formulations for use in the Veterinary, Dental and Cosmetic markets. The Terms are being held confidential.

6 Jul 2010

Columbia closes sale of progesterone related assets and 11.2M shares to Watson

Columbia Laboratories, Inc. announced today that it has closed the sale of its progesterone related assets and 11.2 million shares of common stock to Watson Pharmaceuticals, Inc.. Columbia's business now consists of its royalty and manufacturing revenues, potential milestone payments, its collaboration with Watson on the development of next-generation progesterone products, and its novel bioadhesive drug delivery technologies and other products.

6 Jul 2010

Raydiance demonstrates ability to machine precise, micron-resolution features in gold, platinum

Raydiance, Inc., the world's leading developer of ultrafast laser technology, announced today that it has demonstrated the ability to machine precise, micron-resolution features in gold and platinum, two of the more difficult-to-process materials used in advanced medical devices. Raydiance engineers achieved the results using the company's Smart LightTM 50 femtosecond pulse laser integrated into a Rofin StarCut Tube workstation.

6 Jul 2010

Watson acquires U.S. rights to CRINONE, PROCHIEVE product line from Columbia Laboratories

Watson Pharmaceuticals, Inc. today completed the acquisition of the U.S. rights to Columbia Laboratories' CRINONE® and PROCHIEVE® progesterone gel product line and 11,200,000 shares of Columbia common stock.

3 Jul 2010

WaferGen Biosystems to raise $7 million in registered direct offering

WaferGen Biosystems, Inc., a leading developer of state-of-the-art genomic analysis systems, today announced that it has received commitments from certain investors to purchase approximately $7 million of previously unissued securities in a registered direct offering. The investors include the Chairman and CEO, Alnoor Shivji, who has agreed to purchase $1 million of securities in the registered direct offering.

2 Jul 2010

Spectranetics commences voluntary recall and replacement of specific lots of thrombus extraction catheter

Spectranetics Corporation today initiated a voluntary recall of specific lots of its thrombus extraction catheter (product number 60090-01) manufactured by Spectranetics since October 2009. The Food and Drug Administration has been informed of this action and communication to various Competent Authorities outside of the United States has begun. While Spectranetics has received and confirmed customer complaints on this issue, no adverse events have been reported to the Company.

2 Jul 2010

Haitian President rejects U.S. Senate's recommendations for upcoming elections

A day after Haitian President Rene Preval signed a decree authorizing a date for November elections, he rebuffed other recommendations issued by the U.S. Senate, which include "holding an election for his successor, brushing off criticism that the current process will leave the shattered country without a credible leader," the Associated Press reports.

2 Jul 2010

FIOCRUZ receives Brazil's Anvisa regulatory approval to market Chembio's Dual Path Platform HIV 1/2 rapid test

Chembio Diagnostics, Inc., which develops, manufactures, markets and licenses point-of-care diagnostic tests, has been notified that Bio-Manguinhos, a division of the Oswaldo Cruz Foundation of Brazil ("FIOCRUZ"), has received regulatory approval from Brazil's National Health Surveillance Agency (Anvisa) to market Chembio's Dual Path Platform (DPP®) HIV 1/2 rapid test for use with oral fluid, blood, serum or plasma samples. The approval triggers $400,000 in license revenues payable to Chembio within 120 days of the date of approval.

1 Jul 2010

Düsseldorf court awards AGA Medical €2.1 million in Occlutech patent infringement case

AGA Medical Holdings, Inc. today announced the Düsseldorf Regional Court has awarded €2.1 million in damages to AGA Medical as a result of a patent infringement case filed by AGA Medical against Occlutech GmbH (Occlutech), based in Jena, Germany. AGA Medical is a leading developer of interventional devices for the minimally invasive treatment of structural heart defects and vascular abnormalities.

1 Jul 2010

Aptuit to acquire GSK's research business in Verona

GlaxoSmithKline (GSK) and Aptuit, Inc. announced today that they have finalized an agreement for Aptuit to acquire operations at GSK's Medicines Research Centre in Verona, Italy. The arrangement, which is effective as of July 1, 2010, provides for ongoing employment of the staff at the centre and for Aptuit to supply GSK with R&D services from the facilities. Financial terms have not been disclosed.

1 Jul 2010

Bacterin International completes reverse merger transaction

Bacterin International, Inc., a Nevada company, today announced that it has completed a reverse merger transaction with Bacterin International Holdings, Inc. f/k/a K-Kitz, in which the Company caused its wholly-owned subsidiary to be merged with and into Bacterin, with Bacterin as the surviving company.

1 Jul 2010

GSD signs agreement with Axis-Shield to distribute its proprietary assays in the U.S. Market

Gold Standard Diagnostics, Inc. a leading supplier of products and services to the medical diagnostic industry today announced the execution of an agreement with Axis-Shield to distribute their proprietary assays in the U.S. Market. Axis-Shield owns a number of patents in the areas of cardiovascular and neurodegenerative diseases, rheumatoid arthritis, diabetes and more recently, sepsis. GSD will initially focus on distribution of Homocysteine, but also gains access to distribute Axis-Shield's other key products such as Anti-CCP.

1 Jul 2010

GE Capital to provide Swift Group £30 million of dealer stocking funds

GE Capital announced that it agreed to provide Swift Group Ltd, the UK's leading manufacturer of caravans, motorhomes and holiday homes, with a distribution finance facility that will provide the company with an estimated £30 million of dealer stocking funds in 2010.

30 Jun 2010

Genomatica achieves two key commercialization milestones

Genomatica announced today that it has achieved two key commercialization milestones ahead of schedule. First, the company achieved pilot-scale validation, at 3,000 liters, of the manufacturability and commercial viability of a 'green' version of 1,4-butanediol (BDO), its first commercial product. And second, the company confirmed the accelerated development time and reduced development and production costs made possible through use of its technology platform, from concept to commercialization.

30 Jun 2010

Manufacturing News and Research

Further Reading

New York Times examines India's growing influence on global drug industry

SurModics licenses biodegradable polymer implant technology to Clinuvel

Millipore launches new ProRes-S media for downstream purification of monoclonal antibodies, proteins

Oramed Pharmaceuticals signs MSA with sanofi-aventis

Apicore files DMF for Fondaparinux Sodium API with U.S. FDA

FDA approves Glassia for treating Alpha 1 deficiency

BioNeutral, KRP complete manufacturing and distribution agreement

Columbia closes sale of progesterone related assets and 11.2M shares to Watson

Raydiance demonstrates ability to machine precise, micron-resolution features in gold, platinum

Watson acquires U.S. rights to CRINONE, PROCHIEVE product line from Columbia Laboratories

WaferGen Biosystems to raise $7 million in registered direct offering

Spectranetics commences voluntary recall and replacement of specific lots of thrombus extraction catheter

Haitian President rejects U.S. Senate's recommendations for upcoming elections

FIOCRUZ receives Brazil's Anvisa regulatory approval to market Chembio's Dual Path Platform HIV 1/2 rapid test

Düsseldorf court awards AGA Medical €2.1 million in Occlutech patent infringement case

Aptuit to acquire GSK's research business in Verona

Bacterin International completes reverse merger transaction

GSD signs agreement with Axis-Shield to distribute its proprietary assays in the U.S. Market

GE Capital to provide Swift Group £30 million of dealer stocking funds

Genomatica achieves two key commercialization milestones

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