Manufacturing News and Research

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

Sangamo's preclinical ZFN-gene modification studies for HIV/AIDS treatment presented at CROI

Sangamo BioSciences, Inc. announced that data from its programs to develop ZFN-based therapeutic approaches for the treatment of HIV/AIDS were discussed in four oral presentations at the 18th Conference on Retroviruses and Opportunistic Infections, held in Boston from February 27 to March 2, 2011.

4 Mar 2011

SERS nanosubstrates revolutionize medical diagnostics

Gold-coated substrates of gallium nitride with specifically formed surface, developed by researchers from the Institute of Physical Chemistry of the Polish Academy of Sciences and the Institute of High Pressure Physics of the PAS display worldwide unique properties. Thanks to these new substrates, an extremely sensitive SERS analytical technique, capable of detecting even single molecules, after decades of waiting in specialized laboratories has finally got a chance to widespread and revolutionize medical diagnostics.

4 Mar 2011

New computer-controlled system to create cell assembly line

Borrowing a page from modern manufacturing, scientists from the Florida campus of The Scripps Research Institute have built a microscopic assembly line that mass produces synthetic cell-like compartments.

4 Mar 2011

Wako i30 Immunoanalyzer incorporating Caliper's microfluidic LabChip technologies receives 510(k) clearance

Caliper Life Sciences, Inc. today announced that its licensee Wako Pure Chemical Industries, through its Wako Diagnostics division, has obtained 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its uTASWako® i30 Immunoanalyzer and AFP-L3 and DCP Assays, which are used to assess liver cancer risk in patients with chronic liver disease.

4 Mar 2011

FDA approves Amneal's Indomethacin ER capsules

Amneal Pharmaceuticals, LLC is pleased to announce that it received U.S. FDA approval for Indomethacin Extended Release capsules, USP in the 75 mg strength effective December 1, 2010.

3 Mar 2011

Celerion completes Clean Room, pharmacist certification to comply with USP 797 guidelines

Celerion, the premier provider of innovative early stage drug development solutions, announces the completion of a Clean Room and pharmacist certification to comply with USP 797 guidelines.

3 Mar 2011

FDA takes action against companies that manufacture unapproved prescription drugs

The U.S. Food and Drug Administration today took action against companies that manufacture, distribute, or market certain unapproved prescription oral cough, cold, and allergy products. The affected products cannot be legally marketed in the United States.

3 Mar 2011

ITI, Takeda collaborate to develop and commercialize PDE1 inhibitors for schizophrenia

Intra-Cellular Therapies, Inc. ("ITI") and Takeda Pharmaceutical Company Limited, today announced that they have entered into an exclusive collaboration to develop and commercialize selective phosphodiesterase type 1 (PDE1) inhibitors, discovered by ITI, for the treatment of cognitive impairment associated with schizophrenia. This agreement is targeted worldwide, but ITI has retained the option to co-promote with Takeda in the United States.

3 Mar 2011

International Surf Resorts to acquire BioZone Laboratories

International Surf Resorts, Inc., to be renamed BioZone Pharmaceuticals, Inc., today announced a binding option and letter of intent with BioZone Laboratories, Inc. and related companies.

2 Mar 2011

Thermo Fisher Scientific plans for new manufacturing facility in China

Thermo Fisher Scientific Inc., the world leader in serving science, today announced plans for a new manufacturing facility in China within the Suzhou Science and Technology Town - part of the company's strategy to aggressively expand its presence in the Asia-Pacific region.

From Thermo Fisher Scientific Inc. 2 Mar 2011

Four pharmaceutical companies partner to create new single-source industry

Four successful contract packaging and re-packaging companies in the pharmaceutical industry recently joined forces to create a new, single-source industry leader called Aphena Pharma Solutions.

2 Mar 2011

QLT fourth quarter revenues decrease 7.3% to $10.0 million

QLT Inc. today reported financial results for the fourth quarter ended December 31, 2010 and full year 2010 as well as issued its guidance for 2011. Unless specified otherwise, all amounts are in U.S. dollars and in accordance with U.S. GAAP.

1 Mar 2011

Star-Ledger examines Tibotec's agreement with generic drug makers on experimental HIV/AIDS treatment

In a piece on the move by drug manufacturer Tibotec Pharmaceuticals to grant licenses to generic manufacturers in India and South Africa to create copies of its experimental HIV/AIDS drug, the New Jersey Star-Ledger examines why drug companies are particularly focused on expanding their reach in sub-Saharan Africa.

1 Mar 2011

Medical experts propose six-point framework for safe production and use of Kava plant

Medical and scientific experts propose a global framework for the safe production and use of the medicinal plant Kava, including further clinical testing In Australia.

1 Mar 2011

Excella achieves SafeBridge Potent Compound Safety Certification

SAFEBRIDGE® CONSULTANTS, INC., headquartered in Mountain View, California, has announced that Excella GmbH in Feucht, Germany has met the criteria established under the SafeBridge program for "Potent Compound Safety Certification" and has been deemed competent and proficient in the safe handling of potent active pharmaceutical ingredients ("APIs") and potent drug products.

1 Mar 2011

Objet, Remedent partner to enhance 3D printing solutions for cosmetic dentistry

Remedent, a global leader in porcelain veneers and teeth whitening solutions for the cosmetic dental industry, announced today that it has teamed up with Objet Geometries, the innovation leader in 3D printing for rapid prototyping and additive manufacturing, to enhance the fabrication process for dental veneer try-ins and delivery guides using Objet's 3D printing solutions.

1 Mar 2011

Novavax announces agreement to license VLP vaccine technology to LGLS

Novavax, Inc. announced today an agreement to license its proprietary, recombinant virus-like-particle vaccine technology to LG Life Sciences, Ltd.

1 Mar 2011

HHS awards two contracts to accelerate flu vaccine availability

U.S. Department of Health and Human Services awarded two contracts today to help make vaccine available more quickly for seasonal flu outbreaks and pandemics. The contracts for advanced development of new types of vaccine and new ways to make flu vaccine known as next-generation recombinant influenza vaccine total $215 million.

28 Feb 2011

Mindray Medical enters agreement to acquire controlling stake of Shenke

Mindray Medical International Limited, a leading developer, manufacturer and marketer of medical devices worldwide, announced today an agreement to acquire a controlling stake of Shenzhen Shenke Medical Instrument Technical Development Co. Ltd. The terms of the transaction were not disclosed as the transaction is non-material to Mindray's financial statements.

From Mindray 28 Feb 2011

Astra Tech enters global strategic alliance with 3Shape

Astra Tech, a market leader and innovator in the field of implant dentistry and CAD/CAM abutments, announces a global strategic alliance with 3Shape A/S, the Danish-based provider of 3D scanners and CAD/CAM software solutions.

28 Feb 2011

Manufacturing News and Research

Further Reading

Sangamo's preclinical ZFN-gene modification studies for HIV/AIDS treatment presented at CROI

SERS nanosubstrates revolutionize medical diagnostics

New computer-controlled system to create cell assembly line

Wako i30 Immunoanalyzer incorporating Caliper's microfluidic LabChip technologies receives 510(k) clearance

FDA approves Amneal's Indomethacin ER capsules

Celerion completes Clean Room, pharmacist certification to comply with USP 797 guidelines

FDA takes action against companies that manufacture unapproved prescription drugs

ITI, Takeda collaborate to develop and commercialize PDE1 inhibitors for schizophrenia

International Surf Resorts to acquire BioZone Laboratories

Thermo Fisher Scientific plans for new manufacturing facility in China

Four pharmaceutical companies partner to create new single-source industry

QLT fourth quarter revenues decrease 7.3% to $10.0 million

Star-Ledger examines Tibotec's agreement with generic drug makers on experimental HIV/AIDS treatment

Medical experts propose six-point framework for safe production and use of Kava plant

Excella achieves SafeBridge Potent Compound Safety Certification

Objet, Remedent partner to enhance 3D printing solutions for cosmetic dentistry

Novavax announces agreement to license VLP vaccine technology to LGLS

HHS awards two contracts to accelerate flu vaccine availability

Mindray Medical enters agreement to acquire controlling stake of Shenke

Astra Tech enters global strategic alliance with 3Shape

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