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

Kamada commences enrollment in European inhaled AAT clinical trial for alpha-1 antitrypsin deficiency

Kamada, a bio-pharmaceutical company engaged in the development, manufacturing and marketing of specialty life-saving therapeutics, announced today that it has enrolled the first patient into its pivotal clinical trial with its new breakthrough compound of inhaled alpha-1 antitrypsin (AAT) delivered by an Investigational eFlow Nebulizer System (PARI Pharma GmbH), in patients with alpha-1 antitrypsin deficiency.

9 Feb 2010

FDA approves Amneal Pharmaceuticals' Tramadol/APAP tablets

Amneal Pharmaceuticals is pleased to announce that it received U.S. FDA approval to manufacture combination Tramadol HCl in 37.5 mg strength and Acetaminophen in 325 mg strength (Tramadol/APAP) in tablet form effective December 9, 2009. Amneal’s generic is an AB-rated, therapeutically equivalent alternative to Ultracet® (a licensed trademark of Ortho-McNeil Janssen). U.S. sales of Tramadol/APAP were $61 MM according to June 2009 IMS Health market data.

8 Feb 2010

AMRI announces fourth-quarter and full-year 2009 results

AMRI today reported financial and operating results for the fourth quarter and full year ending December 31, 2009.

8 Feb 2010

3SBio announces Nephoxil collaboration and license agreement with Panacor Bioscience

3SBio Inc., a leading China-based biotechnology company focused on researching, developing, manufacturing and marketing biopharmaceutical products, today announced a collaboration and license agreement with Panacor Bioscience Ltd. to develop and commercialize its Nephoxil(R) pharmaceutical product for the treatment of hyperphosphatemia in China.

8 Feb 2010

BioTime announces results of independent Hextend study in hemodynamically unstable trauma patients

BioTime, Inc. today reported recently-released results from an independent study evaluating the use of Hextend® in hemodynamically unstable trauma patients. Hextend (6% Hetastarch in Lactated Electrolyte Injection) is BioTime’s commercially-available blood plasma volume expander used to treat hypovolemia (low blood volume). The study, conducted at the University of Miami Ryder Trauma Center, reported that initial resuscitation with Hextend was associated with no obvious coagulopathy and reduced mortality compared to fluid resuscitation without Hextend.

5 Feb 2010

FDA investigates Salmonella Montevideo outbreak in Italian sausage products

The Food and Drug Administration, along with the Centers for Disease Control and Prevention and the U.S. Department of Agriculture's Food Safety and Inspection Service, continues to work closely with the Rhode Island Department of Health and other states in the investigation of an outbreak of Salmonella Montevideo infections associated with certain Italian-style sausage products including salami/salame.

5 Feb 2010

Emerson Ecologics officially launches Emerson Quality Program

Emerson Ecologics, LLC announces the official launch of the Emerson Quality Program(SM) (EQP) on their website, www.emersonecologics.com/quality. This one-of-a-kind quality assurance program for the nutritional supplements industry will showcase the quality practices of the industry's leading manufacturers.

5 Feb 2010

World Heart consortium awarded $5.6M NIH contract for developing PediaFlow VAD

World Heart Corporation ("WorldHeart") announced today that it was part of a consortium awarded a $5.6 million, 4-year contract by the National Institutes of Health (NIH) to further develop the PediaFlow™ VAD to clinical trial readiness.

5 Feb 2010

Tecan Group, Enigma Diagnostics sign manufacturing and supply agreement for Enigma ML instruments

The Tecan Group, a leading global provider of laboratory instruments and solutions, and Enigma Diagnostics Limited, the decentralised and point-of-care molecular diagnostics company, announced today the signing of a manufacturing and supply agreement for Enigma's ML instruments.

From Tecan 5 Feb 2010

International Stem Cell opens new cell production facility in Oceanside, California

International Stem Cell Corporation, www.internationalstemcell.com, announced today that its new cell production facility has passed final building inspection, which will enable development and manufacturing of the company and its partners’ clinical-grade stem cell products.

5 Feb 2010

Bioheart initiates REGEN Phase I Clinical Trial for testing genetically modified MyoCell in CHF patients

Bioheart, Inc., announced today that the company has commenced work on its REGEN trial, a Phase I Clinical Trial to test genetically modified MyoCell® in patients suffering from Congestive Heart Failure (CHF). Bioheart’s MyoCell® is a regenerative cell therapy that uses myoblasts, or muscle stem cells,that are grown from a patient’s own muscle. MyoCell® has been tested successfully on patients in four clinical trials.

5 Feb 2010

Allergan acquires Serica Technologies

Morningside Technology Ventures, Prism VentureWorks, and Ivy Capital Partners are pleased to announce the acquisition of their portfolio company, Serica Technologies, Inc. by Allergan, Inc. Serica is a growth-stage medical device company focused on the development of biodegradable silk-based scaffolds for use in tissue regeneration in numerous therapeutic areas. Following the acquisition, Serica became a wholly owned subsidiary of Allergan.

4 Feb 2010

TenX Biopharma acquires exclusive global rights to zanolimumab from Genmab

TenX Biopharma, Inc. announced today it has signed a licensing agreement to acquire exclusive worldwide rights to develop and commercialize zanolimumab (HuMax-CD4®) from Genmab A/S.

4 Feb 2010

Alkermes develops proprietary LinkeRx technology platform to create injectable antipsychotics

Alkermes, Inc. today announced that it has developed a novel, proprietary LinkeRx™ technology platform to enable the creation of injectable extended-release versions of antipsychotics and other central nervous system (CNS) therapies.

4 Feb 2010

BioCryst Pharmaceuticals announces fourth-quarter and full-year 2009 financial results

BioCryst Pharmaceuticals, Inc. today announced financial results for the fourth quarter and year ended December 31, 2009.

4 Feb 2010

Discussion on IATA Chapter 17 compliance for temperature-sensitive products at 8th Cold Chain Summit

Pharma IQ, a division of IQPC, announces that Kevin O’Donnell Director & CTA of Tegrant Corporation and Chair of IATA’s Time & Temperature Task Force will discuss compliance with IATA’s revised Chapter 17 at the 8th Cold Chain Management and Temperature Control Summit.

From IQPC Ltd 4 Feb 2010

NovaBone Products relocates operations division to expanded and upgraded facilities

NovaBone Products, LLC has announced the relocation of its operations division to expanded and upgraded facilities where it will meet increasing demands of higher sales to a more geographically diverse distributor network.

4 Feb 2010

Akela announces the outcomes of two legal cases involving former employees

Akela a leader in the development of therapeutics for the treatment of pain and its wholly owned subsidiary, PharmaForm, a leader in the contract pharmaceutical development and manufacturing business, today announced the outcomes of two legal cases involving former employees.

4 Feb 2010

EUCODIS Bioscience to utilize EUR 2M capital injection for adding enzyme families and development of international markets

EUCODIS Bioscience, a company providing customized enzymes to the pharmaceutical, chemical, and other industries, announced today that it has received a cash injection of EUR 2 million from existing shareholders.

4 Feb 2010

CRN issues statement on "The Dietary Supplement Safety Act of 2010"

The responsible dietary supplement industry represents the health and wellness interests of more than 150 million Americans who use dietary supplements each year. The number one priority for CRN and our members is to ensure that our consumers have access to safe, beneficial products that they can incorporate into their daily wellness regimens.

4 Feb 2010

Manufacturing News and Research

Further Reading

Kamada commences enrollment in European inhaled AAT clinical trial for alpha-1 antitrypsin deficiency

FDA approves Amneal Pharmaceuticals' Tramadol/APAP tablets

AMRI announces fourth-quarter and full-year 2009 results

3SBio announces Nephoxil collaboration and license agreement with Panacor Bioscience

BioTime announces results of independent Hextend study in hemodynamically unstable trauma patients

FDA investigates Salmonella Montevideo outbreak in Italian sausage products

Emerson Ecologics officially launches Emerson Quality Program

World Heart consortium awarded $5.6M NIH contract for developing PediaFlow VAD

Tecan Group, Enigma Diagnostics sign manufacturing and supply agreement for Enigma ML instruments

International Stem Cell opens new cell production facility in Oceanside, California

Bioheart initiates REGEN Phase I Clinical Trial for testing genetically modified MyoCell in CHF patients

Allergan acquires Serica Technologies

TenX Biopharma acquires exclusive global rights to zanolimumab from Genmab

Alkermes develops proprietary LinkeRx technology platform to create injectable antipsychotics

BioCryst Pharmaceuticals announces fourth-quarter and full-year 2009 financial results

Discussion on IATA Chapter 17 compliance for temperature-sensitive products at 8th Cold Chain Summit

NovaBone Products relocates operations division to expanded and upgraded facilities

Akela announces the outcomes of two legal cases involving former employees

EUCODIS Bioscience to utilize EUR 2M capital injection for adding enzyme families and development of international markets

CRN issues statement on "The Dietary Supplement Safety Act of 2010"

Achieving and maintaining ISO/IEC 27001 and BS 10012 certifications

Expanding research and clinical options for children with cancer

Examining how pain could play a direct protective role in the gut

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