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

FDA approves CSL Behring's Hizentra for PI

CSL Behring announced today that the U.S. Food and Drug Administration (FDA) has granted marketing approval for HizentraTM, Immune Globulin Subcutaneous (Human), 20% Liquid, for treating patients diagnosed with primary immunodeficiency (PI). A once weekly immunoglobulin (Ig) replacement therapy, Hizentra provides effective protection against infection by maintaining a steady and normal level of immunoglobulin in the body.

4 Mar 2010

Columbia Laboratories to sell progesterone related assets and 11.2M shares to Watson Pharmaceuticals

Columbia Laboratories, Inc. has entered into a definitive agreement to sell substantially all of its progesterone related assets and 11.2 million shares of common stock to Watson Pharmaceuticals, Inc. for a $47 million upfront payment plus royalties of 10 to 20 percent of annual net sales of certain progesterone products. Additional payments up to $45.5 million can be earned by the successful completion of clinical development milestones in the ongoing PREGNANT Study, regulatory filings, receipt of regulatory approvals and product launches.

4 Mar 2010

Enigma Diagnostics opens new Regional HQ office in San Diego

Enigma Diagnostics Limited, the decentralised and point-of-care molecular diagnostics company, announced today the opening of its new Regional HQ office in San Diego, CA and the appointment of Joel Centeno as VP Regulatory & Quality.

4 Mar 2010

Watson Pharmaceuticals to acquire U.S. rights to Columbia's bioadhesive progesterone gel products

Watson Pharmaceuticals, Inc. today announced an agreement to expand their Women's Health brand product portfolio with the acquisition of the exclusive U.S. rights to Columbia Laboratories, Inc.'s bioadhesive progesterone gel products currently marketed under the trade names CRINONE® and PROCHIEVE® for the indications of infertility and secondary amenorrhea.

4 Mar 2010

Atacama Labs and Excella partner to sell PDG Granule and Tablet Manufacturing Services

Atacama Labs Oy has developed an innovative oral drug delivery technology (called 'pneumatic dry granulation' or 'PDG Technology(TM)'). The technology is aimed to replace existing solid dosage form development and manufacturing methods (like wet granulation or standard roller compaction) and will help both NCE galenic developers and life cycle managers to overcome development or differentiation issues.

4 Mar 2010

Corning commercializes new Synthemax synthetic surface for supporting growth and differentiation of stem cells

Corning Incorporated today introduced the Corning® Synthemax™ surface, a novel synthetic surface that supports the growth and differentiation of stem cells. The surface is being commercialized as a result of Corning’s ongoing collaboration with Geron Corporation. This development enables researchers to take the next step toward scalable and cost-effective manufacturing of stem cells for potential therapies in the treatment of degenerative diseases.

4 Mar 2010

Repligen acquires BioFlash

Repligen Corporation announced today that it has acquired the assets of BioFlash Partners, LLC, (BioFlash) including a technology platform for the production of pre-packed, "plug and play" chromatography columns. This patented technology enables economical production of chromatography columns in a format that is ready for use in the production of a broad range of biopharmaceuticals including monoclonal antibodies, vaccines and recombinant proteins.

4 Mar 2010

Lemelson-MIT Collegiate Student Prizes awarded to inventive students nationwide

A scientific "Renaissance man" whose work spans the fields of mathematics, linguistics, biotechnology and polymer physics, Erez Lieberman-Aiden, graduate student at the Harvard-MIT Division of Health Sciences and Technology, has been named the winner of the prestigious $30,000 Lemelson-MIT Student Prize. Lieberman-Aiden, one of four 2010 $30,000 Lemelson-MIT Collegiate Student Prize winners announced today, was selected for the breadth and depth of his innovations.

4 Mar 2010

Hand sanitizers sold in Puerto Rico contain harmful bacteria, says FDA

The U.S. Food and Drug Administration is warning consumers in Puerto Rico that two hand sanitizers - "Bee-Shield Hand Sanitizer" with Aloe Vera (10 fl. oz. or 1 gallon bottles) and "MD Quality Hand Sanitizer" with Aloe Vera (10 fl oz. bottles) - contain high levels of a bacteria, Burkholderia cepacia, that can cause serious infections in humans.

4 Mar 2010

Covidien: Mallinckrodt launches Oral Transmucosal Fentanyl Citrate

Covidien, a leading global provider of healthcare products, today announced that Mallinckrodt Inc., a Covidien company, has launched its Oral Transmucosal Fentanyl Citrate (CII) to distributors serving retail pharmacies across the country.

3 Mar 2010

General Nutrition Centers' net income up 56.3% for fourth-quarter 2009

General Nutrition Centers, Inc., a leading global specialty retailer of nutritional products, today reported its financial results for the year and quarter ended December 31, 2009.

3 Mar 2010

Seattle Genetics generates $110M through ADC technology license agreements

Seattle Genetics, Inc. announced today that it has achieved a milestone under its antibody-drug conjugate (ADC) collaboration with Genentech, Inc., a wholly owned member of the Roche Group.

3 Mar 2010

Rigel Pharmaceuticals reports net loss of $0.48 per share for fourth-quarter 2009

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

2 Mar 2010

MAP Pharmaceuticals announces net loss of $13.4M for fourth-quarter 2009

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

2 Mar 2010

FDA approves CombinatoRx's NDA for Exalgo extended-release tablets

CombinatoRx, Incorporated today announced that the U.S. Food and Drug Administration has approved the New Drug Application (NDA) for Exalgo™ (hydromorphone HCl) extended-release tablets, for the management of moderate to severe pain in opioid tolerant patients requiring continuous, around-the-clock opioid analgesia for an extended period of time.

2 Mar 2010

FDA announces membership, meeting information for TPSAC; Committee to provide advice on tobacco-related issues

The U.S. Food and Drug Administration today announced membership and meeting information for the Tobacco Products Scientific Advisory Committee. The Committee, required through the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act), will provide advice, information, and recommendations to FDA on a wide range of tobacco-related issues.

2 Mar 2010

Latest FCC edition includes standards covering quality and purity for 1,100 food ingredients

New and updated quality standards for ingredients used in functional foods and a host of other food products manufactured, sold and consumed every day are included in the newly released seventh edition of the Food Chemicals Codex. Published by the U.S. Pharmacopeial Convention, the FCC is an internationally recognized compendium of standards that helps ensure the identity, quality, purity and consistency of food ingredients.

2 Mar 2010

Inovio Biomedical's SynCon preventive DNA vaccine receives approval in Korea for Phase I clinical trial

Inovio Biomedical Corporation, a leader in DNA vaccine design, development and delivery, announced today that its affiliate VGX International Inc. has received approval in Korea to begin a Phase I clinical trial in healthy volunteers for Inovio’s SynCon™ preventive DNA vaccine (VGX-3400) targeting H5N1 avian influenza.

2 Mar 2010

Archimedes Pharma raises GBP65 million in new funding

Archimedes Pharma, the leading specialty pharma company, today announced that it has raised GBP65 million (approx US$100 million) in new funding. The round was led by new investor Novo Growth Equity, the growth equity fund of Novo A/S, and included participation by major current investor, Warburg Pincus, a global private equity firm. Archimedes also announced the appointment of a new President and Chief Executive Officer, Jeffrey H. Buchalter, formerly President and Chief Executive Officer of US-based Enzon.

2 Mar 2010

BioSante Pharmaceuticals announces receipt of two US patents directed to 2A/Furin technology

BioSante Pharmaceuticals, Inc. today announced the receipt of two US patents directed to its 2A/Furin technology for expressing proteins. The first issued US patent, US Pat. No., 7,632,059, covers methods for manufacturing recombinant antibodies.

2 Mar 2010

Manufacturing News and Research

Further Reading

FDA approves CSL Behring's Hizentra for PI

Columbia Laboratories to sell progesterone related assets and 11.2M shares to Watson Pharmaceuticals

Enigma Diagnostics opens new Regional HQ office in San Diego

Watson Pharmaceuticals to acquire U.S. rights to Columbia's bioadhesive progesterone gel products

Atacama Labs and Excella partner to sell PDG Granule and Tablet Manufacturing Services

Corning commercializes new Synthemax synthetic surface for supporting growth and differentiation of stem cells

Repligen acquires BioFlash

Lemelson-MIT Collegiate Student Prizes awarded to inventive students nationwide

Hand sanitizers sold in Puerto Rico contain harmful bacteria, says FDA

Covidien: Mallinckrodt launches Oral Transmucosal Fentanyl Citrate

General Nutrition Centers' net income up 56.3% for fourth-quarter 2009

Seattle Genetics generates $110M through ADC technology license agreements

Rigel Pharmaceuticals reports net loss of $0.48 per share for fourth-quarter 2009

MAP Pharmaceuticals announces net loss of $13.4M for fourth-quarter 2009

FDA approves CombinatoRx's NDA for Exalgo extended-release tablets

FDA announces membership, meeting information for TPSAC; Committee to provide advice on tobacco-related issues

Latest FCC edition includes standards covering quality and purity for 1,100 food ingredients

Inovio Biomedical's SynCon preventive DNA vaccine receives approval in Korea for Phase I clinical trial

Archimedes Pharma raises GBP65 million in new funding

BioSante Pharmaceuticals announces receipt of two US patents directed to 2A/Furin technology

Achieving and maintaining ISO 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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