Manufacturing News and Research

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

sanofi-aventis reports 2009 fourth-quarter and full-year net earnings

Commenting on the Group's 2009 performance, sanofi-aventis Chief Executive Officer Christopher A. Viehbacher said, "2009 was the first year of implementation of our new strategy. Major steps have already been achieved in strengthening our growth platforms and reinforcing our R&D pipeline while delivering a double-digit EPS(1) growth".

10 Feb 2010

Goodwin Biotechnology, Macrocyclics announce collaboration on Chelation and Bioconjugation

Goodwin Biotechnology Inc., a full service Contract Biomanufacturing Company and Macrocyclics, Inc., a manufacturer of customized chelating agents, jointly announced today their collaborative agreement on Chelation and Bioconjugation. The collaboration will strengthen joint customer projects in Nuclear Medicine involving Chelation, Bioconjugation and GMP manufacturing.

10 Feb 2010

Avrio Biopharmaceuticals receives Cal FDB approval to manufacture and ship pharmaceutical products

Avrio Biopharmaceuticals, LLC, a wholly-owned subsidiary of Irvine Pharmaceutical Services, Inc., received approval to manufacture and ship pharmaceutical products by the California Department of Public Health, Food and Drug Branch (Cal FDB), completing the organization's portfolio of product development services in support of its pharmaceutical, biopharmaceutical, and medical device clients.

10 Feb 2010

Alexza Pharmaceuticals announces development and commercialization collaboration with Biovail Laboratories International

Alexza Pharmaceuticals, Inc. announced today that it has established a collaboration with Biovail Laboratories International SRL, a subsidiary of Biovail Corporation, to develop and commercialize AZ-004 (Staccato® loxapine) in the U.S. and Canada. AZ-004 is Alexza's lead program, based on the company's proprietary technology, the Staccato system. Alexza submitted its New Drug Application (NDA) for Staccato loxapine in December 2009. Alexza is seeking regulatory approval to market AZ-004, an inhalation product candidate developed for the rapid treatment of agitation in patients with schizophrenia or bipolar disorder.

10 Feb 2010

Biovail and Alexza Pharmaceuticals sign collaboration and license agreement for anti-agitation drug

Biovail Corporation today announced that its subsidiary, Biovail Laboratories International SRL (BLS), has entered into a collaboration and license agreement with Alexza Pharmaceuticals, Inc.

10 Feb 2010

Glissandra Skincare signs first distribution agreement with Enchanted Meadow

Glissandra Skincare™ Inc., dedicated to the research, development, and manufacturing of anti-aging skincare products, announced it has signed its first distributorship agreement granting Enchanted Meadow the rights to distribute Glissandra to its more than 2000 spa and gift industry retailers throughout the US and Canada.

10 Feb 2010

Cost reductions offset sales decline to move Allied Healthcare Products back into profitability

Cost reductions offset a recession-driven sales decline to move Allied Healthcare Products narrowly back into profitability in the second quarter of fiscal year 2010.

10 Feb 2010

AdvanSource Biomaterials' polymer product lines comply with the guidelines of European Council Decision

AdvanSource Biomaterials Corporation, a leading developer of advanced polymer materials for a broad range of medical devices, today announced that its polymer product lines are compliant with measures applying to the processing of certain animal waste to protect against transmissible spongiform encephalopathies as set forth in European Council Decision 1999/534/EC.

10 Feb 2010

Glide Pharma to utilize $4.3M funding for progressing octreotide programme into clinical development

Glide Pharma, a specialty pharmaceutical company focused on the needle-free administration of solid dose therapeutics and vaccines, today announced that it has completed an oversubscribed GBP2.7 million ($4.3 million) investment round. The fundraising was supported by a number of existing institutional and private investors, including Hygea VCT and Oxford Technology VCTs. The company has now completed four successful investment rounds, securing funding totalling approximately GBP10 million.

10 Feb 2010

Unassisted cessation proves to be most successful in quitting smoking

Health authorities should emphasize the positive message that the most successful method used by most ex-smokers is unassisted cessation, despite the promotion of cessation drugs by pharmaceutical companies and many tobacco control advocates.

10 Feb 2010

Elan announces fourth-quarter and full-year financial results ended December 31, 2009

Elan Corporation, plc today reported its fourth quarter and full-year 2009 financial results and provides financial guidance for 2010.

10 Feb 2010

Sony acquires iCyt Mission Technology

Sony Corporation (Sony) announced today that it has acquired iCyt Mission Technology, Inc. (iCyt), a leading producer of high-performance cell sorters used for stem cell and disease research, through its U.S. subsidiary, Sony Corporation of America (SCA).

10 Feb 2010

New filtration process to improve safety and quality of infant formula

Pall Corporation, a global leader in filtration, separation and purification, today introduced a new filtration process that significantly improves the safety and quality of infant formula. The Pall process is engineered to prevent microbial contamination through intensive filtration, while preserving nutritional quality by minimizing the need for repeated heat treatment during manufacturing.

From Pall Corporation 10 Feb 2010

Biogen Idec reports 2009 fourth quarter and full year earnings

Biogen Idec Inc., a global biotechnology leader in the discovery, development, manufacturing, and commercialization of innovative therapies, today announced its full year and fourth quarter 2009 results.

9 Feb 2010

Targeted Genetics receives milestone payments from Genzyme and Amsterdam Molecular Therapeutics

Targeted Genetics Corporation (the “Company”) today announced that it has completed the technology transfer portion of the September 2009 asset sale transaction executed between the Company and Genzyme Corporation (“Genzyme”) and has received the full $7.0 million provided for in the asset purchase agreement.

9 Feb 2010

BD recalls certain lots of BD Q-Syte Luer Access Devices and BD Nexiva Closed IV Catheter Systems

BD (Becton, Dickinson and Company) has voluntarily executed a product recall of certain lots of BD Q-Syte™ Luer Access Devices and BD Nexiva™ Closed IV Catheter Systems. Use of the affected devices may cause an air embolism or leakage of blood and/or therapy, which may result in serious injury or death. This field corrective action included notification to customers worldwide by letter. Neither the costs anticipated with the recall, nor the impact on BD's business, are expected to be material.

From BD (Becton, Dickinson and Company) 9 Feb 2010

FHCO announces first-quarter fiscal 2010 results

The Female Health Company (FHCO), which manufactures and markets the FC2 Female Condom®, today reported its operating results for the first quarter of FY2010.

9 Feb 2010

Plant-produced antibodies can help prevent infection

The first head-to-head comparison of therapeutic monoclonal antibodies produced from plants versus the same antibodies produced from mammalian cells has shown that plant-produced antibodies can fight infection equally well.

9 Feb 2010

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

Manufacturing News and Research

Further Reading

sanofi-aventis reports 2009 fourth-quarter and full-year net earnings

Goodwin Biotechnology, Macrocyclics announce collaboration on Chelation and Bioconjugation

Avrio Biopharmaceuticals receives Cal FDB approval to manufacture and ship pharmaceutical products

Alexza Pharmaceuticals announces development and commercialization collaboration with Biovail Laboratories International

Biovail and Alexza Pharmaceuticals sign collaboration and license agreement for anti-agitation drug

Glissandra Skincare signs first distribution agreement with Enchanted Meadow

Cost reductions offset sales decline to move Allied Healthcare Products back into profitability

AdvanSource Biomaterials' polymer product lines comply with the guidelines of European Council Decision

Glide Pharma to utilize $4.3M funding for progressing octreotide programme into clinical development

Unassisted cessation proves to be most successful in quitting smoking

Elan announces fourth-quarter and full-year financial results ended December 31, 2009

Sony acquires iCyt Mission Technology

New filtration process to improve safety and quality of infant formula

Biogen Idec reports 2009 fourth quarter and full year earnings

Targeted Genetics receives milestone payments from Genzyme and Amsterdam Molecular Therapeutics

BD recalls certain lots of BD Q-Syte Luer Access Devices and BD Nexiva Closed IV Catheter Systems

FHCO announces first-quarter fiscal 2010 results

Plant-produced antibodies can help prevent infection

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

FDA approves Amneal Pharmaceuticals' Tramadol/APAP tablets

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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