Manufacturing News and Research

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

Cardiac Science receives warning from FDA

Cardiac Science, Inc., a leading manufacturer of life-saving automated public-access defibrillators (AED) and provider of comprehensive AED/CPR training services, said today that it received a Warning Letter following a routine inspection of its manufacturing facility in Minneapolis conducted by the U.S. Food and Drug Administration

20 Apr 2004

FDA announces science-based approach to protecting Americans from unsafe dietary supplements

Speaking before the American Society for Pharmacology and Experimental Therapeutics (ASPET) and the American Society for Nutritional Sciences, Dr. Lester M. Crawford, Acting Commissioner of the Food and Drug Administration (FDA), today outlined the agency's science-based approach to protecting American consumers from unsafe dietary supplements.

19 Apr 2004

Canadian health groups urge ban on exportation of pharmaceutical drugs from Canada to the U.S.

Canadian health groups today called on the Government of Canada to ban the exportation of pharmaceutical drugs from Canada to the U.S. The groups, who represent the interests of millions of Canadian patients, were in Washington to highlight their concerns with Internet pharmacies.

14 Apr 2004

Foreign drug repackager complies with FDA order

The Food and Drug Administration today announced the settlement of a court case against an Illinois firm involved last year in FDA's seizure of thousands of imported unapproved drugs, including those that were labeled in foreign languages and/or labeled as repacked.

13 Apr 2004

GlaxoSmithKline acquires injectable anti-thrombotic agents Fraxiparine® and Arixtra®

GlaxoSmithKline plc announced today that they have signed an agreement regarding the acquisition, on a worldwide basis, of the injectable anti-thrombotic agents Fraxiparine® and Arixtra® and related assets including a manufacturing facility located in Notre-Dame de Bondeville, France from Sanofi-Synthelabo.

13 Apr 2004

Coronary stent drives Johnson & Johnson to record profits

Johnson & Johnson today announced sales for the first quarter of $11.6 billion, an increase of 17.7% over the prior year. The increase represented operational growth of 12.3% and a currency impact of 5.4%. Domestic sales were up 15.1%, while international sales increased 21.8%, including operational growth of 7.8% and a positive currency impact of 14.0%.

13 Apr 2004

FDA claims high levels of lead in Mexican candy

The Food and Drug Administration (FDA) has announced that it is aware of a problem associated with lead contamination of some Mexican candy products being sold in the United States and is suggesting that parents, care providers and other responsible individuals do not allow children to eat these products at this time.

11 Apr 2004

New microgel could potentially recover any enzyme and save manufacturers considerable money

Carnegie Mellon University scientists have employed biological molecules to create a microgel that could recover costly enzymes for repeated use in catalyzing commercially important reactions. The microgel could potentially recover any enzyme and theoretically save manufacturers considerable money.

8 Apr 2004

NeoRx Corporation acquires worldwide rights to platinum-based anti-cancer agent

NeoRx Corporation today announced that it has acquired from AnorMED Inc. the worldwide exclusive rights, excluding Japan, to develop, manufacture and commercialize AMD473, a platinum-based anti-cancer agent. AMD473 has been administered to more than 500 cancer patients in phase I and phase II clinical trials, demonstrating anti-cancer activity in a wide range of tumors and a manageable safety profile. NeoRx expects to initiate clinical studies of AMD473 in one or more cancer indications in the second half of this year.

5 Apr 2004

Cordis Cardiology receives warning from the U.S. Food and Drug Administration

Cordis Cardiology, a division of Cordis Corporation, a Johnson & Johnson Company, reported today that it received a warning letter from the U.S. Food and Drug Administration (FDA) regarding FDA's observations concerning the Good Manufacturing Practice (GMP) regulations.

5 Apr 2004

New device filters blood supplies on-site reducing the possible transmission of Creutzfeldt-Jakob disease

ProMetic Life Sciences Inc. has announced today that its joint venture with the American Red Cross, Pathogen Removal and Diagnostic Technology Inc. ("PRDT"), has confirmed that treatment of TSE spiked red blood cell concentrate with its Prion Reduction Device results in a significant decrease in associated infectivity.

5 Apr 2004

SkyePharma agreement with Medeus Pharma for marketing and distribution of DepoMorphine

SkyePharma PLC has announced that it has entered into a strategic marketing agreement with Medeus Pharma for the marketing and distribution of DepoMorphine(TM) in Europe. DepoMorphine(TM) is SkyePharma's novel sustained-release injectable formulation of morphine for relief of moderate-to-severe post-operative pain. DepoMorphine(TM) was filed in the US and Europe last year and approvals are anticipated to commence in the second half of 2004.

5 Apr 2004

New center enables genetic treatments and advances

A new state-of-the-art research facility dedicated to helping produce modified cells for treatment of cancer and other diseases recently opened at the Siteman Cancer Center.

1 Apr 2004

SARS virus vaccine stimulates protective immune response

An experimental vaccine prevents the SARS virus from replicating in laboratory mice, according to a new report in the April 1 issue of Nature. Scientists at the Vaccine Research Center (VRC) of the National Institute of Allergy and Infectious Diseases (NIAID), one of the National Institutes of Health, developed the vaccine. The vaccine was tested in a mouse model of SARS infection recently validated by other NIAID investigators.

31 Mar 2004

GlaxoSmithKline and Theravance to form strategic alliance

GlaxoSmithKline plc (GSK) and Theravance, Inc., a privately-held pharmaceutical company, announced today that they have entered into an innovative broad-based strategic alliance to develop and commercialise novel medicines across a variety of important therapeutic areas, including bacterial infection, respiratory, urinary incontinence and gastrointestinal.

31 Mar 2004

Researchers tap modified plant viruses to ward off cervical cancer-causing infections

New vaccinations to prevent infections that lead to cervical cancer and targeted therapeutics aimed at breast cancer were examples of research highlights presented by scientists today at the 95th Annual Meeting of the American Association for Cancer Research. Scientists described advances that feed into the drug development 'pipeline,' and show strong promise for controlling existing tumors or addressing the pathogen that causes tumors.

29 Mar 2004

Anti-ageing formula recalled due to excessive vitamin D3

Aloe Commodities International, Inc., Carrollton, Texas, is recalling 1600 bottles of Solutions IE Ageless Formula II, Lot numbers P2207 and P2221 because they contain a significantly higher-than-labeled level of vitamin D3. (Approximately 188,640 International Units (IU) are present in each serving size of 6 capsules instead of the intended level of 400 IU). The product is distributed by Solutions International, Inc., Orem, UT.

27 Mar 2004

iCAD issued with Fulcrum mammography film digitizer patent

iCAD, Inc., which designs, develops and markets Computer Aided Detection (CAD) imaging technology and systems for the early detection of breast cancer and other medical applications, today announced that the U.S. Patent and Trademark Office has issued the Company two patents for its Fulcrum mammography film digitizer and technology.

24 Mar 2004

LAM Pharmaceutical receives approval to sell it's wound gel in China

LAM Pharmaceutical, a biomedical company focused on the development and commercialization of novel wound healing and transdermal drug delivery systems, announced today that the Chinese State Food and Drug Administration ("SFDA") has granted approval for the importation and sale of its patented LAM IPM Wound Gel(TM) in China

24 Mar 2004

Manufacturing News and Research

Further Reading

Cardiac Science receives warning from FDA

FDA announces science-based approach to protecting Americans from unsafe dietary supplements

Canadian health groups urge ban on exportation of pharmaceutical drugs from Canada to the U.S.

Foreign drug repackager complies with FDA order

GlaxoSmithKline acquires injectable anti-thrombotic agents Fraxiparine® and Arixtra®

Coronary stent drives Johnson & Johnson to record profits

FDA claims high levels of lead in Mexican candy

New microgel could potentially recover any enzyme and save manufacturers considerable money

NeoRx Corporation acquires worldwide rights to platinum-based anti-cancer agent

Cordis Cardiology receives warning from the U.S. Food and Drug Administration

New device filters blood supplies on-site reducing the possible transmission of Creutzfeldt-Jakob disease

SkyePharma agreement with Medeus Pharma for marketing and distribution of DepoMorphine

New center enables genetic treatments and advances

SARS virus vaccine stimulates protective immune response

GlaxoSmithKline and Theravance to form strategic alliance

Researchers tap modified plant viruses to ward off cervical cancer-causing infections

Anti-ageing formula recalled due to excessive vitamin D3

iCAD issued with Fulcrum mammography film digitizer patent

LAM Pharmaceutical receives approval to sell it's wound gel in China

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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