Manufacturing News and Research

RSS

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

FDA requires pancreatic extract manufacturers to get approval to remain on the market

The Food and Drug Administration (FDA) today formally notified manufacturers of pancreatic insufficiency products that these drugs must get approval by FDA within the next four years in order to remain on the market.

28 Apr 2004

Carbohydrate-binding proteins are becoming extremely useful in curing various illnesses

Researchers are beginning to see the potential for breakthrough in healthcare through glycomics, which studies carbohydrates, proteins and their interactions. In fact, these carbohydrates are moving beyond their regular roles as sugar storage bins.

28 Apr 2004

Wyeth to appeal $1 billion awarded to the family of a woman who died after using fen-phen diet drug

Wyeth said today it will appeal today's verdict in the case of Jerry Coffey (representing the estate of Cynthia Cappel-Coffey), et al. v. Wyeth, et al.

27 Apr 2004

FDA mandates approval for all pancreatic enzyme replacements

The Cystic Fibrosis Foundation has announced its support of the Food and Drug Administration's (FDA) requirement that manufacturers of pancreatic enzyme replacements obtain FDA approval for their products within the next four years.

27 Apr 2004

FDA approval for Cladribine to treat active Hairy Cell Leukemia

American Pharmaceutical Partners, Inc. today announced it has received approval from the U.S. Food and Drug Administration (FDA) of its Abbreviated New Drug Application (ANDA) for Cladribine Injection.

27 Apr 2004

FDA revises guidance on changes to an approved NDA, ANDA

FDA has issued a revised guidance to help drugmakers determine how they should report postapproval manufacturing changes to new drug applications (NDAs) or abbreviated new drug applications (ANDAs).

21 Apr 2004

Soy infant formula recalled

The Food Standards Agency today warned that small fragments of metal have been found in some tins of SMA Wysoy milk formula powder.

21 Apr 2004

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

Manufacturing News and Research

Further Reading

FDA requires pancreatic extract manufacturers to get approval to remain on the market

Carbohydrate-binding proteins are becoming extremely useful in curing various illnesses

Wyeth to appeal $1 billion awarded to the family of a woman who died after using fen-phen diet drug

FDA mandates approval for all pancreatic enzyme replacements

FDA approval for Cladribine to treat active Hairy Cell Leukemia

FDA revises guidance on changes to an approved NDA, ANDA

Soy infant formula recalled

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

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

Latest Life Science News