Industry News:
- FDA Approves Updated Warfarin (Coumadin) Prescribing Information
- Millipore and Novo Nordisk Expand Agreement to Supply Biopharm Market with Recombinant Human Insulin
- Healthcare Organizations Launch Disaster Response Initiative
- Manufacturers of Some Diabetes Drugs to Strengthen Warning on Heart Failure Risk
- FDA Approves Novel Antiretroviral Drug
- GSK's Application for Rotarix® is Accepted for Review by the FDA
- Sanofi pasteur First Manufacturer to Ship Doses of Influenza Vaccine for the 2007-2008 Season
- Reclast® Receives FDA Approval For Treatment of Women With Postmenopausal Osteoporosis
- Environmental Tectonics Corporation's Sterilization Systems Division Forms New Operational Group and Expands Service Offerings
- Canadian Business Leader Purchases Assets Of Mathis Instruments And Launches C-Therm Technologies Ltd.


Industry News
FDA Approves Updated Warfarin (Coumadin) Prescribing Information
The FDA recently announced the approval of updated labeling for the widely used blood-thinning drug, Coumadin, to explain that people's genetic makeup may influence how they respond to the drug...  continue

Millipore and Novo Nordisk Expand Agreement to Supply Biopharm Market with Recombinant Human Insulin
Millipore Corporation recently announced an expansion of its agreement with Novo Nordisk to provide the biopharmaceutical market with recombinant human insulin, a key cell culture supplement used to manufacture biologic drugs...  continue

Healthcare Organizations Launch Disaster Response Initiative
Health care organizations involved in the manufacturing, distribution and dispensing of pharmaceutical products recently announced the creation of Rx Response – a program designed to help support the continued delivery of medicines during a severe public health emergency...  continue

Manufacturers of Some Diabetes Drugs to Strengthen Warning on Heart Failure Risk
The FDA recently announced that manufacturers of certain drugs approved to treat Type 2 diabetes have agreed to add a stronger warning on the risk of heart failure, a condition that occurs when the heart does not adequately pump blood...  continue

FDA Approves Novel Antiretroviral Drug
The FDA has approved maraviroc, an antiretroviral drug for use in adult HIV patients. Maraviroc, sold under the trade name Selzentry, is the first in a new class of drugs designed to slow the advancement of HIV and received priority review by the FDA...  continue

2008 FACILITY OF THE YEAR AWARD
CALL FOR ENTRIES
Sponsored by ISPE, INTERPHEX and Pharmaceutical Processing

The Facility of the Year Awards (FOYA) program recognizes state-of-the-art pharmaceutical manufacturing projects that utilize new and innovative technologies to enhance the delivery of a quality project, as well as reduce the cost of producing high quality medicines.

Entries are now being accepted to participate in the 2008 awards program. For more information, entry forms and submission information, click here.


GSK's Application for Rotarix® is Accepted for Review by the FDA
GlaxoSmithKline (GSK) has announced that the FDA has accepted for review its Biologics License Application (BLA) for Rotarix®, an oral candidate vaccine for infants to prevent rotavirus gastroenteritis...  continue

Sanofi pasteur First Manufacturer to Ship Doses of Influenza Vaccine for the 2007-2008 Season
Sanofi pasteur, the vaccines division of the sanofi-aventis Group, has begun shipment of influenza vaccine (Fluzone®, Influenza Virus Vaccine) in the United States for the 2007-2008 season...  continue

Reclast® Receives FDA Approval For Treatment of Women With Postmenopausal Osteoporosis
Reclast® (zoledronic acid) Injection has been approved by the FDA as the first and only once-yearly medicine for postmenopausal osteoporosis...  continue

Environmental Tectonics Corporation's Sterilization Systems Division Forms New Operational Group and Expands Service Offerings
Environmental Tectonics Corporation's (ETC) Sterilization Systems Division has created a new Professional Services Group within the Sterilization Systems Group (SSG)...  continue

Canadian Business Leader Purchases Assets Of Mathis Instruments And Launches C-Therm Technologies Ltd.
The assets and intellectual property of Mathis Instruments Ltd. have been acquired and are to be re-launched as C-Therm Technologies Ltd...  continue

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