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Industry News: Page 278
Adherence/Delivery
Cancer chemo patients improve quality of life; complex sugar drug DAVANAT proven in four FDA trials*
In four FDA trials, 97 cancer patients were dosed with a combination of chemotherapy and DAVANAT. During the trials, patients taking DAVANAT experienced significantly fewer serious side effects of chemotherapy including mucositis, gastrointestinal problems, loss of hair, nausea and vomiting according to Pro-Pharmaceuticals, Inc. DAVANAT targets the chemo into the tumors thereby protecting the healthy cells and reducing the chemo¹s side effects.
November 17, 2009
Pharmaceuticals
Nationwide recall of all size kits due to inaccurate glucose values above 200mg/dL range*
Pointe Scientific and FDA notified healthcare professionals of a nationwide recall of all size kits of Liquid Glucose Hexokinase Reagent catalog number G7517.
November 17, 2009
Medical Device/Packaging
Cordis CROSSOVER SheathIntroducer: Nationwide recall due to stretching or fracture of the sheath during use*
Cordis and FDA notified healthcare professionals of a nationwide recall of all lots of the CROSSOVER Sheath Introducer, a long-coil reinforced,kink-resistant catheter sheath intended for use in arterial and venous procedures requiring the percutaneous introduction of therapeutic or diagnostic intravascular devices or fluids.
November 17, 2009
Materials
Accusure Insulin Syringes (Qualitest Pharmaceuticals) - Recall*
Qualitest Pharmaceuticals and FDA notified healthcare professionals of a nationwide recall of Accusure Insulin Syringes.
November 14, 2009
Regulatory
Say yes to a clinical trial; it may be good for your health*
Study finds that heart failure patients willing to take part in clinical trials have a better prognosis than those unwilling to do so.
November 14, 2009
Regulatory
Paragraph IV Patent Certifications*
The PDF contains a list of drug products for which an Abbreviated New Drug Application (ANDA) has been received by the Office of Generic Drugs (OGD) containing a "Paragraph IV" patent certification. This list includes the name of the drug product, dosage form, strength (subject of Paragraph IV certification), reference listed drug (RLD), and the date on which the first substantially complete generic drug application was submitted to the Agency (on a prospective basis beginning 3/2/04).
November 14, 2009
Regulatory
Pharmaceuticals: 'Fragmented' future with regulatory benefits?
As the focus changes from blockbuster drug development to more targeted therapies, pharmaceutical firms and the FDA could work more closely.
November 12, 2009
Pharmaceuticals
Manage your validation missions with GxP Manager*
As a Validation Manager, you know the validation team is usually the last on the scene when money and time have run out!
November 10, 2009
Pharmaceuticals
Micro-Tag technology alliance announced for solid oral-dose pharmaceuticals
ARmark Authentication Technologies, LLC, and Colorcon, Inc. announced an alliance in the development and introduction of mark On-Dose ID, an authentication technology that incorporates microscopic covert micro-tags into the immediate-release film coatings of solid oral-dosage forms (SODFs) to prevent counterfeiting.
November 10, 2009
Regulatory
What's New from the Office of Oncology Drug Products*
2009 * FDA granted accelerated approval to ofatumumab (Arzerra, GlaxoSmithKline) for the treatment of patients with chronic lymphocytic leukemia (CLL) refractory to fludarabine and alemtuzumab. More Information (October 26, 2009)
November 6, 2009
Supply Chain
Anti-counterfeiting system
November 5, 2009
Pharmaceuticals
Allergan challenges government's 'off-label' use
Company seeks to share information on off-label usage of Botox.
November 5, 2009
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