Companies sometimes slow to alert FDA to adverse drug events | Novartis' aplastic anemia drug gets EMA panel backing | EMA to expedite review of Bristol-Myers' myeloma drug
July 28, 2015
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Companies sometimes slow to alert FDA to adverse drug events
(Philippe Huguen/Getty Images)
Ten percent of unexpected, serious adverse drug events are not reported to the FDA within the established 15-day window, according to a study published in JAMA Internal Medicine. That amounts to 160,383 adverse events, including 40,500 deaths, that were not reported in a timely manner. Kenneth Getz of the Center for the Study of Drug Development at Tufts University School of Medicine said some delays may involve the difficult process of verifying reports. Reuters (7/27) Share: Email
Novartis' aplastic anemia drug gets EMA panel backing
Novartis received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use for Revolade, or eltrombopag, as a treatment for patients with severe aplastic anemia who respond inadequately to immunosuppressive therapy and who are ineligible for hematopoietic stem cell transplantation. The opinion was based on data from three midstage trials. A final decision from the European Commission is expected within three months. European Pharmaceutical Review (U.K.) (7/27) Share: Email
EMA to expedite review of Bristol-Myers' myeloma drug
Bristol-Myers Squibb's marketing authorization application for Empliciti, or elotuzumab, has been accepted by the European Medicines Agency for review as a treatment for previously treated multiple myeloma patients, in combination with lenalidomide and dexamethasone. The application, which was backed by data from two trials, was granted accelerated-assessment status. European Pharmaceutical Review (U.K.) (7/27), Seeking Alpha (free registration) (7/27) Share: Email
FDA to check safety risk of gadolinium deposits in brain
The FDA's National Center for Toxicological Research plans to investigate the risk of gadolinium-based contrast agents after several reports indicated residual gadolinium may persist in the brains of patients who received multiple contrast-enhanced MRI scans. It is not known whether gadolinium deposits present any adverse health effects, the FDA said, but it urged providers to re-evaluate treatment protocols for repetitive GBCA MRIs. Medscape (free registration) (7/27), (free registration) (7/27) Share: Email
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Global Focus
India faces export losses following EC generic drug ban
Exports of pharmaceuticals from India could drop by as much as $1 billion after the European Commission banned about 700 generic drugs manufactured in the country, the director general of the Pharmaceuticals Export Promotion Council said. The action was triggered by charges that the contract research firm GVK Bio, based in Hyderabad, manipulated clinical trials. The Economic Times (India) (7/27) Share: Email
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Food & Dietary Supplements
FDA: Cilantro from Mexican state banned in U.S.
The FDA has ordered that fresh cilantro imported from the Mexican state of Puebla be banned in the U.S. from April through August after a probe detected toilet paper and human feces in the area's growing fields. Cilantro from Puebla has been tied to a stomach illness outbreak in the U.S. in 2013 and 2014 and is suspected in illnesses this year in two states. Investigations that led to the import alert issued Monday included other "objectionable conditions" at eight of 11 farms inspected. The Washington Times/The Associated Press (7/27) Share: Email
Salmonella risk triggers recall of Kroger seasonings
Kroger is recalling its store-branded Bac'n Buds, Coarse Ground Black Pepper, Garlic Powder and Ground Cinnamon because of possible salmonella contamination. The FDA found salmonella in some of the store's garlic powder during routine sampling, and the other products were pulled because they were processed with the same equipment. The Huntsville Times (Ala.) (7/27) Share: Email
Undeclared allergens prompt recall of Keg Horseradish beef burgers
Wheat and soy not listed on the label caused Belmont Meat Products to pull its Keg Horseradish Blended Prime Rib Beef Burgers. Affected products have the UPC number 6 95676 00617 5 and were distributed throughout Canada. Food Poisoning Bulletin (7/27) Share: Email
Medical Devices
FDA labels Philips' CT scanners recall as Class II
A recall initiated by Philips Healthcare involving about 480 CT scanners has been labeled as Class II by the FDA. The firm recalled the products after internal testing uncovered a software issue that could put users or patients at risk. The affected scanners include the Ingenuity CT, Ingenuity Core 128, Ingenuity Core, Brilliance iCT SP, Brilliance CT 64-channel with Essence technology and Brilliance iCT. (free registration) (7/28) Share: Email
Bill would streamline drug-device combo filings in U.S.
The FDA approval process for drug-device combinations would become more streamlined under the Combination Product Regulatory Fairness Act recently introduced in the Senate. The bill would allow the FDA to consider previous findings of the effectiveness and safety of each of the combination product's components and would also require the agency to prove it has enough cause to designate a combination product as one with a drug primary mode of action, which comes with greater data demands. AdvaMed praised the legislation and predicted it would improve the FDA's efficiency in considering combination products. Clinica (7/27) Share: Email
FDLI Items
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Register now for FDLI's Food Advertising & Litigation Conference in Chicago!
With recent developments in the litigation and regulatory enforcement of the advertising of food, professionals need to be aware of the emerging parameters of an evolving marketplace. This one-day conference is essential to understanding the current landscape and is an excellent resource for litigators and marketing professionals in the food industry. The conference also features various experts from the food advertising and marketing fields, including our keynote speaker, C. Steven Baker, director of the Federal Trade Commission Midwest Region. Register now for Food Advertising and Litigation to join the action on Sept. 24 in Chicago. Share: Email
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