A.M. Vitals: Pfizer Gets FDA Warning on Adverse Event Reporting

Published On: June 10th, 2010

Also: new safeguards on medical radiation; a research project will disclose some genetic data to participants; overweight firefighters in Boston.

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A.M. Vitals: Pfizer Gets FDA Warning on Adverse Event Reporting

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A.M. Vitals: Amgen’s Osteoporosis Drug Gets FDA Okay
Also: the price tag for a tobacco tax loophole; the downside of shorter hospital stays; unique research on Alzheimer’s prevention. ..
Pfizer Gets Some Wyeth Payback as FDA Approves Vaccine
Pfizer has won FDA approval of a product developed by Wyeth, which Pfizer bought last year for $68 billion. And it’s a biggie — a updated version of the world’s best-selling vaccine Prevnar ..
A.M. Vitals: Pfizer and Novartis Drugs Get FDA Panel Recommendation
FDA Panel Votes: Kidney-cancer drugs made by Pfizer and Novartis have received a thumbs-up from an FDA advisory panel, bolstering their chances of gaining approval to also treat rare advanced pancreatic neuroendocrine tumors, the WSJ reports . The panel voted 10-0 on the question of whether the benefits of Novartis’s Afinitor outweighed the risks, and..
A.M. Vitals: House Votes to Repeal Health Law’s Reporting Provision
Cutting a Provision: The House voted to repeal the unpopular so-called 1099 provision of the health-care overhaul law, which requires small businesses to report to the IRS whenever they do at least $600 worth of business with a single vendor, the WSJ reports . ..
Botox Gets Stuck With Black-Box Warning
It’s been a tough week for Botox. First, the FDA approved a competitor drug called Dysport. Then the agency said both drugs, along with a third called Myobloc, should carry black-box warnings to alert patients and doctors to serious safety risks. Here’s the “early communication” the FDA released yesterday on Botox and Myobloc. All three drugs..
A.M. Vitals: Warning on Health Industry Mergers; Scanning Autistic Brains
Also: guidance on ordering scanning tests; C. diff can float, but handwashing is still the way to prevent infection ..

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