FDA advisors vote against new diabetes drug; Astrazenaca stock drops
A US Food and Drug Administration (FDA) advisory committee has recommended against the approval of dapagliflozin, a diabetes drug that acts by increasing the body’s excretion of sugar. The final vote was six in favor and nine against the notion that the efficacy and safety data gathered by Bristol-Myers Squibb and AstraZeneca, the drug’s developers, […]
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FDA Is Urged To Suspend Trials Of Novartis Drug
In letters to the FDA and the Office for Human Research Protections, Public Citizen charges that clinical trials being run by Novartis for its Ilaris medication – which is approved for treating several rare and serious genetic disorders – should be suspended. Why? The watchdog group says Novartis is taking a “shotgun approach†to its […]
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Are Commitments Made to FDA to be taken Seriously?
Responses to FD483’s and Warning Letters are usually fully of commitments. They involve “what†will be done to correct compliance problems, and “when†it will be done. FDA has even started to ask “how†they will be done, meaning— Do you have the resources to do the work? Best Selling Webinar 2010 – July 21 […]
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Drug company CEO’s child dies from injuries
Four days after the girlfriend of a wealthy pharmaceutical executive was found hanged at his mansion near San Diego, his 6-year-old son has died from injuries suffered in an apparent stairway fall, police said on Monday. Max Shacknai’s death was first revealed in a joint statement released Sunday night by his father, Medicis Pharmaceutical Corp […]
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Is Brain Swelling Common To Alzheimer’s Drugs?
Three patients who were treated with an Alzheimer’s med being developed by Bristol-Myers Squibb wound up with a brain-swelling condition known as vasogenic edema, but the side effect may be common in Alzheimer’s patients, according to researchers who were speaking at the Alzheimer’s International Conference in Paris. Best Selling Webinar 2010 – July 21 2 […]
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Glaxo Threatened With Legal Action By Hong Kong
One month after finding traces of chemicals banned for use in food and drinks in the Augmentin pediatric antibiotic sold by GlaxoSmithKline, Hong Kong health officials are now threatening to take legal action against the drugmaker and widened a product recall to include not only powered syrups but also tablets. Best Selling Webinar 2010 – […]
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FDA issues warning on cardiac PET scans
The FDA has notified the public and the medical imaging community about the potential for inadvertent, increased radiation exposure in patients who underwent or will be undergoing cardiac PET scans with rubidium (Rb)-82 chloride injection from CardioGen-82 (Bracco Diagnostics). A CardioGen-82 PET scan is one of a variety of nuclear medicine scans and uses Rb-82 […]
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Medicis Shares Sink on Death of CEO’s Girlfriend
When do a CEO’s personal problems become worrisome to investors? Well, it depends on the problem. In the case of Medicis Pharmaceutical chief Jonah Shacknai, the answer is, “Almost immediately.” Two days after his 6-year-old son suffered critical injuries from a fall down a staircase at his Coronado, CA, house, Shacknai’s live-in girlfriend was found […]
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Maine Repeals Three Get-Tough-On-Pharma Laws
In the latest move by the Republican-dominated legislature in Maine to undo laws that have made the pharmaceutical industry uncomfortable, three bills were repealed this week that required drugmakers to report three things: marketing costs, prices subject to the Medicaid Drug Rebate Program and negative findings in clinical trials. Best Selling Webinar 2010 – July […]
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BioSan Fails to Correct GMP Violations
FDA found BioSan Laboratories Inc. failed to correct a number of cGMPs (current good manufacturing practices) violations found during the agency’s Dec. 6, 2010, to Jan. 25, 2011, inspection, according to a letter FDA sent to Carl Jackson, owner and president of the company. FDA reported BioSan Lab’s facility in Derry, NH, did not properly […]
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