FDA backs Remicade for ulcerative colitis in children
The US Food and Drug Administration has granted another approval for Johnson & Johnson’s blockbuster Remicade, this time for the treatment of ulcerative colitis in paediatric patients who have had an inadequate response to conventional therapy. The healthcare giant noted that this marks marks the 16th approval of Remicade (infliximab) in the USA and the […]
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The ‘Witches Brew’ Of Drugs In The Water Supply
As a steady stream of studies and investigations reveal the extent to which pharmaceuticals are found in the US water supply, a new bill has been introduced in Congress that would create a non-profit organization to develop a nationwide program for disposing of medicines. And the non-profit would be financed by the pharmaceutical industry. “The […]
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AstraZeneca Rep Is Sued By Nexium Patients
In the pharmaceutical world, product-liability lawsuits are an everyday affair. Generally, a patient claims that a medicine caused them harm and a lawsuit accuses a drugmaker of failing to adequately warn of certain risks. Rarely, though, are individual sales reps also named as defendants. Now, though, two people have filed a lawsuit in a Texas […]
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The Johnson & Johnson Recalls Keep On Coming
Just as Johnson & Johnson finally resumes shipments of one of its Tylenol over-the-counter meds, the healthcare giant is once again beset by manufacturing problems that have hurt sales and its venerable corporate image. This time, thousands of prefilled syringes containing its Eprex anemia drug have been recalled from 17 countries due to inconsistent potency. […]
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FDA Biosimilar Guidance May Be Here In ‘Days’
The long-awaited arrival of the FDA guidance for biosimilars may be imminent, at least according to one agency official. Although the FDA plans to release the document by the end of the year, Janet Woodcock, who heads the FDA’s Center for Drug Evaluation and Researcy, has indicated the guidance may be “as early as the […]
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Indian API Facility Slammed in Warning Letter
The FDA has fired off a strongly worded warning letter to Yag-Mag Labs Private Limited of India, hitting the API manufacturer with an import alert. According to the FDA, the company’s Hyderabad facility “was not adequately designed to facilitate cleaning and minimize the potential for contamination.” Inspectors saw “residues and corrosion on processing equipment,” leaky […]
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Study Finds Quality Risk Gap Between US, PR Plants
Location apparently does matter to drug quality risk after all. Even though pharma companies may be able to produce their meds more cheaply offshore than on, “substantial evidence” shows the quality risks are higher, according to recent research. “It’s a powerful result that is surprising to many people,” says John Gray of Ohio State University’s […]
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U.S. district judge rejects FDA’s attempted regulatory authority over compounding pharmacies in United States v. Franck’s Lab, Inc.
On September 12, 2011, the U.S. District Court for the Middle District of Florida in United States v. Franck’s Lab, Inc. denied a request by the U.S. Food and Drug Administration (“FDA”) for an injunction and summary judgment against a compounding pharmacy, Franck’s, and firmly rejected the FDA’s contention that it had per se authority […]
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FDA phases out inhaler due to environmental impact
Federal health officials are alerting asthma patients that a type of inhaler sold over the counter will be phased out at year’s end because it uses carbon gas that depletes the Earth’s atmosphere. The Food and Drug Administration says patients who use the epinephrine inhalers will need to switch to other types of inhalers which […]
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A Controversial Bayer Drug Returns To Canada
Four years after Bayer agreed to suspend sales of its Trasylol drug, which is used to control bleeding during heart surgery, Health Canada is allowing the drugmaker to resume sales after conducting a safety review that the agency says shows the benefits outweigh the risks. NEW WEBINAR – What You’ve Got to Know About the […]
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