Will Pfizer Pay $2B To Settle A Protonix Probe?
Two months ago, Pfizer disclosed that talks are under way with the US Department of Justice to settle charges the drugmaker committed fraud against government health programs by failing to report discounts and rebates for its Protonix heartburn med. And at the time, Pfizer also disclosed the feds alleged its potential liability is more than […]
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FDA’s Warning Letter “Close-Out†Process Is Not Working
In an August 2009 speech to the Food and Drug Law Institute, FDA Commissioner Margaret A. Hamburg, M.D., emphasized the importance of enforcement (see our previous post here). Among other actions announced by Dr. Hamburg was a warning letter “close-out†process. Dr. Hamburg stated that “[i]f the FDA can determine, usually based on a re-inspection, […]
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Genzyme Charged With Double Standard By Patients
In the latest flap over Genzyme, its ongoing manufacturing problems and subsequent product shortages, a group of Fabry patients are charging the biotech has employed a double standard when it comes to providing its Fabrazyme med to US patients and those in Europe. New Webinar – July 28 – Dangerous Documents: How to Avoid Landmines […]
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Biosimilar User Fees-FDA Requests Comments But When FDA Plans to Issue Guidance for Biosimilar Pathway Remains Unclear
On May 10, FDA published a Federal Register Notice requesting comments on FDA’s proposed development of a user fee program for biosimilar and interchangeable biosimilar biological product applications submitted under Section 351(k) of the Public Health Service Act (“PHS Act”). The biosimilar pathway was added to the PHS Act by the Biologics Price Competition and […]
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Drugmakers gear up to copy biotech drugs in U.S.
NEW YORK (Reuters) – Plenty of industry players want a piece of the U.S. market for generic versions of complex biotech drugs, but winners are likely to need the marketing muscle of a big pharmaceutical company. That is a departure from the traditional generic drug industry, which has given rise to dozens of companies that […]
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Janssen Identifies Trace Amounts of TBA in 5 Batches of PREZISTA® (darunavir) in the EU and Canada
The Company is Working With Regulatory Authorities High Wycombe, UK – (May 11 2011) – Janssen-Cilag International N.V. today announced the company is working with regulatory authorities in five countries to address trace amounts of TBA (2,4,6 tribromoanisole) identified in five batches of the HIV/AIDS medicine PREZISTA® (darunavir). The countries affected include the United Kingdom, […]
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What’s That? Another Johnson & Johnson Recall
Nearly a month has passed without a recall from Johnson & Johnson. This may cause recall withdrawal – pun intended – among those closely tracking the plethora of goods the health care giant has yanked over the past year; over-the-counter meds, hip replacement devices, contact lenses, prescription drugs and surgical sutures. But never fear. Bill […]
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Novartis CEO Warns On Misconduct After Executive Firings
Novartis AG (NVS) Chief Executive Joe Jimenez has sent a strongly worded memo to the company’s more than 100,000 employees after the Swiss pharmaceuticals firm ousted several senior managers for misconduct. In the memo, which was posted as a blog on Novartis’s internal website and was seen by Dow Jones Newswires, Jimenez said the staff […]
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Phase II Clinical Trial Failures Are Rising
If numbers tell a story, then the numbers pertaining to Phase II clinical trials offer a sobering tale. A new analysis finds that Phase II success rates fell from 28 percent in 2006 and 2007 to just 18 percent in 2008 and 2009, according to the Centre for Medicines Research, which examined trials undertaken by […]
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Increased FDA Scrutiny of Medical Devices Imported to the U.S.
MDCI, a full-service CRO, has recently run across a number of cases where companies who have been importing medical devices into the U.S. for years suddenly encounter issues at U.S. Customs. In some cases, companies are not even aware that their products are regulated as medical devices by the FDA. In others, shipments of medical […]
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