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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Ex-Glaxo Lawyer Wins Acquittal from Federal Judge at Obstruction Trial
An ex-GlaxoSmithKline Plc (GSK) attorney accused of covering up the company’s improper marketing of its antidepressant drug Wellbutrin SR won acquittal by a federal judge at her criminal trial. Lauren Stevens, 61, was cleared of wrongdoing today by U.S. District Judge Roger Titus in Greenbelt, Maryland, before the case went to the jury. Titus ended […]
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Forest Receives Subpoena Over Blood Pressure Meds
The legal problems are piling up at Forest Laboratories. The drugmaker has just disclosed that a subpoena arrived from the US Attorney in Boston seeking documents relating to the marketing of the Benicar, Benicar HCT and Azor high blood pressure meds. Forest and Daiichi Sankyo, which developed the drugs, jointly promoted the pills from 2002 […]
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Former Glaxo Lawyers Asks Judge To Dismiss Case
On the eve of presenting her defense, former GlaxoSmithKline lawyer Lauren Stevens has asked a federal judge to toss the indictment in which she is charged with obstructing an FDA probe into off-label marketing of the Wellbutrin SR antidepressant and making false statements to the agency. If US District Court Judge Roger Titus denies her […]
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