Comments Sent to FDA on Its Draft Biosimilars Guidance Mostly Conveyed Discontent
While FDA’s biosimilar draft guidance may have succeeded in conveying the agency’s expectations, it has also sparked resistance among some industry players. Comments received by FDA show that the proposal it released on February 9 has generated discontent over certain definitions as well as requirements. FDA’s comment period on the draft document ended today. Stakeholders […]
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ViroPharma Sues FDA – Challenges Denial of 3-Year Exclusivity
Source Last Friday, ViroPharma Incorporated (“ViroPharmaâ€) filed a Complaint and a Motion for Temporary Restraining Order And/Or Preliminary Injunction in the U.S. District Court for the District of Columbia challenging FDA’s approval of three ANDAs for generic versions of ViroPharma’s VANCOCIN (vancomycin HCl) Capsules (Case No. 1:12-cv-00584-ESH). The lawsuit follows FDA’s April 9, 2012 response […]
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Kanye West Changes Song ‘Theraflu’ to Avoid Law Suit
Source Two weeks after igniting a controversy with a new song called ‘Theraflu,’ which is the same name as the over-the-counter cough and cold medicine sold by Novartis, the rapper has changed the title. In a move announced on his web site over the weekend, when people are less likely to pay attention to certain […]
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Amgen CEO Admits He Was Arrogant and Bad Listener
Source To hear Kevin Sharer tell it, he was not always a very good listener. And perhaps few would disagree. But one day, he had an epiphany when an IBM executive told him that listening was about comprehension. Until then, the outgoing Amgen ceo was more concerned with making sure he got his point across. […]
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FDA and Wireless Medical App Manufacturers Square Off
An onslaught of mobile health technology has forced an arranged marriage between smartphone app makers and the Food and Drug Administration — because someone had to regulate them. There’s just one problem: Many of the tech wizards aren’t used to FDA supervision. And now, both sides are struggling to figure out how to live with […]
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Lobbying Controversy at Bristol Myers
Source Getting insurance coverage for a drug is always paramount. But what should a drugmaker do when a state Medicaid program or two refuse to play ball? One answer: enlist a few willing physicians to help your cause. Of course, there is a need to be discreet about how many doctors are asked by sales […]
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Novartis Drug May Have Caused Rare Brain Disease
Source More bad news for Novartis and its Gilenya multiple sclerosis pill? The drugmaker this morning disclosed that a patient taking the drug has been diagnosed with progressive multifocal leukoencephalopathy, or PML, a rare and often fatal brain disease. This is the first case of PML in a Gilenya patient and the disclosure comes just […]
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Drug Firms Won’t Back Down on ALEC
Source As more corporations flee the American Legislative Exchange Council – better known as ALEC – in response to a growing pressure campaign, the pharmaceutical industry is stubbornly holding its ground. In recent days, Coca-Cola, Kraft Foods, PepsiCo, Wendy’s, Elseiver and McDonald’s, as well as the Bill and Melinda Gates Foundation, have left or agreed […]
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J&J Legal Strategy Questioned After $1 Billion Debacle
An Arkansas judge’s $1.1 billion verdict against a Johnson & Johnson subsidiary on Wednesday for defrauding the state’s Medicaid program had consumer advocates and lawyers wondering: Why didn’t the New Brunswick-based pharmaceutical giant simply settle the case before it reached a jury? It marked the third jury trial Janssen Pharmaceuticals Inc. has lost over its […]
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Cetero Bankruptcy Good Business For Execs
Source Last month, Cetero Research filed for bankruptcy protection after the FDA issued an alert last year to drugmakers to reevaluate clinical tests over concerns about falsified data and manipulated samples. The CRO blamed the problem on a handful of employees who allegedly corrupted data as part of a scheme to work longer hours and […]
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