Gilead Getting Hosed on $11 Billion Hep C Deal
Source: Pharmalot Three months after agreeing to pay an eye-popping $11 billion to buy Pharmasset and gain a lock on the lucrative Hepatitis C market, Gilead Sciences had the unpleasant task this morning of disclosing that its first announcement to stem from the controversial deal has nothing but bad news. Why was the deal a […]
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Former FDA Commissioner Offers Strange Idea: Test Efficacy in Post-Marketing
File this under ‘What was he thinking?’ In an op-ed in The Wall Street Journal, former FDA commish Andy von Eschenbach proposes that the “FDA should approve drugs based on safety and leave efficacy testing for post-market studies.†How would this work? Well, Andy suggests creating pilot programs in which patients would be entered in […]
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OSC Now Involved Over Probe on FDA Employee Whistleblowers
Source: Pharmalot The probe into the sensational charges that the FDA secretly monitored several former and current employees, and then harassed and dismissed some of them, has now widened. The Office of Special Counsel, which is an independent federal investigative and prosecutorial agency, is also investigating. This follows a probe opened by the House Committee […]
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Merck Receives Unusual, Holistic Warning Letter from FDA
Source: http://www.pharmalot.com/ In what appears to be a calculated review of a supply chain, the FDA last summer inspected three Merck KGgA manufacturing plants in Europe – one that makes active pharmaceutical ingredients, another that makes finished prescription drugs and a third that is responsible for testing meds for the US market – and all […]
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J&J Reputation Going Down the Tubes
Source: Pharmalot The latest corporate reputation poll from Harris Interactive is out and the results for Johnson & Johnson are not so good. This is a classic a case of the glass being half full or half empty. On one hand, the health care giant ranked 7th, which is not too shabby. Yet, this was […]
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Pharma Industry Blasts Obama Budget
Source: Pharmalot The latest annual budget from the White House was, not surprisingly, met with disappointment by the pharmaceutical industry. The Obama administration proposes a significant boost in rebates for Medicare Part D; limit so-called pay-to-delay patent settlements and reduce data exclusivity from 12 years to seven years for drugmakers that develop biosimilars (you can […]
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FDA Lays Out Ground Rules for Biosimilar Drugs
New Webinar With Highly Detailed FDA 483/WL Data! Source: Pharmalot The Food and Drug Administration’s long-awaited guidelines for the sale of lower-cost versions of biotechnology drugs leave open the possibility that some products might not need to be tested in humans. The proposed rules, issued on Thursday, require studies showing that the generic copies are […]
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Amgen Best Spender of R&D Money; AstraZeneca the Worst
New Webinar With Highly Detailed FDA 483/WL Data! Source: Pharmalot As the feared patent cliff loomed, drugmakers began talking up their R&D priorities and efficiencies with an eye toward easing investor anxiety and positioning themselves for presumably better times. At the same time, pharma continually trumpted the high cost – still higher failure rates – […]
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FDA Whistleblower Employees Bring Questions from Congress
New Webinar With Highly Detailed FDA 483/WL Data! Source: Pharmalot And now, the House Committee on Government Oversight and Reform is investigating the FDA surrounding a sensational episode in which several current and former agency employees have charged in a lawsuit that they were harassed and dismissed after complaining about device reviews to Congress. In […]
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New FDA Biosimilar Guidance Highly Complex, Contains Surprises
New Webinar With Highly Detailed FDA 483/WL Data! Source: Pharmalot Yesterday, the FDA issued its long-awaited guidance for a pathway to develop biosimilars. A wide array of groups – drugmakers, investors and payers, among others – have been clamoring for details about the approval process that would be required to bring lower-cost versions of expensive […]
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