Pharma Forced to Get Rid of Unused Medications
Source: Pharmalot A county in California took a big step closer yesterday to becoming the first in the nation to require drugmakers to dispose of unused and expired pharmaceuticals that are contaminating drinking water and putting youngsters and seniors at risk. In a 4-to-0 vote, the Alameda County Board of Supervisors approved a plan that […]
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FDA OKs new suppliers to temporarily solve critical shortages of 2 cancer drugs
Federal regulators said Tuesday that they’ve approved new suppliers for two crucial cancer drugs, easing critical shortages — at least for the time being — that have left patients and parents frightened about missing life-saving treatments. The news brings a light at the end of the tunnel for some patients, but not for thousands of […]
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Fake Avastin had salt, starch, chemicals: Roche
Counterfeit versions of the cancer drug Avastin found in Europe and the United States earlier this month contained salt, starch and a variety of chemicals, but none of the life extending medicine or any other biotech drug, Roche said. The Swiss drugmaker said on Monday that British health regulators sent it a small number of […]
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Firm Gets Subpoena for Bribery
Source: Pharmalot File this under ‘what did they do right?’ Put another way, Warner Chilcott may have done just about everything wrong. Consider that Warner Chilcott and some ‘non-executive employees’ in the sales division last week received a subpoena from the US Attorney in Boston for a wide array of activities. To wit, the feds […]
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Die From Taking a Sleeping Pill?
Source: Pharmalot Take a sleeping pill and never wake up? Not quite. But a new study finds that several commonly prescribed meds are linked to a significantly higher risk of premature death. Moreover, those who took the pills were 35 percent more likely to develop cancer. The pills in question include Ambien, Lunesta, Restoril and […]
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FDA Difference of Opinion Helps Chelsea Therapeutics in Big Way
Source: Pharmalot In an era when an emphasis on safety is increasingly bumping up against calls for more regulatory flexibility for approving drugs for rare disorders, consider the reversal of fortunes involving a medication from Chelsea Therapeutics. Two weeks ago, the drugmaker disclosed trial data that spooked investors. So did an FDA review that was […]
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FDA Panel Surprisingly Ok’s Vivus Diet Pill
Source: Pharmalot In a surprise move, an FDA panel this afternoon voted overwhelmingly 20-to-2 in favor of recommending that the Qnexa diet pill developed by Vivus should be approved by the FDA. The endorsement marks the first time that an FDA panel had taken such a step during a two-year period in which a trio […]
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CA Wants to Dump State Drug Plant Inspections to Save Money
Source: Pharmalot In a bid to eliminate what were described as “senseless regulations,†a California congressman has introduced a bill to prevent any state from requiring inspections of drug or device facilities that, essentially, would duplicate inspections that are already required and conducted by the FDA. The bill was introduced by Brian Bilbray, a Republican […]
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Recalls? J&J CEO Still Scores 55% Bonus Hike
Source: Pharmalot Never mind the recalls, Johnson & Johnson ceo Bill Weldon worked hard at succession planning. Yes, folks, despite ongoing recalls and other gaffes that hurt the venerable J&J corporate reputation, Weldon received an annual bonus of $3.1 million for last year, which amounts to a 55 percent increase from the year before. The […]
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FDA Comes Out With Draft Guidance for Drug Shortages
Source: Pharmalot Last October, the FDA wrote drugmakers to remind them they are required to report any life-savings meds that are discontinued and encourage them to voluntarily report any supply disruptions that could lead to a shortage (read the letter). Now, the agency has issued a draft guidance that instructs drugmakers on the specific procedures […]
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