The Food and Drug Administration announced that it has signed an agreement with PatientsLikeMe for access to data generated by the sites 350,000 members in order to help the FDA in post market surveillance of drugs on the market.The FDA needs the information because companies whose drugs are approved with minimal clinical trials do...
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Category: Pharmaceutical
Two whistleblower scientists say Merck falsified data on mumps vaccine
Two former Merck scientists have filed a whistleblower lawsuit saying that the company falsified data about its mumps vaccine and its actual effectiveness rate. The former virologists charged the drug maker knew its vaccine was less effective than the purported 95% level, and alleged senior management was aware and also oversaw testing that concealed...
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Teva Pharmaceutical to pay $1.2 billion over delaying generic drug makers
Teva Pharmaceutical Industries Ltd. has now agreed to pay $1.2 billion to settle Federal Trade Commision allegations that Cephalon, Teva's subsidiary, paid generic-drug makers to delay competing generic versions of its of Provigil, its sleep disorder drug.
The FTC case is considered landmark because Teva us not the only company seeking to buy off generic...
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Shire Pharmaceuticals pays $56.5 million to settle False Claims Act case for fraudulent marketing
Pharmaceutical company Shire Pharmaceuticals LLC will pay $56.5 million to settle civil allegations that it violated the False Claims Act as a result of its marketing and promotion of several drugs, the Justice Department announced today. Shire, located in Wayne, Pennsylvania, manufactures and sells pharmaceuticals, including Adderall XR, Vyvanse and Daytrana, which...
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Pharmacy PharMerica pays $31.5 Million settling whistleblower suit alleging drug distribution without physician ok
Long-Term Care Pharmacy to Pay $31.5 Million to Settle Lawsuit Alleging Violations of Controlled Substances Act and False Claims Act, according to the United States Department of Justice. The False Claims Act claims resolved by today's settlement were originally brought by whistleblower Jennifer Denk, a pharmacist formerly employed by PharMerica, under the...
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IRISH PHARMA MAKER AMARIN SUES FDA FOR LIMITING SPEECH BY OFF LABEL DRUG PROMOTION
The Irish drug manufacturer Amarin, has filed a lawsuit seeking to limit the powers of the Food and Drug Administration (FDA) in prohibiting so called "offĀ label" promotion of uses of drugs. The FDA gives approval of specific uses of drugs after reviewing the proper testing data submitted by the drug companies. That approval...
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Express Scripts pays $60 million to resolve Novartis kickback arrangement
Express Scripts will pay $60 million to end allegations by The Department of Justice that it participated in a kickback scheme with Novartis that caused federal health care programs to pay for a medicine based on false claims.
The U.S. Department of Justice alleged that Novartis offered patient referrals to Accredo Health...
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Drug maker Cephalon sanctioned for paying competition not to make generic version of Privigil
A new scheme has entered the pharmaceutical industry involving what the courts have now deemed as illegal payoffs in which drug-makers holding patents, sue generic manufacturers then settle the case paying millions to keep them from making the less expensive version.
Pharmaceutical manufacturer Cephalon was sanctioned by the Federal Trade Commission for the so called...
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Pharma maker Daiichi-Sankyo pays $39 million to settle whistleblower cases
New York and 48 other states and the District of Columbia have reached a settlement with Daiichi Sankyo, Inc. (Daiichi), a global pharmaceutical company with US headquarters in New Jersey which will pay $39 million. It was alleged that Daiichi violated the False Claims Act by using lavish meals and...
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U.S. judge pushes for settlement in transvaginal mesh lawsuits
U.S. Judge Joseph Goodwin requested transvaginal mesh device makers and the women suing them to resolve their tens of thousands of lawsuits in one of the biggest U.S. mass torts in history.More than 70,000 transvaginal mesh lawsuits against seven companies have been consolidated before Goodwin,...
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