Tag Archives: OPDP

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EMA Seeks Stronger Pradaxa Guidance for Bleeding Side Effects

Regulators in Europe have again asked Boehringer Ingelheim, the manufacturer of the blood thinner Pradaxa, to update the drug’s label with additional information regarding Pradaxa bleeding side effects. According to the European Medicines Agency (EMA), the new guidance should include more specific information on when Pradaxa must not be used, ...

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National Law Firms Calls for More FDA Action on Actos Bladder Cancer Threat

A national law firm is not satisfied with the way the U.S. Food & Drug Administration (FDA) has handled warnings regarding Actos (pioglitazone) bladder cancer risks. In a statement published today, Parker Waichman LLP called on the FDA to compel Takeda Pharmaceuticals, the maker of the type 2 diabetes drug, ...

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Two Men Found Dead of Carbon Monoxide Poisoning

Two Men Found Dead of Carbon Monoxide Poisoning at Long Island, New York Auto Shop

Two men were found dead of apparent carbon monoxide poisoning in a Holbrook, New York, auto-detailing shop Thursday night, Suffolk County police say.

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DeflateGate’s Effects Impact Legal Gambling and the Economy

DeflateGate’s Effects Impact Legal Gambling and the Economy

The NFL has initiated a probe into the New England Patriots following allegations that the team intentionally used overly deflated footballs.

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Bayer Yaz, Yasmin Blood Clot Lawsuit Settlements Stand at $147 Million

Bayer AG reported yesterday that it continues to settle Yaz and Yasmin birth control pill lawsuits. According to a report from Bloomberg News, the company said in its latest Stockholder Newsletter that it has settled 651 Yaz and Yasmin blood clot lawsuits for a total of $147 million. The average ...

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FDA Metal-On-Metal Hip Replacement Investigation Is Flawed, Researchers Say

The U.S. Food & Drug Administration’s (FDA) metal-on-metal hip replacement investigation is flawed, according to researchers.

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1,000+ Australians Join DePuy ASR Hip Implant Class Action Lawsuit

A class action lawsuit filed in Australia over DePuy Orthopaedics’ recalled metal-on-metal ASR Hip Implants has signed up more than 1,000 plaintiffs. The attorneys representing the Australian ASR Hip Implant lawsuit plaintiffs recently told The Courier-Mail that damages in the lawsuit are expected to be worth more than $200 million. One ...

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Federal Judge Certifies Medtronic Infuse Shareholder Class Action Lawsuit

A shareholder lawsuit alleging Medtronic Inc. illegally promoted the off-label use of its Infuse bone growth product has been granted class action status by U.S. District Judge Paul Magnuson of Minnesota. According to a report from Law360.com, the Medtronic Infuse off-label promotion lawsuit was filed by several institutional investors on ...

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Fracking Boom Changing Way of Life in Pennsylvania's Northern Tier

In just a few years, the impact of hydraulic fracturing (fracking) drilling on northeastern Pennsylvania is hard to miss. Thousands of natural gas wells have been opened in that area specifically in the last five years as companies look to exploit the vast Marcellus shale formation about two miles below the ...

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System for Tracking Prescription Drug Side Effects Flawed

Study Finds System for Tracking Prescription Drug Side Effects Flawed

System for keeping track of dangerous side effects of prescription drugs is flawed because drug makers are submitting incomplete information about problems to the FDA.

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FDA Sends Warning to Company for Promoting Drug for Unapproved Uses

FDA Sends Warning to Company for Promoting Drug

The Office of Prescription Drug Promotion (OPDP), the Food and Drug Administration’s pharmaceutical advertising watchdog unit, has issued a warning to a company for allegedly promoting its product Injectafer for uses for which it had not received FDA approval. The warning, … Continue reading

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