Category Archives: Pharmaceuticals

Pennsylvania Supreme Court Opens Door for Negligent Design Claims Against Pharmaceutical Manufacturers

In a decision with significant potential ramifications, the Pennsylvania Supreme Court has issued a ruling that pharmaceutical companies can be held liable for negligence in the design and marketing of drugs, regardless of claims that the drugs had been properly labeled and tested, as well as approved by the U.S. Food and Drug Administration. The ruling, announced January 22nd, upholds an intermediate appellate court decision against a Pfizer, Inc. subsidiary in a wrongful death action involving the diet drug Redux. In its 4-2 decision, the…

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Regulatory

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First Drugs Approved for Combination Treatment of Melanoma by the FDA

Melanoma is the most aggressive type of skin cancer and is the leading cause of death from skin disease.  Last week the FDA approved GSK’s Mekinist (trametinib) in combination with Tafinlar (dabrafenib) to treat patients with advanced melanoma that cannot be removed by surgery or that is metastatic. The drugs were approved under the agency’s accelerated approval program.  More information is available click here. Previously both drugs were approved by the FDA as single agents to treat late-stage or unresectable melanoma. Both drugs are…

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Drug Quality and Security Act

In October of 2012, a meningitis outbreak that caused the death of sixty-four people was traced to tainted steroids purchased from a Compounding Center in New England.  In response to this outbreak, last November President Barack Obama signed the Drug Quality and Security Act into law, which overhauls the FDA’s regulation of Compounding Pharmacies by establishing a system to trace the supply chain of prescription drugs. (See the bill here). Furthermore, under this bill, the FDA is given more authority to regulate and monitor…

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Regulatory Recalls

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