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GPhA has jumped into the biosimilars substitution debate, saying it prefers that doctors not be notified when a pharmacist substitutes a biosimilar for a name-brand biologic, and it is supporting legislative language that would implement that approach in states throughout the U.S. Read More
European regulators want drugmakers to develop pharmacovigilance plans that include tracking pharmacogenomic data to assess drug safety risks that may apply only to small patient populations. Read More
The Department of Justice (DOJ) wants to see that when it settles a fraud case with a drugmaker the company does not slip back to its old, bad habits once the prosecutors leave, and it’s increasingly using corporate integrity agreements to make that happen. Read More
Johnson & Johnson scored a major victory Tuesday as the Supreme Court of Louisiana threw out a jury’s order that the company pay the state $258 million for deceptive marketing of its antipsychotic drug Risperdal. Read More
The FDA’s ban on the sale of prescription acetaminophen/opioid combination drugs that use more than 325 mg of acetaminophen per tablet took effect Jan. 15, and the agency will soon begin withdrawing approvals for products made by companies that defy the ban. Read More
Generic drugmakers have joined forces with the biotech industry to craft biosimilar substitution legislation in Washington State. They plan to use the bill as a template for similar drives across the country. Read More
Valeant Pharmaceuticals is objecting to the FDA’s planned eye-tracking study to assess how viewers see risk information in ads because it would exclude individuals wearing bifocals and hard contact lenses. Read More
The FDA’s ban on the sale of prescription acetaminophen/opioid combination drugs that use more than 325 mg of acetaminophen per tablet went into effect Jan. 14, and the agency will soon begin withdrawing approvals for products made by companies defying the ban. Read More
The Supreme Court on Wednesday, in a closely-watched case, issued a unanimous 9-0 ruling stating that regardless of whether a patent holder is the plaintiff or defendant in a patent infringement case, the burden-of-proof for infringement remains with the patent holder. Read More