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Johnson & Johnson Thursday unveiled a clinical trial data-sharing plan that it hopes will become a model for all industry transparency initiatives: instead of providing direct access to trial data, a third party will serve as gatekeeper and approve access requests for data. Read More
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
Jane Axelrad, CDER’s associate director for policy, spoke with Drug Daily Bulletin to discuss the FDA’s strategy for regulating compounding pharmacies. Read More
After a tough 2013, Teva received some good news Tuesday in the form of a newly approved formulation of its blockbuster drug Copaxone, helping the product gain new market share as Teva fights off generic competition. 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
A powerful house subcommittee chair wants the Centers for Medicare & Medicaid Services to defend its proposal to remove antidepressants from the list of drugs that must be carried on all drug formularies under Medicare Part D. Read More
The U.S. Supreme Court Jan. 22, 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
A New Jersey federal judge Friday dismissed a pay-for-delay case involving a “no-authorized generic agreement” between GlaxoSmithKline and Teva, saying the Supreme Court’s landmark 2013 ruling in Federal Trade Commission v. Actavis applies antitrust scrutiny only to pay-for-delay deals that involve money. 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