Sen. Orrin Hatch (R-Utah) proposes to amend the landmark Hatch-Waxman Act to require generic drugmakers challenging brand patents to choose between inter partes reviews or Hatch-Waxman litigation. Source: Drug Industry…
The European Medicines Agency proposes to merge two guidances on clinical evaluations of bacterial infection treatments to reflect the latest scientific advice from its Committee for Medicinal Products for Human…
Endo Pharmaceuticals agreed to settle more than 1,300 lawsuits over its testosterone replacement drug from a $200 million fund it set aside last year. The drugmaker announced a master settlement…
A bill introduced in the House by Rep. Doris Matsui (D-Calif.) Wednesday would strengthen the 340B program to provide increased funding for anti-addiction efforts. Source: Drug Industry Daily
The House of Representatives passed 25 bills this week aimed at curbing the opioid crisis, with numerous others slated for votes next week. Source: Drug Industry Daily
In a second successful legal challenge of the FDA’s approach to orphan drug designations, a federal court ordered the agency to grant Eagle Pharmaceuticals orphan drug exclusivity for its cancer…
Clinical trials for HIV prevention drugs should generally involve two well-controlled trials, but a single Phase III trial can suffice if the results are supported by additional evidence, the FDA…
The FDA released a list of alternative suggestions for complying with CGMP requirements for drug combination products that covers stability testing, release for distribution, reserve samples and special testing requirements.…
The FDA warned finished drugmaker Taiwan Biotech for significant CGMP violations at its facility in Taoyuan City, Taiwan, including inadequate environmental monitoring. Source: Drug Industry Daily
Massachusetts opened a new front in litigation against opioid manufacturers as Attorney General Maura Healey filed a lawsuit Tuesday accusing Purdue and 16 current and former executives and directors of…