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After a flurry of opioid- related bills passed the House earlier last week, the chamber on Friday passed legislation that will limit the availability of synthetic drugs. Read More
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. Read More
The CHMP working group also recommended the clarification of clinical data requirements used to support new combinations of known beta-lactam agents with new beta-lactamase inhibitors. Read More
Endo said it believes it has correctly estimated the total liability cost it faces, but the litigation could ultimately carry a bigger price tag. Read More
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 Use. Read More
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 agreement that will resolve all current cases involving the drug, Testim, including multidistrict litigation involving about 900 lawsuits. Read More
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. Read More
An increased number of generic appeals has led CDER to transfer the management of its Formal Dispute Resolution program for sponsors of user fee products from the Office of New Drugs to the Office of Executive Programs, CDER Director Janet Woodcock said in a staff memo. Read More