Some state Medicaid programs have held back on covering pricey hep C meds, limiting access to the drugs to the sickest individuals to save cash. But the Centers for Medicare and Medicaid Services is not pleased with this approach and is calling on hep C drugmakers to lay out some pricing options that could help expand coverage for patients.
Thousands of pages of the final text of the 12-nation Trans-Pacific Partnership trade deal were released by the White House on Nov. 5 in hopes of persuading critics to come out in favor of it. But those hopes were dashed when critics from all walks of the economy in the U.S. and elsewhere criticized the provisions.
Gilead Sciences won FDA approval for another combination tablet designed to keep HIV from replicating itself, a drug the company touts as a safer alternative to products already on the market.
An Indiana aspirin and acetaminophen producer closed up production last year for lack of funds, but the FDA is making sure that it doesn't open back up again without meeting basic standards after the agency found it using slipshod manufacturing methods and producing OTC pain meds that failed to meet standards on just about every measure.
It's been more than 3 years since the FDA approved Vivus' obesity med Qsymia, but the company has yet to start up a required cardiovascular safety trial. And with sales disappointing and debt piling up, that's a problem.
A surgically implanted artificial kidney under development at the University of California, San Francisco, has been accepted into the FDA's Expedited Access Pathway for "breakthrough" technologies that debuted just 6 months ago.
Following on from a presentation to the State Council earlier this week, China announced Thursday it will launch a three-year pilot plan to speed up approvals for new drugs.
Sen. Claire McCaskill (D-MO) is turning up the heat on Canadian pharma Valeant, launching a bipartisan Senate investigation into drug pricing by companies including Valeant and Turing Pharmaceuticals.
Indian pharma executives attending a seminar on FDA compliance at the Pharma Tech Expo are "spooked" by a raft of U.S. FDA Form 483 letters that document "concerns" FDA inspectors find when they visit factories.
The government of Australia said it will no longer cover basic nonprescription drugs like paracetamol and aspirin which are among 17 basic medicines that will be removed from the country's Pharmaceutical Benefits Scheme starting in 2016. The move will save half a billion Australian dollars over the next 5 years, which Health Minister Sussan Ley said will be spent on listing new lifesaving drugs, according to a report in The Australian.