Latest Headlines

Latest Headlines

Medicaid calls on Gilead, AbbVie to answer hep C drug pricing questions

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.

Final text of TPP fails to allay critics of drug agreement

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 wins FDA approval for a new HIV combo pill with rivals at its heels

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.

FDA savages U.S. acetaminophen, aspirin maker in warning letter

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.

Vivus counts $25M in Q3 sales, $300M in debt. How can it possibly cover a $200M-plus Qsymia trial?

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.

FDA adds another artificial kidney to its Expedited Access Pathway program

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.

Drug approval pilot plan formally launched in China

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.

UPDATED: McCaskill turns up heat on Valeant with Senate pricing probe

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.

U.S. FDA Form 483 has Indian drugmakers 'spooked'

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.

Australia looks to save cash by cutting scripts for common drugs

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.