Topic:

Regulatory

Latest Headlines

Latest Headlines

Tear up the rules and start again, Lancet panel says to India on drug safety

SINGAPORE-- One of the world's most prestigious medical journals called for India to abandon its current proposal to change the way it regulates drugs and come up with a new plan.

UPDATED: With hep C approval app, AbbVie eyes franchise growth in Japan

SINGAPORE-- Here's some expansion news for AbbVie's hepatitis C franchise. The U.S.-based drugmaker has asked Japanese regulators to approve its antiviral cocktail, hoping to grab a piece of that market as it fights for share in the States.

Report: 'Carrot and stick' needed to deal with drug shortages

Canada will now require drugmakers to report drug shortages, a practice that has been voluntary. But a new report from Pew Charitable Trusts says solving the problem of drug shortages will require a multipronged attack by regulators, payers and the industry.

AdvaMed unveils its 2015 Innovation Agenda, proposes automatic Medicare coverage of device clinical trials

AdvaMed CEO Stephen Ubl said the med tech innovation ecosystem is "fraying" at a news conference unveiling the trade association's 2015 Innovation Agenda to fix the ills of the industry.

AstraZeneca $7.9M kickback settlement shows risks of payer discounting

The U.S. Justice Department has slapped AstraZeneca for an alleged kickback scheme. The $7.9 million penalty is peanuts compared with Big Pharma's other marketing settlements--in fact, AstraZeneca's own settlement topped $500 million.

Intraocular lens maker Staar Surgical gets warning letter over its manufacturing practices

Intraocular lens maker Staar Surgical was hit by an FDA warning letter over compliance with Good Manufacturing Practices at its plant in Monrovia, CA. The company says that on Feb. 4 the FDA issued a Form 483 warning letter with 10 observations.

MerLion becomes first homegrown Singapore company to win U.S. FDA novel drug nod

SINGAPORE-- MerLion Pharmaceuticals announced Wednesday that the U.S. FDA has approved an otic suspension of finafloxacin to treat acute otitis externa, commonly known as "swimmer's ear."

Breakthrough? Not anymore says FDA as Bristol-Myers joins Merck in hep C's coach section

Merck's not the only big player in the hepatitis C competition to face losing bragging rights to the FDA's "breakthrough" drug designation for a late-stage program. It turns out that Bristol-Myers Squibb, another laggard in the race to hatch new therapies for the virus, also finds its daclatasvir on the FDA's chopping block.

Zimmer revises its regulatory submission in bid to get approval of Biomet acquisition

Zimmer revealed that it has submitted a revised package to the European Commission to get approval of its $13 billion purchase of Biomet. The revision makes changes from the package proposed in December based on feedback from the commission. The deadline for the commission's decision is May 26. Zimmer still expects the transaction to close by the end of the current quarter.

Endoscopes linked to spread of deadly drug-resistant bacteria in hospitals

In the latest incidence of the outbreak of infections stemming from unclean endoscopes, 8 patients in Philadelphia were recently infected with bacteria resistant to the antibiotics known as carbapenems, which kill up to half of those infected, the  Philadelphia Inquirer  reports.