Topic:

Regulatory

Latest Headlines

Latest Headlines

Will FDA advisers shoot down Amgen's cancer vaccine?

Amgen has high hopes for its new cancer vaccine, barreling toward global approvals with positive data in melanoma. But a narrow miss on one key endpoint could present a major hurdle, and Amgen will soon get a chance to defend the treatment before a panel of FDA advisers.

Hospira recalls 60 lots of pain drug

Hospira said on Tuesday that it was recalling more than 60 lots of the pain reliever ketorolac tromethamine injection in the U.S. and Singapore just 5 days after Pfizer said it would pay $15 billion for the specialist in sterile injectable drugs. In fact, on the day the deal was announced, the FDA announced a Hospira recall of the sedative propofol.

Another doctor convicted for selling foreign-made drugs

Federal authorities have extracted another guilty plea from a doctor found to be using unapproved foreign versions of drugs on his patients, including Rituxan, Remicade and Prolia. The Kentucky physician, who bought the drugs at a deep discount from the U.K., will pay more than half a million dollars in restitution and has received a year of probation.

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."