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 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.
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.
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.
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.
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 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.
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 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.
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."