Topic:
Regulatory
Latest Headlines
Latest Headlines
FDA gives Novartis' Ilaris big boost with nod for rare juvenile arthritis
Novartis has grabbed one of two new indications it was shooting for with its rare disease drug Ilaris, one step toward turning the drug into a blockbuster.
UPDATED: GlaxoSmithKline gains blockbuster FDA approval of lung drug Breo
GlaxoSmithKline and Theravance have won FDA approval for their drug Breo Ellipta for treating chronic obstructive pulmonary disease, the third-biggest killer of Americans, the agency announced. The approval comes with an undesirable boxed warning from the agency that LABA therapies boost risk of asthma-related deaths.
Quest settles New York case over illegal hiring practices
Quest Diagnostics will fork over a $70,000 fine to settle claims in New York State that it pursued illegal hiring practices by automatically rejecting applicants with criminal records.
New Jersey looks to law that would allow unused drugs to be donated
What to do with unused drugs has been a flash point in the U.S. Some states want drugmakers to set up recycling programs, an expense they don't want to undertake.
CytRx dumps failed IIb trial for lung cancer, focuses on aldoxorubicin
CytRx has decided to dump a Phase IIb lung cancer study for the number-two drug program in the pipeline after the monitoring committee concluded that the trial was unlikely to find any improvement in progression-free survival compared to standard treatments.
Pediatric drug shortages draw Congressional attention
The problem of drug shortages in the U.S. is generally discussed in the industry terms of products, plant remediation and FDA approvals. But when the human element is interjected, particularly the effects of drug shortages on infants, it takes a more tragic tone.
Hamburg faces Senate as new compounding regulations progress
FDA Commissioner Margaret Hamburg is slated to testify Thursday before the Senate Health, Education, Labor, and Pensions Committee, along with a panel made up mostly of compounding industry officials, as part of the continuing congressional investigation into last year's meningitis outbreak tied to a compounding pharmacy.
Abbott wins CE mark for diabetes Dx
Abbott Laboratories has locked down European approval for a new diabetes diagnostic, getting the green light to market a test that can help diagnose and monitor diabetics as well as flag patients at risk for developing the disease.
Proposed law would delay unit drug tracking for 15 years
The tracking of individual drug units looks to be coming to the U.S, just not for 15 years or more. A bill being pushed by U.S. House Republicans would start the process for tracking lots of drug units through the supply chain but would not allow the FDA to even consider tracking on the unit level until 2017, Reuters reports.
St. Jude cardiac devices win CE mark approval
St. Jude Medical gained a pivotal CE mark for two next-generation lines of implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators, advancing in Europe even as its rivals win U.S. approval for competing devices.
