Topic:

Regulatory

Latest Headlines

Latest Headlines

UPDATED: FDA stops import of Lilly's Cialis from Australia but Lilly says it doesn't make it there

The FDA issued an import alert on Monday, saying it was banning Eli Lilly's Cialis made at a plant in Australia because testing showed it contained not only the active pharmaceutical ingredient approved for Cialis but also the API that goes in Pfizer's competing erectile dysfunction drug Viagra. The problem, Lilly said in a statement, is that it doesn't currently have a plant in Australia, making Cialis or anything else.

Group wants FDA to include Indian regulators on plant visits

Last year, as tensions grew between the U.S. and India over plants the FDA had banned, the head of the FDA's operation in India said that the agency would start inviting Indian drug inspectors along on plant inspections. The idea was to allow them to learn what the U.S. expected from manufacturers. Now the Indian government is insisting on it.

Vertex's big plans for Kalydeco sales just got bigger

Vertex is already awaiting the FDA's decision on a Kalydeco combo that could exponentially amp up its cystic fibrosis patient pool. But in the meantime, it announced Sunday evening, it's starting in on a Phase III program for yet another Kalydeco pairing.

AbbVie wins FDA nod for a long-acting Parkinson's treatment

AbbVie picked up FDA approval for Duopa, an extended-release combination of two standard Parkinson's disease treatments that relies on an external pump.

Pharma calls for NICE overhaul as special cancer drugs fund nixes meds

Last week, British officials unveiled plans to toss out certain meds from the Cancer Drugs Fund, which covers drugs rejected by the country's cost-effectiveness gatekeepers. Now, the industry is calling for an overhaul in the way pricey cancer drugs are evaluated by the National Institute for Health and Care Excellence.

FDA to publish guidance on social media and clinical trial e-consent in 2015

The FDA has released a list of almost 100 draft drug guidance documents it plans to introduce or update in 2015. The documents cover a range of biotech IT-related topics, including electronic informed consent in clinical trials, links to third-party sites in social media adverts and statistical approaches to showing biosimilarity.

Bristol-Myers gets U.K. boost for blockbuster contender Opdivo, weeks after FDA approval

Bristol-Myers Squibb just snagged U.S. approval for its new PD-1 cancer immunotherapy Opdivo, but already is building some momentum for the drug it expects to lead its growth this year. Just two weeks after the FDA gave the melanoma drug an early approval, the U.K.s Medicines and Healthcare products Regulatory Agency (MHRA), has tagged it with designation that could lead to early approval there.

FDA approves first blood screening test to detect HIV, HCV and HBV from Roche

The FDA has approved a triple test from Roche to simultaneously detect HIV, hepatitis C and hepatitis B in donated blood and blood products. It's the first test approved by the agency to simultaneously test for all three of these blood-borne diseases and is expected to reduce the necessary sample volume and the testing turnaround time.

In a win for Spectranetics, Covidien's to-be-divested drug-coated balloon earns CE mark

Covidien today announced the CE mark granted for its Stellarex drug-coated balloon for peripheral artery disease. In addition to physically displacing the lesion with angiopolasty, Stellarex delivers the drug paclitaxel like many of its European competitors.

FDA says Expedited Access PMA, new LDT regulations, will be implemented this year

The FDA promised to finalize an expedited approval pathway for medical devices that address critical unmet needs and to officially expand its authority into the regulation of lab-developed molecular diagnostic tests in its annual list of upcoming medical device-related guidance documents for the new year.