Topic:

Regulatory

Latest Headlines

Latest Headlines

That Namenda hard switch Actavis wants? It could cost HHS $6B

Actavis said last month it stood to lose $200 million in sales if an appeals court didn't let it force patients over to a new, patent-protected version of Alzheimer's treatment Namenda before generics hit. But if it does? The Department of Health and Human Services (HHS) predicts it'll cost the federal government $6 billion at the least.

Japan's Oncolys begins PhI trial of cancer drug licensed from Astellas

Japan's Oncolys BioPharma has started a U.S.-based Phase I trial of cancer drug candidate OBP-801 licensed from Astellas Pharma in 2009.

Push to use big data in Japan gets help from industry, academia

The pharmaceutical industry's producers and academic researchers in Japan are actively engaged, despite setbacks experienced by others such as Google, in building a big-data pipeline, this one now including 10 drugmakers and 30 medical institutions.

Australia negotiates pharmacy reimbursement increase as part of budget savings

Even as Australia takes measures to trim the nation's spending on medicines as part of overall healthcare funding pressures, it is busy negotiating a deal in the $15 billion range that could be more than a 20% increase in pharmacy reimbursements.

China gears up to change the rules of the game on drug sales

If China has its way, within another year or two, a repeat of the GlaxoSmithKline and similar scandals will be far less likely, but drugmakers can expect to face a harder sell as a result. The government just completed a comprehensive healthcare reform plan centered on the nation's public-hospital system, but with a reach throughout the medical process.

FDA reveals it's received 142 reports of contaminated duodenoscopes since 2010

In preparation for an upcoming meeting on duodenoscope safety, the FDA revealed it's received 142 reports of contaminated duodenoscopes since 2010.

FDA approves Medtronic lead for tough implantations

The FDA granted its stringent PMA approval to Medtronic's surgically implanted Model 5071 Lead for use in conjunction with cardiology devices like pacemakers, defibrillators and CRT-Ds, which combine the benefits of pacemakers and defibrillation therapy.

FDA staffers raise doubts over key Vertex combo

As an FDA review nears for Vertex's Kalydeco-lumacaftor tandem--approval of which could help Kalydeco reach 10 times the number of cystic fibrosis patients it currently does--the agency's staffers have some concerns.

Pfizer settles lawsuits tying sex and gambling addictions to dopamine meds

Pfizer is settling class-action litigation brought by patients who claimed the drugmaker did not adequately warn them of possible side effects of drugs they were taking to treat their Parkinson's disease or restless leg syndrome.

Novartis grabs Zykadia approval in Europe, setting the stage for showdown

Novartis' Zykadia picked up some steam in its head-to-head rivalry with Pfizer's Xalkori, snagging EU approval and setting the stage for a showdown as the companies compete for top dog.