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Regulatory

Latest Headlines

Latest Headlines

Novo Nordisk pulls Tresiba in Germany on pricing dispute

Germany's tough price negotiators went too far for Novo Nordisk. The Danish drugmaker is pulling its new diabetes drug Tresiba off the market after authorities said they'd price the long-acting basal insulin on par with old human insulin injections.

FDA taps the brakes on Genentech's cobimetinib review

The FDA has opted to delay its review of cobimetinib in order to give regulators more time to consider additional Phase III data provided by Genentech.

Feds demand $3.4B in damages, fines in Novartis kickback case

Kickback allegations against Novartis just got scarier. After years of investigating the Swiss drugmaker, the Justice Department and 11 states are demanding almost $3.4 billion in damages and fines in a False Claims Act lawsuit nearing trial.

India's Marksans Pharma buys U.S.-based Time-Cap, a trend in the making?

More than a few analysts and company executives are watching Indian drug companies in expectations of consolidation among smaller players and possibly daring moves by mid-cap and larger at home and abroad.

Purdue pulls out of FDA panel on abuse-deterrent OxyContin just days before meeting

Purdue Pharma has canceled an all-important discussion with FDA advisers about its latest spin on OxyContin less than a week ahead of the scheduled meeting, an uncommon move the company said will ultimately improve its odds of success.

Australia's Prana Biotech touts Imagine PBT2 safety trial outcome in comeback bid

Australian biotech Prana Biotechnology said an Imagine extension trial on the safety of a PBT2 neurodegenerative disease candidate did not identify any concerns, raising hopes that the company will lift a Partial Clinical Hold in the U.S. and head on to Phase III trials related to orphan status for Huntington's disease.

Survey: Hypertension, diabetes among key rising chronic diseases in China

Hypertension afflicted 25.2% of China's adult population and diabetes 9.7%, according to the state-run Xinhua news agency. That's according to a survey conducted by the National Health and Family Planning Commission over a decade that jibes with other recent public policy healthcare reform efforts by the State Council.

House bill would force FDA to ease up on social media

A Missouri congressman wants to know why the pharma industry is sitting on the sidelines of social media. Actually, Rep. Billy Long (R-MO) has an idea why--and he's proposing legislation to change it. He recently introduced H.R. 2479, which would force the FDA to let pharma share more info about its products online.

Intercept files its 'breakthrough' liver drug for rare disease approval

Intercept Pharmaceuticals has submitted its top candidate to the FDA for approval in primary biliary cirrhosis, a rare disease that results in serious liver damage.

FDA, Gates Foundation call for improved global access to veterinary drugs

In late June, drug regulators from around the world gathered in Dar Es Salaam, Tanzania, to brainstorm solutions for solving a major problem in many African countries and other developing nations: a lack of access to veterinary care, and most importantly, to particular drugs and vaccines that could protect against livestock losses.