Topic:

Regulatory

Latest Headlines

Latest Headlines

Ranbaxy faces U.S. racketeering suit for blocking launch of Roche, Novartis generics

Ranbaxy Laboratories and its new parent, Sun Pharmaceutical Industries, have been named in a U.S. district court suit accusing Ranbaxy of racketeering by blocking generics of two drugs, one each by Roche and Novartis.

Japan readies to sign new IP law it sees as win-win

Japan is due to sign off on an international intellectual property patent treaty that would require it to make some reforms in its own laws to make it easier for foreigners to apply. But its own exporting companies also stand to benefit.

Australia budget promises more digging on reimbursement, fees

An analysis of Australia's federal budget released this week showed that healthcare remains a sharp cost focus, though a bit less compared with the aggressive reforms proposed by the government last year.

Japan's MHLW sets Sovaldi price, hep C competition heats up

Gilead and its controversially expensive Sovaldi (sofosbuvir) hepatitis C drug is set to gain a major new market, Japan and its half-million people with the type the drug treats, though other major drugmakers are in or eyeing the same market.

FDA clears BD insulin infusion set developed with diabetes patient advocacy groups

Becton Dickinson worked with diabetes patient advocate groups to develop its latest insulin infusion set, which is designed for improved insulin flow with reduced interruptions. Now the FDA has cleared the new infusion set based on BD FlowSmart.

Contrave controversy puts Orexigen, Takeda in unwelcome spotlight

The FDA was none too happy with Orexigen when it put out some early positive cardio data for obesity drug Contrave in March. One reason? Early data can be misleading--and now, it looks like that might have been the case for Contrave.

Vertex eyes big revenue boost with FDA panel backing for Orkambi

Vertex Pharmaceuticals wants to expand its cystic fibrosis market tenfold, and on Tuesday, it got one step closer. An FDA advisory committee voted 12 to 1 in favor of a new combo drug Orkambi, which marries current CF star Kalydeco with an experimental med, lumacaftor.

Look out, payers. Vertex's new CF med Orkambi is one step closer to market

Vertex is looking to expand its market for cystic fibrosis drug Kalydeco tenfold, but to do that, it needs the FDA's backing. On Tuesday, it got one step closer, grabbing an advisory committee nod for a new Kalydeco combo.

Chi-Med unit slated for $18M in milestones from Lilly

Eli Lilly is set to make an $18 million milestone payment to Hutchison MediPharma, majority owned by Hutchison China MediTech, or Chi-Med, in the second quarter of 2015 after a positive first proof-of-concept study result for fruquintinib, a candidate for treatment of patients with metastatic colorectal cancer in China.

Contrave trial tussle brews between Takeda, Orexigen with Cleveland Clinic on the scene

A tussle over the termination of a trial to assess the cardiovascular safety of obesity drug Contrave is in swing, with Orexigen Therapeutics and Takeda Pharmaceutical entering a dispute process, according to Reuters, with earlier data breaches the subject of a separate issue.