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Generic versions of the Hoffman-La Roche AIDS drug Valcyte can move forward after a federal judge denied Ranbaxy’s request for a restraining order on alternate versions of the therapy, as well as AstraZeneca’s blockbuster heartburn drug Nexium. Read More
India’s drug pricing authority is proposing a requirement to display special markings and ceiling prices on labels for life-saving and essential drugs, an idea that one observer says should have included input from the country’s drug regulator. Read More
The recent spike in generic drug prices is not an isolated phenomenon, says a senator who introduced legislation yesterday that would require generics firms to provide a rebate to Medicaid if their prices rise faster than inflation, something that brandmakers already are required to do. Read More
The FDA touted its approval of an abuse-deterrent, single-entity opioid yesterday and sought to beat back congressional criticism it has done little to curb prescription drug abuse. Read More
Australia and New Zealand have abandoned plans for a joint drug regulatory agency, although both countries say they will continue to cooperate on regulations that are mutually beneficial. Read More
Mallinckrodt has sued the FDA over its decision last week to revoke the equivalence rating on the company’s generic version of Janssen’s attention deficit hyperactivity disorder drug Concerta. Read More
UK’s healthcare cost watchdog says Novartis must provide significantly more clinical trial data on its hives drug Xolair before the group can recommend the therapy for national coverage. Read More
Global sales of pharmaceuticals are expected to surge 30 percent to $1.3 trillion by 2018, as more high-priced therapies enter the market and fewer drugs face generic competition, a new study finds. Read More
The FDA’s citizen petition process is overloaded with meritless petitions whose only purpose is to try to delay competition from generic drugs, despite past efforts at reforming it, the agency says. Read More
Australia’s supreme court has struck a victory for brandmakers in the country with a finding that extends the time they have to seek an extension on their drug patents. Read More