A U.S. federal judge has turned down Ranbaxy Laboratories' request for a temporary restraining order against the FDA after the agency revoked the Indian drugmaker's approvals to make generics of AstraZeneca's blockbuster Nexium and Roche's antiviral Valcyte because of its manufacturing shortcomings.
A U.S. oncologist who thought he was getting a great deal on drugs that were almost the same thing as Avastin has found they will cost him an extra $2 million and a federal misdemeanor conviction.
As Pfizer's Trumenba rolls out in the U.S., it may get a head start on Novartis' Bexsero, which is still awaiting FDA approval. But the drug giant still doesn't yet have what it needs to build a considerable lead: a recommendation from the CDC's Advisory Committee on Immunization Practices.
Federal regulators are proposing a rule that would require makers of drugs and medical devices to publicize the results of thousands of clinical trials, regardless of whether they succeed, part of a global move toward transparency in R&D.
The FDA has cleared BrainScope's Ahead 100 device that uses a wearable device to provide an electroencephalograph that is analyzed to assess the structural condition of a patient's brain after head injury. The first-line diagnostic device for traumatic brain injury is typically a computed tomography scan.
The U.K.'s cost-effectiveness gatekeepers have flip-flopped on Novartis' Xolair before, withdrawing support for the drug in 2012 before expanding its approval for asthma the following year. Now, the National Institute for Health and Clinical is asking the drugmaker to pony up more information about the product before recommending it to treat chronic spontaneous urticarial (CSU), or psoriasis.
The market price of a priority review voucher at the FDA just doubled. Canada's Knight Therapeutics has auctioned off its voucher--which can be turned in to the FDA in exchange for a regulatory shortcut on a drug decision--for $125 million to Gilead, one of the most aggressive developers in the industry.
Open up the floodgates: Gilead's hep C wonder-cocktail, Harvoni, has won approval in Europe.
Ranbaxy Laboratories has filed a federal lawsuit trying to reverse the FDA's decision to cancel its approvals to make generics of AstraZeneca's blockbuster Nexium and Roche's Valcyte.
This month, the FDA yanked the approvals it granted Ranbaxy to make generics of two blockbuster drugs, saying it was a mistake to grant the approval given that the plants where they were to be made were out of compliance. Ranbaxy has now filed a federal lawsuit against the FDA for canceling the approvals.