Teva is on track to respond to FDA’s complete response letter for deutetrabenazine by the end of September, with a potential for approval and launch in early 2017.
Teva Pharmaceutical Industries Ltd. intends to respond to FDA’s complete response letter for deutetrabenazine for the treatment of chorea associated with Huntington disease by the end of September, which could position the drug for approval and launch in March 2017, President Global R&D Michael Hayden said during the company’s second quarter conference call Aug. 4.
Teva is working to quickly resolve the outstanding issues because deutetrabenazine (also known as SD-809) is expected to be an...
Expanded funding for cost recovery could dovetail with FDA Commissioner Martin Makary’s idea for a “conditional approval” pathway based on a plausible mechanism of action.
Julian Beach, interim executive director of healthcare quality and access at the UK drug regulator, the MHRA, tells the Pink Sheet how the agency is responding to increased efforts to develop bacteriophage therapies.
The US FDA ended efforts to regulate lab-developed tests as medical devices for now when it did not appeal a decision from the Eastern District of Texas that tossed out the agency's final rule.
The UK regulator wants to help companies to develop bacteriophages for the treatment of infections. Its first guidance on this topic offers advice to researchers and sets out the regulatory requirements they will need to meet.
Darko has become the first director-general of the AMA, an organization set up to transform access to quality-assured medicines across Africa and foster a more predictable, efficient regulatory environment for innovation.
Julian Beach, interim executive director of healthcare quality and access at the UK drug regulator, the MHRA, tells the Pink Sheet how the agency is responding to increased efforts to develop bacteriophage therapies.
Exclusive analysis by the Pink Sheet explores how non-submissions by pharmaceutical companies to England’s health technology appraisal body are impacting the availability of medicines on the National Health Service.
