Government
We round out the month of October and start the month of November with four PDUFA dates on the U.S. Food and Drug Administration’s calendar. Here’s a look.
Genentech’s flu medication Xofluza won a new indication for the treatment of acute, uncomplicated influenza in people 12 years of age and older who have been symptomatic for less than 48 hours and are at high risk of flu-related complications.
Two teams and an individual have been awarded this year’s President’s Science and Technology Awards[1][1], the highest honours bestowed upon research scientists and engineers in Singapore whose work have resulted in significant scientific, technological or economic benefits for the country.
ADC Therapeutics SA announced that the first patients have been dosed in a 100-patient pivotal Phase 2 clinical trial evaluating the efficacy and safety of ADCT-301 in patients with relapsed or refractory Hodgkin lymphoma The trial is intended to support the submission of a Biologics License Application to the U.S. Food and Drug Administration.
For fiscal year 2019, the agency reported 1,171 generic drug approvals, 935 of them full approvals and 236 tentative approvals. This is up from last year’s all-time record of 971 generic drug approvals.
Alzheimer’s Research UK has responded to an announcement that could see new legislation aimed at providing faster access to medicines.
The patch is a once-per-day treatment that provides sustained concentrations of Secuado (asenapine), an atypical antipsychotic drug used to treat schizophrenia.
Sanofi is pressing the U.S. Food and Drug Administration to keep its patient experience data consistent following a review of approved applications required by the 21st Century Cures Act.
Researchers found that an injectable hormone called tesamorelin decreases liver fat and prevented liver fibrosis in this patient population.
The U.S. Food and Drug Administration approved Janssen Pharmaceutical’s Xarelto for the prevention of venous thromboembolism, or blood clots, in acutely sick patients in hospitals who are at risk for blood clots but who are not at high risk of bleeding.
PRESS RELEASES