FDA
The FDA said it found an issue with the “size of the treatment effect and clinical relevance” of Ardelyx’s new drug tenapanor without providing additional details.
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A week into his tenure as head of the FDA’s Center for Drug Evaluation and Research, experts agree that Rick Pazdur is the “ideal fit” to stabilize the agency. And, according to one ex-FDA official, if his CBER counterpart Vinay Prasad tries to supersede Pazdur’s authority, “there will be hell to pay.”
Priority voucher awardees and regulators could feel pressure to “meet the moment” as FDA watchers question the intent and feasibility of the Commissioner’s National Priority Voucher program.
Through substantial leadership turnover and workforce cuts, the FDA has continued to support the advanced therapy sector, actively working to remove obstacles to innovation.
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Thanks to a new regulatory win, AstraZeneca’s Farxiga can now be used to reduce the risk of hospitalization for heart failure in type 2 diabetes patients with cardiovascular disease and with certain risk factors.
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.
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.
The patch is a once-per-day treatment that provides sustained concentrations of Secuado (asenapine), an atypical antipsychotic drug used to treat schizophrenia.
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.
The U.S. Food and Drug Administration approved Eli Lilly’s Reyvow (lasmiditan) for the acute treatment of migraines.
Scenesse is an under-the-skin implant. The drug is the company’s only approved product.
The approval of Beovu was based on findings from the Phase III HAWK and HARRIER clinical trials, in which Novartis’ drug demonstrated non-inferiority versus Eylea in mean change in best-corrected visual acuity at 48 weeks.
The approval was based on data from the Phase III GRECO clinical trial and the Phase I AMES trial.
The only other drug currently approved in the U.S. for HIV PrEP is Gilead’s Truvada (emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg).