FDA’s Antiviral Drugs Advisory Committee takes up the four-drug HIV-1 regimen, which includes two new agents, on May 11. The firm hopes to be able to sell the combination in part on its favorable side effects profile if the product is approved.
A favorable adverse event profile in two head-to-head trials with other HIV treatment regimens could help Gilead Sciences Inc.’s four-active-ingredient HIV treatment Quad (elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil fumarate) in its review by FDA's Antiviral Drugs Advisory Committee May 11, and in marketing if the drug is approved.
Quad has two unapproved ingredients; cobicistat is a novel boosting agent and elvitegravir is an investigational integrase inhibitor. But the...
Returning FDA biologics center director Vinay Prasad used the Papzimeous approval announcement to reinforce his flexibility on rare disease therapies after several complete response letters and his brief departure from the agency.
Enhancing the consistency and clarity of information requests and discipline review letters, and improving assessment milestone communications are key areas targeted by generic drug makers for user fee program negotiations.
Pfizer still has not submitted a supplemental biologics license application for the youngest population even though people familiar say it has dominated that market. Moderna says it can “step up” supply.
Aurobindo is confident its planned Lannett acquisition will meet US FTC standards after an attempt to acquire Sandoz assets was nixed in 2020. The deal also could widen Aurobindo’s US manufacturing presence.
The Pink Sheet takes an exclusive look at the complete response letter, which shows the information on application deficiencies that could become widely available if FDA leaders succeed in releasing CRLs in real time.
The arrangement, which implies a behind the scenes negotiated discount, may signal a trend toward less price transparency in foreign markets as manufacturers parry Trump’s Most Favored Nation price demands.
Vinay Prasad’s exit from the US FDA reignited conversations about integrating its drugs and biologics centers under George Tidmarsh. Those plans appear to be shelved, but the leadership transition could be an opportunity to fully realize the vision for the Oncology Center of Excellence.
