Complete Response Letters

After sharing multiple updates to the regulatory status of its ketamine formulation, PharmaTher received a complete response letter from the FDA, which required minor information and clarifications from the company.

The company will file a new drug application with the US FDA by the end of the year for tradipitant in a different indication, motion sickness.

The company will file a new drug application with the US FDA by the end of the year for tradipitant in a different indication, motion sickness.

Historically, announcements from biotech companies have triggered stock price fluctuations as investors misinterpret the details. However, two recent instances suggest this pattern might be shifting.

Sponsor of psychedelic PTSD treatment will try rarely successful formal dispute resolution process after receiving a complete response letter. 

US FDA would need to approve 44 novel agents by year-end to match 2023’s big total, but only 40 candidates are known to have user fee goals in the second half of 2024.

The drug maker said the US FDA issued a complete response letter for insulin icodec that included requests related to manufacturing process and the type 1 diabetes indication.

A Pink Sheet analysis finds US approval preceded European Union clearance for 80% of products approved in both areas, but when EU approval came first, it beat the FDA by a median of 13 months. US-first approvals came close to six months before the EU.

Rocket Pharmaceuticals’ gene therapy Kresladi, Daiichi Sankyo/Merck’s patritumab deruxtecan, and AbbVie’s foscarbidopa/foslevodopa (ABBV-951) received CRLs because of manufacturing concerns.

While there were no issues of efficacy or safety behind a new US CRL for Daiichi Sankyo/Merck & Co's anti-HER3 antibody-drug conjugate patritumab, the FDA decision marks a hit to the companies' first ADC collaboration and the latest in a string of regulatory blows to Japanese firms in the US.