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Complete Response Letters
Another regulatory blow has not stopped Outlook Therapeutics and its ophthalmic bevacizumab, yet.
FDA's release of CRLs for unapproved products could bring a court challenge, but for now, sponsors should expect all past and future letters will be made public, experts said.
Generics Bulletin reviews global regulatory developments across the world.
After pinning its hopes on a trial that did not meet its primary endpoint, Outlook Therapeutics is disappointed that the US FDA has again rejected its Lytenava ophthalmic formulation of bevacizumab, with the firm pointing to “only one deficiency, for a lack of substantial evidence of effectiveness.”
PTC said it got a complete response letter for the Friedreich’s ataxia drug, with the agency asking for an additional clinical trial.
The Pierre Fabre-partnered allogeneic T-cell immunotherapy is already available in Europe but hopes of a US approval have been hit by a complete response letter citing problems at a third-party manufacturing facility.
During a virtual appearance at a CERSI meeting two days after announcing retirement plans, the CDER director also said she wished agency reviews of unapproved drugs could be published.
Tanvex has seen its application for a trastuzumab biosimilar knocked back by the US Food and Drug Administration, receiving a complete response letter over the filing.
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.