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A federal court sided in favor of Vanda Pharmaceuticals in its Freedom of Information Act case against the FDA regarding the CRL for its sleep drug label expansion.
In an earnings call Wednesday, bluebird bio revealed it is unlikely to meet its first-quarter goal to submit a Biologics License Application for sickle cell disease (SCD) gene therapy lovo-cel.
There have already been several big biotech licensing deals in Q1. See inside for some of this quarter’s biggest licensing deals — from the surprising and pivotal to the lucrative and consequential.
Citing reports of “alarming toxicity” among other accusations, short-seller Scorpion Capital will file a Citizen’s Petition with the FDA to have its approval of Wakix withdrawn.
Boston-based Covant Therapeutics gained $10 million upfront in a deal with Boehringer Ingelheim to chase after a cancer immunotherapy target, ADAR1.
Tuesday, Viking Therapeutics released Phase I results for its weight-loss candidate VK2735, which demonstrated a good safety and tolerability profile and resulted in significant weight reductions.
Intra-Cellular Therapies’ Caplyta met its primary endpoint in the Phase III Study 403 trial, easing the burden of depressive episodes in patients with major depressive disorder or bipolar depression.
Notch Therapeutics, Inc., a biotechnology company developing renewable, induced pluripotent stem cell (iPSC)-derived cell therapies for cancer, is pleased to announce Dr. Chris Bond has been promoted to Chief Scientific Officer.
Bristol Myers Squibb is expanding its strategic collaboration with German partner Evotec for eight more years to discover and develop treatments for neurodegenerative diseases.
Bicycle Therapeutics and Novartis announced Tuesday they have inked a deal worth up to $1.7 billion to discover and develop targeted radioligand therapies in oncology.
Monopar Therapeutics is dropping its lead candidate, Validive, after it failed to meet efficacy markers in Phase IIb/III trials for severe oral mucositis.
Merck’s Keytruda appeared to outperform GSK’s Jemperli in a key endometrial cancer patient subgroup, based on late-stage data revealed Monday during the Society of Gynecologic Oncology 2023 Annual Meeting.