Phase III
The end of July is busy for the FDA, with Coherus, Sanofi, Acadia, Myovant and Pfizer having PDUFA dates filling the calendar. Here’s a look.
InMed updated its INM-755 for patients with epidermolysis bullosa, Seagen and Astellas announced positive topline results for Padcev with Merck’s Keytruda, and more.
The DESTINY-Breast04 trial introduces a new option for breast cancer diagnosis – HER2-low. The trial data received a standing ovation from thousands of oncologists at this year’s ASCO meeting.
On Wednesday, Swiss women’s health company ObsEva announced that it is dropping linzagolix, its leading candidate for uterine fibroids.
Ionis announced that the FDA has accepted its NDA for tofersen for SOD1-ALS. The application has been given the priority review designation and an action date of January 25, 2023.
Daiichi-Sankyo and AstraZeneca’s sBLA for HER2 directed Enhertu accepted by FDA. Novartis gets BLA acceptance for MS biosimilar. HOOKIPA’s IND for prostate cancer immunotherapy candidate accepted
VistaGenTherapeutics announced data showing that its nasal spray candidate for anxiety, depression and other central nervous system disorders, fell short of its primary endpoint.
Prometheus completed its Phase II trial in UC, Algernon announced its Phase II trial of IPF and chronic coffee, Seelos dosed the first patient of SLS-005 for patients with ALS.
Assembly Biosciences and X4 Pharmaceuticals have announced significant layoffs and reprioritization endeavors to let go of underperforming initiatives.
Hansa Biopharma secured $70 million in non-dilutive financing, OSE secured $300 million in funding while CN Bio opened a new contract research facility and more global biopharma news.
PRESS RELEASES