Latest from Jessica Merrill
The US FDA approved Blujepa for the treatment of uncomplicated urinary tract infections, marking the first new mechanism of action for the infection in more than 30 years.
The founder and CEO of Ultragenyx talked with Scrip as the company approaches a pivotal data readout and awaits US FDA action on its first gene therapy.
Amvuttra will target a substantially larger patient population with a new indication, but it is third to market behind Pfizer’s Vyndaqel and Bridge Bio’s Attruby and will cost more.
The company’s Immunovant announced positive data from a Phase III trial in myasthenia gravis but the focus is on next-generation drug IMVT-1402.
A Phase III trial testing the protein degrader in breast cancer met the primary endpoint and showed an efficacy benefit only in the subgroup of ESR1 mutant patients, not the full population.
A Phase IIa trial studying Haduvio for the treatment of refractory chronic cough showed a benefit for patients, opening the door to a broad market and impressing investors.