Biotech | January 24, 2022
USFDA approves IND application for Allied’s cancer treatment
APS03118 is a novel innovative drug developed by APS with global independent intellectual property rights for unlimited cancer types
APS03118 is a novel innovative drug developed by APS with global independent intellectual property rights for unlimited cancer types
The FDA grants ODD status to medicines and potential new medicines intended for the treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the US
Pfizer is evaluating the FDA’s comments and will work with the agency to determine an appropriate path forward
Previously, the use of the drug was limited to patients requiring hospitalization
Go-ahead for pivotal clinical trial which is expected to commence by March
Phase 1/2 trial of E-602 expected to open in Q1 2022 in patients with solid tumours
Quviviq is a dual orexin receptor antagonist, which blocks the binding of the wake-promoting neuropeptides orexins and is thought to turn down overactive wakefulness, as opposed to treatments that generally sedate the brain
First launches expected in H1 2022
The company has 47 ANDA's pending approval with the U.S.FDA
The global multi-center phase-II clinical trial will be a 36-week, multi-center, randomized, double-blind, placebo-controlled trial, followed by a 36-week open-label extension period
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