FDA
To say that 2seventy bio’s short two years of existence have been dramatic is an understatement. CEO Chip Baird told BioSpace transparency and a committed staff have kept the biotech going through thick and thin.
Bristol Myers Squibb wins approval for the first novel schizophrenia drug in decades; Pfizer pulls Oxbryta from the market; new IVF and abortion laws could derail women’s health research; Roche touts CDK inhibitor deal and obesity pipeline and BioSpace heads to Meeting on the Mesa.
One upcoming decision—on a perioperative PD-1 regimen for lung cancer—comes as the FDA considers an overhaul of trial designs in this treatment setting.
Already approved in six indications, Sanofi and Regeneron can now add chronic obstructive pulmonary disease to the list for their blockbuster injection.
The FDA’s Oncology Drugs Advisory Committee voted near-unanimously that the benefits of PD-1 inhibitors like Keytruda and Opdivo in PD-L1 low patients do not outweigh the risks.
If approved, the potential restrictions would impact Merck’s Keytruda and Bristol Myers Squibb’s Opdivo, which are marketed for the first-line treatment of several types of stomach cancer regardless of PD-L1 expression.
IntraBio’s Aqneursa is the second drug within a week approved by the regulator for treating Niemann-Pick disease type C, just days behind Zevra Therapeutics’ Miplyffa.
With Friday’s approval, Sanofi’s anti-CD38 antibody Sarclisa will go head-to-head with the first such therapy for multiple myeloma, Johnson & Johnson’s Darzalex, which raked in nearly $10 billion last year.
Vanda Pharmaceuticals on Thursday announced that the regulator declined to approve its application, a decision the company says was delayed by more than 185 days and failed to satisfy the requirements of the Federal Drug and Cosmetic Act.
With the FDA’s approval, Fasenra will compete with GSK’s Nucala, which in December 2017 became the first biologic approved for eosinophilic granulomatosis with polyangiitis.
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