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US FDA approves first non-gene edited allogeneic CAR T-cell candidate for trials

Unlike gene-edited CAR T-cell therapies, this approach does not cut the genome to knock out, or knock in, a gene, says Celyad.

LenioBio and Fraunhofer Institute to develop protein expression platform

LenioBio and Fraunhofer Institute IME have entered a licensing agreement, allowing LenioBio to commercialize technology into a protein expression platform.

US FDA grants Breakthrough Therapy Designation for food allergy drug Xolair

Genentech’s Xolair was granted a Breakthrough Therapy Designation by the US FDA.

Motion to dismiss Inflectra case denied, but J&J insists ‘Pfizer’s lawsuit is without merit’

A US district court has denied Johnson & Johnson’s motion to dismiss Pfizer’s Inflectra lawsuit, a case claiming anticompetitive practices blocked US uptake of the Remicade biosimilar.

Regulatory eyes on Regeneron: US FDA issues CRL for Eylea

The US Food and Drug Administration has rejected Regeneron’s eye candidate, Eylea, but the biotech says it expects a final regulatory decision within two months.