Look back at pharma news in the week to July 2, 2021

US pharma major AbbVie revealed it has received a notification from the Food and Drug Administration relating to a regulatory delay for its supplemental New Drug Application (sNDA) for Rinvoq in psoriatic arthritis and ankylosing spondylitis. Merck & Co last Tuesday gained European approval for blockbuster immune-oncology drug Keytruda, in the new indication of esophageal or GES carcinoma. USA-based biotech Orchard Therapeutics entered into a strategic collaboration with Dutch firm Pharming on its HSC gene therapy for hereditary angioedema, a life-threatening rare disorder. UK pharma major GlaxoSmithKline on Friday announced an immuno-neurology deal worth a potential $2.2 billion with US biotech Alector, which hopefully will lead to treatments for Alzheimer’s and Parkinson’s diseases. Indian drugmaker Zydus Cadila last week applied for emergency use approval for its ZyCoV-D, a plasma DNA COVID-19 vaccine candidate.

Rinvoq PDUFAs for PsA and AS delayed again

The FDA has informed AbbVie that the regulator would not meet the June target action dates for evaluating its JAK inhibitor Rinvoq for psoriatic arthritis (PSA) and ankylosing spondylitis (AS) due to the ongoing safety review pf Pfizer’s Xeljanz, noted SVB Leerink analyst Geoffrey Porges.