autoimmune disease

Lilly has a bad hair day as Pfizer rival hits the mark in alopecia

Eli Lilly and Incyte have another rival in the rear-view mirror for Olumiant in alopecia areata after Pfizer reported that its ritlecitinib improved scalp hair regrowth in a late-stage trial. In the phase 2b/3 ALLEGRO trial, JAK inhibitor ritlecitinib hit its primary objective of improving the area of scalp covered by hair in people with …

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FDA sets September review date for Calliditas’ rare kidney disease drug

Calliditas Therapeutics could have its first product on the market in the US this autumn, as the FDA has now started a priority review of Nefecon for rare disease primary IgA nephropathy (IgAN).  The Swedish biotech says the IUS regulator has set an action date of 15 September for its review of Nefecon, a novel …

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Calliditas eyes 2022 approval in EU for rare kidney disease drug Nefecon

Calliditas Therapeutics is on course to launch its first product, Nefecon for rare disease primary IgA nephropathy (IgAN), in the first half of 2022 after getting the green light for an accelerated review by the EMA.  The Swedish biotech is planning to file Nefecon for approval in the second quarter to the EU regulator, which …

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Merck takes on Lilly/Nektar in IL-2 with $1.85bn Pandion buy

Merck & Co/MSD has agreed to buy Pandion for $1.85 billion, bolting on a pipeline of drugs for autoimmune and other immunological disorders headed by interleukin-2 (IL-2) based therapy PT-101.  The $60 per share is a handsome, more than 100% premium on Pandion’s closing share price yesterday, and gives Merck a foothold in the hot …

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J&J to buy Momenta Pharmaceuticals for $6.5B

The drugmaker emphasized the full global rights it would acquire to Momenta’s lead asset, nipocalimab, which it is developing for several autoantibody-driven diseases and that in certain indications could have peak sales of more than $1 billion.

FDA issues surprise rejection of Gilead, Galapagos rheumatoid arthritis drug

While there had been some risks to filgotinib’s approval cited before, analysts expressed surprise at the decision, with one writing it would likely delay approval by at least a year. Shares of both companies fell sharply on the news.