Category: autoimmune disease

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

alopecia, autoimmune disease, Concert Pharma, Eli Lilly, Incyte, JAK inhibitor, News, Pfizer, R&D / August 4, 2021 August 4, 2021

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 …

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

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

autoimmune disease, Calliditas, FDA, IGaN, kidney disease, Market Access, nephrology, News, rare disease / April 29, 2021 April 29, 2021

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 …

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

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

autoimmune disease, Calliditas, EMA, kidney disease, Market Access, nephrology, News, rare disease / April 23, 2021 April 23, 2021

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 …

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

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

autoimmune disease, lupus, M&A, Merck & Co, News, Pandion Therapeutics, R&D, Ulcerative Colitis / February 25, 2021 February 25, 2021

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 …

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

New Models of Care in the Post-Covid Healthcare World

autoimmune disease, care delivery, digital health, Medical Care, primary care, rheumatology / January 5, 2021 January 5, 2021

New Models of Care in the Post-Covid Healthcare World Observations on models of care in a post-COVID world from HLTH VRTL 2020 with comments on applicability to autoimmune conditions. The Doctor Weighs In

Dealing with a Rare Eye Disease in the Midst of COVID19

autoimmune disease, COVID, COVID-19, covid19, Medical Care, ophthalmology / August 26, 2020 August 26, 2020

Dealing with a Rare Eye Disease in the Midst of COVID19 After being diagnosed with a rare eye disease, a doctor learns the best treatment is immunosuppression-a risky choice in the midst of COVID19 The Doctor Weighs In

J&J to buy Momenta Pharmaceuticals for $6.5B

autoantibody-driven diseases, autoimmune disease, BioPharma, biopharma nl, Cambridge, Johnson & Johnson, Massachusetts, Momenta Pharmaceuticals, New Brunswick, New Jersey, nipocalimab, SYN, Top Story / August 20, 2020 August 20, 2020

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

autoimmune disease, BioPharma, biopharma nl, California, Complete Response Letter, CRL, Daily, FDA, Filgotinib, Food and Drug Administration, Foster City, Galapagos, Gilead Sciences, rheumatoid arthritis, rheumatology, SYN, Top Story / August 19, 2020 August 19, 2020

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.

FDA approves Roche drug for rare autoimmune disorder NMOSD

(satralizumab-mwge), autoimmune disease, Basel, BioPharma, biopharma nl, Daily, Enspryng, Food and Drug Administration, Neuromyelitis Optica Spectrum Disorder, NMOSD, Roche, Switzerland, SYN, Top Story / August 17, 2020 August 17, 2020

The agency approved Enspryng for the disease, which is often misdiagnosed as multiple sclerosis and can cause blindness, muscle weakness and paralysis.