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Immunology

Set Alert for Immunology

Etrasimod Results Justify Pfizer’s Leap Of Faith In Arena Buyout

Detailed data presented at Digestive Disease Week show competitive efficacy in ulcerative colitis and a potential best-in-class safety profile for the S1P receptor modulator Pfizer acquired earlier this year. 

Clinical Trials Gastrointestinal

Concert’s CTP-543 Shows Advantages Over Lilly, Pfizer Candidates For Alopecia

Concert’s deuterated ruxolitinib analog is potentially third in line to market for alopecia areata, behind Lilly’s Olumiant and a Pfizer JAK3 inhibitor, but may be demonstrating a best-in-class profile.

Clinical Trials Business Strategies

Sanofi Closes In On A Pair Of Approval Firsts

The French major has secured a fourth approval, in eosinophilic esophagitis, for Dupixent, while the EMA is set to make Sanofi's enzyme replacement therapy, Xenpozyme, the first drug approved in Europe for acid sphingomyelinase deficiency.

Approvals Rare Diseases

Bayer Shuffles Atara’s CAR-Ts Out Of Its Cell Therapy Deck

Bayer is handing back rights to two early-stage off-the-shelf CAR-Ts to Atara, but the split could still be good news for the biotech company.

Companies Deals

UCB Rocked By US FDA Rejection Of Blockbuster-In-Waiting Bimzelx

The Belgian group’s US launch of Bimzelx could be delayed by up to a year after the FDA hit UCB with a complete response letter which states that "certain pre-approval inspection observations must be resolved” before the drug can get the green light for psoriasis.

Complete Response Letters Immune Disorders

AbbVie Ups Its IBD Game With Latest Crohn’s Data For Rinvoq

The leader in inflammatory bowel disease via Humira, AbbVie awaits a US FDA decision in June for Skyrizi in Crohn’s disease and plans to add a Crohn’s indication to Rinvoq’s ulcerative colitis approval.

Clinical Trials Gastrointestinal

Stoffels Sets Out Strategy To Save Galapagos

Pharma veteran Paul Stoffels, the new CEO of Galapagos, is not thinking about using the Belgian biotech’s cash pile to buy Phase III drugs but is open to licensing deals with US firms who have drugs approved at home and are looking for a European partner.

Business Strategies Sales & Earnings

Pfizer Highlights Next I&I Star As Xeljanz Sales Fall

The company is looking to refuel its immunology & inflammation portfolio as Xeljanz safety takes a toll and the franchise approaches loss of exclusivity.

Inflammation Immune Disorders

AbbVie Focuses On Humira’s Formulary Positioning Ahead Of Biosimilars

A year out from the US patent expiration for top-seller Humira, AbbVie is negotiating for formulary position alongside biosimilars. Analysts said success there could delay some patent cliff pain until 2024.

Sales & Earnings Business Strategies

Protagonist Weaves Positive Story From Mixed Phase II Data In Ulcerative Colitis

The company is pushing ahead into Phase III development with the lower dose of an oral drug for ulcerative colitis, even though a Phase II study missed the primary endpoint.

Clinical Trials Business Strategies

Hereditary Angioedema Market Snapshot: Room For Pills And Injections As Prophylaxis Makes Gains

While many HAE patients converted from injectable prophylaxis to BioCryst’s oral Orladeyo last year, physicians said a promising injectable candidate from Ionis could benefit from varied patient preference.

Market Snapshot Rare Diseases

TG Shifts Focus To MS After Pausing Oncology Programs, Ukoniq Withdrawal

TG Therapeutics is withdrawing the PI3K-delta inhibitor from the market and halting enrolling in other umbralisib oncology studies to focus attention on ublituximab in relapsing multiple sclerosis.

Companies Business Strategies
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