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AbbVie Remains Confident About Rinvoq Despite Coming Safety Labeling Update

 
• By Joseph Haas

A safety-related FDA revision of Rinvoq’s label in rheumatoid arthritis is a perceived threat to the JAK inhibitor’s growth, but it and fellow immunology asset Skyrizi produced another strong sales quarter.

Business growth
AbbVie remains optimistic about Rinvoq growth despite pending FDA label revision

The US Food and Drug Administration’s September drug safety communication on cardiovascular and cancer risks posed by the Janus kinase inhibitor class of drugs means thatAbbVie Inc.’s oral rheumatoid arthritis therapy Rinvoq (upadacitinib) soon will get a revised label, but the pharma’s top execs expressed confidence about growth projections for the JAK inhibitor during a 29 October sales and earnings call, even if the safety update is restrictive.

In its 1 September announcement that Pfizer Inc.’s Xeljanz (tofacitinib) will add a black box warning after a post-marketing...

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More from Earnings

Zydus Looks To Ride gIbrance Exclusivity Wave; GLP-1 Battle-Ready With Differentiated Pen

 
• By Vibha Ravi

Ibrance is losing share to other drugs, but Zydus looks forward to a late 2027/early 2028 launch of its generic in the US where partner Synthon might have 180-day exclusivity. In India, as Lilly launches Mounjaro KwikPen, it hopes for a GLP-1 edge with a differentiated device and formulation.

Japan Results Roundup: Reduced Forex Impact, Uncertain US Tariff Outlook

 
• By Lisa Takagi

Most major Japanese firms report generally positive fiscal first quarter results, led by mainstay growth and despite lower currency effects. But the future impact of any US pharma tariffs remains an overhang.

S&E In Brief: Launch Updates And Political Headwinds

 
• By Sushmita Panda

Madrigal and Syndax update investors on their key launches, while Merck KGaA weighs in on the possibility of direct-to-consumer sales in the US.

Lupin Confident Of US Growth On Tariff Mitigation, Rides High On Tolvaptan

 
• By Vibha Ravi

Lupin is hoping moves like intellectual property transfer for some products to the US will help mitigate the tariff impact even as it counts on growth from planned launches of GLP-1s and biosimilars while riding high on tolvaptan launched in Q1.

More from Business

Sarepta Sells Arrowhead Shares To Raise Cash, Pay Arrowhead

 
• By Mandy Jackson

Sarepta is in a cash crunch with sales of Elevidys slumping due to safety concerns and with financial commitments coming due, including debt repayments and milestone fees for its partner Arrowhead.

Deal Watch: Lilly Teams With GPCR-Focused Superluminal In Cardiometabolic Disease

 
• By Joseph Haas

Plus deals involving Basilea/Venatorx, CorMedix/Melinta, SERB/Y-mAbs, XOMA/Lava, XOMA/Hillevax, MaxCyte/Adicet/Anocca and Bausch Health/DURECT.

Schrödinger Drops CDC7 Inhibitor SGR-2921 After Two Patient Deaths

 
• By Alaric DeArment

The drug is one of multiple candidates in the class that have been pulled from development, though it is not the company’s lead candidate.