Sanofi

Biologic drugs for asthma can be used during conception, pregnancy, and breastfeeding with shared decision-making. Use should be recorded in registries, and restarting after birth is recommended if halted. Inactivated vaccinations for infants are safe even if mothers received biologics. Concerns remain due to limited clinical trial data, especially for newer biologics like tezepelumab.

ArtLifting, founded by Liz and Spencer Powers, brokers art by disadvantaged artists, earning them $6.5 million. Their works, including by Allen Chamberland and Lisa Murphy, are displayed in corporate offices, including Moderna and Foundation Medicine, aiming to break stigmas and provide income.

The FDA has fully approved sparsentan (Filspari; Travere Therapeutics), an oral, non-immunosuppressive medication that significantly slows kidney function decline in adults with primary immunoglobulin A nephropathy (IgAN). The approval is based on the PROTECT study, which showed a 1.2 mL/min/1.73m²/year treatment effect over 2 years compared to irbesartan. Sparsentan is well-tolerated and offers a superior option for preserving kidney function.

The atopic dermatitis (AD) market is projected to reach $16.7bn by 2030, driven by global AD prevalence and clinical trial advancements. Standard treatments offer temporary relief, prompting the need for more effective therapies. Innovative treatments like BTLA and OX40 inhibitors, bacterial therapies, and NTMs show promise. Pharmaceutical companies should invest in R&D, form alliances, and adopt patient-focused strategies to capitalize on market growth.

Roche's fenebrutinib achieved a mid-stage win in RMS, showing near-total elimination of disease activity, while Sanofi's tolebrutinib had mixed results, missing primary endpoints in two Phase III studies but succeeding in a third, delaying disability progression in progressive MS. Both drugs face safety concerns, particularly liver injury, which will be a key focus at upcoming presentations. Despite mixed results, tolebrutinib is expected to generate $2.6 billion in sales by 2030, while fenebrutinib is projected to reach $810 million.

GSK's Nucala succeeded in a Phase 3 study for COPD patients with chronic bronchitis/emphysema, significantly reducing exacerbations. This follows a 2018 FDA rejection for lack of data. Nucala targets interleukin-5 and is already approved for severe asthma. GSK will discuss the new data with regulators and present it at a future medical meeting.

GSK announced positive Phase III MATINEE trial results for Nucala, showing a reduction in COPD exacerbations. Nucala, a monoclonal antibody targeting IL-5, is currently approved for severe asthma and other conditions but not COPD. GSK plans to present full trial findings and share results with health authorities. The COPD market is anticipating potential approvals for Sanofi and Regeneron's Dupixent and Verona's Ohtuvayre.

Lykos Therapeutics CEO Amy Emerson steps down, interim CEO Michael Mullette appointed. Emerson to remain as senior advisor. Lykos faces FDA rejection for MDMA therapy, plans resubmission. Company also names David Hough as CMO and lays off 75% of workforce.

M.J.D. has consulted, advised, and spoken for Boehringer Ingelheim, Eli Lilly, Novo Nordisk, Sanofi, Pfizer, AstraZeneca, Zealand Pharma, Carmot/Roche, and Amgen. She has also received grants from AstraZeneca, Novo Nordisk, Boehringer Ingelheim, Janssen, Sanofi-Aventis, and Eli Lilly. J.G. has no competing interests.

GSK's asthma drug Nucala met primary endpoint in Phase III COPD trial, reducing exacerbations when added to inhaled therapy. GSK anticipates EU and Canada regulatory submission in 2025. Nucala, an IL-5 antagonist, generated £1.6bn in 2023 and is predicted to reach $2.35bn by 2026.