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Under terms of the deal, Alchemab will lead early Phase I trials for ATLX-1282 in amyotrophic lateral sclerosis, while Lilly will assume responsibility for further development and commercialization of the novel platform.

The Refusal to File letter comes despite the FDA’s prior encouragement to submit a supplemental biologics license application for Anktiva in patients with BCG-unresponsive non-muscle invasive bladder cancer with papillary disease.

Chip Parkinson, CEO, GiftHealth, explains how AI-powered data integration is bringing new hope to patients by revealing hidden access barriers, streamlining treatment pathways, and challenging outdated utilization management practices.

Tiara Green, president, Accessia Health, explains how empowering trusted local leaders and involving communities early are key to closing persistent gaps in preventive care and healthcare access.

Selarsdi, a biosimilar to Stelara, is approved for adult and pediatric psoriatic arthritis, plaque psoriasis, Crohn disease, and ulcerative colitis.

The 470,000-square-foot facility will support the launch and commercial production of next-generation biologics and therapies, including antibody-drug conjugates.

The basketball star has a personal history with the medication and the struggles with access to it.

This will bring Regulus’ farabursen into Novartis’ renal disease pipeline.

The Zensights Federated Healthcare Advisory Panel explores how shifting global dynamics are reshaping access and strategic planning across the healthcare system.

Will Pih, co-founder, Two Labs, explains how specialty pharmacies and manufacturers are adapting to financial pressures in rare disease care through patient-centric services, hub innovation, and hybrid technology models.

Fran Gregory, VP, emerging therapies, Cardinal Health, discusses the evolving cell and gene therapy landscape, highlighting pipeline growth, cost challenges, and emerging therapeutic areas beyond oncology and hematology.

A panel of experts examines how stakeholders can support strategies that improve patient outcomes, while also navigating various distribution models.

Approval is based on results from the pivotal Vivacity-MG3 trial in which IMAAVY (nipocalimab-aahu) demonstrated superior disease control throughout 24 weeks when compared to placebo plus standard of care.

A monthly roundup of business and people news in the pharmaceutical industry.

AbbVie secures FDA approval for Rinvoq as the first oral Janus kinase inhibitor indicated for giant cell arteritis, expanding its immunology portfolio and signaling strategic growth opportunities in underserved autoimmune markets.

Doug Long, VP, industry relations, IQVIA, examines shifting pharmaceutical trends, including specialty growth, biosimilar gaps, reimbursement pressure from GLP-1s, and persistent access challenges.

Chip Parkinson, CEO, GiftHealth, explains how AI, real-time data, and closer payer collaboration are driving the next phase of growth and efficiency in specialty pharmacy.

IQVIA’s Doug Long offers a lay of the land, including trends and developing issues that are shaping the current market.

Brett Casper explores the marketplace complexities that manufacturers face regularly.

The German company will expand its access into the United States through the acquisition.

A session dives into the trends surrounding specialty drugs and therapies, along with providing an overview of the drug development landscape.

Tiara Green, president, Accessia Health, highlights key themes from the upcoming discussion on how health equity, literacy, and social determinants are reshaping patient care—especially for those with chronic and rare conditions.

Blake Powers, CEO, Medigi, discusses how face-to-face collaboration and streamlined commercialization strategies are helping life sciences companies deliver therapies more efficiently to patients.

Investment includes $1.5 billion in capital expenditures to expand manufacturing and $500 million dedicated to R&D focused on high-impact innovations.

Approval of penpulimab-kcqx marks the company’s US regulatory debut and introduces a new immunotherapy option for advanced nasopharyngeal carcinoma.

The company will be adding a new manufacturing site to its NJ campus for the drug Adstiladrin.

A new study shows that varenicline combined with brief remote counseling significantly improves vaping abstinence in in patients between 16 and 25 years of age.

The submission is backed by clinical data from over 2,100 patients, including two pivotal Phase III trials in patients treated with trenibotulinumtoxinE for moderate to severe glabellar lines.