Don Tracy, Associate Editor

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

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.

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.

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.

Chris Springate, CEO, ARC Medical, discusses how postoperative adhesions continue to cause chronic pain, infertility, and life-threatening complications—despite advances in surgical techniques and often going undiagnosed for years.

In the Phase III HARMONi-6 trial, ivonescimab plus chemotherapy significantly outperformed tislelizumab plus chemotherapy as a first-line treatment for advanced squamous non-small cell lung cancer.

Results from the dual Phase III TRIUMpH trials demonstrated the statistical superiority of tegoprazan over lansoprazole in patients with erosive esophagitis and non-erosive reflux disease.

In the Phase III ARISE trial, Cobenfy administered as an adjunctive treatment to atypical antipsychotics for patients with inadequately controlled schizophrenia did not achieve statistically significant improvements.

Results from the Phase IIb SunRISe-1 study demonstrated a one-year duration of response with the TAR-200 intravesical gemcitabine-releasing system in patients with Bacillus Calmette-Guérin-unresponsive high-risk non-muscle-invasive bladder cancer.

With combined investments exceeding $53 billion, both companies are deepening their US presence through expanded biologics production, gene therapy capabilities, and next generation R&D centers.

Nigel McCracken, chief operating officer, Virax Biolabs, discusses the expansion of its ViraxImmune platform into areas such as transplant monitoring, vaccine efficacy, latent virus reactivation, and CAR T cell therapy.

The simplified requirements for Camzyos are expected to ease prior contraindications, thereby simplifying treatment and expanding eligibility in patients with symptomatic New York Heart Association Class II-III obstructive hypertrophic cardiomyopathy.

Nigel McCracken, chief operating officer, Virax Biolabs explains how the ViraxImmune PAIS assay uses T cell responses and cytokine levels to detect immune dysfunction and identify viral triggers of chronic inflammation.

New Phase II data demonstrate amlitelimab’s efficacy in heterogeneous inflammatory asthma, as lunsekimig and itepekimab advance into chronic rhinosinusitis, chronic obstructive pulmonary disease, and bronchiectasis.

Dupixent is the first new targeted therapy to receive FDA-approval for chronic spontaneous urticaria in adults and adolescents over 12 years of age in over a decade.

Regulatory action was based on data from the Phase III QUASAR trial, which demonstrated that Eylea HD dosed every eight weeks achieved non-inferior visual acuity outcomes compared to Eylea in patients with macular edema following retinal vein occlusion.

The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices voted to expand access to Pfizer’s respiratory syncytial virus vaccine Abrysvo for high-risk adults in their 50s and voted in favor of GSK’s meningococcal vaccine, Penmenvy, for streamlined adolescent protection.

A new study found that patients with type 2 diabetes treated with GLP-1 receptor agonists and sodium-glucose cotransporter-2 inhibitors demonstrated lower risks of developing Alzheimer disease compared to other glucose-lowering drugs.

Nigel McCracken, chief operating officer, Virax Biolabs, discusses new findings that reveal altered cytokine activity and evidence of T cell exhaustion in long COVID patients, providing deeper insight into post-infection immune disruption.

Ziresovir is the first antiviral to demonstrate significant clinical efficacy and long-term respiratory benefits in hospitalized infants under six months of age with respiratory syncytial virus.

In the Phase III DeLLphi-304 trial, patients with small cell lung cancer administered Imdelltra achieved a statistically significant and clinically meaningful improvement in overall survival compared to standard-of-care chemotherapy.

In the Phase III ODYSSEY-HCM trial, patients treated with Camzyos for symptomatic non-obstructive hypertrophic cardiomyopathy did not show significant improvements based on Kansas City Cardiomyopathy Questionnaire – Clinical Summary Scores and peak oxygen consumption.

Nigel McCracken, chief operating officer, Virax Biolabs, discusses results from new data on the role of T cell dysfunction in post-acute infection syndromes.

Despite meeting key pharmacokinetic goals, a potential case of drug-induced liver injury led Pfizer to conclude that danuglipron’s risk-benefit profile did not support further development for chronic weight management.