Don Tracy, Associate Editor

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.

Odylia Therapeutics event brings together leaders across biotech, pharma, venture capital, patient advocacy, and research sectors to address the financial and structural barriers that impede rare disease drug development.

Approval of Opdivo plus Yervoy combination was based on results from the Phase III CheckMate-9DW trial, which demonstrated significantly improved overall survival and overall response rate in patients with unresectable or metastatic hepatocellular carcinoma.

Investment is expected to bring approximately 1,000 new jobs at Novartis and 4,000 additional roles across the United States.

Full approval of Vitrakvi was based on results from three clinical trials in patients with unresectable or metastatic NTRK fusion-positive solid tumors.

In the Phase III ICONIC-LEAD trial, 75% of adolescents with moderate-to-severe plaque psoriasis treated with icotrokinra achieved completely clear skin by week 24.

Financing of Merida Biosciences was backed by Bain Capital Life Sciences, BVF Partners and Third Rock Ventures, with participation from multiple other investors.

Davidi Vortman, CEO, UltraSight, discusses how AI-powered heart scan technology can help high-risk cardiovascular disease patients.

PharmaLogic states that the acquisition of Agilera Pharma AS will place the company in a unique global role in radiopharmaceutical production and distribution.

Approval of the Opdivo plus Yervoy combination regimen was based on results from the Phase III CheckMate-8HW trial, which was the largest immunotherapy study in patients with previously untreated, unresectable, or metastatic microsatellite instability-high or mismatch repair deficient colorectal cancer.

Brimochol PF, a combination of brimonidine and carbachol, was found to enhance depth of focus and visual acuity in clinical trials among patients with presbyopia.

Results from Phase II studies demonstrated that rilzabrutinib showed clinically meaningful outcomes in patients with warm autoimmune hemolytic anemia and IgG4-related disease.

Results from the Phase III SPACE trial show that Ajovy significantly reduced monthly migraines in pediatric patients between six and 17 years of age.

Enrollment for the Phase II trial follows FDA clearance of SPG302 Investigational New Drug application for schizophrenia.

Approval was based on results from the Phase III ALIGN study, which demonstrated a significant reduction in proteinuria at 36 weeks in patients with primary immunoglobulin A nephropathy.

Results from the Phase III ZENITH trial show that Winrevair lowered the risk of all-cause death, lung transplantation, and pulmonary arterial hypertension-related hospitalization by 76%.

Results from the SOLARIS trial survey showed that over 92% of patients, 87% of nurses, and 72% of physicians expressed satisfaction with TEV-'749’s initiation regimen, dosing schedule, and overall treatment experience.

BIIB080 marks the first antisense oligonucleotide targeting tau to enter clinical development for the treatment of Alzheimer disease.

In the SOUL trial, Rybelsus produced a 14% risk reduction of major adverse cardiovascular events in patients with type 2 diabetes and cardiovascular disease and/or chronic kidney disease.

The trial size adjustment, along with protocol modifications and the addition of higher-enrollment sites, is expected to facilitate completion of the NEPHRO CRRT study of Niyad in patients undergoing renal replacement therapy by the end of 2025.

Qfitlia is the first FDA-approved antithrombin-lowering therapy indicated for routine prophylaxis to prevent or reduce bleeding episodes in patients over 12 years of age with hemophilia A or B.

Approval of Imfinzi marks the first and only perioperative immunotherapy indicated for muscle-invasive bladder cancer.

Results from the COCOON study showed that Rybrevant plus Lacluze reduced grade 2 or higher dermatologic events by 50% compared to standard care in patients with epidermal growth factor receptor-mutated non-small cell lung cancer.

Under terms of the deal, Novo Nordisk will obtain global rights to develop, manufacture, and commercialize LX9851 for obesity and metabolic disorders.

As part of the Fast Track designation, Sanofi is set to launch a Phase I/II trial to evaluate the immunogenicity and safety of its novel mRNA vaccine in preventing chlamydia.

Approval of Vykat XR marks the first treatment indicated for hyperphagia in patients with Prader-Willi syndrome.

Results from multiple clinical trials showed that Tagrisso demonstrated survival benefits in EGFR-mutated non-small cell lung cancer, both as monotherapy and in combination therapies.

Blujepa marks the first new oral antibiotic to gain FDA approval for uncomplicated urinary tract infections in nearly 30 years.

Under terms of the deal, Merck will gain global rights to develop, manufacture, and commercialize HRS-5346 for cardiovascular disease, excluding Greater China.

Under terms of the license agreement, Novo Nordisk will acquire the rights to develop and commercialize UBT251 outside of China for obesity and type 2 diabetes for an upfront payment of $200 million.