Aquatic Vaccines: Current Status and Future Development Prospects in Global Aquaculture
Global aquaculture faces significant disease challenges with estimated annual losses of $10 billion, driving urgent need for effective vaccine development as an ecological alternative to antibiotics.
Altimmune Expands Pemvidutide Testing to Alcohol Use Disorder and Liver Disease
Altimmune announced plans to initiate Phase II trials of its GLP-1/glucagon agonist pemvidutide for alcohol use disorder in Q2 2025 and alcohol-related liver disease in Q3, expanding beyond obesity treatment.
Sanofi Acquires Dren Bio's Novel B-Cell Depleter for $600 Million, Expanding Immunology Pipeline
Sanofi has agreed to acquire Dren Bio's DR-0201, a first-in-class bispecific myeloid cell engager that induces deep B-cell depletion, for an upfront payment of $600 million.
atai Life Sciences Advances Psychedelic Therapy Pipeline with Key Clinical Milestones and Extended Financial Runway
atai Life Sciences has dosed the first patient in its Phase 2 Elumina trial of VLS-01 (buccal film DMT) for treatment-resistant depression, with topline data expected in Q1 2026.
Hong Kong Streamlines Drug Registration Process with New Consultation Services
Hong Kong's Department of Health is launching consultation services to help pharmaceutical companies navigate the "1+" drug registration mechanism, starting with an online seminar on March 31, 2025.
Senate Confirms Dr. Marty Makary as FDA Commissioner, Signaling Potential Agency Reforms
The U.S. Senate has confirmed Dr. Marty Makary, Johns Hopkins School of Medicine professor and former Fox News medical contributor, as the new FDA Commissioner with a 56-44 vote.
FDA Removes REMS Requirement for TRYVIO, Simplifying Access to Novel Hypertension Treatment
The US FDA has eliminated the Risk Evaluation and Mitigation Strategy (REMS) requirement for TRYVIO (aprocitentan), determining that standard labeling is sufficient to communicate safety information.
Vaximm's VXM01-Avelumab Combination Shows Promise in Phase 2a Glioblastoma Trial
Vaximm AG's Phase 2a trial demonstrates that VXM01, an oral anti-VEGFR-2 vaccine, combined with avelumab shows a favorable safety profile in recurrent glioblastoma patients, with no serious adverse events attributed to VXM01.
Aprea Therapeutics Advances APR-1051 Clinical Trial with First HPV+ Head and Neck Cancer Patient Dosed
Aprea Therapeutics has dosed the first HPV+ head and neck squamous cell carcinoma (HNSCC) patient in Cohort 5 of the ACESOT-1051 trial, evaluating their WEE1 kinase inhibitor APR-1051.
Vtama Cream Shows Positive Long-Term Results in Atopic Dermatitis Trial
Dermavant's Vtama (tapinarof) cream demonstrated efficacy and safety in treating atopic dermatitis (AD) in patients as young as two years old.
Ultimovacs ASA Provides Update on Clinical Trials and Financial Strategy
Ultimovacs ASA reported active enrollment in the DVO trial for BRCA-negative ovarian cancer, with results expected in the first half of 2025.
Africa CDC and PANTHER Launch Mpox Study in Africa to Evaluate Brincidofovir
The Africa CDC and PANTHER have launched the Mpox Study in Africa (MOSA) to address the urgent need for effective Mpox treatments.
Atrasentan Significantly Reduces Proteinuria in IgA Nephropathy Patients: Phase III ALIGN Trial
Interim analysis of the Phase III ALIGN trial shows atrasentan significantly reduced proteinuria in high-risk IgA nephropathy patients after 36 weeks.
FDA Filing Accepted for Sunvozertinib in EGFR Exon 20 Insertion-Positive NSCLC
Dizal's sunvozertinib NDA has been submitted to the FDA for treating NSCLC with EGFR exon 20 insertion mutations after platinum-based chemotherapy.
Regeneron's Fianlimab and Libtayo Combo Shows Sustained Melanoma Response
Regeneron's combination therapy of fianlimab and Libtayo demonstrates continued benefit in advanced melanoma patients after two years, according to Phase I trial data.
FDA Grants Fast Track Designation to Shionogi's Novel Anti-RSV Drug Candidate S-337395
The FDA has granted Fast Track designation to Shionogi's S-337395, a novel oral anti-RSV drug candidate, to expedite its development and review process.
PTC Therapeutics' Sephience Receives Positive CHMP Opinion for Phenylketonuria Treatment Across All Age Groups
The European Medicines Agency's CHMP has issued a positive opinion for Sephience (sepiapterin) to treat phenylketonuria in patients of all ages and disease severities, addressing a significant unmet medical need.
hVIVO Completes Pilot Study for Human Metapneumovirus (hMPV) Challenge Model
hVIVO has successfully completed a pilot characterization study for its human metapneumovirus (hMPV) strain A2 challenge agent, demonstrating proof-of-concept.
Jazz Pharmaceuticals Highlights Oncology Pipeline Expansion at JP Morgan 2025
Jazz Pharmaceuticals is focusing on expanding its oncology pipeline, with key developments expected for zanidatamab and Zepzelca.
Ketamir-2 Demonstrates Superior Efficacy in Chemotherapy-Induced Neuropathic Pain Model
MIRA Pharmaceuticals' Ketamir-2 shows 60% greater efficacy than gabapentin in reducing chemotherapy-induced neuropathic pain in preclinical studies.