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EMA Validates Marketing Authorization Application for Pfizer/Valneva's Lyme Disease Vaccine Candidate

FDA Grants Fast Track Designation to Phanes' Spevatamig for Biliary Tract Cancer

Fate Therapeutics Initiates Potentially Registrational Trial of Off-the-Shelf CAR T-Cell Therapy FT819 for Lupus Nephritis

The BioPharm Brief: Approval, Investment, and Antibodies

Infinimmune Raises $75 Million Series A to Advance Human-Derived Antibody Pipeline for Atopic Dermatitis

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Why Cancer Vaccines' Greatest Advantage May Be Durability of Response, Not Immediate Tumor Shrinkage
Cellex Life CEO Dr Eric von Hofe and Professor of Immunology at Mayo Clinic, Dr Keith L. Knutson, explain why individualized tumor profiling, not off-the-shelf targeting, is key to effective personalized cancer vaccines.

Fresh $175 million in funding follows Silence's 88% response rate in its divesiran polycythemia vera trials, positioning the company for a planned 2027 phase 3 push.

China's NMPA has approved ivonescimab plus chemotherapy for first-line advanced squamous non-small cell lung cancer, based on Phase III HARMONi-6 data showing the PD-1/VEGF bispecific antibody combination reduced the risk of death by 34% compared with a PD-1 inhibitor plus chemotherapy.

Under the 5-year manufacturing deal, NurExone will access Made Scientific's Princeton, NJ, GMP facility to speed regenerative exosome therapies toward clinical trials.

Today’s BioPharm Brief looks at new financing for multispecific antibody development, AbCellera’s $200 million public offering, and an expanded AI collaboration between Nucleai and Gilead focused on ADC development.

Boulevard Bio has emerged from stealth with $65 million in financing from Deerfield Management and early Phase 1 data for BLVD101, a bispecific BAFF/APRIL antibody for IgA nephropathy supporting once-quarterly dosing, alongside two additional multi-specific antibody candidates for B cell-driven autoimmune disease.

Not all regulatory milestones are equal, and the differences can determine how fast a therapy reaches patients. Read this guide to 4 key FDA and EU pathways.

AbCellera aims to tap public markets to push ABCL635 forward after the therapy cut menopause hot flash severity 58% versus 12% for placebo in trials.

Nucleai has announced an ongoing translational research collaboration with Gilead Sciences applying AI-powered tissue analytics to support Gilead's global antibody-drug conjugate clinical development programs, generating candidate spatial biomarkers across multiple oncology indications.

Zamubafusp alfa's FDA fast track status highlights the therapy's ability to remove toxic amyloid already damaging the heart and kidneys in AL amyloidosis patients.

SynaptixBio says rare disease biotech investment is increasing in the US following renewal of the FDA's Priority Review Voucher program, while UK-based rare disease companies continue to lack an equivalent incentive and remain dependent on public markets, private investment, or acquisition to secure capital.

Today’s BioPharm Brief covers rare disease investment, an FDA fast track designation for a Parkinson disease therapy, and phase 2 results for an siRNA treatment in polycythemia vera.

Dr Steve Harr, Sana Biotechnology's CEO, identifies scalability, commercialization, and reimbursement as the defining hurdles for curative islet cell therapy in type 1 diabetes.

Silence's siRNA drug freed 88% of trial patients from ongoing phlebotomies, a chronic burden for people with polycythemia vera.

Stand Up To Cancer has awarded its Nina Nicolai Pancreatic Cancer Innovation in Collaboration Award to a research team developing a combination approach that pairs an engineered mRNA vaccine with KRAS G12D-directed TCR-T cell therapy, aiming to sustain antigen production and improve T-cell responses against pancreatic cancer.















