News

The FDA has granted Fast Track designation to C-1101, Consano Bio's investigational platelet-derived multi-protein biologic for chronic, painful lumbosacral radiculopathy, following the drug's recent IND clearance and as the company advances a Phase 1 trial evaluating the epidural injection.

Genprex moves its diabetes gene therapy toward the clinic, tapping a CGMP CDMO after preclinical models reversed hyperglycemia in mice.

Today’s BioPharm Brief looks at an oncology trial discontinuation, an AI-designed glioblastoma vaccine, and an expanded biosimilars collaboration.

Outsourced cell and gene therapy manufacturing is set to grow nearly 6-fold by 2035 as biotech pipelines outpace in-house capacity.

The independent data monitoring committee's finding leaves clinicians without a new option for PD-L1-low NSCLC, a population historically underserved by current immunotherapies.

Evaxion has added EVX-05, an AI-designed, off-the-shelf therapeutic vaccine targeting glioblastoma, to its pipeline, discontinuing the EVX-03 program as part of a broader R&D refocus while maintaining its cash runway into the second half of 2027.

OncoC4 has dosed the first patient in a phase 1 trial of ONC-783, a T-cell engager targeting neoCD24, a cancer-specific glycoform of CD24, positioning the subcutaneously administered candidate as a potential treatment across multiple solid tumor types.

Shanghai Henlius Biotech has entered a strategic collaboration with Sandoz covering up to 10 proposed monoclonal antibody and antibody-drug conjugate biosimilar assets, deepening the companies' existing oncology biosimilars partnership with initial deals worth up to $322 million.

IASO Bio adds a fratricide-resistant CAR-T platform to its pipeline, aiming to speed novel T-cell malignancy therapies to patients.

Spevatamig's fast track status targets a cancer where 5-year survival is under 20%, pairing a novel mechanism with pembrolizumab.

Fate Therapeutics has initiated RECLAIM-LN, a Phase 2 potentially registrational trial of its off-the-shelf, iPSC-derived CD19-targeting CAR T-cell candidate FT819, in patients with refractory lupus nephritis, following favorable Phase 1 safety and efficacy data.

Today’s BioPharm Brief covers NMPA approval of ivonescimab plus chemotherapy for first-line squamous NSCLC, a $175 million financing for Silence Therapeutics, and Infinimmune’s $75 million Series A for its human-derived antibody pipeline.

Infinimmune has closed a $75 million Series A financing co-led by Regeneron Ventures and Playground Global to advance its lead atopic dermatitis programs, IFX-101 (targeting IL-22) and IFX-201 (targeting IL-13), both derived from its Anthrobody platform for discovering fully human antibodies.

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.