News

The facility aims to scale global biologics supply, supporting patient access to advanced therapies as manufacturing capacity becomes a bottleneck in drug delivery.

Mediar Therapeutics has signed a collaboration and option agreement with Ono Pharmaceutical to co-develop novel antibody therapeutics targeting myofibroblast biology in fibro-inflammatory diseases, building on Mediar's existing three-program antifibrotic antibody pipeline.

Backed by an 84.3% drop in RSV hospitalizations, Enflonsia could extend protection to high-risk infants still vulnerable in their second season.

Sanofi has suspended a phase 2 trial of SAR445399, an anti-IL-1R3 monoclonal antibody, in non-cystic fibrosis bronchiectasis, part of new ceo Belén Garijo's ongoing portfolio review rather than a safety concern.

The FDA's approval of mFLUSIVA (mRNA-1010) extends Moderna's lipid nanoparticle platform to a new indication, with broad implications for biopharmaceutical manufacturing flexibility and regulatory precedent.

Today’s BioPharm Brief highlights new advances in engineered tissues, regenerative medicine, and biologics delivery, including clinical progress for a tissue-engineered therapy, late-stage wound healing data, and a major subcutaneous delivery licensing deal.

Nonhealing wounds precede 80% of diabetes-related amputations, and BIOxHEAL is now cleared to test whether it can change that in a controlled trial.

Alteogen has licensed its ALT-B4 subcutaneous platform to an undisclosed global pharmaceutical company in a deal worth up to $365 million.

The FDA has cleared Satellite Bio's IND application for SB-101, an off-the-shelf hepatocyte cell therapy for urea cycle disorders, marking the company's transition to clinical-stage status ahead of a planned Phase 1/2 trial in infants later this year.

This episode of The BioPharm Brief explores three stories shaping biopharma today: an AI-driven licensing deal for a next-generation bispecific ADC, an FDA regulatory milestone for BOTOX Cosmetic, and the first patients dosed with a trispecific T-cell engager for autoimmune disease.

ConcertAI executives discussed how the company's integration of CancerLinQ has expanded the platform beyond quality reporting, using artificial intelligence to deliver faster clinical insights, improve trial matching, and support oncology practices with real-time data.

Sana Biotechnology's CEO, Dr Steve Harr, weighs in on how CRISPR-edited donor islet cells have survived 14 months without immunosuppression in a type 1 diabetes patient.

Dash Bio has raised $30 million in Series A financing led by Oak HC/FT to scale its automated, GLP-compliant bioanalysis platform, bringing total funding to $47.5 million as the company works to compress preclinical and clinical sample-testing timelines.

Under the deal, Pathos gains ex-China rights and will fund development of the bispecific ADC, already in phase 3 testing for triple-negative breast cancer.

The FDA has accepted Allergan Aesthetics' supplemental Biologics License Application for BOTOX Cosmetic to treat masseter muscle prominence, a submission that could make it the first neurotoxin approved for this indication in the US.

Oblenio Bio has dosed the first patients in a phase 1a trial of tri-specific T-cell engager LBL-051 for refractory autoimmune disease.

New clinical updates this week highlight progress across rare disease gene therapy, food allergy immunotherapy, and immuno-oncology, with developers advancing treatments for high unmet need through regulatory milestones and early clinical development.

In an interview with BioPharm International, Stephanie Fradette, head of Biogen’s Rare Neurology Development Unit, discussed FDA Breakthrough Therapy designation for salanersen and early Phase 1b data evaluating the therapy in individuals with spinal muscular atrophy who had suboptimal responses following gene therapy.

Laurent Levy, founder and CEO of Nanobiotix, discusses why physics-based therapeutics could complement traditional biology-driven drug development and explains how the company's NanoPrimer platform is designed to improve delivery of complex medicines.

Rocket Pharmaceuticals has reported a positive safety update for RP-A501 from the first 3 patients treated under a modified phase 2 protocol in Danon disease.

FDA has granted fast track designation to Aravax's PVX108, a peptide immunotherapy for peanut allergy, ahead of phase 2 data.

Opus Genetics has enrolled the last patient in its registrational Phase 3 trial of OPGx-LCA5, an AAV8 gene therapy for LCA5-associated inherited retinal disease, keeping the program on track for a potential first-in-disease approval.

China's NMPA has approved an IND for a Phase Ib/II trial combining Leads Biolabs' PD-L1/4-1BB bispecific antibody opamtistomig with standard regimens in metastatic colorectal cancer, extending the drug's reach into one of oncology's most immunotherapy-resistant tumor types.

Precision analytics and flexible manufacturing are helping to advance safer, scalable bispecific antibodies, antibody-drug conjugates, and central nervous system monoclonal antibodies from development to patients.

Three major regulatory milestones highlight this week's biopharmaceutical news, from a biosimilar advancing through FDA and EMA review to a new first-line breast cancer approval in Europe and fresh Phase 3 cardiovascular data that could reshape inflammatory disease drug development.

Planning the analytical strategy for product release should be started as early as possible to ensure product quality and regulatory success.

Novo Nordisk's ziltivekimab failed to reduce cardiovascular events in the phase 3 ZEUS trial despite confirmed IL-6 target engagement.

The EC has approved AstraZeneca and Daiichi Sankyo’s datopotamab deruxtecan ADC for 1st-line metastatic TNBC, which showed a 5.0-month overall survival benefit over chemotherapy.