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Silence Therapeutics Locks In $175 Million to Fuel siRNA Pipeline After Upsized ADS Offering

NMPA Approves Ivonescimab Plus Chemotherapy for First-Line Squamous NSCLC Based on HARMONi-6 Data

NurExone Partners with Made Scientific to Scale US GMP Exosome Manufacturing

The BioPharm Brief: Capital, Antibodies, and Algorithms

Boulevard Bio Launches with $65 Million to Advance Multi-Specific Antibody Pipeline for B Cell-Driven Autoimmune Disease

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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.

Early Parkinson patients could gain a first disease-modifying option as ACI-7104 clears a major FDA hurdle after strong interim results.

Today’s BioPharm Brief looks at Akeso’s bispecific ADC and ivonescimab combination in breast cancer, Novo Nordisk’s AI partnership with AWS, and Ascletis’ once-monthly obesity candidates.

Ascletis Begins Phase I Studies of Amylin Agonist ASC36 and Its GLP-1/GIP Co-Formulation for Obesity
Ascletis has initiated two Phase I studies for its obesity pipeline: ASC36, a once-monthly amylin receptor peptide agonist, and ASC36_35FDC, a once-monthly fixed-dose co-formulation of ASC36 with its GLP-1R/GIPR dual agonist ASC35, following recent FDA IND clearances for both candidates.

Bristol Myers Squibb has selected Houston's Generation Park for a new $2.3 billion multi-modal manufacturing campus capable of producing small molecules, biologics, and antibody-drug conjugates, adding to a growing wave of large-scale US pharmaceutical manufacturing investment.

Akeso is pairing a next-gen bispecific ADC with its PD-1/VEGF antibody, ivonescimab, in a first-line push against hard-to-treat breast cancer.

AWS's AI and cloud tools aim to compress Novo Nordisk's path from drug target to first human dose for chronic disease patients.















