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.
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.
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.
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.
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.
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 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.
This week’s BioPharm Brief looks at FDA Fast Track designation for BioInvent’s BI-1808, Neurocrine’s Phase 1 obesity study of a GLP-1/GIP/glucagon triple agonist, and Replimune’s accelerated approval for Tudriqev plus nivolumab in advanced melanoma.
Moderna's mFLUSIVA approval offers a regulatory case study for mRNA vaccine sponsors, covering comparator selection lessons from the FDA's reversed refusal-to-file, competitive implications for Pfizer and Sanofi's mRNA flu programs, and what the accelerated approval pathway means for long-term regulatory risk.
Neurocrine Biosciences has dosed the first participants in a Phase 1 study of NBIP-'1968, an investigational GLP-1/GIP/glucagon receptor triple agonist for obesity, marking the company's entry into the increasingly competitive multi-agonist incretin therapeutics space.
The European Commission has approved an expanded indication for Bavarian Nordic's IMVANEX (MVA-BN) mpox and smallpox vaccine, extending eligibility down to children 2 to less than 12 years old, based on phase 2 data showing an immune response and safety profile comparable to adults.
Moderna expands the reach of mRNA technology with the first FDA-approved mRNA influenza vaccine, Merck seeks to extend RSV protection for vulnerable children, and AstraZeneca and CSPC deepen their manufacturing footprint in China.
Biotech companies entering new markets must consider talent availability, reimbursement strategy, and regional expertise early in development, according to Kirsten Detrick, chief representative, USA, at the Basel Area Life Sciences Supercluster.
Laurent Levy, founder and CEO of Nanobiotix, explains how a physics-based approach to drug delivery could complement existing therapeutic platforms by improving particle behavior in the body while avoiding added complexity.
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.
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.
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.
Kyverna Therapeutics and ElevateBio have entered a commercial manufacturing and supply agreement for miv-cel, Kyverna's autologous CD19-targeting CAR T-cell therapy, securing scalable production ahead of a planned launch in stiff person syndrome.
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.
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.
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.
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.
