BioBusiness

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.

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.

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.

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.

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.

BI-1808 plus pembrolizumab posted a 24% response rate in platinum-resistant ovarian cancer, tripling pembrolizumab's historical rate alone.

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.

Melanoma patients who failed anti-PD-1 therapy gain a new option after Replimune's oncolytic virus clears FDA on its third try.

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.

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.

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.

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.

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

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.