Feliza Mirasol

Generare CEO Guillaume Vandenesch explains that genomics and synthetic biology are positioning natural molecule discovery as a leading small molecule modality for the 21st century.

Johnson & Johnson reported that phase 3 MonumenTAL-6 data show Tecvayli plus Talvey cut the risk of progression or death by 89% in relapsed/refractory multiple myeloma.

Sanofi announced it has discontinued amlitelimab in atopic dermatitis, forgoing global regulatory submissions despite positive long-term phase 3 data.

Repligen will acquire BioLife Solutions for $1.5 billion, adding CryoStor biopreservation media to its cell therapy portfolio.

HCW Biologics has requested an FDA meeting for HCW11-018b, its tetravalent T-cell engager for solid tumors, targeting trials in the first half o 2027.

Ipsen has completed its acquisition of Memo Therapeutics, which adds potravitug, an anti-BKPyV antibody, to its rare disease pipeline.

Phase 3 SHASTA-3/4 trials show plozasiran cut triglycerides up to 81% and reduced pancreatitis events up to 100% in high-risk sHTG patients.

Propanc Biopharma has reported peer-reviewed data on scalable recombinant production of trypsinogen and chymotrypsinogen, supporting a synthetic backup to its lead cancer candidate, PRP.

Under the deal, Lonza will grant Engitix a single-target ADC license for SYNtecan E, GlycoConnect, and HydraSpace to advance ECM-targeted fibrosis and cancer therapies.

MilliporeSigma's Sebastián Arana outlines why flexible, platform-based manufacturing and workforce training are now table stakes for competitive biomanufacturers.

Scholar Rock’s apitegromab is awaiting a US manufacturing facility resolution, which may impact the therapy’s European review, for which clinical assessment has been completed.

Halozyme and Incyte will advance subcutaneous INCA033989 for mutCALR-positive MPNs, with the aim of improving treatment delivery while supporting targeted clinical development.

The EC has approved AbbVie's Boey (trenibotulinumtoxinE), the first serotype E neurotoxin for glabellar lines, with faster onset than current options.

At BIO 2026, Thermo Fisher Scientific's Paul Jorjorian highlighted late-stage raw material switches as being among the most disruptive and underestimated risks in biopharma development.

Boehringer Ingelheim has started a phase 2 trial of BI 3034701, an investigational triple GLP-1/GIP/NPY2 receptor agonist for obesity and overweight.

Oncolytics Biotech CEO Jared Kelly warns that investor demand for near-term tumor response data is blocking funding for trials with proven overall survival benefits.

FDA has granted priority review to obinutuzumab (Gazyva) for primary membranous nephropathy after phase 3 MAJESTY trial results showed superior remission versus tacrolimus.

Innovent Biologics and Spero Therapeutics have signed a $1.1 billion licensing deal for IBI355, a phase 2-ready Fc-silent anti-CD40L antibody planned for testing in IgG4-related disease and Sjögren's disease.

Speaking at BIO 2026, Novartis Contract Manufacturing's Carrie Bracco explains how capacity pressures and biotech flexibility needs are reshaping CMO partnerships.

GSK reports that dostarlimab (Jemperli) monotherapy achieved sustained clinical complete responses in the phase 2 AZUR-1 trial for dMMR/MSI-H locally advanced rectal cancer, with data to be submitted for regulatory review.

BIO 2026 highlighted biotech's resurgence through M&A dealmaking, CDMO diversification, and renewed investor confidence in biopharma development.

Speaking at BIO 2026, Kasper Øland, Samsung Biologics' vice president of sales execution, emphasizes how complex molecules now exceed 55% of the company’s pipeline as biotechs demand faster, more flexible CDMO partnerships.

FDA reported that the PRECISION-T trial showed 78% chronic GVHD-free survival at 1 year versus 38.4% with standard transplant and granted the approval to Orca Biosystems, making the therapy the first Treg cell–based therapy in blood cancers.

The European Investment Bank-backed investment establishes a new single-use GMP facility with which Icosagen can support complex protein therapeutics from early discovery through phase 1/2 clinical manufacturing.

From his presentation at BIO 2026, Infinimune CEO Dr Wyatt McDonnell makes the case for how human-derived antibodies and human-trained AI models eliminate species translation failure and compress time to IND.

Dr Wyatt McDonnell, Infinimune CEO, details how FDA's non-animal model guidances are reshaping non-clinical safety strategies for mAb developers in his talk at BIO 2026.

Lumvoa gains FDA approval for thyroid eye disease, adding an IGF-1R antagonist supported by phase 3 active and chronic TED trials.

At BIO 2026, Baker McKenzie's Oren Livne explains how MFN pricing, tariffs, and geopolitical risk are driving demand for flexible deal structures in biopharma licensing.

Industry experts from Sanofi, GxP Frame, and Open Biopharma outline how AI is transforming drug discovery, manufacturing, and workforce strategy through biopharma partnerships in the latest episode of Drug Digest.

Crystalys Therapeutics CEO Dr James Mackay explains at BIO 2026 that gout remains an underserved therapeutic are and represents a compelling drug development target due to its unmet need and simple biology.