Editorial Podcasts

This episode of the BioPharm Brief highlights Roche’s Tam-Peli phase 3 survival data in relapsed small-cell lung cancer, Cellectis’ shift to in vivo gene editing for lipid disorders, and Phio Pharmaceuticals’ FDA briefing package for PH-762 in cutaneous squamous cell carcinoma.

The BioPharm Brief covers Resolution Therapeutics’ completed enrollment of RTX001 in the EMERALD trial, Samsung Biologics’ $262 million manufacturing deal, and CordenPharma’s $80 million investment to expand sterile injectable capacity.

The BioPharm Brief highlights Biora Therapeutics’ first human trial of its BioJet oral delivery system, FDA priority review of Roche’s satralizumab for MOGAD, and Encoded Therapeutics’ $275 million financing for its Dravet syndrome gene therapy ETX101.

Today’s BioPharm Brief looks at a phase 3 survival win for Imdelltra plus Imfinzi in first-line small cell lung cancer, FDA review of Rezolute’s ersodetug, and Novartis’s del-desiran setback in myotonic dystrophy type 1.

BrainChild Bio, Moonwalk Biosciences, and Aptar Pharma are advancing new approaches to CAR-T therapy, RNAi for obesity, and inhaled antisense oligonucleotide delivery.

Today’s BioPharm Brief leads with a late-stage clinical setback for Ultragenyx, a major gene therapy filing from uniQure, and a billion-dollar oncology licensing deal between HUTCHMED and GSK.

Melanie Whittington, managing director and head of the Leerink Center for Pharmacoeconomics, joins Ron Lanton to argue that biopharmaceutical policy only makes sense when traced back to its purpose.

Today’s BioPharm Brief covers a new first-line HER2 breast cancer approval in Europe, a $1.5 billion Roche deal, and new survival data for Ziihera in gastroesophageal cancer.

Today’s BioPharm Brief looks at a new treatment for essential thrombocythemia, a halted cancer vaccine trial, and updated COVID-19 vaccine approvals ahead of the 2026-2027 season.

Today’s BioPharm Brief covers positive Phase 3 data for Akeso’s ivonescimab in biliary tract cancer, FDA Fast Track designation for CytomX’s Varseta-M in colorectal cancer, and positive Phase 3 results for Tezspire in eosinophilic esophagitis.

Today’s BioPharm Brief covers FDA approval of daraxonrasib for metastatic pancreatic cancer, the first patient dosed in HaemaLogiX’s KMCAR CAR-T trial, and a new collaboration to advance cell-free synthetic DNA for viral vector manufacturing.

Welcome to The BioPharm Brief, your daily snapshot of developments shaping the biopharmaceutical industry. It’s a busy day for FDA action, with two approvals and a new designation spanning cancer, autoimmune disease, and rare disease. Here’s what we have today.

Today’s BioPharm Brief covers FDA priority review for GSK’s Jemperli in locally advanced rectal cancer, Genentech’s $2.3 billion deal for Hanmi’s investigational obesity drug, and an extended FDA review of Capricor’s deramiocel for Duchenne muscular dystrophy.

Today’s BioPharm Brief covers promising early-stage lung cancer data from AbbVie, an NMPA-accepted NDA for Leads Biolabs’ opamtistomig in rare neuroendocrine cancer, and a first-in-human trial of a brain-penetrant bispecific T-cell engager for glioblastoma.

This edition of The BioPharm Brief covers FDA approvals for Pasatru in fibrodysplasia ossificans progressiva and Genglycos in glycogen storage disease type Ia, along with a new bispecific CAR-T entering clinical development for large B-cell lymphoma.

This week’s BioPharm Brief covers positive phase 3 melanoma results for Merck and Moderna’s individualized neoantigen therapy, a personalized cancer vaccine manufacturing platform entering clinical use, and a new brain-penetrant antibody approach for glioblastoma.

Today’s BioPharm Brief looks at a long-acting anti-VEGF therapy entering clinical trials, the first commercial use of imlifidase in Australia for kidney transplantation, and FDA Fast Track designation for a platelet-derived biologic for chronic sciatica.

Today’s BioPharm Brief looks at an oncology trial discontinuation, an AI-designed glioblastoma vaccine, and an expanded biosimilars collaboration.

Today’s BioPharm Brief covers NMPA approval of ivonescimab plus chemotherapy for first-line squamous NSCLC, a $175 million financing for Silence Therapeutics, and Infinimmune’s $75 million Series A for its human-derived antibody pipeline.

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.

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.

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.

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 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.

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.

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.

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.

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.