Podcasts

The FDA grants accelerated approval to Ultomiris for IgA nephropathy, Alcon acquires Neurotech and its MacTel cell therapy for $550 million, and BioNTech and Bristol Myers Squibb add Trodelvy to a phase 3 trial in triple-negative breast cancer.

Sanofi breaks ground on an EU-backed insulin API plant in Frankfurt, Summit and ECOG-ACRIN launch a phase 2/3 trial of ivonescimab in first-line biliary tract cancer, and TaiMed’s anti-CD4 antibody TMB-365 lowers HIV viral load in phase 1.

Nano24’s inhaled exosome therapy reduces mortality in a phase 2b ARDS trial, the FDA grants fast track designation to Nuravax’s preventive Alzheimer vaccine, and Bionyra’s long-acting anti-TL1A antibody shows a half-life that could support dosing every 3 to 6 months.

The FDA grants accelerated approval to dostarlimab for rectal cancer, Lilly reports one-year remission data for pediatric ulcerative colitis, and Johnson & Johnson shares longer-term fistula remission results for Tremfya.

Opus Genetics reports sustained vision gains with gene therapy, the FDA approves Roche’s Enspryng for at-home treatment of thyroid eye disease, and Estuary Biotherapeutics launches with $103 million to develop gene therapies for polycystic kidney disease.

FDA expands Anktiva’s bladder cancer indication, Alvotech and Advanz submit a proposed Eylea 8 mg biosimilar in Europe, and Lilly reports new remission data for Omvoh in inflammatory bowel disease.

The FDA launches a new rare disease development initiative, BioNTech’s BNT113 misses a progression-free survival endpoint, and Viking Therapeutics begins Phase III trials of its oral obesity candidate.

FDA reviews a proposed Keytruda biosimilar, Roche expands its obesity pipeline with an RNAi deal, and guselkumab shows promise for fistula remission in Crohn disease.

Clinical results reveal new opportunities and setbacks in rare disease and cancer care, shaping treatment strategies and future regulatory decisions.

New clinical data highlight improved disease control, reduced eye bulging, and weight-loss benefits, potentially broadening options for patients with unmet needs.

New clinical milestones, manufacturing investments, and regulatory incentives could help developers overcome barriers to delivering treatments for patients with rare diseases.

New regulatory decisions, manufacturing partnerships, and financing pressures are reshaping access, supply, and development pathways for emerging advanced therapies.

New data and partnerships are advancing brain-penetrant enzyme therapy, targeted antibodies, flexible obesity dosing, and frontline lymphoma treatment strategies.

Survodutide advances metabolic disease treatment, while biosimilar capacity expands, FDA delays hemophilia review, and lupus data support next steps.

CaseBioscience joins an ARPA-H effort to develop room-temperature cell therapy preservation, Novartis licenses an mRNA-encoded T-cell engager from Abogen, and AstraZeneca, Daiichi Sankyo, and Summit plan to combine Datroway with ivonescimab.

Real-world data show weight loss after switching to the Wegovy pill, Lilly reports positive hand and foot atopic dermatitis data, and Teva wins FDA approval for a Xgeva biosimilar.

Novo Nordisk licenses a once-weekly oral GLP-1/GIP candidate, uniQure reports 48-month Huntington’s disease data, and AstraZeneca invests $2 billion in Summit Therapeutics.

Today’s biopharma news highlights how new data could reduce treatment burden, improve excipient information sharing, and shape future options for patients with difficult-to-treat cancers.

FDA expands Winrevair’s label with HYPERION data, formalizes the use of non-animal testing methods, and Amgen reports positive Phase 3 results for dazodalibep in Sjögren disease.

Novo Nordisk reports positive phase 3 CagriSema data, Biocon’s pertuzumab biosimilar gets a positive CHMP opinion under EMA’s new tailored pathway, and Vironexis reports complete responses with its one-time in vivo therapy for relapsed ALL.

Today’s biopharma news highlights GSK’s myeloma strategy, Insilico’s AI longevity research, and innovations that may improve future treatment outcomes.

In this exclusive podcast, Bo Watkins (SVP, Sales & Business Management) and Pat Adams (VP, Expansion Operations) of Simtra BioPharma Solutions discuss the company's major manufacturing expansion in Bloomington, Indiana. The conversation covers the new Building H facility and the Park Campus development, and how these investments are designed to expand US sterile injectable and high-potency manufacturing capacity. They also detail the practical benefits for customers, the digital capabilities supporting the buildout, and what the expansion means for Simtra's Bloomington workforce and community.

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.