Today’s biopharma news highlights GSK’s myeloma strategy, Insilico’s AI longevity research, and innovations that may improve future treatment outcomes.
News|Podcasts|September 22, 2026
The BioPharm Brief: Weight Loss, Biosimilars, and In Vivo Therapy
Author(s)Feliza Mirasol
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.
Advertisement
Welcome to The BioPharm Brief, your daily snapshot of developments shaping the biopharmaceutical industry. Here’s what we have today.
First, Novo Nordisk’s CagriSema delivered positive phase 3 results. In the REIMAGINE 5 trial, CagriSema produced 12.4% weight loss compared with 9.1% for tirzepatide in adults with type 2 diabetes, while also meeting the trial’s non-inferiority endpoint for HbA1c reduction. In a separate trial, CagriSema produced 21% weight loss in adults with overweight or obesity. The company has already filed an NDA with FDA, with a decision expected in the fourth quarter.
Next, a notable development for biosimilars in Europe. Biocon’s pertuzumab biosimilar, Pebrilzo, received a positive CHMP opinion under EMA’s newly adopted tailored clinical development approach. The recommendation makes Pebrilzo the first monoclonal antibody biosimilar to receive a positive CHMP opinion under the pathway, which can allow developers to establish biosimilarity without a dedicated comparative efficacy study when analytical, pharmacologic, and pharmacokinetic evidence is sufficient.
And in cell therapy, Vironexis is reporting early results from an unusual approach. Its investigational VNX-101 is designed to turn the patient’s own liver into a “biofactory” that produces a CD19/CD3 T-cell engager after a single infusion. All three antibody-naive patients with relapsed or refractory ALL in the reported group achieved MRD-negative complete responses, with the first patient maintaining that response through day 260. The data are early, but the company says the results provide clinical evidence for a one-time, systemically delivered in vivo therapy.
Thanks for listening to The BioPharm Brief. For analysis and expert insights, please visit
Key takeaways
- CagriSema posts positive Phase 3 results, with 12.4% weight loss versus 9.1% for tirzepatide in adults with type 2 diabetes.
- Biocon’s pertuzumab biosimilar advances in Europe under the EMA’s new tailored clinical development pathway.
- Vironexis reports complete responses with a one-time in vivo therapy in patients with relapsed or refractory acute lymphoblastic leukemia.
Advertisement
Related to this article
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.
Eron Kelly, CEO of ConcertAI, and Dr. Shaalan Beg, CMO, oncology, ConcertAI, discuss how AI can help physicians access the right information at the right time while supporting clinical trials, research, and quality initiatives.
Biocon's Pebrilzo, a pertuzumab biosimilar for HER2-positive breast cancer, has become the first monoclonal antibody biosimilar to receive a positive CHMP opinion under EMA's newly adopted tailored clinical approach, which can reduce comparative efficacy trial requirements.
Vironexis Biotherapeutics reported that the first three antibody-naive patients with relapsed/refractory acute lymphoblastic leukemia treated with its one-time in vivo immunotherapy VNX-101 all achieved MRD-negative complete responses, with durability tracked through at least nine months.
Athenecia Faggins of Minaris Advanced Therapies discusses raw material qualification, supplier management, testing, and risk control for advanced therapy manufacturing.
Advertisement
Advertisement