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Evidence-based coverage of pharmaceutical development, regulatory affairs, and biotech innovation
Biocon's pertuzumab biosimilar Pebrilzo has received a positive CHMP opinion — the first monoclonal antibody biosimilar under the EMA's tailored clinical development approach for HER2-positive breast cancer.
By Dr. Eleanor Vance, Regulatory Affairs Editor
The FDA has fully approved imlunestrant plus abemaciclib for ESR1-mutated ER-positive breast cancer, with EMBER-3 showing 11.1 vs 5.5 months PFS. Read on.
By Tom Okafor, Clinical Trials Correspondent
A 242-patient trial with a urinary biomarker endpoint has carried finerenone into a new US indication. The number that matters is not the 25% in the headlines, and no UK or EU decision for type 1 diabetes has been reported.
By Tom Okafor, Clinical Trials Correspondent
MHRA asked OS Therapies to bring OST-HER2 into Project Orbis and accepted literature-derived historical controls in resected metastatic osteosarcoma. The procedural precedent matters more than the candidate, and every load-bearing fact is the sponsor's.
By Dr. Eleanor Vance, Regulatory Affairs Editor
Rising costs and stagnating productivity define the drug development problem that Eroom’s Law describes. The inflation-adjusted cost of bringing a new medicine to market has roughly doubled every 9 years since the 1980s, despite advances in screening and molecular biology. The…
By Megan Liu, Digital Health Reporter
The primary endpoint data from the EVOKE and EVOKE Plus trials, presented at the Clinical Trials on Alzheimer's Disease (CTAD) conference in late 2024 and subsequently reported in Nature Medicine (2025), show that semaglutide (Novo Nordisk; Ozempic at 1mg subcutaneous weekly)…
By Tom Okafor, Clinical Trials Correspondent
More than 100 animal studies suggest BPC-157 helps tendons heal, yet as of 2026 not a single controlled human trial has tested whether it works in people. A US advisory panel has voted to loosen access all the same.
By Tom Okafor, Clinical Trials Correspondent
PCSK9 inhibitors reduce LDL-C by up to 60% on top of statins. Discover the mechanism, FOURIER and ODYSSEY OUTCOMES trial findings, and UK NICE access criteria.
By Tom Okafor, Clinical Trials Correspondent
A bespoke mRNA vaccine built from a patient’s own tumour, given with Keytruda, kept high-risk melanoma from returning in a phase 3 trial. The proof of principle now shifts the hard problem to manufacturing and regulation.
By Tom Okafor, Clinical Trials Correspondent
NICE NG28 now recommends SGLT2 inhibitors as first-line therapy alongside metformin for most adults with type 2 diabetes, prioritising cardiorenal protection from diagnosis.
By Dr. Eleanor Vance, Regulatory Affairs Editor
Modular RNA nanoparticles from the University of Nottingham show breast tumour gene knockdown and influenza protection in mice — could this platform transform oncology delivery?
By Dr. Eleanor Vance, Regulatory Affairs Editor
Long COVID symptoms can drag on for years. Learn what's driving them and how treatments like H.E.L.P. apheresis are being used to address the underlying causes.
By Tom Okafor, Clinical Trials Correspondent
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