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MHRA approves new biosimilar●AstraZeneca Q1 results exceed forecast●NICE updates TA guidance for oncology●Roche launches Phase III rare disease trial●FDA grants breakthrough therapy designation●UK Biobank releases genomic dataset●GSK acquires clinical-stage biotech firm●EMA recommends novel gene therapy●MHRA approves new biosimilar●AstraZeneca Q1 results exceed forecast●NICE updates TA guidance for oncology●Roche launches Phase III rare disease trial●FDA grants breakthrough therapy designation●UK Biobank releases genomic dataset●GSK acquires clinical-stage biotech firm●EMA recommends novel gene therapy●

PCSK9 Inhibitors and LDL Reduction Beyond the Statin Ceiling

PCSK9 inhibitors reduce LDL-C by up to 60% on top of statins. Explore the mechanism, FOURIER and ODYSSEY OUTCOMES trial data, and current UK NICE prescribing criteria.

Tom Okafor, Clinical Trials Correspondent|13 October 2026|9 min read

Clinical Trials

What the New UK Clinical Trials Regulations Mean for Sponsors

The UK's new clinical trials regulations enter force 28 April 2026. Here is what the notification scheme, combined review, and results disclosure obligations mean for sponsors and CROs.

Dr. Eleanor Vance, Regulatory Affairs Editor·5 October 2026·7 min read

Treatments

Biocon Pertuzumab Biosimilar Pebrilzo Wins CHMP Opinion

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.

Dr. Eleanor Vance, Regulatory Affairs Editor·28 September 2026·6 min read

Treatments

FDA Approves Imlunestrant Combination for ESR1 Breast Cancer

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.

Tom Okafor, Clinical Trials Correspondent·24 September 2026·3 min read

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Research

AstraZeneca and insitro Sign AI Deal for MASH and Heart Disease

AstraZeneca and insitro have signed a $40m AI collaboration targeting MASH and cardiomyopathies, with up to $1.46bn in milestones. Here is what the terms mean.

Priya Raghavan, Biotech & Markets Analyst·16 October 2026·6 min read