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- PMLiVE

AstraZeneca’s Enhertu receives FDA grant for priority review

The approval is based on results from the DESTINY-Breast03 trial which showed a significant risk reduction of unresectable or metastatic HER-2 positive breast cancer progression

- PMLiVE

‘Excitement’ around new data for Enhertu

New analyses from the DESTINY-Breast03 trial shows Enhertu is effective against metastatic HER2-positive breast cancer in specific patient subgroups including those with stable brain metastases

- PMLiVE

FDA grants Enhertu Breakthrough Therapy Designation in breast cancer

Phase 3 trial data presented at ESMO shows Enhertu significantly reduced the risk of disease progression or death

Biomarin

FDA pauses BioMarin gene therapy trial

The study for BMN 307 in genetic disease phenylketonuria will be paused while malignancies in mice are explored

- PMLiVE

Sarepta Therapeutics’ DMD gene therapy shows early success

Most patients with Duchenne muscular dystrophy require full-time use of a wheelchair by their early teens

- PMLiVE

AZ, Daiichi Sankyo reveal new TNBC data for next-gen antibody drug conjugate

Datopotamab deruxtecan shows early promise in heavily pre-treated patient group

- PMLiVE

Lilly links up with Precision BioSciences in genome editing deal

Precision will receive an upfront cash payment of $100m

- PMLiVE

AZ strengthens Daiichi Sankyo partnership with new ADC deal

Deal for experimental antibody drug conjugate could reach $6bn

- PMLiVE

EMA fast-tracks review of AZ/Daiichi Sankyo’s HER2 drug

Antibody drug conjugate gained approval in US in December

- PMLiVE

AZ, Daiichi Sankyo’s Enhertu set fair for filing in gastric cancer

Improved overall survival when compared to chemotherapy

- PMLiVE

Presidential hopeful Bernie Sanders criticises BioMarin’s gene therapy price

Vowed to break patent if company goes ahead with proposed price

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