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- PMLiVE

Adakveo

- PMLiVE

Positive CHMP opinion issued for PTC Therapeutics’ Upstaza

The treatment for AADC will be the first marketed gene therapy to be administered directly into the brain

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EMA accepts Valneva’s marketing authorisation application for COVID-19 vaccine

The vaccine is currently the only inactivated, whole virus adjuvanted candidate in clinical trials in Europe

- PMLiVE

EC approves Novartis’ Kymriah for advanced blood cancer

Kymriah is the first CAR-T cell therapy of its kind approved in the EU for follicular lymphoma

- PMLiVE

Biogen retracts EMA application for Alzheimer’s drug Aduhelm

The application was pulled after the CHMP said the data provided was not enough to support a marketing authorisation

- PMLiVE

EMA and ECDC publish advice on fourth doses of mRNA COVID-19 vaccines

The regulators have concluded that there is not enough supporting evidence for an immediate fourth dose

- PMLiVE

Novartis restructures organisation to support growth and innovation

The new operational structure will involve integrating pharmaceuticals and oncology business units into an Innovative Medicines business

- PMLiVE

Novartis’ Kesimpta trial evaluates treatment of COVID-19 in MS patients

There are an estimated 130,000 people with MS in the UK

- PMLiVE

FDA approves Novartis’ Pluvicto for prostate cancer

The treatment is the first FDA approved targeted radioligand therapy for mCRPC patients

- PMLiVE

Novartis and Voyager Therapeutics agree on gene therapy deal worth 1.7bn

The licence option agreement is for next-generation gene therapy vectors for neurological diseases

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EMA establishes DARWIN EU Coordination Centre

The new centre will give the EMA and other EU member states access to reliable, real-world evidence for EU medicine assessments

- PMLiVE

Pfizer’s Paxlovid receives positive opinion from CHMP

If authorised, the drug would be the first COVID-19 oral treatment recommended in the EU

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EMA proposes EU clinical trial reforms

The ACT EU paper provides a list of regulatory network objectives, priorities and governance strategies for 2022-2023

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