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- PMLiVE

Decibel Therapeutics

- PMLiVE

FDA publishes final industry guidance for CAR-T and gene therapies

The new guidance can also be applied to other genetically modified lymphocyte products, including  CAR NK cells

- PMLiVE

Sanofi/Regeneron’s Dupixent approved by FDA for younger eosinophilic oesophagitis patients

Around 21,000 children aged under 12 years in the US are being treated for the inflammatory disease

- PMLiVE

Sanofi/Regeneron’s Dupixent gets US label update for atopic dermatitis

Dupixent’s label now includes data supporting its use in hand and foot atopic dermatitis

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Study suggests hearing aids could prevent onset and progression of dementia

People with severe hearing loss had an increased risk of up to 20% of developing dementia

- PMLiVE

Sanofi/Regeneron’s Dupixent shows promise in chronic obstructive pulmonary disease

About 300,000 people in the US have uncontrolled COPD and type 2 inflammation

- PMLiVE

AstraZeneca and Cellectis enter gene therapy partnership worth over $2.2bn

The deal gives AZ access to Cellectis’ gene editing technologies and manufacturing capabilities

regeneron headquarters

Regeneron’s odronextamab granted FDA priority review for non-Hodgkin lymphoma

The regulator is expected to make a decision on the drug by the end of March 2024

Biomarin

BioMarin announces first patient dosed with haemophilia A gene therapy in Europe

The therapy was granted conditional marketing authorisation by the EC in August 2022

- PMLiVE

US government awards $1.4bn for development of COVID-19 vaccines and therapeutics

The funding includes a contract with Regeneron for a next-generation antibody therapy

regeneron headquarters

Regeneron to acquire Decibel Therapeutics in deal worth up to $213m

The transaction expands the company’s gene therapy and hearing loss pipeline

- PMLiVE

NICE publishes draft guidance not recommending CSL’s haemophilia B gene therapy

The company has been seeking approval for use of the therapy in adults with severe or moderately severe haemophilia B without a history of factor IX inhibitors

- PMLiVE

FDA approves BioMarin’s Roctavian as first gene therapy for severe haemophilia A

Approximately 2,500 patients are expected to be eligible to receive the one-time therapy

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