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- PMLiVE

Ferring Pharmaceuticals

- PMLiVE

Bristol Myers Squibb’s Opdivo combination receives FDA approval for urothelial carcinoma

More than 83,000 news cases of bladder cancer are expected to be diagnosed in the US this year

- PMLiVE

Merck shares positive results for Keytruda in phase 3 bladder cancer study

About 83,000 people in the US will be diagnosed with bladder cancer in 2024

- 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

Johnson & Johnson’s bladder cancer drug Balversa granted full FDA approval

Urothelial carcinoma accounts for approximately 90% of bladder cancer cases

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

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

- PMLiVE

Merck shares positive results for Keytruda in phase 3 bladder cancer study

Over 82,000 people in the US will be be diagnosed with bladder cancer in 2023

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

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NICE publishes draft guidance not recommending CSL’s haemophilia B gene therapy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

- PMLiVE

FDA grants accelerated approval to Sarepta’s Duchenne muscular dystrophy gene therapy

The disease occurs in up to one in every 5,000 newborn males worldwide

- PMLiVE

Janssen shares positive phase 3 results for erdafitinib in bladder cancer

Urothelial carcinoma accounts for approximately 90% of bladder cancer cases

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