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- PMLiVE

bluebird bio sells Rare Pediatric Disease Priority Review Voucher

The company was granted two PRVs upon the FDA approvals of Zynteglo and Skysona

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Bayer’s Nubeqa receives MHRA approval to treat metastatic prostate cancer

The treatment will be made available immediately through an early access deal with NHS England

- PMLiVE

Precision medicine trial opens for patients with rare cancers

Rare cancers make up 22% of cancers that are diagnosed globally each year, more than any single type of cancer

regeneron headquarters

Regeneron’s Libtayo granted EC approval for recurrent or metastatic cervical cancer

A phase 3 trial demonstrated a 31% reduction in the risk of death compared to chemotherapy

- PMLiVE

FDA approves first gene therapy for adults with haemophilia B

CSL’s Hemgenix allowed patients to produce mean factor IX activity of 39% at six months

regeneron headquarters

Regeneron and CytomX partner to create conditional bispecific cancer therapies

CytomX is set to receive an upfront payment of $30m as well as milestones of up to $2bn

- PMLiVE

Roche’s high-throughput monkeypox test approved for emergency use by FDA

The tests will be conducted on the company’s 6800/8800 cobas systems

- PMLiVE

FDA advisory committee recommends Ardelyx’s Xphozah for chronic kidney disease

The phase 3 trials supporting the submission met all primary and key secondary endpoints

- PMLiVE

FDA approves ImmunoGen’s Elahere for platinum-resistant ovarian cancer

An overall response rate of 31.7% was demonstrated, including five complete responses

- PMLiVE

Roche enters into second collaboration with Jnana to address complex drug targets

The Boston-based biotech will receive an upfront payment of $50m

- PMLiVE

AZ and Avillion’s asthma rescue treatment recommended by FDA Advisory Committee

PT027 significantly reduced the risk of severe asthma exacerbations

regeneron headquarters

Regeneron’s Libtayo combination granted FDA approval for non-small-cell lung cancer

The decision was based on superior survival outcomes of Libtayo plus chemotherapy

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