News

FDA approves first chemo antidote

US regulators have issued a speedy green light for the first and only drug able to treat chemotherapy overdose or severe allergic reactions.

Landmark NICE recommendation for AZ’ Lynparza

NICE has published final draft guidelines now supporting the use of AstraZeneca’s Lynparza on the NHS in England and Wales, marking the first time a cancer drug targeting an inherited genetic fault will be made available on the health service.

UCL, Syncona create new gene therapy biopharma

UCL Business, the wholly-owned technology transfer company of UCL, has teamed up with investment group Syncona to create a new biopharmaceutical company called Freeline Therapeutics, which will focus on development and commercialisation of gene therapies for bleeding and other debilitating disorders.

EMA head outlines five-year plan

The EMA is ready to address the challenges ahead, according to the agency’s incoming executive director Professor Guido Rasi, who has outlined his vision for the next five years.

Limited time left to enter!

You’ve only got until 28 January to submit your essay for the Clinical Researcher of the Year – The Americas 2016 competition, and with Christmas approaching, time is definitely limited.

Pfizer’s Xalkori gets speedy review for ROS1 NSCLC

The US Food and Drug Administration is undertaking a speedy review of Pfizer’s kinase inhibitor Xalkori for the treatment of patients with metastatic non-small cell lung cancer whose tumours are ROS1-positive.

FDA clears Alexion’s enzyme replacement therapy Kanuma

US regulators have issued a green light for Alexion’s long-term enzyme replacement therapy Kanuma, giving patients with the ultra rare genetic disorder lysosomal acid lipase deficiency access to a targeted treatment for the first time.