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bluebird bio has chosen to suspend sales of Zynteglo while they investigate whether safety concerns identified with a related investigational gene therapy may apply to the licenced medicine.
As the UK enters new territory following its departure from the EU, legal experts Marie Manley and Chris Boyle from Sidley Austin explore the resultant consequences for biopharma companies and the regulatory opportunities that lie ahead.
The emergence of CAR T-cell therapies has ignited a revolution in the field of cancer treatments. While existing products show outstanding curative capability, they are hampered by significant clinical and commercial challenges, many of which stem from their manufacturing process. Maciej Nakoniecznik discusses how a combination of biological and technological advances…
The rolling review will assess CVnCoV’s efficacy and immunogenicity data as it becomes available, speeding the decision process for an eventual marketing authorisation application.
The European medical cannabis market lacks a common regulatory framework; Peter Kohut charts a route through the complexity and highlights opportunities for the taking.
According to Jazz Pharmaceuticals, the combined company will be a leader in neuroscience, well positioned to maximise the value of its diversified portfolio.
J&J have submitted Phase III trial data in their application to the FDA for emergency authorisation of their COVID-19 vaccine candidate.
The review will evaluate data from preclinical and clinical studies of NVX-CoV2373 to expedite the vaccine’s marketing authorisation approval later.
The EMA's CHMP has begun a rolling review of REGN-COV2, Regeneron's COVID-19 antibody candidate, after successful pre-clinical trials.
The committee for human medicinal products recommended AstraZeneca’s COVID-19 vaccine be granted conditional marketing authorisation alongside 12 other approvals.
In a Phase II trial, sotorasib was shown to be effective against pre-treated non-small cell lung cancer (NSCLC).
The EMA has accepted Global Blood Therapeutics' marketing authorisation application for Oxbryta (voxelotor) to treat haemolytic anaemia in sickle cell disease.
The EMA has received a conditional marketing authorisation application for the Oxford-AstraZeneca COVID-19 vaccine.