UK – Bayer’s Nubeqa combination recommended by NICE to treat metastatic prostate cance
The final draft guidance from NICE specifically recommends Nubeqa tablets in combination with androgen deprivation therapy (ADT) and docetaxel.
The decision follows the Medicines and...
USA – FDA finalizes guidance on dose banding for injectables
The US Food and Drug Administration (FDA) has finalized its guidance on dose banding to assist sponsors in labeling ready-to-use containers for injectable drug...
Europe – First therapy to treat two types of Niemann-Pick disease, a rare genetic...
EMA has recommended granting a marketing authorisation in the European Union (EU) for Xenpozyme (olipudase alfa), a therapy for the treatment of non-central nervous system (CNS)...
Europe – Start of rolling review for adapted Spikevax COVID-19 vaccine
EMA has started a rolling review for a version of Spikevax adapted to provide better protection against specific variants of SARS-CoV-2, the virus that...
UK – Merck’s Keytruda receives NICE recommendation as breast cancer treatment option
Specifically, NICE’s recommends Keytruda as an option with chemotherapy for neoadjuvant, and alone as adjuvant treatment after surgery for patients with early triple-negative or...
USA – FDA announces CMC review pilot for drugs with expedited development
The US Food and Drug Administration (FDA) announced on 31 October a limited chemistry, manufacturing and controls (CMC) development and readiness pilot (CDRP) program...
France – La HAS publie le référentiel de certification des logiciels d’aide à la...
La Haute autorité de santé (HAS) a publié le 29 septembre le référentiel de certification par essai de type des logiciels d'aide à la...
UK – NICE rejects AstraZeneca and MSD’s Lynparza as NHS prostate cancer treatment
NICE has said it is unable to recommend NHS use of AstraZeneca’s Lynparza for some patients with prostate cancer, after failing to reach an...
USA – FDA describes plans to expand remote regulatory assessments
The US Food and Drug Administration (FDA) released draft guidance on Friday that formalizes its plans for using remote regulatory assessments (RRAs) for FDA-regulated...
UK – NICE issues final draft recommending Novartis’ Scemblix to treat chronic myeloid leukaemia
NICE’s decision will allow access to an innovative treatment channel which will help to address an unmet need for eligible people in England and...
