Europe – EMA recommends approval of Comirnaty and Spikevax COVID-19 vaccines for children from...
EMA’s human medicines committee (CHMP) has recommended extending the use of Comirnaty and Spikevax targeting the original strain of SARS-CoV-2. The Committee recommended including...
Europe – Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 26-29 September 2022
New measures for terlipressin-containing medicines in the treatment of hepatorenal syndrome
EMA’s safety committee (PRAC) recommended new measures to reduce the risk of respiratory failure...
Europe – PRAC starts review of topiramate use in pregnancy and women of childbearing...
EMA’s safety committee (PRAC) has started a review of topiramate and the risk of neurodevelopmental disorders in children whose mothers were taking topiramate during...
UK – NICE recommends Novartis’ Piqray in combination with Faslodex for advanced breast cancer...
The recommendation follows the ‘consistent, significant improvements’ in median progression-free survival and overall response rates when using Piqray in combination with Faslodex.
Breast cancer is...
USA – FDA to form task force, public-private partnership on rare neurodegenerative diseases
The US Food and Drug Administration (FDA) released a five-year action plan for accelerating drug development for rare neurodegenerative diseases, such as amyotrophic lateral...
Europe – COVID-19 vaccines safety update
The safety of authorised COVID-19 vaccines is continuously monitored and updated information is regularly provided to the public.
Safety updates outline the outcomes from assessments...
USA – Study: Extrapolation used in more than half of pediatric drug labeling changes
Some form of data extrapolation – either full or partial – was used in making more than 63% of pediatric labeling changes in the...
USA – Generic drugmakers seek clarity on pre-submission facility correspondence
Drugmakers want clarifications on an updated draft guidance the US Food and Drug Administration (FDA) recently released on pre-submission facility correspondence (PFC) for generic...
UK – AstraZeneca/Daiichi Sankyo’s Enhertu recommended by NICE for advanced breast cancer
The recommendation follows updated results from the DESTINY-Breast03 phase 3 trial, announced by the companies earlier this month, in which Enhertu demonstrated a statistically...
Singapore – Singapore’s HSA finalizes LDT guidelines
Singapore’s Health Sciences Authority (HSA) has finalized guidance intended to help clinical laboratories understand the regulatory requirements for tests they develop internally.
To date, HSA...
