Europe – Regulatory, industry panels address EU GMP Annex 1 implementation
Pharmaceutical manufacturers in the EU may have to approach the manufacturing of sterile drugs a little differently under the EU’s Annex 1 covering good...
UK – MHRA announces new recognition routes to facilitate safe access to new medicines...
New regulatory recognition routes for medicines will be established using approvals from Australia, Canada, the European Union, Japan, Switzerland, Singapore and the United States,...
USA – FDA officials: ‘New normal’ may include annual COVID vaccination
In a new editorial, top officials at the US Food and Drug Administration (FDA) outlined some of the key considerations for an annual COVID-19...
UK – NICE recommends Vazkepa for patients at risk of stroke and heart attacks...
Vazkepa is a new active substance, made up of a highly purified omega-3 fatty acid and is the first in this class to be...
Europe – EMA validates application for Byondis’ trastuzumab duocarmazine
Byondis has announced that the European Medicines Agency (EMA) has validated the Marketing Authorisation Application (MAA) for the company’s investigational next generation anti-HER2 antibody-drug...
UK – MSD’s pembrolizumab therapy gets NICE approval
An estimated 1,500 people aged 12 years and over with melanoma are set to benefit from MSD’s – known as Merck & Co in the...
UK – NICE publishes draft guidance recommending three COVID-19 treatments
The treatments recommended by NICE are Roche’s RoActemra (tocilizumab) and Eli Lilly’s Olumiant (baricitinib), both indicated for use in a hospitalised setting in patients...
UK – NICE recommends PTC Therapeutics’ Translarna reimbursement
PTC Therapeutics has announced that the National Institute for Health and Care Excellence (NICE) has issued a final evaluation document recommending Translarna.
It involves reimbursement...
Europe – New features further strengthen Priority Medicines scheme (PRIME)
EMA is introducing a number of new features to the PRIority Medicines (PRIME) scheme to strengthen its support for the development of medicines in areas of...
UK – NICE recommends Roche’s Columvi for advanced lymphoma in UK
The National Institute for Care and Excellence (NICE) has recommended Roche’s Columvi (glofitamab) for NHS use as a treatment option for a type of...
