Europe – EMA offers insights on when biologics qualify as new active substances
The European Medicines Agency (EMA) is looking for feedback on a draft reflection paper that lays out its criteria for determining whether biological substances...
Europe – New Quality Innovation Expert Group (QIG) supports medicine innovation
EMA has established a Quality Innovation Expert Group (QIG) to support innovative approaches for the development, manufacture, and quality control of medicines for the benefit of...
USA – Most FDA warning letters this year from onsite inspections
A US Food and Drug Administration (FDA) official said that most warning letters issued for drug good manufacturing practice (GMP) issues in fiscal year...
Europe – Best practices to fight antimicrobial resistance
The International Coalition of Medicines Regulatory Authorities (ICMRA) highlights successful regulatory and non-regulatory interventions used in different countries to address the growing public health problem of...
France – « Contre la résistance aux antibiotiques, la recherche et la production publiques...
La Journée mondiale de prévention de l’antibiorésistance qui s’est tenue le 18 novembre a alerté sur cette menace sanitaire croissante considérée par les instances internationales...
UK – NICE recommends Sobi’s Doptelet to treat thrombocytopenia
Sobi has announced that the National Institute for Health and Care Excellence (NICE) has issued the Final Appraisal Document in England and Wales recommending...
UK – Kidney Cancer UK receives commission from NICE
The charity Kidney Cancer UK has, through its approach to NHS England, secured a commission for the National Institute for Health and Care Excellence...
USA – FDA approves first drug to delay onset of type 1 diabetes
The company submitted positive results from the randomised, double-blind, placebo-controlled TN-10 trial that included 76 patients with stage 2 type 1 diabetes.
Results showed that,...
UK – NICE recommends Pfizer’s Paxlovid on NHS
Pfizer has announced today that the National Institute for Health and Care Excellence (NICE) has issued an appraisal consultation document which recommends Paxlovid.
Also known...
UK – Takeda’s Exkivity receives NICE recommendation for rare form of lung cancer
The treatment was licensed through by Project Orbis, an international programme to review and approve promising cancer drugs helping patients access treatments faster.
NICE’s decision...
