Europe – Guidance : Anonymisation of personal data and assessment of commercially confidential information...
This document gives general guidance to applicants/marketing authorisation holders (MAHs) on the retention/removal of personal data (PD) and identification of commercially confidential information (CCI)...
USA – FDA finalizes guidance on DSCSA verification systems
The US Food and Drug Administration (FDA) on 7 December issued a final guidance describing procedures to help trading partners establish systems to identify,...
Europe – ETF statement on the loss of activity of anti-spike protein monoclonal antibodies...
Since the declaration of the COVID-19 public health emergency in early 2020, four monoclonal antibody products have been approved in the European Union for...
UK – NICE recommends STADA and Calliditas’ Kinpeygo to treat rare kidney disease IgAN
Affecting approximately 14,000 people in England, IgAN occurs when IgA accumulates in the kidneys, causing inflammation and scarring, which can lead to kidney failure.
Patients...
Europe – Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 23-26 October 2023
GLP-1 receptor agonists: available evidence not supporting link with thyroid cancer
EMA’s safety committee (PRAC) has concluded that the available evidence does not support a...
France – La HAS actualise la doctrine vaccinale de lutte contre les orthopoxvirus
Les orthopoxvirus constituent une famille de virus à laquelle appartiennent la variole, mais aussi la vaccine et le mpox (nouveau nom du virus monkeypox). Comme...
France – Relocalisations de médicaments essentiels – Dossier de presse le 13/06/2023
France 2030 traduit une double ambition : transformer durablement des secteurs clefs de notre économie (énergie, automobile, santé, aéronautique, etc.) par l’innovation
technologique et industrielle,...
USA – FDA approves alectinib as adjuvant treatment for ALK-positive non-small cell lung cancer
Efficacy was demonstrated in a global, randomized, open-label trial (ALINA, NCT03456076) in patients with ALK-positive NSCLC who had complete tumor resection. Eligible patients were...
Europe – Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP)...
Three new medicines recommended for approval
EMA’s human medicines committee (CHMP) recommended three medicines for approval at its January 2024 meeting.
The committee recommended granting a marketing...
Switzerland – Swissmedic updates guidances on API, fast-track pathway, and more
Swissmedic has made updates to several of guidances related to active pharmaceutical ingredients (API), temporary authorization, products that receive fast-track authorization, and other documents...
