France – L’agence du médicament sonne l’alarme au sujet de réactions allergiques associées à...
L’Agence nationale de sécurité du médicament et des produits de santé (ANSM) a observé une « augmentation constante du nombre de déclarations de réactions allergiques graves...
USA – FDA investigates risk of secondary malignancies with CAR T-cell therapy
The US Food and Drug Administration (FDA) is investigating reports of a “serious risk” of T-cell malignancies linked to treatment with chimeric antigen receptor...
USA – Combination products: Non-harmonized regulations are hurting manufacturers
Divergent global regulatory frameworks are making it tough for manufacturers to move ahead with innovative combination drug/device products, according to a panel of experts...
UK – Pfizer’s RSV vaccine granted MHRA approval to protect infants and older adults
RSV is a common contagious virus characterised by several mild, cold-like symptoms. Although most people recover within a week or two, the virus can...
USA – FDA outlines process for recognizing standards for regenerative medicines
The US Food and Drug Administration (FDA) has issued final guidance describing its process for recognizing voluntary consensus standards (VCS) to spur the development...
UK – MHRA instructs health organisations to prepare now for new measures to reduce...
Healthcare organisations are being instructed by the Medicines and Healthcare products Regulatory Agency (MHRA) now to put in place a plan to implement the first phase...
Europe – Pharma groups fight proposed ban on titanium dioxide in Europe
Pharmaceutical industry groups are working to submit comments to the European Medicines Agency (EMA) to oppose a proposed ban on the use of titanium...
UK – AstraZeneca’s rare disease unit receives NICE recommendation for Wolman disease therapy in...
Alexion’s Kanuma (sebelipase alfa), which has been specifically recommended for use in patients who are aged two years or younger when administration begins, will...
USA – Stakeholders urge FDA to retain interchangeability statements on biosimilar labeling
Two major pharmaceutical industry groups opposed the US Food and Drug Administration’s (FDA) proposal to remove details about interchangeability from product labels in its...
USA – FDA issues new standards for DTC prescription drug ads
The US Food and Drug Administration (FDA) published its final rule changing how companies must present the “major statement” in direct-to-consumer (DTC) TV and...
