Europe – Expert: Combination product firms need EU guidance amid regulatory ambiguity
The EU Medical Device Regulation (MDR) created confusion for medical device manufacturers in Europe, including drug-device combination (DDC) producers. As stakeholders seek more guidance...
UK – New T-cell study demonstrates ‘powerful’ potential for tailored cancer medicine
The clinical study involved 16 patients with either colon, breast or lung cancers that had failed to respond to other treatments, and was made...
USA – Industry pushes FDA for tailored complex generics post-approval changes guidance
The US Food and Drug Administration (FDA) needs to develop guidance on post-approval changes for complex generics, and to update its guidance on post-approval...
USA – FDA takes first step to allow low-dose OTC naloxone on market
Low-dose naloxone drug products, including certain nasal sprays and autoinjectors, could one day be sold without a prescription, according to an initial assessment by...
USA – Biosimilar facilities usually get onsite inspections
A US Food and Drug Administration (FDA) official said that sites making biosimilars will be inspected in person, as opposed to virtual methods, as...
France – Covid-19 : intégration du vaccin bivalent Spikevax® (BA.4-BA.5) dans la stratégie vaccinale
Après la validation par l’Agence européenne du médicament (EMA) du vaccin Spikevax® de Moderna le 21 octobre dernier, la HAS ajoute ce vaccin à...
Europe – EMA confirms recommendation to withdraw marketing authorisations for amfepramone medicines
On 27 October 2022, EMA’s safety committee (PRAC) confirmed its recommendation to withdraw the marketing authorisations for amfepramone obesity medicines. This follows a re-examination of its previous recommendation of June...
Europe – New recommendations for terlipressin-containing medicines in the treatment of hepatorenal syndrome
On 29 September 2022, EMA’s safety committee (PRAC) recommended new measures to reduce the risk of respiratory failure (severe breathing difficulties that may be...
Europe – EMA confirms measures to minimise risk of serious side effects with Janus...
EMA’s human medicines committee (CHMP) has endorsed the measures recommended by the Pharmacovigilance Risk Assessment Committee (PRAC) to minimise the risk of serious side effects with...
Europe – EMA recommends approval of VidPrevtyn Beta as a COVID 19 booster vaccine
EMA’s human medicines committee (CHMP) has recommended authorising the COVID-19 vaccine VidPrevtyn Beta as a booster in adults previously vaccinated with an mRNA or...
