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...
Ajovy bags NICE approval

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...
NICE ‘OK’ for Lynparza

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...

UK – NICE publishes draft guidance recommending three COVID-19 treatments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...

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...

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...

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