UK – NICE nod for Darzalex with lenalidomide and dexamethasone
The Janssen Pharmaceutical Companies of Johnson & Johnson has announced that the National Institute for Health and Care Excellence (NICE) has recommended Darzalex –...
Suisse – Swissmedic updates guidance on temporary medicine authorization to harmonize deadlines
The Swiss Agency for Therapeutic Products (Swissmedic) has updated its guidance on the temporary authorization of human medicinal products.
In the document, Swissmedic outlines the...
UK – COVID-19: guidance for people whose immune system means they are at higher...
The success of the coronavirus (COVID-19) vaccination programme has meant that the requirement for shielding and identifying people as clinically extremely vulnerable (CEV) is...
UK – NICE recommends more genetic testing for links to ovarian cancer
The National Institute for Health and Care Excellence (NICE) has recommended that more people get tested for genes linked to ovarian cancer.
The new guideline...
UK- Pfizer’s Vydura recommended by NICE for acute migraines
The National Institute for Health and Care Excellence (NICE) has recommended Pfizer’s Vydura (rimegepant) as a cost-effective option for the treatment of acute migraines...
Europe – Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP)...
Nine new medicines recommended for approval
EMA’s human medicines committee (CHMP) recommended nine medicines for approval at its September 2023 meeting.
The CHMP recommended granting a marketing authorisation for Ebglyss (lebrikizumab), for...
Europe – EMA recommends non-renewal of authorisation of multiple myeloma medicine Blenrep
EMA’s human medicines committee (CHMP) has recommended not renewing the conditional marketing authorisation for Blenrep (belantamab mafodotin), a medicine used to treat multiple myeloma (a cancer...
Europe – EMA recommends non-renewal of authorisation of Duchenne muscular dystrophy medicine Translarna
EMA’s human medicines committee (CHMP) has recommended not renewing the marketing authorisation for Translarna (ataluren), a medicine for treating patients with Duchenne muscular dystrophy whose disease...
Europe – Spikevax: EMA recommends approval of adapted COVID-19 vaccine targeting Omicron XBB.1.5
EMA’s human medicines committee (CHMP) has recommended authorising an adapted Spikevax vaccine targeting the Omicron XBB.1.5 subvariant.
The vaccine — known as Spikevax XBB.1.5 — is...
UK – Eli Lilly’s Mounjaro receives NICE recommendation to treat type 2 diabetes
According to NICE’s draft guidance, around 180,000 people living with difficult-to-manage type 2 diabetes could benefit from the new treatment option.
The recommendation follows additional...
