MHRA Archives -

MHRA gives Alnylam ‘innovation passport’ for hypertension drug zilebesiran

Phil Taylor Alnylam, HEOR, hypertension, innovation passport, MHRA, NHS, regulatory, UK, zilebesiran 0 Comment

The UK medicines regulator has awarded Alnylam’s RNAi-based therapy zilebesiran for hypertension an ‘innovation passport‘, a designation designed

MHRA gives Alnylam ‘innovation passport’ for hypertension drug zilebesiran

https://pharmaphorum.com/news/mhra-gives-alnylam-innovation-passport-for-hypertension-drug-zilebesiran/

Market Access/ News/ News/ News/ Patients

UK grants early access to Argenx’ efgartigimod for myasthenia gravis

Phil Taylor access, Argenx, efgartigimod, MHRA, myasthenia gravis, patients, rare disease, UK, Vyvgart 0 Comment

The UK regulatory authority has cleared the path for some patients with generalised myasthenia gravis (gMG) to get

UK grants early access to Argenx’ efgartigimod for myasthenia gravis

https://pharmaphorum.com/news/uk-grants-early-access-to-argenx-efgartigimod-for-myasthenia-gravis/

Market Access/ News/ News

UK grants early access to Novartis’ prostate cancer radioligand

Phil Taylor Advanced Accelerator Applications, Early Access to Medicines Scheme, MHRA, Novartis, Pluvicto, Prostate cancer, Radiopharmaceutical, UK 0 Comment

The UK regulator has said eligible patients with prostate cancer will get early access to a radioligand therapy

UK grants early access to Novartis’ prostate cancer radioligand

https://pharmaphorum.com/news/uk-grants-early-access-to-novartis-prostate-cancer-radioligand/

Market Access/ News/ News

EU regulator backs Idorsia’s Quviviq for adults with insomnia

Joy Persaud CHMP, EU, Idorsia, insomnia, market access, MHRA, pharma 0 Comment

A new treatment for adults with insomnia disorder has been recommended for use in Europe, giving hope to

EU regulator backs Idorsia’s Quviviq for adults with insomnia

https://pharmaphorum.com/news/eu-regulator-backs-idorsias-quviviq-for-adults-with-insomnia/

Market Access/ Views & Analysis/ Views and analysis

How do UK market access prospects look in 2022?

Leela Barham Brexit, Life Sciences, MHRA, NICE 0 Comment

Leela Barham and Neil Grubert look back at what was expected for market access in 2021 and look

How do UK market access prospects look in 2022?

https://pharmaphorum.com/market-access-2/uk-market-access-prospects-2022/

Data hackathon analyses truth behind ‘game-changer’ COVID vaccine

Market Access/ News/ News

Novavax COVID jab ‘could save UK money on boosters’

Phil Taylor coronavirus, COVID-19, COVID-19 vaccine, MHRA, Novavax, UK 0 Comment

The approval of Novavax’ COVID-19 vaccine in Great Britain could help the country save a “considerable amount of

Novavax COVID jab ‘could save UK money on boosters’

https://pharmaphorum.com/news/novavax-covid-jab-could-save-uk-money-on-boosters/

Why we need the human element of remote clinical trials

News/ News/ Patients

MHRA seeks comments on post-Brexit clinical trial legislation

Phil Taylor Brexit, clinical trials, MHRA, regulatory 0 Comment

The MHRA has kicked off an eight-week consultation on proposals for changes to laws governing the conduct of

MHRA seeks comments on post-Brexit clinical trial legislation

https://pharmaphorum.com/news/mhra-seeks-comments-on-post-brexit-clinical-trial-legislation/

Market Access/ News/ News

UK green lights Gilead Sciences, Galapagos ulcerative colitis drug

Joy Persaud Galapagos, Gilead, market access, MHRA, pharma 0 Comment

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved Jyseleca (filgotinib) 200mg tablets to treat ulcerative

UK green lights Gilead Sciences, Galapagos ulcerative colitis drug

https://pharmaphorum.com/news/uk-green-lights-gilead-sciences-galapagos-ulcerative-colitis-drug/

Market Access/ News

MHRA okays GSK’s Xevudy as data suggest it works against Omicron

Phil Taylor antibody, coronavirus, COVID-19, GlaxoSmithKline, MHRA, regulatory approval, sotrovimab, Vir Biotechnology, xevudy 0 Comment

The UK medicines regulator has approved GlaxoSmithKline and Vir Biotech’s antibody for COVID-19, Xevudy, which has been shown

MHRA okays GSK’s Xevudy as data suggest it works against Omicron

https://pharmaphorum.com/market-access-2/mhra-okays-gsks-xevudy-as-data-suggest-it-works-against-omicron/

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