CHMP Archives -

PTC gets green light for gene therapy Upstaza in EU

Phil Taylor AADC deficiency, CHMP, EU, gene therapy, PTC Therapeutics, rare disease, Upstaza 0 Comment

PTC Therapeutic’s Upstaza gene therapy for patients with genetic disorder AADC deficiency has been recommended for approval in

PTC gets green light for gene therapy Upstaza in EU

https://pharmaphorum.com/news/ptc-gets-green-light-for-gene-therapy-upstaza-in-eu/

Market Access/ News/ News/ News/ Oncology

CHMP backs Roche’s lymphoma bispecific mosunetuzumab

Phil Taylor CHMP, immuno-oncology, mosunetuzumab, non-Hodgkin lymphoma, Non-small cell lung cancer, Oncology, Roche, Tecentriq 0 Comment

Roche is on the brink of its first regulatory approval for what could be the first bispecific antibody

CHMP backs Roche’s lymphoma bispecific mosunetuzumab

https://pharmaphorum.com/news/chmp-backs-roches-lymphoma-bispecific-mosunetuzumab/

Market Access/ News/ News

Biogen pulls EU application for Alzheimer’s drug Aduhelm

Phil Taylor Aduhelm, Alzheimer's disease, Biogen, CHMP, ema, EU, market access, neurology 0 Comment

Biogen has given up on seeking approval for its Alzheimer’s disease therapy Aduhelm in the EU, saying that

Biogen pulls EU application for Alzheimer’s drug Aduhelm

https://pharmaphorum.com/news/biogen-pulls-eu-application-for-alzheimers-drug-aduhelm/

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/ News/ News

Biogen’s Alzheimer’s drug Aduhelm is rejected by EU advisors

Phil Taylor Aduhelm, Alzheimer's disease, Biogen, CHMP, Eisai, ema, neurology 0 Comment

The EMA’s human medicines committee has said it cannot approve Biogen and Eisai’s Alzheimer’s disease therapy Aduhelm, saying

Biogen’s Alzheimer’s drug Aduhelm is rejected by EU advisors

https://pharmaphorum.com/news/biogens-alzheimers-drug-aduhelm-is-rejected-by-eu-advisors/

Market Access/ News/ News

CHMP minded to turn down Alzheimer’s drug Aduhelm, says Biogen

Phil Taylor Aduhelm, Alzheimer's disease, Biogen, CHMP, Eisai, ema, EU, neurology 0 Comment

Biogen and Eisai have said that the EMA’s human medicines committee looks unlikely recommended approval of their Alzheimer’s

CHMP minded to turn down Alzheimer’s drug Aduhelm, says Biogen

https://pharmaphorum.com/news/chmp-minded-to-turn-down-alzheimers-drug-aduhelm-says-biogen/

Market Access/ News/ News

Novo Nordisk nears EU approval of obesity drug Wegovy

Phil Taylor CHMP, Novo Nordisk, obesity, Saxenda, Wegovy 0 Comment

Danish drugmaker Novo Nordisk is hoping to launch its once-weekly injectable treatment for obesity, Wegovy, in the EU

Novo Nordisk nears EU approval of obesity drug Wegovy

https://pharmaphorum.com/news/novo-nordisk-nears-eu-approval-of-obesity-drug-wegovy/

Market Access/ News/ News

COVID antibodies from Roche, Celltrion backed for approval in EU

Phil Taylor antibody, Celltrion, CHMP, coronavirus, COVID-19, Regeneron, Roche 0 Comment

The EMA’s human medicines committee has recommended approval of Roche’s Ronapreve and Celltrion’s Regkirona for use in COVID-19,

COVID antibodies from Roche, Celltrion backed for approval in EU

https://pharmaphorum.com/news/first-covid-antibodies-from-roche-celltrion-backed-in-eu/

Targeting COVID-19 and cancer with immunotherapy advancements

News/ News/ Patients

EU backs broader use of Comirnaty as COVID booster than US

Phil Taylor BioNTech, CHMP, Comirnaty, coronavirus, COVID-19, COVID-19 vaccine, ema, Pfizer 0 Comment

The EMA has given the go-ahead to the use of Pfizer and BioNTech’s COVID-19 vaccine Comirnaty as a

EU backs broader use of Comirnaty as COVID booster than US

https://pharmaphorum.com/news/eu-backs-broader-use-of-comirnaty-as-covid-booster-than-us/

Trending

CHMP

Login