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After FDA nod, Eisai and Biogen file lecanemab in EU

Phil Taylor Alzheimer's disease, Biogen, Eisai, ema, lecanemab, Leqembi, neurology 0 Comment

Eisai and Biogen have moved swiftly ahead with regulatory filings for their new Alzheimer’s therapy lecanemab in the

After FDA nod, Eisai and Biogen file lecanemab in EU

https://pharmaphorum.com/news/after-fda-nod-eisai-and-biogen-file-lecanemab-in-eu/

Janssen J&J Johnson and Johnson pharmaceutical companies

News/ News/ Oncology

Janssen makes EMA marketing application for talquetamab for RRMM

Nicole Raleigh ASH 2022, bispecifics, ema, fda, Janssen, MAA, multiple myeloma, talquetamab 0 Comment

The Janssen Pharmaceutical Companies of Johnson & Johnson have submitted a Marketing Authorisation Application (MAA) to the European

Janssen makes EMA marketing application for talquetamab for RRMM

https://pharmaphorum.com/news/janssen-makes-ema-marketing-application-for-multiple-myeloma-treatment/

Digital/ News/ News

EMA unveils first projects as data partners join DARWIN EU project

Phil Taylor big data, DARWIN, digital, digital health, ema, EU, real world data, Real World Evidence 0 Comment

Two years ago, the EMA proposed a set of recommendations to unlock the potential of big data for

EMA unveils first projects as data partners join DARWIN EU project

https://pharmaphorum.com/news/ema-unveils-first-projects-as-data-partners-join-darwin-eu-project/

Market Access/ News/ News

EU regulator lifts GSK amid torrid week for company’s pipeline

Phil Taylor cabotegravir, ema, GlaxoSmithKline, respiratory syncytial virus, vaccine 0 Comment

The EMA has delivered some good news to GSK on a new long-acting HIV drug and vaccine for

EU regulator lifts GSK amid torrid week for company’s pipeline

https://pharmaphorum.com/news/eu-regulator-lifts-gsk-amid-torrid-week-for-companys-pipeline/

Mosquito Biting Skin is Filled with Red Blood

Market Access/ News/ News

Takeda dengue vaccine receives positive CHMP opinion

Nicole Raleigh CHMP, dengue, ema, mosquitoes, Qdenga, regulatory, TAK-003, Takeda, vaccine 0 Comment

The European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion

Takeda dengue vaccine receives positive CHMP opinion

https://pharmaphorum.com/news/takeda-dengue-vaccine-receives-positive-chmp-opinion/

Young attractive female scientist holding a red transparent pill

Digital/ News/ News/ News/ R&D

EMA pilot will see if clinical trial data should be digested ‘raw’

Phil Taylor clinical research, clinical trials, data, ema, regulatory 0 Comment

A pilot study has been launched by the EMA to see whether it is helpful for regulators to

EMA pilot will see if clinical trial data should be digested ‘raw’

https://pharmaphorum.com/news/ema-pilot-will-see-if-clinical-trial-data-should-be-digested-raw/

Market Access/ Oncology/ Views & Analysis/ Views & Analysis/ Views and analysis

Are timely access and robust safety mutually exclusive?

Amanda Barrell EFPIA, ema, fda, Kristina Jenei, Oncology 0 Comment

The FDA approves new cancer treatments in half the time of the EMA – but does faster mean

Are timely access and robust safety mutually exclusive?

https://pharmaphorum.com/market-access-2/are-timely-access-and-robust-safety-mutually-exclusive/

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/

News/ News/ Patients

EU says not enough evidence to warrant fourth COVID jabs

Phil Taylor BioNTech, Comirnaty, coronavirus, COVID-19, COVID-19 vaccine, ema, fda, Moderna, Pfizer, Spikevax 0 Comment

It is too early to consider widespread use of a second COVID-19 vaccine booster dose, according to the

EU says not enough evidence to warrant fourth COVID jabs

https://pharmaphorum.com/news/eu-says-not-enough-evidence-to-warrant-fourth-covid-jabs/

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