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EMA
This page shows the latest EMA news and features for those working in and with pharma, biotech and healthcare.
Valneva and Pfizer initiate phase 3 Lyme disease vaccine study
Upon successful completion, Pfizer could submit a Biologics Licence Application (BLA) to the US Food and Drug Administration (FDA) and Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) in
Latest news
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GSK to supply 85 million doses of pandemic influenza vaccine to EU
Adjupanrix is a vaccine for use in adults to protect against pandemic influenza and, according to the European Medicines Agency (EMA), should only be used once an influenza pandemic has been
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Pfizer and BioNTech initiate phase 2 study of ‘enhanced’ COVID-19 vaccine
Earlier in July, Pfizer and BioNTech completed a submission to the European Medicines Agency (EMA) for their Omicron-adapted bivalent COVID-19 vaccine, based on the BA.1 sub-lineage, for
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Bristol Myers Squibb’s Opdualag approved by CHMP for melanoma
The Committee for Medicinal Products for Human Use (CHMP) branch of the European Medicines Agency (EMA) has recommended approval of the fixed-dose of Bristol Myers Squibb’s (BMS) Opdualag – a
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AstraZeneca’s Tezspire recommended for approval in the EU by CHMP
AstraZeneca (AZ) has received a recommendation from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) for the EU approval of Tezspire (tezepelumab) as an
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Sandoz’s application for MS biosimilar accepted by FDA
A marketing authorisation application (MAA) for natalizumab was accepted on 15 July 2022 by the European Medicines Agencies (EMA), as a single disease-modifying therapy (DMT) in adults with highly active
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Approximately 295 fully matching, plus 859 partially matching documents found.
Latest Intelligence
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Listen, learn and lift off
The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) are expecting a busy year for approvals, with frantic activity in orphan diseases as gene and cell therapy
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Pre-launch planning and DSLs – the new ways to create launch excellence in pharma
Despite the global pandemic, in 2020 the European Medicines Agency (EMA) approved 39 new active substances, nine more than in 2019.
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Pharma’s authentic proof of purpose influences decisions among HCPs and payers
as respondents representing the FDA and EMA regional regulators.
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Patient diversity in clinical trials needs to be centre stage
Regulatory pressure, particularly from the FDA and more recently by the MHRA and EMA, is encouraging inclusivity and diversity, she added. ... This is a strong position to adopt and it’s good to see NICE and the EMA now want patient experience data.”.
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Piloting a route to the biosimilars opportunities in Europe
There are more than 70 biosimilars registered in the EU, with others are under evaluation, thanks to the efforts of the European Medicines Agency (EMA) to continuously improve guidelines and provide ... The US market also has a lot of interest in
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Approximately 8 fully matching, plus 88 partially matching documents found.
Latest appointments
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New hires at EMA, Gilead and BeiGene
EMA gains a new executive director, Gilead appoints a new senior vice president and BeiGene hires a new chief business exec. ... European Medicines Agency (EMA). The European Medicines Agency (EMA) management board has nominated Emer Cooke (pictured above
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New faces at Synergy Vision, Makara Health and JPA Health
regional health communications campaigns. In her new role, she will leverage her expertise in FDA/EMA communications, patient and physician education, scientific communications, issues management and celebrity engagement to serve JPA
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NDA Group appoints Alison McGregor as its principal consultant
Johan Stromquist, chief executive officer, NDA Group, said: “The US expansion is our main focus in 2018 and we are planning expanding our support for FDA and EMA submissions, milestone meetings
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Dr Paula Salmikangas joins NDA Group
She is the former chair of the EMA’s Committee for Advanced Therapies and comes to NDA from the Finnish Medicines Agency, where she served as a research professor.
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Dr Desiree Luthman joins Verona Pharma
She has an accomplished track record of working closely with the FDA and EMA on behalf of international healthcare companies to achieve key regulatory milestones.
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Approximately 14 fully matching, plus 18 partially matching documents found.
Latest from PMHub
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Genesis Research Acquires Market Access Transformation
MAT’s Envision is the only syndicated research platform that provides forward thinking evaluations of the market access viability for a product after it has received positive EMA or FDA guidance.
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The future of nanomedicine regulation
Since 1989, 78 medicines have received approval on a global scale with 66 nanodrugs being approved by the FDA and 31 by the EMA.
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Rare Disease Day – why it’s important to show your stripes
A standardised definition for rare diseases is currently lacking, with incidences typically defined by regional legislations developed to incentivise drug development (termed ‘orphan medicines/drugs’ by the FDA and EMA).
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What does the COVID-19 vaccine mean for the future of R&D?
as the European Medicines Agency (EMA) introduced “rolling reviews”, to monitor data as and when it was produced.
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Mistrust in medical research: a patient perspective
The recent development of several COVID-19 vaccines has placed medical research firmly in the spotlight, highlighting public confusion and misinformation about clinical trials. Patient advocate, Trishna Bharadia reveals what the life sciences
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Approximately 0 fully matching, plus 23 partially matching documents found.
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- Sanofi halts recruitment for trials assessing MS treatment
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- Environment: where does the pharmaceutical industry stand?
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- Novartis reports death of two patients treated with Zolgensma
- AstraZeneca and Daiichi Sankyo receive FDA approval for lung cancer drug
- Are we the masters or servants of omnichannel engagement?
- JCVI publishes advice on COVID-19 vaccines ahead of autumn booster campaign
- AstraZeneca and Daiichi Sankyo’s Enhertu shows significant improvement for breast cancer patients
- Gilead Sciences announce positive results for Trodelvy in breast cancer patients
- UK government to launch national mission to tackle dementia
- WHO publishes first position paper on optimising brain health
- Novartis’ Pluvicto receives MHRA marketing authorisation to treat advanced prostate cancer
- Sanofi halts recruitment for trials assessing MS treatment
- Environment: where does the pharmaceutical industry stand?
- AstraZeneca and Daiichi Sankyo receive FDA approval for lung cancer drug
- Amgen acquires ChemoCentryx in $3.7bn cash deal
- Avastin wins EU approval for advanced renal cancer
PMHub
Life Healthcare Communications
Life is a creative communications agency offering multi-channel solutions for the healthcare industry. We use a storytelling approach to turn...
Latest intelligence
- Environment: where does the pharmaceutical industry stand?
- ...
- The communication challenge of helping he next generation to be healthier
- As the pressure on the health service increases the health of the next generation is vital for everyone. How do we show positive attitudes and change behaviour while future proofing...
- Are we losing sight of what the democratisation of healthcare really looks like?
- We have a core responsibility as healthcare communicators to consistently drive for better inclusion, engagement and compliance. What does the ‘democratisation of healthcare’ really look like?...
