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European Medicines Agency
This page shows the latest European Medicines Agency news and features for those working in and with pharma, biotech and healthcare.
EMA grants Bavarian Nordic access to PRIME scheme for RSV vaccine candidate
Bavarian Nordic has announced that the European Medicines Agency (EMA) has granted access to its priority (PRIME) scheme for the company's vaccine candidate for the prevention of lower respiratory tract ... The EMA launched its PRIME scheme to enhance
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European Commission approves potential new treatment for Pompe disease
The European Commission (EC) has issued a marketing authorisation for Sanofi Genzyme’s therapy Nexviadyme (avalglucosidase alfa) for the long-term treatment of both late-onset and infantile-onset Pompe disease. ... In November 2021, Sanofi announced
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Pfizer and BioNTech share positive results for Omicron-adapted COVID-19 vaccine
The latest results will be shared with the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) ahead of discussions with the FDA Vaccines and Related Biological Products Advisory ... Committee on 28 June and with the International
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FDA grants Pfizer/BioNTech’s COVID-19 vaccine emergency use authorisation for infants
The companies plan to submit requests for authorization of their COVID-19 vaccine in this age group to the European Medicines Agency and other global regulators in early July.
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Shionogi, GARDP and CHAI team up to increase antibiotic access worldwide
After approval by the US Food and Drug Administration (FDA) in 2019 and subsequent approval by the European Medicines Agency (EMA) in 2020, cefiderocol was recently added to the World Health ... Shionogi and GARDP will work with CHAI, which has expertise
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Positive CHMP opinion issued for PTC Therapeutics’ Upstaza
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has issued a positive opinion for PTC Therapeutics’ Upstaza (eladocagene exuparvovec). ... PTC anticipates that the European Commission will ratify the marketing
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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 ... Grimes- Crompton, senior adviser at healthtech agency VISFO,
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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. ... One trend that we’re witnessing in industry data, and from anecdotal evidence from our clients, is that more
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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 ... Acceptance of biosimilars in Europe. It is
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Assessing the impact of disease prevalence on access and pricing of rare disease drugs in England
We reviewed 47 non-oncology ODs that were approved by the European Medicines Agency (EMA) between 2006 and 2019. ... The overall level of reimbursement for non- oncology ODs in England is high, with 70.2% (33/47) of medicines in the sample being
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Medicinal data – what’s next for IDMP?
The European Medicines Agency's (EMA) headquarters in Amsterdam. The global response to COVID-19 has shone a light on the broader potential for global data standards, including those defined via ... the International Organization for Standardization (ISO)
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Latest appointments
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New hires at EMA, Gilead and BeiGene
European Medicines Agency (EMA). The European Medicines Agency (EMA) management board has nominated Emer Cooke (pictured above) as its new executive director. ... Cooke worked for the pharmaceutical unit of the European Commission from 1998 to 2002, and
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Emotive grows medical writing capacity
Dr Silvana Bardelli and Dr Ann Gilliat join the agency. Healthcare Communications agency Emotive has strengthened its medical writing team with the addition of two new hires. ... Dr Silvana Bardelli (pictured right) joins as a senior medical writer
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Zelluna appoints Miguel Forte as CEO
Prior to his new role, Forte has held roles for Bone Therapeutics, TxCell, the European Medicines Agency, and UCB to name a few.
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Bone Therapeutics strengthens clinical development team
His career to date has also seen him hold positions such as vice president, global medical affairs at UCB, as well as senior positions at the European Medicines agency, Bristol-Myers
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EMA’s head of international affairs steps down
The European Medicines Agency's (EMA) Emer Cooke has resigned as head of international affairs, to be replaced ad interim by Agnès Saint-Raymond. ... She has served as head of international affairs since 2013, and is leaving the agency to pursue a new
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Improving healthcare for rare disease patients
Accessed March 1, 2022. European Medicines Agency. Orphan designation: Overview. ... Accessed March 1, 2022. NHS England. NHS England announces new Innovative Medicines Fund to fast-track promising new drugs.
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What does the COVID-19 vaccine mean for the future of R&D?
The European Commission and the UK Government Vaccine Taskforce have also been significant contributors to a wide variety of vaccine projects. ... as the European Medicines Agency (EMA) introduced “rolling reviews”, to monitor data as and when it was
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Mistrust in medical research: a patient perspective
She concludes that Thalidomide completely changed the way medicines are tested and approved. ... More public awareness initiatives, such as the European Medicines Agency’s recent public stakeholders meeting on the scientific evaluation of the COVID-19
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EU Pharmaceutical Strategy Roadmap
Orphan Medicinal Products were a major focus. The European Parliament also adopted a resolution in 2017, on possible EU options for improving access to medicines. ... for the European Medicines Agency.
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World Ovarian Cancer Day: Current treatments and future hopes for ovarian cancer
10. European Medicines Agency. Lynparza. Available at: https://www.ema.europa.eu/en/medicines/human/EPAR/lynparza. Accessed April 2019. ... 11. European Medicines Agency. Zejula. Available at: https://www.ema.europa.eu/en/medicines/human/EPAR/zejula.
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Onyx Health is a healthcare communications and PR agency based in the North East of England, but with a national...
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