This page shows the latest EMA news and features for those working in and with pharma, biotech and healthcare.
The European Medicines Agency’s (EMA) human medicines committee has recommended revoking the conditional marketing authorisation for Novartis’ sickle cell disease (SCD) drug Adakveo (crizanlizumab). ... SCD. However, due to the data being limited and
The European Medicines Agency (EMA) has published a reflection paper discussing key considerations for single-arm clinical trials that are used as pivotal evidence in regulatory filings. ... The reflection paper has been adopted by EMA’s human
The companies have also submitted an application to the EMA for this age group. ... Pfizer and BioNTech said that, in addition to their US application, they have made a submission to the European Medicines Agency (EMA) for use of the bivalent vaccine as
symptoms. Biogen withdrew its application for the use of Aduhelm in Europe in April 2022 after discussions with the European Medicine Agency’s (EMA’s) Committee for Medicinal Products for Human ... The EMA explained that, despite Aduhelm reducing
Bristol Myers Squibb (BMS) has announced that its plaque psoriasis treatment, Sotyktu (deucravacitinib), has been recommended by the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use ... psoriasis. BMS also outlined
European officials have said that they are closely monitoring and responding to the current shortage of antibiotics across the EU through the European Medicines Agency’s (EMA’s) Executive Steering Group ... The European Commission, Head of Medicines
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Incentive offers from regulators such as the Food and Drug Administration (FDA), the European Medicines Agency (EMA) and the Medicines and Healthcare products Regulatory Agency (MHRA) to address unmet medical needs. ... evaluation. This approach is
to the EMA most efficiently.
The impact of biosimilar interchangeability. In 2022, an important milestone for our industry was the publication of the joint European Medicines Agency (EMA) and Heads of Medicines Agencies (HMA) statement on
We analysed 22 non-oncology orphan drugs (ODs) that received EMA approval between July 2012 to the end of 2019, focusing on chronic, non-curative treatments. ... Dosing assumptions followed EMA or HAS (Haute Autorité de Santé) guidelines.
The European Medicines Agency (EMA) updated its Clinical Trials Regulation to ensure sponsors justify any non-representative procedures in January this year; this was followed by the US Food and Drug ... The current state of trial participation. With the
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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
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
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
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.
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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The European Medicines Agency (EMA) supports the development and authorisation of medicines for rare diseases (often referred to as ‘orphan’ diseases) through incentives such as protocol assistance, grants, and reduced fees.
3. Similarly, the EMA published an update to their Engagement Framework earlier this year. ... Available at www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm368342.htm. Accessed November 2022. European Medicines Agency. Engagement Framework:
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.
Since 1989, 78 medicines have received approval on a global scale with 66 nanodrugs being approved by the FDA and 31 by the EMA.
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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