Please login to the form below
EMA
This page shows the latest EMA news and features for those working in and with pharma, biotech and healthcare.
EMA recommends revoking marketing authorisation for Novartis’ sickle cell disease drug
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
Latest news
-
EMA addresses considerations for single-arm trials as pivotal evidence in regulatory filings
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
-
Pfizer/BioNTech’s Omicron-adapted booster approved by FDA for young children
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
-
Safety-related change to label for Biogen’s Alzheimer's drug Aduhelm approved by FDA
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’s plaque psoriasis treatment recommended by CHMP
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
-
EU outlines measures to mitigate antibiotic shortage across Europe
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
More from news
Approximately 297 fully matching, plus 907 partially matching documents found.
Latest Intelligence
-
Rare diseases: not so rare after all
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
-
Life sciences reimagined
to the EMA most efficiently.
-
Biosimilars and beyond: innovating for improved patient outcomes
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
-
Assessing the impact of rarity on French HTA and pricing decisions
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.
-
Addressing the diversity issue in clinical trials
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
More from intelligence
Approximately 8 fully matching, plus 94 partially matching documents found.
Latest appointments
-
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
-
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
-
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
-
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.
-
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.
More from appointments
Approximately 14 fully matching, plus 18 partially matching documents found.
Latest from PMHub
-
Rare Diseases - not as rare as you think
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.
-
End-to-end patient strategy: Making a treatment for patients, with patients
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:
-
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.
-
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.
-
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).
More from PMHub
Approximately 0 fully matching, plus 25 partially matching documents found.
Subscribe to our email news alerts
- Home Based Account Manager, Medical Communications, UK, Pharma/M...
- Highly competitive salary
- Market Access Director, six figure base salary and £5K joining b...
- Highly competitive salary
- Account Manager, 6 month contract, Healthcare Brand communicatio...
- Highly competitive salary
- Account Director, Healthcare Marketing Creative Agency, Fixed te...
- Highly competitive salary
- Account Manager, Healthcare Marketing Creative Agency, Fixed ter...
- Highly competitive salary
- Senior Medical Copywriter - Highly Awarded Advertising Agency
- £50,000 - £60,000 yearly
- Novartis receives EC approval for Cosentyx in hidradenitis suppurativa
- BMS and Janssen’s antithrombotic granted FDA fast track designation
- Pfizer’s antibiotic combination shows promise in treating multi-drug resistant infections
- Sanofi's frexalimab shows promise in relapsing forms of MS
- EMA recommends revoking marketing authorisation for Novartis’ sickle cell disease drug
- Pfizer’s RSV vaccine approved by FDA for older adults
- Archetypes: Rethinking go-to-market expectations to drive commercial success
- Navigating patients step by step on their clinical trial journey
- Innovative Trials responds to national recommendations to tackle UK clinical trial decline
- AstraZeneca shares positive phase 3 results for Tagrisso in lung cancer
- BMS presents positive four-year results for Opdivo combination in lung cancer
- Tuberculosis – why it remains a major global public health challenge
No results were found
PMHub
11 London
We live in a hyper-connected world. This has clear benefits for the health of our communities, our businesses and our...
Latest intelligence
- Archetypes: Rethinking go-to-market expectations to drive commercial success
- In this white paper, our consultants analyze trends spanning global policy developments, rising inflation, and increasingly complex customer journeys, and reveal a new data-driven approach to archetyping that crystalizes the...
- Tuberculosis – why it remains a major global public health challenge
- Innovative collaboration is required to address the major public health challenges around TB and expedite drug development...
- Whitepaper: Closing the gap with compelling healthcare communications
- Want to learn how to close the distance between a person’s current health and their healthiest possible self?...
