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 introduces new measures to enable flexibility for non-COVID-19 procedures
For all applications the EMA will also temporarily remove the need for a separate, formally appointed peer reviewer. ... For post-authorisation procedures, the EMA has amended the co-rapporteurs’ involvement in the assessment process.
Latest news
-
Pfizer asks UK's MHRA to approve its COVID-19 vaccine in adolescents
The companies also announced earlier this week that they have submitted the data from this trial to a number of additional global regulators, including the European Medicines Agency (EMA).
-
Emergency authorisation for Pfizer/BioNTech vaccine expanded in the US
Data from a study involving 12 to 15 year olds has also been submitted to the EMA for potential approval. ... Pfizer and BioNTech have also submitted the data from this trial to a number of additional global regulators, including the European Medicines
-
EMA launches rolling review of GSK/Vir Biotech’s mAb for early COVID-19
The European Medicines Agency (EMA) has launched a rolling review of GlaxoSmithKline (GSK) and Vir Biotechnology’s SARS-CoV-2 monoclonal antibody (mAb) VIR-7831 for the early treatment of ... The EMA will review all data on VIR-7831 to reach a decision
-
Novavax is close to finalising a COVID-19 vaccine supply deal with the EU
The European Medicines Agency (EMA) initiated a rolling review of Novavax’s COVID-19 vaccine in February, based on preliminary results from lab studies and early clinical studies in adults.
-
GSK wins approval for anti-PD-1 antibody Jemperli in endometrial cancer
Last year, the company also received milestone payments of $10m and $5m, respectively, for the FDA’s and European Medicines Agency’s (EMA) acceptances of filings for Jemperli.
Pfizer asks UK's MHRA to approve its COVID-19 vaccine in adolescents
Emergency authorisation for Pfizer/BioNTech vaccine expanded in the US
EMA launches rolling review of GSK/Vir Biotech’s mAb for early COVID-19
Novavax is close to finalising a COVID-19 vaccine supply deal with the EU
GSK wins approval for anti-PD-1 antibody Jemperli in endometrial cancer
More from news
Approximately 279 fully matching, plus 801 partially matching documents found.
Latest Intelligence
-
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.
-
Setting up for success in a post-Brexit, post-pandemic Britain
of the EMA submission are real issues that we need to address.
-
A new era for UK-Japanese scientific research relations
EMA. By continuing to deliver these protocols and maintaining close relationships with the MHRA, as a regulator facilitating this innovation through the MHRA Innovation Office, the UK research industry has an ... The MHRA meets the standards of the EMA,
-
Rare genetic diseases – what’s in store for 2021?
In 2020 we saw breakthroughs for the treatment of many diseases, with over 76 positive opinions granted by the EMA.
-
Medicinal data – what’s next for IDMP?
Over the last 12 months, the EMA completed its reorganisation and ‘future- proofing’ exercise. ... Another crucial development towards this end in 2020 has been the replacement of the Common European Single Submission Portal (CESSP) initiative with
Assessing the impact of disease prevalence on access and pricing of rare disease drugs in England
Setting up for success in a post-Brexit, post-pandemic Britain
A new era for UK-Japanese scientific research relations
Rare genetic diseases – what’s in store for 2021?
Medicinal data – what’s next for IDMP?
More from intelligence
Approximately 8 fully matching, plus 83 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.
New hires at EMA, Gilead and BeiGene
New faces at Synergy Vision, Makara Health and JPA Health
NDA Group appoints Alison McGregor as its principal consultant
Dr Paula Salmikangas joins NDA Group
Dr Desiree Luthman joins Verona Pharma
More from appointments
Approximately 14 fully matching, plus 18 partially matching documents found.
Latest from PMHub
-
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).
-
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.
-
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
-
Are biobetters a market access opportunity?
Mircera, used in the treatment of anaemia in Chronic Kidney Disease (CKD), was approved in 2007 by the European Medicines Agency (EMA) for once-monthly dosing as opposed to weekly dosing
-
Why are new medicinal products denied reimbursement in France?
This is different to the remit of regulators; while the European Medicines Agency (EMA) conducts a risk/benefit assessment based on efficacy and safety data that takes into consideration the availability ... European Medicines Agency. 2015. Available at:
Rare Disease Day – why it’s important to show your stripes
Why are new medicinal products denied reimbursement in France?
More from PMHub
Approximately 0 fully matching, plus 24 partially matching documents found.
COVID-19 Updates and Daily News
Featured jobs
-
Publications Director
-
Competitive Salary
-
Senior Account Executive
-
Competitive Salary
-
Medical Editor
-
Competitive Salary
- Senior Account / Programme Manager - MedComms - Buckinghamshire
-
Highly Competitive Remuneration packages
- Senior & Principal Medical Writer
-
Competitive Salary Offered
- Senior Medical Writer– Medical Education – Oxford - London
-
Excellent Remuneration Package
- Account Manager / Senior Account Manager - Creative MedComms - C...
-
Excellent Remuneration
-
Account Manager
-
Competitive Salary
- Head of Strategic Planning, Healthcare Advertising/ Brand comms,...
-
Six figure salary
- Senior Account Manager/ Account Director
-
Competitive Salary Offered
- Medical Writers (All levels) Editorial / Scientific Leads & ...
-
Highly Competitive Remuneration packages
-
Associate Account Director
-
Competitive Salary
-
Senior Medical Writer
-
Competitive Salary
- Account Manager - Creative Healthcare Communications - South Wes...
-
Excellent Remuneration
-
Account Management
-
Competitive Salary Offered
- Group Account Director, Healthcare Advertising/ Brand comms, Lon...
-
8 month contract up to £90K
- Merck & Co reveals plans for women’s health spinoff Organon
- Novavax announces further delays for regulatory filings of COVID-19 vaccine
- EMA launches rolling review of GSK/Vir Biotech’s mAb for early COVID-19
- AbbVie lauds head-to-head win for Skyrizi versus Cosentyx
- AZ, Amgen file first-in-class asthma drug with the FDA
- bluebird bio aiming to separate business units by year-end
- Research Partnership’s MedTech Division appoints two Directors
- VMLY&Rx launches new payer agency in the US
- Biogen and Envisagenics to advance RNA splicing research for CNS diseases
- Positive results for GSK/CureVac’s COVID-19 vaccine
- New trial data for Keytruda in triple-negative breast cancer
- NICE recommends Keytruda for colorectal cancer patients with rare mutations
- New trial data for Keytruda in triple-negative breast cancer
- Positive results for GSK/CureVac’s COVID-19 vaccine
- Pfizer asks UK's MHRA to approve its COVID-19 vaccine in adolescents
- US backs proposal to waive IP protection for COVID-19 vaccines
- Virtual agency The Difference Collective makes new hires to senior team
- bluebird bio aiming to separate business units by year-end
PMHub
JPA Health
JPA Health is an award-winning public relations, marketing and advocacy firm known for sharing our clients’ commitment to making people...
Latest intelligence
- How innovating study sites can improve patient recruitment efficiency
- There are so many ways that clinical trials have innovated over the last few years. There is now a larger focus on making trials more patient-centric, more virtualised, and more...
- Avoiding A Series of Unfortunate Events: launch lessons from lockdown
- Chris Ross takes a novel look at launch excellence through the lens of COVID-19 and explores how pharma’s launch leaders are rewriting the story...
- 6 reasons patients drop out of clinical trials and 6 ways to fix it
- If you’ve successfully recruited patients for your clinical trial, but one by one, they begin to drop out, then this information could be for you....
