Please login to the form below
Marketing Authorisation Application
This page shows the latest Marketing Authorisation Application news and features for those working in and with pharma, biotech and healthcare.
Janssen reports updated phase 3 results for niraparib combination in prostate cancer
The company has already submitted a marketing authorisation application to the European Medicines Agency for the niraparib-AAP combination, based on earlier data from the study, with applications also under review
Latest news
-
EC approves Atara and Pierre Fabre’s Ebvallo as monotherapy for Epstein-Barr patients
Atara Biotherapeutics (Atara) and Pierre Fabre have announced that the European Commission (EC) has granted marketing authorisation for Ebvallo (tabelecleucel) as a monotherapy for adult and paediatric patients two years of ... following the transfer of
-
Pfizer and Valneva report six-month antibody persistence data for Lyme disease vaccine
Upon successful completion of the studies, Pfizer could submit a Biologics Licence Application to the US Food and Drug Administration and Marketing Authorisation Application to the European Medicines Agency in 2025.
-
FDA receives Santhera and ReveraGen’s application for Duchenne muscular dystrophy treatment
The US Food and Drug Administration (FDA) has received Santhera Pharmaceuticals (Santhera) and ReveraGen BioPharma’s completed rolling submission of a New Drug Application (NDA) for the priority review of vamorolone ... In Europe, Santhera has
-
GSK’s anaemia drug gets FDA advisory committee support for patients on dialysis
The FDA will consider the vote, feedback and recommendations from the CRDAC as it reviews the New Drug Application for daprodustat, with a final decision expected by 1 February 2023. ... In March 2022, the European Medicines Agency validated the
-
EMA accepts Santen’s application for glaucoma treatment STN1013001
The European Medicines Agency (EMA) has accepted Santen Pharmaceutical’s (Santen) marketing authorisation application (MAA) for use of STN1013001 (cationic emulsion of latanoprost 50μg/ml) for lowering of intraocular pressure (IOP) ... The application
More from news
Approximately 1 fully matching, plus 107 partially matching documents found.
Latest Intelligence
-
Transforming clinical trial data into a long-term asset
The TMF is central to drug development and key to any marketing authorisation application (MAA). ... They could even have a negative impact on good clinical practice and engender regulatory risk during the trial, potentially causing delays to marketing
-
The European Medicines Agency: PRIME’d for access?
Getting into the PRIME scheme offers a number of benefits. They include early appointment of a rapporteur to provide support and guidance for later application for marketing authorisation, a kick-off ... that an application for marketing authorisation is
-
Protecting patient privacy
Once companies submit a marketing authorisation application to EMA, the guidance specifies that they should ideally take no more than 180 days to provide the equivalent anonymised content for the designated
-
The logistics of orphan drugs
These programmes facilitate access to medicines that are in clinical development, are unlicensed in a specific market but licensed elsewhere, or are in the marketing authorisation application (MAA) process.
-
Orphan drugs: the early access regulatory environment
the marketing authorisation application (MAA) process.
More from intelligence
Approximately 0 fully matching, plus 7 partially matching documents found.
Latest from PMHub
-
21st Century Cures Act: a commercial perspective on how the new FDA regulation could revolutionise use of RWE and analytics in healthcare
market. For years, the priorities of drug development programmes were to prove the safety and efficacy of a drug in a placebo controlled, double-blind clinical trial that would support application ... for marketing authorisation.
-
Real world project management
market but licensed elsewhere, or are in the marketing authorisation application (MAA) process.
More from PMHub
Approximately 0 fully matching, plus 2 partially matching documents found.
Subscribe to our email news alerts
- Strategy Director - Healthcare Advertising
- £90,000 - £120,000 yearly
-
Senior Medical Writer
- Highly competitive salary
- Early Access Program - Regulatory Affairs (EAP-RA)
- Highly competitive salary
- Associate Director - Global Healthcare Consulting
- £100,000 - £115,000 yearly
-
Technical Sales Representative
- Highly competitive salary
-
Omnichannel Account Director
- £55,000 - £65,000 yearly
-
Pharmacovigilance Project Lead
- Highly competitive salary
-
Pharmacovigilance Manager
- Highly competitive salary
- FDA proposes improvements for oncology clinical trials supporting accelerated approval
- AbbVie’s Parkinson’s disease therapy application rejected by FDA
- AstraZeneca’s mild combination asthma reliever approved in UK
- Eli Lilly increases investment to almost $1bn for new Irish manufacturing facility
- Merck reports positive results for Keytruda plus chemotherapy in endometrial cancer
- AstraZeneca/MSD’s Lynparza combination approved in UK for prostate cancer
- Bristol Myers Squibb’s Sotyktu approved by EC for plaque psoriasis
- Positive results for Almirall’s lebrikizumab in atopic dermatitis published in NEJM and BJD
- When to call in the specialists: strategy in Medical Affairs
- Time to talk about health inequalities
- Powering Rapid Cognitive Analysis with AI
- AstraZeneca and Amgen’s Tezspire recommended by NICE for severe asthma
PMHub
Say Communications
We focus on what matters most…. Driven by insight, expertise and fresh thinking, our award-winning communications programmes are designed to...
Latest intelligence
- Time to talk about health inequalities
- Health inequalities are increasingly being recognised as a crucial healthcare challenge in the UK...
- The speed of science and the pace of comms
- Pharma red tape slows comms but there is a solution, Paul Hutchings, founder of fox&cat, writes....
- Improving cardiovascular disease care and awareness
- Scott Curley talks to PME about the risks of CVD and the importance of getting the right treatment at the right time...
