Challenges Bringing Drugs to All EU Member States Worry Pharma
As the European Commission prepares for a major revamp to drug legislation, pharma executives and thought leaders worry that even with the new laws, rolling out new drugs to all 27 member states in a short timeframe will be a difficult task to achieve. The proposed law would offer pharma companies an additional years of data protection if new drugs reach all EU markets within 2-3 years of launch, which will be complicated if reimbursement decisions must be made in that period.
Aligning Cancer Therapeutic Evidence Between EMA and EU HTAs
Many of the health technology assessment agencies (HTAs) of EU member nations have evidence requirements for cancer drugs that are different than those of the European Medicines Agency (EMA). This disparity often delays patient access. In a new article in Value in Health, authors break down these different requirements to highlight the need for alignment between EMA and EU HTA requirements.
EMA Leans into Push to Improve Real-World Data Sources for Regulatory Decision-Making
Officials from the European Medicines Agency (EMA) and member state national health technology assessment (HTA) agencies recently announced they were going forward with plans to improve the quality of real-world data (RWD) resources for use in regulatory decision-making. The EMA and HTA bodies established a Big Data Steering Group, which has already endorsed documents that will go through a phase of public consultation.
Pfizer Gets Positive Data in EU Trial for 20-Valent Pneumococcal Vaccine
Pfizer has reported promising results from an EU late-stage trial supporting the use of its 20-valent pneumococcal vaccine in infants. The results will be used in Pfizer’s filing of the vaccine with the European Medicines Agency, which is expected to be completed by the end of 2022. This news comes just over a month after the company reported results from a similar trial in the US.
EU Commission Approves Novavax COVID-19 Boosters
The EU Commission has approved the Novavax COVID-19 vaccine booster for adults 18 and above. The move comes only weeks after the European Medicine Agency (EMA) recommended the use of booster doses of the protein-based vaccine. The shot is currently authorized for the purpose in 3 APAC countries, Japan, New Zealand, and Japan.
Pfizer and BioNTech’s Bivalent COVID-19 Vaccine Boosters Get EU Approval
The European Medicines Agency (EMA) has just issued conditional marketing authorization (CMA) for both Pfizer and BioNTech’s bivalent COVID-19 vaccines. The agency’s Committee for Medicinal Products for Human Use (CHMP) approved the vaccines as boosters for people 12 and up. These vaccines contain spike protein mRNA for the original SARS-CoV-2 virus and the BA.4/BA.5 Omicron strains currently dominant across the globe.
Contract research organization Service Market Trends, Leading Key Players, Future Growth, Revenue, Demand Forecast, Applications 2021-2027
A comprehensive overview of the contract research organization services market is recently added by UnivDatos Market Insights to its humongous [...]
Your 3-Step Strategy For A Successful Drug Candidate
While scientific innovation is propelling healthcare into the future, there remains a distinct gap between technologies that make it to [...]
Abbvie Applies for EMA Marketing Authorization for Migraine Drug Atogepant
The drugmaker Abbvie has applied to the European Medicines Agency (EMA) for marketing authorization for Atogepant, its prophylactic migrain treatment. Data supporting the application comes from two phase three studies, which showed the drug was well tolerated and was effective at reducing the occurrence of migraines.
Bavarian Nordic’s RSV Vaccine Candidate Granted PRIME Eligibility
The PRIME scheme helps accelerate assessment by the European Medicines Agency for therapeutics that treat otherwise unmet medical needs. Bavarian [...]
European Medicines Agency Recommends Suspension of 100 Drugs Due to CRO Data Concerns
Data integrity issues at Synchron Research Services spurred the European Medicines Agency to recommend the suspension of 100 drugs. Synchron, [...]
Biogen Alzheimer’s Drug Pulled from European Application Process
Following a rocky series of setbacks in Europe and abroad, Biogen has backed out of the application process in Europe [...]
European Medical Agency: Clinical Trials Require Substantial Changes Due to War in Ukraine.
The invasion of Ukraine has greatly impacted clinical trials in Europe, as the country housed many clinical trial sites. Sponsors [...]
Moderna seeks FDA Emergency Authorization for Children Under 6
Moderna touts new data supporting the use of its COVID-19 vaccine Spikevax in children under 6 as it prepares to [...]
EMA Issues Guideline on RWE in Registry-Based Studies
The European Medicines Agency (EMA) has released new guidelines for using and generating RWE in registry-based studies. The guideline highlighted [...]
EMA Data Expert Discusses Gaps in RWE Framework
The European Medicines Agency (EMA) has recognized gaps in guidelines on real world evidence (RWE) submissions. The EMA’s Xavier Kurz [...]
Report: European Drug Regulatory Network Faces Uncertain, Complex Future
A new strategy produced by European regulators considers future challenges for the European drug regulatory network, The Pink Sheet reports. [...]
EMA Calls for Transparency, Collaboration in COVID-19 Studies
The European Medicines Agency (EMA) is urging transparency and collaboration on COVID-19 studies to facilitate more robust results. "High-quality observational [...]
EMA Reportedly Preparing Q&A Guidance on Big Data
The European Medicines Agency (EMA) is reportedly preparing new guidance on the application of EU data rules for secondary use [...]
