Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) have submitted on Monday, November 30, 2020, a formal Application for Conditional Marketing Authorization (CMA) to the European Medicines Agency (EMA) for their mRNA vaccine candidate, BNT162b2, against COVID-19. This submission completes the rolling review process initiated on October 6, 2020, with nonclinical data and partial […]
The Commission has today adopted a Pharmaceutical Strategy for Europe to ensure patients have access to innovative and affordable medicines and to support the competitiveness, innovative capacity and sustainability of the EU’s pharmaceutical industry. The Strategy will allow Europe to cover its pharmaceutical needs, including in times of crisis, through robust supply chains. A key […]
To create a more robust mandate for coordination by the Commission and EU agencies, the Commission is today proposing a new Regulation on serious cross-border threats to health. The new framework will: For More Information European Health Union website https://ec.europa.eu/info/strategy/priorities-2019-2024/promoting-our-european-way-life/european-health-union_en
The European Centre for Disease Control and Prevention and the European Medicines Agency have been at the forefront of the EU’s work to address COVID-19 since the outbreak of the pandemic. However, COVID-19 has shown that both agencies need to be reinforced and equipped with stronger mandates to better protect EU citizens and address cross […]
Today, the European Commission is taking the first steps towards building the European Health Union announced by President von der Leyen in her State of the Union address. The Commission is putting forward a set of proposals to strengthen the EU’s health security framework, and to reinforce the crisis preparedness and response role of key […]
Long-term collaboration underpins BioNTech’s strategy to leverage Artificial Intelligence (AI) and Machine Learning (ML) technologies to support the discovery and development of novel immunotherapies based on InstaDeep’s DeepChainTM technology platform BioNTech and InstaDeep to establish a joint AI Innovation Lab to advance a portfolio of enterprise-wide digital initiatives in the areas of drug discovery and […]
BioNTech SE (“BioNTech”; Nasdaq: BNTX,) and Shanghai Fosun Pharmaceutical (Group) Co., Ltd (“Fosun Pharma”; Stock Code: 600196.SH, 02196.HK) jointly announced that their lead mRNA COVID-19 vaccine candidate BNT162b2 will be evaluated in a Phase 2 clinical trial in Taizhou and Lianshui, Jiangsu Province, China. The Phase 2 clinical trial of BNT162b2 in China will be […]
—————————————————————————————————————- Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced they will submit a request today to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of their mRNA vaccine candidate, BNT162b2 against SARS-CoV-2, which will potentially enable use of the vaccine in high-risk populations in the U.S. by the middle […]
• Novartis enters into exclusive worldwide license with Mesoblast to develop, commercialize and manufacture remestemcel-L for treatment of acute respiratory distress syndrome (ARDS) and other indications • Addition of remestemcel-L could expand Novartis respiratory portfolio by adding potential first-in-class ARDS therapy using innovative cell-based technology with platform potential • Deal includes $50 million upfront cash […]
Pfizer and BioNTech plan to submit the efficacy and safety data from the study for peer-review in a scientific journal once analysis of the data is completed. Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that, after conducting the final efficacy analysis in their ongoing Phase 3 study, their mRNA-based COVID-19 vaccine […]
Pfizer (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that they have reached an agreement with the European Commission to supply 200 million doses of their investigational BNT162b2 mRNA-based vaccine candidate against COVID-19 to European Union (EU) Member States, with an option for the European Commission to request an additional 100 million doses. Deliveries […]
We are developing a potential vaccine based on our proprietary mRNA technology to induce immunity and prevent COVID-19 infections in response to the growing global health threat. In order to accelerate the rapid development of our product candidate BNT162 we initiated the global development program Lightspeed. The program leverages https://biontech.de/covid-19 BioNTech also photo
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