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Pfizer and BioNTech Submitted Application for Conditional Marketing Authorization for COVID-19 Vaccine to the EMA

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 […]

EU Commission Pharmaceutical Strategy for Europe -Affordable, accessible and safe medicines for all

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 […]

A stronger EU health security framework

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

Stronger and more operational EU Medicine Agencies

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 […]

BioNTech and InstaDeep Announce Strategic Collaboration and Form AI Innovation Lab to Develop Novel Immunotherapies

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 and Fosun Pharma Announce the Start of a Phase 2 Clinical Trial of Lead mRNA COVID-19 Vaccine BNT162b2 in China

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 and BioNTech to Submit Emergency Use Authorization Request Today to the U.S. FDA for COVID-19 Vaccine

—————————————————————————————————————- 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 secures exclusive rights for potential acute respiratory distress syndrome cell therapy

• 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 Conclude Phase 3 Study of COVID-19 Vaccine Candidate, Meeting All Primary Efficacy Endpoints

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 and BioNTech Reach an Agreement to Supply the EU with 200 Million Doses of Their BNT162b2 mRNA-based Vaccine Candidate against COVID-19

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 […]

BioNTech’ Aiming to address the global coronavirus pandemic: Project Lightspeed all details here

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

Merck Collaborates with Mammoth Biosciences to Scale New SARS-CoV-2 Test

Merck today announced a collaboration with Mammoth Biosciences Inc. for the development, scale-up and commercial production of Mammoth’s CRISPR-based SARS CoV-2 diagnostic test. Merck, a leading science and technology company, today announced a collaboration with Mammoth Biosciences Inc., of South San Francisco, California, USA, for the development, scale-up and commercial production of Mammoth’s CRISPR-based SARS […]

Coronavirus: EU Commission lists key steps for effective vaccination strategies and vaccines deployment

As Europe learns to live with the pandemic, the development and swift global deployment of safe and effective vaccines against COVID-19 remains an essential element in the eventual solution to the public health crisis. In this context, the Commission is working to ensure that there will be access to safe vaccines across Europe, and encourages […]

Pfizer and BioNTech Announce New England Journal of Medicine Publication of Phase 1 Data on Lead mRNA Vaccine Candidate BNT162b2 Against COVID-19

Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that preliminary, peer-reviewed data from the Phase 1 portion of their ongoing U.S. study of BNT162b2 were published online in the New England Journal of Medicine (NEJM).   BNT162b2, which has advanced into a global Phase 3 study, is part of the companies’ mRNA-based […]

BioNTech to Present Data from BNT311 (GEN1046) and BNT131 (SAR441000) Programs at SITC 35th Annual Meeting

BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the Company”) today announced that results from three clinical and preclinical studies have been accepted for presentation at the Society for Immunotherapy of Cancer (SITC) 35th Annual Meeting. The data represent the first clinical results from BioNTech’s ongoing collaborations with Genmab and Sanofi from both its mRNA and antibody […]

New Clinical Trial for a COVID-19 Vaccine Authorised in Germany

The Paul-Ehrlich-Institut, Federal Institute for Vaccines and Biomedicines has authorised another Phase-1 clinical trial of a vaccine against COVID-19 in Germany. The new vaccine candidate is a so-called vector vaccine. Trials on vaccine candidates in humans are a significant step in the direction of authorising safe and efficacious vaccines against COVID-19. This new vaccine is […]

BioNTech and Pfizer Announce Nature Publication of German Phase 1/2 Study Data from mRNA-based Vaccine Candidate BNT162b1 Against SARS-CoV-2

BioNTech SE (Nasdaq: BNTX) and Pfizer Inc. (NYSE: PFE) today announced that preliminary, peer-reviewed data from their ongoing German Phase 1/2 Study of BNT162b1 were published online in the journal Nature. BNT162b1 is part of the companies’ mRNA-based vaccine development program Lightspeed against SARS-CoV-2. The preliminary clinical data from the German study of BNT162b1, a […]

BioNTech stock quote 18-9-2020

Company: BioNTechTicker: BNTXExchange: NASDAQLast Trade: $67.00Change: 0.22% Change: +0.33%Volume: 2,607,052Day’s High: $68.44Day’s Low: $65.17Previous Close: $66.78 Service provided by Intrado Digital Media, LLC

Bayer Launches Large-scale Pre-launch Trial of New Tomato Varieties with Resistance to Tomato Brown Rugose Fruit Virus (ToBRFV)

The trials, which begin late September in Mexico, will target two varieties of Roma tomatoes which show little or no symptoms of ToBRFV / Developing these varieties aligns with Bayer’s commitment to provide fruit and vegetable seeds from its Seminis and De Ruiter brands which help growers combat the challenges they face each season Bayer […]

Bayer and Systems Oncology sign exclusive license agreement on innovative breast cancer treatment approach ERSO™

Bayer has entered into an exclusive global license agreement with Systems Oncology, LLC, for ERSO™, a compound in pre-clinical development for the treatment of metastatic Estrogen Receptor-positive (ER+) breast cancer. ERSO is a small molecule activator of the Unfolded Protein Response (UPR) in ER+ breast cancer cells. ERSO’s differentiated mechanism of action offers significant potential […]

BioNTech to Receive up to €375M in Funding from German Federal Ministry of Education and Research to Support COVID-19 Vaccine

BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the Company”) today announced that it will receive a grant of up to 375 million Euro from an initiative by the German Federal Ministry of Education and Research (BMBF) to support the accelerated development of SARS-CoV-2 vaccines. BioNTech will use the milestone-based BMBF funding to support its contribution to […]

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