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Pfizer and BioNTech to Supply the European Union with 100 Million Additional Doses of COMIRNATY®
12/29/2020
Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced they will supply an additional 100 million doses of COMIRNATY®, the companies’ COVID-19 Vaccine, to the 27 European Union (EU) member states in 2021.
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Clinical Catch-Up: December 21-25
12/28/2020
Even with the holidays among us, there were a number of clinical trial announcements. Here’s a look. -
Pfizer and BioNTech to Supply the U.S. with 100 Million Additional Doses of COVID-19 Vaccine
12/23/2020
Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced a second agreement with the U.S. government to supply an additional 100 million doses of the companies’ COVID-19 Vaccine from production facilities in the U.S. This agreement brings the total number of doses to be delivered to the U.S. to 200 million
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Genentech, a Roche company, announced positive topline data from two identical Phase III trials of faricimab in diabetic macular edema (DME).
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Pfizer and BioNTech Receive Authorization in the European Union for COVID-19 Vaccine
12/21/2020
COMIRNATY ® (also known as BNT162b2) receives conditional marketing authorization from the European Commission; this milestone represents a global joint effort to advance the first authorized mRNA vaccine
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Pfizer and BioNTech Receive CHMP Positive Opinion for their COVID-19 Vaccine
12/21/2020
Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion to recommend the conditional marketing authorization (CMA) of the Pfizer-BioNTech COVID-19 Vaccine (also known as BNT162b2), f
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New England Journal of Medicine Publishes Positive Initial Regeneron Antibody Cocktail Results in Non-hospitalized Patients with COVID-19
12/17/2020
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the New England Journal of Medicine (NEJM) has published initial clinical data from an ongoing seamless Phase 1/2/3 trial of the antibody cocktail casirivimab and imdevimab in non-hospitalized patients with COVID-19.
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Pfizer and BioNTech Celebrate Historic First Authorization in the U.S. of Vaccine to Prevent COVID-19
12/12/2020
U.S. FDA authorizes COVID-19 mRNA vaccine for emergency use; companies are prepared to deliver first doses in the U.S. immediately
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U.S. CDC Committee of Independent Health Experts Recommends Vaccination with Pfizer and BioNTech COVID-19 Vaccine for Persons Ages 16 Years and Older
12/12/2020
Recommendation follows yesterday’s FDA authorization for emergency use of the Pfizer-BioNTech COVID-19 vaccine (BNT162b2), to address the crisis
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Pfizer and BioNTech Receive FDA Advisory Committee Vote Supporting Potential First Emergency Use Authorization for Vaccine to Combat COVID-19 in the U.S.
12/10/2020
FDA expected to make a decision on Emergency Use Authorization in the coming days Positive vote based on totality of scientific evidence presented by the companies, including Phase 3 efficacy and safety data If authorized, BNT162b2 would be the first COVID-19 vaccine available in the U.S.
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Pfizer and BioNTech Announce Publication of Results from Landmark Phase 3 Trial of BNT162b2 COVID-19 Vaccine Candidate in The New England Journal of Medicine
12/10/2020
Pfizer and BioNTech Announce Publication of Results from Landmark Phase 3 Trial of BNT162b2 COVID-19 Vaccine Candidate in The New England Journal of Medicine Data from 43,448 participants, half of whom received BNT162b2 and half of whom received placebo, showed that the vaccine candidate was well tolerated and demonstrated 95% efficacy in preventing COVID-19 in those without prior infection 7 days or more after the second dose Vaccine efficacy o
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Bronchial Asthma Treatment Market is expected to see a Significant Growth by 2030
12/9/2020
Bronchial asthma is chronic inflammatory disease in which bronchial hyperactivity occurs and leads to airflow obstruction.
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Pfizer and BioNTech Achieve First Authorization in the World for a Vaccine to Combat COVID-19
12/2/2020
U.K. regulator, MHRA, authorizes supply of COVID-19 mRNA vaccine for emergency supply under Regulation 174; Companies are ready to deliver the first doses to the U.K. immediately
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Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for November 24, 2020.
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Late Friday, the FDA gave the green light to Regeneron's REGN-COV2, a combination of casirivimab and imdevimab.
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Regeneron's REGEN-COV2 is First Antibody Cocktail for COVID-19 to Receive FDA Emergency Use Authorization
11/22/2020
Initial doses of REGEN-COV2 will be made available to approximately 300,000 patients, with no medication out-of-pocket costs, under U.S. government allocation program
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COVID-19 Brief: WHO Recommends Against Remdesivir, Roche Ramps Up to Produce Antibodies Treatment...
11/20/2020
The World Health Organization (WHO) recommends against using Gilead Sciences' remdesivir as a treatment for COVID-19. -
Pfizer and BioNTech to Submit Emergency Use Authorization Request Today to the U.S. FDA for COVID-19 Vaccine
11/20/2020
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 to end of December 2020
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Pfizer and BioNTech Conclude Phase 3 Study of COVID-19 Vaccine Candidate, Meeting All Primary Efficacy Endpoints
11/18/2020
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 candidate, BNT162b2, met all of the study’s primary efficacy endpoints
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Adverum Biotechnologies Announces Positive Interim Data from Cohorts 1-4 from OPTIC Phase 1 Trial of ADVM-022 Intravitreal Gene Therapy for Wet AMD
11/14/2020
Company to host webcast with Key Opinion Leaders to discuss new OPTIC data today, Saturday, November 14, 2020 at 7:30 am PT / 10:30 am ET