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Pharma Tech

Pfizer | November 10, 2020

Pfizer Inc.and BioNTech SE today reported their mRNA-based antibody up-and-comer, BNT162b2, against SARS-CoV-2 has exhibited proof of adequacy against COVID-19 in members without earlier proof of SARS-CoV-2 contamination, in view of the principal break viability examination led on November 8, 2020 by an outer, free Data Monitoring Committee (DMC) from the Phase 3 clinical investigation. After conversation with the FDA, the organizations as of late chosen to drop the 32-case between time examinat...

Leo Lens Pharma | June 23, 2020

Today, Leo Lens Pharma, an emerging San Diego-based pharmaceutical company focused on helping protect sight, is pleased to announce that its lead asset, LL-BMT1, is ready for IND submission and human clinical evaluation. LL-BMT1 is a therapeutic contact lens that delivers preservative-free bimatoprost to the eye to treat glaucoma for one week. After a productive Pre-IND meeting with the FDA, Leo Lens has now successfully completed GLP biocompatibility studies required by the FDA, secured a clini...

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Regeneron Pharmaceuticals, Inc | January 31, 2022

Regeneron Pharmaceuticals, Inc. and Sanofi today announced that the European Medicines Agency's Committee for Medicinal Products for Human Use has adopted a positive opinion, recommending to extend the approval of Dupixent® (dupilumab) in the European Union (EU) to include add-on maintenance treatment for children aged 6 to 11 years with severe asthma with type 2 inflammation characterized by raised blood eosinophils and/or raised fractional exhaled nitric oxide (FeNO) who are inadequate...

Pharma Tech

Globenewswire | May 12, 2023

SERB Pharmaceuticals, a global specialty pharmaceutical company, and SFJ Pharmaceuticals, a global drug development company, announce that SERB has acquired exclusive US rights to the ticagrelor reversal agent bentracimab from SFJ. Bentracimab is a novel, monoclonal antibody fragment designed to reverse the antiplatelet activity of ticagrelor. Ticagrelor, marketed by AstraZeneca as Brilinta®, is a reversible oral P2Y12 platelet inhibitor for patients who have suffered a hear...