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FDA granted fast track designation for AB201, a small recombinant protein that is a potent, selective inhibitor of tissue factor, for the potential treatment of COVID-19. 

FDA Grants Fast Track Designation to ARCA biopharma’s Potential COVID-19 Treatment

The EC’s approval was based on positive results from a Phase III clinical trial that demonstrated a statistically significant and clinically meaningful improvement in patients compared to chemotherapy.

EC Approves Bristol Myers Squibb’s Opdivo in Second-Line Treatment of Esophageal Cancer

The EC’s approval comes after positive results from seven Phase II and III randomized, active-controlled, multi-center studies.

EC Approves Sanofi’s Meningococcal Meningitis Vaccine 

The companies have formed a long-term manufacturing agreement to accelerate the global supply for Lilly’s COVID-19 antibody therapeutics.

Samsung Biologics and Lilly Partner to Accelerate Delivery of COVID-19 Antibody Therapeutics

An independent data safety monitoring board found that clinical trial data demonstrated that the vaccine candidate met its primary endpoint and demonstrated protection from COVID-19.

AstraZeneca Vaccine Candidate ‘Highly-Effective’ in Preventing COVID-19

Researchers concluded that the nasal spray should catch and coat the virus inside the nose, preventing it from spreading throughout the body, and it is then removed by nose-blowing or swallowing.

The University of Birmingham Formulates Nasal Spray to Protect Against COVID-19

The first of its kind, Lycagel is made up of pea starch technology. 

Roquette Launches New Vegetarian Softgel Capsule Formulations

Pfizer and BioNTech’s BNT162b2 shows efficacy of 95%; the companies plan to submit a request, within days, to FDA for an EUA.

Pfizer and BioNTech COVID-19 Vaccine Candidate Meets Endpoints and Achieves Safety Data Milestone 

Moderna’s COVID-19 vaccine candidate can be distributed using widely available vaccine delivery and storage infrastructure.

Moderna Announces Extended Stability Conditions for COVID-19 Vaccine Candidate

The companies will work together on research activities through to the selection of a preclinical candidate, after which Roche will handle further development and global commercialization.

Bio/Pharma News