Biotech | February 22, 2022
Prestige BioPharma’s facility receives EU-GMP certification
The facility will manufacture its Herceptin biosimilar, Tuznue
The facility will manufacture its Herceptin biosimilar, Tuznue
The grants are expected to be received over the next three years, commencing March 2022
Nuvaxovid is the first protein-based Covid-19 vaccine authorized for use in Canada
Application based on the pivotal Phase 3 TRANSFORM study in which Breyanzi showed significant and clinically meaningful improvements over salvage chemotherapy followed by high-dose chemotherapy plus autologous stem cell transplant, which has been the standard of care for more than 20 years
Rimegepant is the first oral calcitonin gene-related peptide receptor antagonist to demonstrate positive results in a pivotal trial in the Asia Pacific
Immune responses were about two-to-three-fold higher in adolescents than in adults against all variants studied. Vaccine was well-tolerated with no safety signals identified
Adds five years of market exclusivity on approval
On track to complete the BLA submission in the first half of 2022
Glenmark received manufacturing and marketing approval from DCGI for Nitric Oxide Nasal Spray (NONS) as part of accelerated approval process
Spikevax has received approval by regulators in more than 70 countries, including Canada, Japan, the European Union, the UK, Israel
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