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Roche Launches Two New Antibodies to Identify Key Clinical Mutations
Thursday, February 23, 2023Roche announced the launch of the IDH RH MRQ Rabbit Monoclonal Primary Antibody and the ATRX Rabbit Polyclonal Antibody to identify mutation status in patients diagnosed with brain cancer The IDH RH and ATRX antibodies are the latest additions to Roc...
Calquence Tablet Formulation Receives Approval in European Union (EU)
Wednesday, February 22, 2023AstraZenecas tablet formulation of Calquence acalabrutinib has been approved in the European Union EU for the treatment of adult patients with chronic lymphocytic leukaemia CLL Calquence is approved as a capsule formulation for CLL in the EU It is al...
Moderna and Life Edit Therapeutics Enter Into Strategic Collaboration
Wednesday, February 22, 2023Moderna announced a strategic research and development collaboration to discover and develop in vivo mRNA gene editing therapies The partnership will combine Life Edits suite of proprietary gene editing technologies including base editing with Modern...
Pfizer’s Elranatamab Receives FDA and EMA Filing Acceptance
Wednesday, February 22, 2023Pfizer announced today that the US Food and Drug Administration FDA has granted priority review for the Biologics Licence Application BLA for elranatamab an investigational Bcell maturation antigen BCMA CDtargeted bispecific antibody BsAb for the tre...
Eterna Therapeutics Enters Into Licence Agreement with Lineage Cell Therapeutics
Wednesday, February 22, 2023Eterna Therapeutics announced that it has entered into an exclusive option and licence agreement the Agreement with Lineage Cell Therapeutics Lineage for the development of novel induced hypoimmune pluripotent stem cell iPSC lines which Lineage will...
Pfizer Gets U.S. FDA Acceptance for Biologics Licence Application for its Respiratory Syncytial Virus Vaccine Candidate
Tuesday, February 21, 2023Pfizer announced that the US Food and Drug Administration FDA has accepted for review a Biologics Licence Application BLA for its respiratory syncytial virus RSV vaccine candidate PF or RSVpreF for the prevention of medically attended lower respirato...
Beckley Psytech Receives FDA Investigational New Drug (IND) Approval for Phase IIb study of BPL-003
Tuesday, February 21, 2023Beckley Psytech announced that it had received Investigational New Drug IND approval from the US Food and Drug Administration FDA for a global multisite Phase IIb study exploring the safety efficacy and tolerability of two distinct doses of its lead...
Alnylam Announces U.S. FDA Acceptance of Supplemental New Drug Application for ONPATTRO® (patisiran)
Tuesday, February 21, 2023Alnylam Pharmaceuticals announced that the US Food and Drug Administration FDA has accepted for filing the Companys supplemental New Drug Application sNDA for patisiran an investigational RNAi therapeutic in development for the treatment of the cardi...
Vaxcyte Announces FDA Clearance of Investigational New Drug Application for VAX-24
Tuesday, February 21, 2023Vaxcyte announced that the US Food and Drug Administration FDA has cleared the Companys infant Investigational New Drug IND application for VAX its lead valent pneumococcal conjugate vaccine PCV candidate designed to prevent invasive pneumococcal dis...
FDA Accepts Priority Review for Pozelimab (C5 Antibody) BLA for Treatment of Children and Adults
Tuesday, February 21, 2023Regeneron Pharmaceuticals announced the US Food and Drug Administration FDA has accepted for Priority Review the Biologics Licence Application BLA for pozelimab as a treatment for adults and children as young as year of age with CHAPLE disease also...
