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FDA Accepts Valneva’s Chikungunya Vaccine Licence Application for Priority Review
Monday, February 20, 2023Valneva announced that the US Food and Drug Administration FDA has completed a filing review of its Biologics Licence Application for Valnevas singleshot chikungunya vaccine candidate VLA and determined that the application is sufficiently complete t...
European Commission Approved CSL's HEMGENIX®, the First Gene Therapy for Hemophilia B
Monday, February 20, 2023Global biotechnology leader CSL announced that the European Commission has granted conditional marketing authorisation CMA for HEMGENIX etranacogene dezaparvovec the first and only onetime gene therapy for the treatment of severe and moderately sever...
Clover Enters into Agreement to Commercialise Quadrivalent Seasonal Influenza Vaccine
Monday, February 20, 2023Clover Biopharmaceuticals announced that it entered into an exclusive agreement with Adimmune Corporation for Clover to distribute AdimFluS QIS in mainland China where it is the only imported quadrivalent seasonal influenza vaccine approved for use i...
Teva Announces FDA Approval of AUSTEDO® XR (deutetrabenazine) Extended-Release Tablets
Friday, February 17, 2023Teva Pharmaceuticals a US affiliate of Teva Pharmaceutical Industries announced that the US Food and Drug Administration FDA has approved AUSTEDOXR deutetrabenazine extendedrelease tablets a new oncedaily formulation indicated in adults for tardive d...
U.S. FDA Accepts for Priority Review the Supplemental New Drug Application for PREVYMIS™
Friday, February 17, 2023Merck known as MSD outside of the United States and Canada announced the US Food and Drug Administration FDA has accepted for review two supplemental new drug applications sNDA for PREVYMIS letermovir The FDA granted priority review for the sNDA for...
Charles River and Purespring Therapeutics Announce Gene Therapy Manufacturing Collaboration
Thursday, February 16, 2023Charles River Laboratories International Inc and Purespring Therapeutics announced a plasmid DNA contract development and manufacturing organization CDMO collaboration Under the terms of an agreement Plasmid CDMO alliance supports the first gene ther...
Bio-Techne and Cell Signalling Technology Announce Partnership
Wednesday, February 15, 2023BioTechne Corporation and Cell Signalling Technology CST announced the addition of Simple Western validation to CST antibodies This will allow researchers in various disciplines an easier way to study important molecular signalling pathways on a trus...
Gritstone Bio and the National Cancer Institute (NCI) Establish a Clinical Trial Agreement
Wednesday, February 15, 2023Gritstone announced that it has entered into a clinical trial agreement with the National Cancer Institute NCI to evaluate an autologous T cell therapy expressing a T cell receptor targeting mutated KRAS in combination with Gritstones KRASdirected va...
Sentia Medical Sciences and Neurocrine Biosciences Extend Research Collaboration
Tuesday, February 14, 2023Sentia Medical Sciences announced that they have extended a research collaboration with Neurocrine Biosciences to discover novel longacting corticotropinreleasing factor CRF receptor antagonist peptide therapeutics The collaboration will continue to...
Astex and Cardiff University Announce New Drug Discovery Collaboration
Monday, February 13, 2023Astex Pharmaceuticals and The Medicines Discovery Institute Cardiff University MDI announced that they have entered into a multiyear multimillion pound drug discovery research collaboration to identify new drugs to treat neurodegenerative diseases
