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ERYTECH Requested a Pre-BLA Meeting with the FDA to Discuss Path to Approval in ALL


Press release content from Globe Newswire. The AP news staff was not involved in its creation.
ERYTECH Requested a Pre-BLA Meeting with the FDA to Discuss Path to Approval in ALL
Erytech Pharma S.A.April 20, 2021 GMT
ERYTECH Requested a Pre-BLA Meeting with the FDA
to Discuss Path to Approval in ALL
ERYTECH invited by FDA to request a pre-BLA meeting
First step in the marketing approval process with the FDA for eryaspase for the treatment of hypersensitive ALL patients based on the positive results of the NOPHO-sponsored Phase 2 clinical trial
Lyon (France) and Cambridge, MA (U.S.), April 20, 2021 – ERYTECH Pharma (Nasdaq & Euronext: ERYP), a clinical-stage biopharmaceutical company developing innovative therapies by encapsulating therapeutic drug substances inside red blood cells, today announced the initiation of the process of seeking marketing approval from the U.S. Food and Drug Administration (US FDA) for its lead product candidate eryaspase i ....

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Onegevity and EmbodyBio Announce Collaboration to Explore Brain Health


Press release content from PR Newswire. The AP news staff was not involved in its creation.
Onegevity and EmbodyBio Announce Collaboration to Explore Brain Health
April 19, 2021 GMT
NEW YORK, April 19, 2021 /PRNewswire/ Onegevity (a division of Thorne HealthTech), a health intelligence company with a proprietary, multi-omic platform that leverages artificial intelligence (AI) and machine learning to map, integrate, and understand the billions of dynamic and biological features that showcase the state of an individual’s health, and EmbodyBio, a startup company at the forefront of ‘digital twin’ technology, today announced a new collaboration aimed at creating next-generation capabilities to advance brain health. ....

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Arcellx Announces Executive Appointments


Press release content from Globe Newswire. The AP news staff was not involved in its creation.
Arcellx Announces Executive Appointments
Arcellx, Inc.April 19, 2021 GMT
GAITHERSBURG, Md., April 19, 2021 (GLOBE NEWSWIRE) Arcellx, a privately held clinical-stage biopharmaceutical company, today announced that it has hired two new executives to join the company’s leadership team. Dr. Christopher Heery has been named Chief Medical Officer (CMO) where he will have responsibility for clinical, regulatory and medical affairs and Neeraj Teotia has been named Chief Commercial Officer where he will have responsibility for marketing, sales, and health economics and reimbursement.
“We are excited to strengthen our leadership team with the additions of Chris and Neeraj as they bring significant expertise to Arcellx and reflect our values and culture. They will lead two critically important areas advancing our clinical programs to meet all requirements for regulatory app ....

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CureVac Swiss AG Initiates Rolling Submission Process for mRNA-based COVID-19 Vaccine Candidate, CVnCoV, with Swissmedic


Press release content from Accesswire. The AP news staff was not involved in its creation.
CureVac Swiss AG Initiates Rolling Submission Process for mRNA-based COVID-19 Vaccine Candidate, CVnCoV, with Swissmedic
April 19, 2021 GMT
Review process started with submission of first CVnCoV data package
TÜBINGEN, GERMANY and BOSTON, MA / ACCESSWIRE / April 19, 2021 / The CureVac Swiss AG, the Swiss subsidiary of CureVac N.V. (Nasdaq:CVAC), a global biopharmaceutical company developing a new class of transformative medicines based on messenger ribonucleic acid (mRNA), today announced initiation of a rolling submission for CVnCoV, the company’s mRNA based COVID-19 vaccine candidate, for the use in Switzerland. The application for authorization was submitted to Swissmedic, the country’s authority responsible for the authorization and supervision of therapeutic products including vaccines. ....

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