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Cellectis Announces First Dosing of a Patient with its In-house Manufactured Product Candidate UCART22 for the treatment of r/r B-cell ALL

Posted: December 26, 2022 at 12:12 am

NEW YORK, Dec. 22, 2022 (GLOBE NEWSWIRE) -- Cellectis (the “Company”) (Euronext Growth: ALCLS - NASDAQ: CLLS), a clinical-stage biotechnology company using its pioneering gene-editing platform to develop life-saving cell and gene therapies, today announced that for the first time, a patient was dosed in the United States with its in-house manufactured product candidate UCART22, and completed the 28 day DLT period on December 14th, 2022, without complication.

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CytomX Therapeutics to Outline 2023 Company Priorities and Provide Pipeline Update on January 5, 2023

Posted: December 26, 2022 at 12:12 am

SOUTH SAN FRANCISCO, Calif., Dec. 22, 2022 (GLOBE NEWSWIRE) -- CytomX Therapeutics, Inc. (Nasdaq: CTMX), a leader in the field of conditionally activated oncology therapeutics, today announced that it plans to outline its pipeline priorities for 2023 and provide a data update for the CX-2029 Phase 2 cohort expansion study, on Thursday, January 5, 2023, after the close of U.S. markets. Following the announcement, the Company will host a conference call and webcast at 5:00 p.m. ET / 2:00 p.m. PT to discuss updates.

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Intelligent Bio Solutions Inc. Announces Closing of Private Placement Offering

Posted: December 26, 2022 at 12:12 am

NEW YORK, Dec. 22, 2022 (GLOBE NEWSWIRE) -- Intelligent Bio Solutions Inc. (Nasdaq: INBS) (the “Company”), a life sciences company developing non-invasive, real-time diagnostic testing for patients and their primary health practitioners at point of care, today announced that it has closed a Regulation S private placement (the “Transaction”) for expected aggregate gross proceeds of $220,585.

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Applied Molecular Transport Announces Top-line Phase 2 Results from LOMBARD Monotherapy Trial of Oral AMT-101 in Patients with Moderate-to-Severe…

Posted: December 26, 2022 at 12:12 am

– Similar clinical remission rates observed in patients receiving AMT-101 monotherapy compared to placebo at week 12

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Applied Molecular Transport Announces Top-line Phase 2 Results from LOMBARD Monotherapy Trial of Oral AMT-101 in Patients with Moderate-to-Severe...

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Mesoblast and Oaktree Extend Availability Period of Undrawn Tranches of Financing Facility

Posted: December 26, 2022 at 12:12 am

NEW YORK, Dec. 22, 2022 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced that funds managed by Oaktree Capital Management, L.P. (“Oaktree”) have extended to Mesoblast the availability of up to an additional US$30.0 million of its US$90 million five year facility subject to achieving certain milestones on or before September 30, 2023.

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Valneva Completes BLA Submission to U.S. FDA for its Single-Shot Chikungunya Vaccine Candidate

Posted: December 26, 2022 at 12:12 am

Saint-Herblain (France), December 23, 2022 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announces that it has completed rolling submission of the Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for its single-shot chikungunya vaccine candidate, VLA1553. Valneva is seeking approval of its investigational chikungunya vaccine in persons aged 18 years and above.

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Valneva Completes BLA Submission to U.S. FDA for its Single-Shot Chikungunya Vaccine Candidate

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Basilea announces regulatory approval of antifungal Cresemba® (isavuconazole) in Japan

Posted: December 26, 2022 at 12:12 am

Basel/Allschwil, Switzerland, December 23, 2022

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DBV Technologies Announces FDA Has Lifted Partial Clinical Hold on VITESSE Phase 3 Pivotal Trial  

Posted: December 26, 2022 at 12:12 am

Montrouge, France, December 23, 2022

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Bavarian Nordic Enters Agreement Valued up to USD 83 Million with the U.S. Department of Defense to Further Advance the Development of Equine…

Posted: December 26, 2022 at 12:12 am

COPENHAGEN, Denmark, December 23, 2022 – Bavarian Nordic A/S (OMX: BAVA) announced today a new agreement with the U.S. Department of Defense’s (DOD) Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND), for the advanced development of MVA-BN® WEV, a prophylactic vaccine candidate against Western, Eastern and Venezuelan equine encephalitis virus, which can cause a rare, but potentially deadly mosquito-borne illness in humans1. Currently, no approved vaccines for human use are available.

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BioNTech Initiates Phase 1 Clinical Trial for Malaria Vaccine Program BNT165

Posted: December 26, 2022 at 12:12 am

MAINZ, Germany, December 23, 2022 – BioNTech SE (Nasdaq: BNTX, “BioNTech”, "the Company") today announced the initiation of a first-in-human Phase 1 study with BNT165b1, the first candidate from the Company’s BNT165 program, to develop a multi-antigen malaria vaccine candidate. BioNTech will initially evaluate a set of mRNA-encoded antigens of the malaria-causing parasite Plasmodium falciparum (P. falciparum) to help select the multi-antigen vaccine candidate to proceed to planned later-stage trials. This first clinical trial (NCT05581641) will evaluate the safety, tolerability and exploratory immunogenicity of the vaccine candidate BNT165b1. BNT165b1 expresses certain parts of the circumsporozoite protein (CSP).

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