European Commission approves Roche’s Alecensa as the first and only targeted adjuvant treatment for people with ALK-positive early-stage lung cancer

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European Commission approves Roche’s Alecensa as the first and only targeted adjuvant treatment for people with ALK-positive early-stage lung cancer

Basel, 10 June 2024 – Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for its cobas® liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test, an automated multiplex real-time polymerase chain reaction (RT-PCR) assay on the cobas® liat system. Producing results in just 20 minutes on a compact analyser suitable for most healthcare settings, the test uses either a single nasopharyngeal or anterior nasal-swab sample to confirm or rule out infection with SARS-CoV-2, influenza A virus, influenza B virus and respiratory syncytial virus (RSV).

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Roche four-in-one molecular test for SARS-CoV-2, Influenza A/B viruses and RSV receives U.S. FDA Emergency Use Authorization

Is Stem Cell Transplant Often The Only Treatment Option For Blood Cancer Patients? Why So?  News18

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Is Stem Cell Transplant Often The Only Treatment Option For Blood Cancer Patients? Why So? - News18

MDNA11 demonstrates durable response in pancreatic cancer patient with 100% regression of target and non-target lesions for over 104 weeks and continues to show remission 4 months after stopping treatment

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Medicenna To Present Evidence of Durable Single Agent Activity and Potent Immune Effector Response with MDNA11 in the Dose Escalation Portion of Phase...

Châtillon, France, May 31, 2024

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DBV Technologies Announces Plan to Implement ADS Ratio Change

Press release – No. 6 / 2024

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Zealand Pharma announces positive CHMP opinion for dasiglucagon for treatment of severe hypoglycemia in diabetes from European Medicines Agency

PRESS RELEASE

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AB Science is providing a summary of the live webcast held on May 30, 2024, giving an update on the application for conditional marketing...

COPENHAGEN, Denmark, May 31, 2024 – Bavarian Nordic A/S (OMX: BAVA) today announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking approval of a freeze-dried formulation of JYNNEOS® for prevention of smallpox and mpox disease in adults 18 years of age and older.

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Bavarian Nordic Submits Supplemental BLA Seeking U.S. FDA Approval of Freeze-Dried Formulation of Smallpox and Mpox Vaccine

Saint Herblain (France), May 31, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending authorization of Valneva’s single-dose vaccine for the prevention of disease caused by the chikungunya virus in individuals 18 years of age and older.

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Valneva Receives EMA’s Positive CHMP Opinion for its Chikungunya Vaccine

Immunocore reports updated Phase 1 data of brenetafusp (IMC-F106C), an ImmTAC bispecific targeting PRAME, in immune checkpoint pre-treated cutaneous melanoma patients at ASCO 2024

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Immunocore reports updated Phase 1 data of brenetafusp (IMC-F106C), an ImmTAC bispecific targeting PRAME, in immune checkpoint pre-treated cutaneous...

CAMBRIDGE, Mass. and ROSTOCK, Germany and BERLIN, May 31, 2024 (GLOBE NEWSWIRE) -- CENTOGENE N.V. (Nasdaq: CNTG) (the “Company”), the essential life science partner for data-driven answers in rare and neurodegenerative diseases, today announced the voting results of the Company’s 2024 Annual General Meeting. Shareholders voted in favor of all proposals.

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CENTOGENE Announces Adoption of All Resolutions Tabled at 2024 Annual General Meeting

BERKELEY, Calif. and MAINZ, Germany, May 31, 2024 (GLOBE NEWSWIRE) -- Mainz Biomed N.V. (NASDAQ: MYNZ), a molecular genetics diagnostic company specializing in the early detection of cancer, held its annual general meeting (“Annual General Meeting”) on Friday, May 31, 2024 in Amsterdam, The Netherlands. Holders of 2,431,947 ordinary shares, representing approximately 10.9% of our outstanding shares on May 3, 2024, the record date for the Annual General Meeting, were present at such meeting, which constituted a quorum under Dutch law. Each of the matters presented at the Annual General Meeting received the requisite shareholder approval as set below:

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Mainz Biomed Reports Results of 2024 Annual General Meeting

Objective response rate of 39% with manageable safety profile in patients with non-small cell lung cancer (NSCLC) harboring EGFR Exon 20 insertion mutations treated with zipalertinib who had progressed after prior amivantamab treatment Objective response rate of 39% with manageable safety profile in patients with non-small cell lung cancer (NSCLC) harboring EGFR Exon 20 insertion mutations treated with zipalertinib who had progressed after prior amivantamab treatment

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Cullinan Therapeutics Announces Positive Initial Data from Pivotal Phase 2b REZILIENT1 Study of Zipalertinib

KT-253 demonstrates initial clinical proof of concept in patients with tumor types shown to be sensitive in preclinical models, including responses in MCC and AML

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Kymera Therapeutics Presents New Clinical Data from Ongoing Phase 1 Trial of MDM2 Degrader KT-253 at ASCO Annual Meeting

Immunocore presents KIMMTRAK clinical data demonstrating that patients with stable disease and confirmed tumor reduction have similar clinical outcomes to patients with partial response

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Immunocore presents KIMMTRAK clinical data demonstrating that patients with stable disease and confirmed tumor reduction have similar clinical...

NEW YORK, June 01, 2024 (GLOBE NEWSWIRE) -- Y-mAbs Therapeutics, Inc. (the “Company” or “Y-mAbs”) (Nasdaq: YMAB), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel radioimmunotherapy and antibody-based therapeutic products for the treatment of cancer, today announced new interim data from the Phase 2 Trial 201 of naxitamab in combination with granulocyte-macrophage colony-stimulating factor (“GM-CSF”) in patients with relapsed or refractory high-risk neuroblastoma with residual disease limited to bone and/or bone marrow. The results are summarized in poster presentations scheduled to be presented today, June 1, 2024, at the 2024 American Society of Clinical Oncology (“ASCO”) Annual Meeting in Chicago, IL.

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Y-mAbs Announces New Interim Analysis of Phase 2 Data for Naxitamab at 2024 ASCO Annual Meeting

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Ultimovacs Announces Poster Presentation at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting

NEW YORK, June 01, 2024 (GLOBE NEWSWIRE) -- Y-mAbs Therapeutics, Inc. (the “Company” or “Y-mAbs”) (Nasdaq: YMAB), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel radioimmunotherapy and antibody-based therapeutic products for the treatment of cancer, today announced the publication of preclinical GD2-SADA data at the 2024 American Society of Clinical Oncology (“ASCO”) Annual Meeting, taking place May 31 through June 4, 2024, in Chicago, IL.

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Y-mAbs Announces Publication of Preclinical GD2-SADA Data at 2024 ASCO Annual Meeting

-  WTX-124 was shown to be clinically active and generally well-tolerated in patients who were relapsed/refractory to immune checkpoint inhibitor therapy -

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Werewolf Therapeutics to Present Data from Ongoing Phase 1/1b Clinical Trial of WTX-124 as Monotherapy and in Combination with Pembrolizumab in Solid...

Media Release

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Investigational Acasunlimab (DuoBody® -PD-L1x4-1BB) in Combination with Pembrolizumab Demonstrates Meaningful Clinical Activity in Phase 2 Trial in...