SOUTH SAN FRANCISCO, Calif., June 08, 2024 (GLOBE NEWSWIRE) -- Akero Therapeutics, Inc. (Nasdaq: AKRO), a clinical-stage biotechnology company developing transformational treatments for patients with serious metabolic disorders marked by high unmet medical need, today announced two presentations featuring its lead product candidate efruxifermin (EFX) at the European Association for the Study of the Liver (EASL) Congress 2024, in Milan, Italy. The presentations will also be available on Akero’s website following the meeting.

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Akero Therapeutics Presents Poster and Late-breaking Oral Presentation on EFX at the EASL Congress 2024

EMERYVILLE, Calif., June 08, 2024 (GLOBE NEWSWIRE) -- 4D Molecular Therapeutics (Nasdaq: FDMT, 4DMT or the Company), a leading clinical-stage genetic medicines company focused on unlocking the full potential of genetic medicines to treat large market diseases, today presented supplemental aflibercept injection-free subgroup analyses of the previously reported 24-week landmark results from the randomized Dose Expansion cohort from the Phase 2 PRISM clinical trial evaluating intravitreal 4D-150 in wet age-related macular degeneration (wet AMD) patients with severe disease activity and a high treatment burden. The data were presented today at Clinical Trials at the Summit 2024 in Park City, Utah, by Carl Danzig, M.D., Rand Eye Institute, Deerfield Beach, Florida.

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4DMT Presents Injection-Free Subgroup Analyses from 4D-150 Phase 2 PRISM Randomized Dose Expansion Cohort in Wet AMD Patients with Severe Disease...

TOKYO and CAMBRIDGE, Mass., June 09, 2024 (GLOBE NEWSWIRE) -- Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, “Biogen”) announced today that the U.S. Food and Drug Administration (FDA) has accepted Eisai’s Supplemental Biologics License Application (sBLA) for monthly lecanemab-irmb (U.S. brand name: LEQEMBI®) intravenous (IV) maintenance dosing. A Prescription Drug User Fee Act (PDUFA) action date is set for January 25, 2025. LEQEMBI is indicated for the treatment of Alzheimer's disease (AD) in patients with mild cognitive impairment or mild dementia stage of disease (collectively referred to as early AD).

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FDA Accepts Eisai’s Filing of LEQEMBI® (lecanemab-irmb) Supplemental Biologics License Application for IV Maintenance Dosing for the Treatment of...

Pratteln, Switzerland, June 10, 2024 – Santhera Pharmaceuticals (SIX: SANN) announces that its partner Sperogenix Therapeutics has launched a paid-for Early Access Program (EAP) for AGAMREE® (vamorolone) in China for patients with Duchenne muscular dystrophy (DMD).

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Santhera Announces Launch of Early Access Program in China for AGAMREE® by its Partner Sperogenix

PRESS RELEASE - 10/06/2024, 07:00 CEST

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Press release Biocartis NV: Biocartis Welcomes Gina Wallar, PhD as Chief Business Officer and Judith Vacchino, PhD as VP Global Marketing

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

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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...