Basel, 27 June 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the World Health Organization (WHO) has awarded the cobas® HPV test prequalification designations for use on the cobas® 5800 system and for self-collected samples on the cobas® 5800, 6800 and 8800 systems. These new prequalification designations come just one month after the U.S. Food and Drug Administration approved Roche’s HPV self-collection solution and less than a year after the WHO awarded prequalification to the cobas HPV test on the cobas 6800/8800 systems.

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Roche expands access to cervical cancer screening tools with two new WHO prequalification designations, including HPV self-collection

First-in-class drug candidate evaluated in first eight patients

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Bioxodes meets first Phase 2a patient enrollment milestone with BIOX-101 in intracerebral hemorrhagic stroke

NEW YORK, June 07, 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 that preclinical GD2-SADA data will be presented at the Society of Nuclear Medicine & Molecular Imaging (SNMMI) 2024 Annual Meeting taking place June 8 – 11, 2024, in Toronto, Canada.

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Y-mAbs Announces Preclinical GD2-SADA Data to be Presented at 2024 SNMMI Annual Meeting

Greg Fuller, M.D., Ph.D., former Professor of Pathology (Neuro-Pathology) & Neuro-Radiology at The University of Texas MD Anderson Cancer Center joins Plus as Vice President of Medical Affairs and Medical Director

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Plus Therapeutics Expands Management Team and Reports $3.3M Advance Payment from CPRIT

Fireside chat scheduled for Tuesday, June 11, 2024, at 1:20 PM ET Fireside chat scheduled for Tuesday, June 11, 2024, at 1:20 PM ET

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TG Therapeutics to Participate in the Goldman Sachs 45th Annual Global Healthcare Conference

VALENCIA, Calif., June 07, 2024 (GLOBE NEWSWIRE) -- Nusano, Inc., a physics company transforming the production of medical radioisotopes, today announced industry veteran D. Scott Holbrook as chairman of its board.

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Nusano Names D. Scott Holbrook as Chairman of its Board

SOUTH SAN FRANCISCO, Calif., June 07, 2024 (GLOBE NEWSWIRE) -- Epic Bio, a leading epigenetic editing company that plans to have its FSHD program enter the clinic this year, today announced its participation in the upcoming FSHD International Research Congress being held June 13-14, 2024, in Denver, Colo.

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Epic Bio to Present IND-Enabling Data Package for EPI-321 at FSHD International Research Congress

WOBURN, Mass., June 07, 2024 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (Nasdaq: REPL), a clinical stage biotechnology company pioneering the development of a novel class of oncolytic immunotherapies, today announced that Sushil Patel, Chief Executive Officer of Replimune, will present at the Goldman Sachs 45th Annual Global Healthcare Conference on Tuesday, June 11, 2024 at 2:00 PM ET.

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Replimune to Present at the Goldman Sachs 45th Annual Global Healthcare Conference

Basel, 07 June 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today new five-year data confirming the sustained efficacy and safety profile of Evrysdi® (risdiplam) in children with Type 1 spinal muscular atrophy (SMA) from the open-label extension of the pivotal FIREFISH study. By the end of Year 5, 91% of children treated with Evrysdi were alive, 81% were alive without permanent ventilation and the majority were able to sit without support for at least 30 seconds (59%). At the end of year 5, seven children were able to stand, three with support, four unaided and six could walk with support. Without disease modifying treatment, natural history studies indicate that children with Type 1 SMA would not only never be able to reach such milestones, but also not typically live past the age of two. The data were presented at the Cure SMA Research & Clinical Care Meeting, June 5 - 7, 2024.

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Five-year data for Roche’s Evrysdi show the majority of treated children with a severe form of spinal muscular atrophy (SMA) achieved or maintained...

“From the start, our corporate mission has been to make regenerative medicine the standard of care. We continue to be true to this goal, and it’s the key reason why we pursued this opportunity.”

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Octane Medical acquires B. Braun’s global orthobiologics business

Lyon (France) and Cambridge (MA, US), 7 June 2024 - 5.45pm CEST - PHAXIAM Therapeutics (Euronext: PHXM; FR0011471135), a biopharmaceutical company developing innovative treatments for severe and resistant bacterial infections, today announced the availability of preparatory documents for the Combined General Meeting of 28 June 2024.

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PHAXIAM announces the availability of the preparatory documents for the Combined General Meeting of 28 June 2024

WARREN, N.J., June 07, 2024 (GLOBE NEWSWIRE) -- A release was issued under a similar headline on Thursday, June 6th by Tevogen Bio Holdings Inc. (Nasdaq: TVGN). Please note that the second paragraph has been corrected and a photo is now included. The corrected release follows:

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CORRECTION – Tevogen Bio Expresses Gratitude to Patients, First Responders, Elected Officials, and Members of the United States Congress for...

NAARDEN, the Netherlands and MIAMI, June 07, 2024 (GLOBE NEWSWIRE) -- NewAmsterdam Pharma Company N.V. (Nasdaq: NAMS or “NewAmsterdam” or the “Company”), a late-stage, clinical biopharmaceutical company developing oral, non-statin medicines for patients at risk of cardiovascular disease (“CVD”) with elevated low-density lipoprotein cholesterol (“LDL-C”), for whom existing therapies are not sufficiently effective or well-tolerated, today announced that the Compensation Committee of NewAmsterdam’s Board of Directors approved the grant of inducement share options covering an aggregate of 90,000 of NewAmsterdam’s ordinary shares to five non-executive new hires. The share options were granted as an inducement material to the employees’ acceptance of employment with NewAmsterdam pursuant to the NewAmsterdam Pharma Company N.V. 2024 Inducement Plan (the “2024 Inducement Plan”) and in accordance with Nasdaq Listing Rule 5635(c)(4).

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NewAmsterdam Pharma Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

TORONTO, June 07, 2024 (GLOBE NEWSWIRE) -- Spectral Medical Inc. ("Spectral" or the "Company") (TSX: EDT), a late-stage theranostic company advancing therapeutic options for sepsis and septic shock, today announced the results of its Annual Meeting of shareholders (the "Shareholders") held earlier today (the "Meeting"). The Company confirms that all resolutions put forward in the Management Information Circular dated April 19, 2024 (the "Circular") to its Shareholders were approved.

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Spectral Medical Inc. Announces Results of Annual Meeting of Shareholders

Vancouver, BC, June 07, 2024 (GLOBE NEWSWIRE) -- Qu Biologics Inc., a Burnaby-based clinical-stage biotechnology company, is pleased to announce that the RESILIENCE Study, a clinical trial evaluating a new immunomodulator designed to strengthen natural immunity among seniors aged 65 or older, is enrolling participants in the study.

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Seniors in Metro Vancouver Invited to Participate in a Clinical Trial Assessing a New Immunomodulator Designed to Restore Immune Function in the...

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