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Tag: clinical trial

COTA partners with LCP Health Analytics to advance the use of US RWD to support HTA decision making internationally

US + UK Data to Address Key Evidence Gaps in Access to Medicines NEW YORK, July 30, 2025 /PRNewswire/ -- LCP Health Analytics is partnering...

Vexev and U.S. Renal Care Complete Enrollment in Groundbreaking Trial Evaluating Use of Robotic Ultrasound Scanning for AV Fistula Mapping in Dialysis Clinics

CANSCAN study enrolled 120 patients with chronic kidney disease using the investigational, semi-autonomous VxWave™ Ultrasound Imaging SystemThe VxWave Ultrasound Imaging System potentially provides important insights...

Perimeter Announces Closing of Final Tranche of Prospectus Offering for $2.25 Million; Total Gross Proceeds of $5.35 Million Raised Under Prospectus Offering

/NOT FOR DISTRIBUTION TO U.S. NEWS WIRE SERVICES OR FOR DISSEMINATION IN THE UNITED STATES/ TORONTO and DALLAS, July 29, 2025 /CNW/ - Perimeter Medical...

RECORDATI: STRONG MOMENTUM OF THE GROUP CONTINUES IN THE FIRST HALF OF 2025 REVENUE +11.7%, EBITDA(1) +9.6%, ADJUSTED NET INCOME(2) +8.9%

Milan, 29th July 2025 – The Board of Directors of Recordati S.p.A. approved the interim financial statements as of June 30, 2025, pursuant to Art. 154-ter of Italian Legislative Decree 58/1998 and subsequent amendments, prepared in accordance with said Decree and the CONSOB Issuers Regulation. The statements were prepared in accordance with International Accounting Standard (IAS) 34 requirements for interim reporting, based on the assessment, measurement and recognition criteria set by the IFRSs. The interim financial statements on June 30, 2025 – as well as the Independent Auditors’ report on such statements - will be available within the legal deadline at the company’s offices and on the company’s website (www.recordati.com) and can also be viewed on the authorized storage system 1Info(www.1Info.it).

Bio Usawa Biotechnology and Sartorius Stedim Biotech Forge Partnership to Pioneer Biopharmaceutical Manufacturing in Africa

KIGALI, Rwanda and SAN FRANCISCO and AUBAGNE, France, July 29, 2025 (GLOBE NEWSWIRE) -- Bio Usawa Biotechnology, Ltd. (Bio Usawa), a leading African biotechnology firm, and Sartorius Stedim Biotech, a global partner of biopharmaceutical manufacturing, have announced a partnership to accelerate Africa’s biopharmaceutical industry and address the continent’s urgent, dual health burdens in infectious and non-communicable diseases.

Monogram Technologies Announces World’s First Fully Autonomous Saw-Based Robotic Knee Replacement Surgery

Monogram Technologies Announces World’s First Fully Autonomous Saw-Based Robotic Knee Replacement Surgery

FDA Approves Apellis’ EMPAVELI® (pegcetacoplan) as the First C3G and Primary IC-MPGN Treatment for Patients 12 and Older

WALTHAM, Mass., July 28, 2025 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) today announced that the U.S. Food and Drug Administration (FDA) has approved EMPAVELI® (pegcetacoplan) as the first treatment for C3 glomerulopathy (C3G) or primary immune complex membranoproliferative glomerulonephritis (IC-MPGN) in patients 12 years of age and older, to reduce proteinuria. C3G and primary IC-MPGN are rare kidney diseases, affecting 5,000 people in the United States.1

NKGen Biotech Presents Troculeucel Mechanism of Action with Corresponding Phase 1 Biomarker Data at the Alzheimer’s Association International Conference 2025

SANTA ANA, Calif., July 28, 2025 (GLOBE NEWSWIRE) -- NKGen Biotech, Inc. (OTC: NKGN) (“NKGen” or the “Company”), a clinical-stage biotechnology company focused on the development and commercialization of innovative autologous and allogeneic natural killer (“NK”) cell therapeutics, today announced the presentation of a poster entitled, “Mechanism of Action of Troculeucel (Non-genetically Modified Natural Killer Cells with Enhanced Cytotoxicity) in Alzheimer's Disease Confirmed by Corresponding Phase I Biomarker Data” at the Alzheimer’s Association International Conference 2025 (“AAIC 2025”) held in Toronto, Canada and online from July 27-31, 2025.

Zevra Therapeutics Submits Marketing Authorization Application to European Medicines Agency to Review Arimoclomol for the Treatment of Niemann-Pick Disease Type C

CELEBRATION, Fla., July 28, 2025 (GLOBE NEWSWIRE) -- Zevra Therapeutics, Inc. (NasdaqGS: ZVRA) (Zevra, or the Company), a commercial-stage company focused on providing therapies for people living with rare diseases, announced the company submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for the evaluation of arimoclomol for the treatment of Niemann-Pick Disease Type C (NPC). NPC is an ultra-rare, neurological disease caused by genetic mutations that result in lipid accumulation in cells, leading to visceral, neurological, and psychiatric symptoms. Arimoclomol is the only treatment shown to directly target the underlying pathology of NPC by increasing gene expression for improved lipid clearance. Arimoclomol for the treatment of NPC has been designated as an Orphan Medicinal Product by the EMA. Arimoclomol is marketed in the U.S. under the brand name MIPLYFFA®.

Roche presents new insights in Alzheimer’s disease research across its diagnostics and pharmaceutical portfolios at AAIC

Basel, 28 July 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that new data from its Alzheimer’s development portfolio is being presented at the Alzheimer’s Association International Conference (AAIC) in Toronto, Canada (July 27-30). These data exemplify the comprehensive approach Roche is taking in addressing Alzheimer’s across the entire patient journey. 

REPL CLASS ACTION ALERT: FDA Response Letter Leads to Replimune Group, Inc. Class Action – Investors are Notified to Contact BFA Law by September...

Replimune Group, Inc. investors that lost money are notified to contact BFA Law about its ongoing securities fraud class action investigation.

CARIBOU ALERT: Bragar Eagel & Squire, P.C. is Investigating Caribou Biosciences, Inc. on Behalf of Long-Term Stockholders and Encourages Investors to Contact the Firm

Bragar Eagel & Squire, P.C. Litigation Partner Brandon Walker Encourages Investors Who Suffered Losses In Caribou (CRBU) To Contact Him Directly To Discuss Their Options

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