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Tag: biotech

IMAAVY™ (nipocalimab-aahu) showed greater sustained disease control versus approved FcRn blockers for generalized myasthenia gravis (gMG) at multiple timepoints over 24 weeks in newly...

The ITC compared all published Phase 3 data of these treatments, leveraging longitudinal results, and findings reinforce the importance of consistent, sustained disease control...

ITM and Debiopharm Announce First Patient Imaged in New Study Arm of Phase 1/2 Trial Evaluating ITM-94 as Diagnostic Agent for Clear Cell Renal...


Garching / Munich, Germany, and Lausanne, Switzerland - June 23, 2025
ITM Isotope Technologies Munich SE (ITM), a leading radiopharmaceutical biotech company and Debiopharm, a Swiss-based, global biopharmaceutical company aiming to establish tomorrow’s standard-of-care to cure cancer and infectious diseases, today announced that the first patient was imaged in a new study arm of a five-part, Phase 1/2 clinical trial (formerly GaLuCi™) (NCT05706129) evaluating the theranostic pair ITM-94/ITM-91 for identification and treatment of patients who have unresectable, locally advanced or metastatic solid tumors. As a new component of a broad clinical development plan for ITM-91/ITM-94, Part D of the trial will evaluate the effectiveness of ITM-94 in classifying indeterminate renal mass as either ccRCC or non-cancerous.

European Medicines Agency Recommends Market Approval of AVT06, Alvotech’s Proposed Biosimilar to Eylea® (aflibercept)

REYKJAVIK, Iceland and LONDON, June 23, 2025 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide and Advanz Pharma, a UK headquartered global pharmaceutical company with a strategic focus on specialty, hospital, and rare disease medicines in Europe, today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human use (CHMP) adopted a positive opinion recommending approval for AVT06, Alvotech’s proposed biosimilar to Eylea® (aflibercept 2 mg). Based on a positive recommendation by CHMP, biosimilar medicines can be approved by the European Commission for marketing in the European Economic Area, that includes the 27 member states of the European Union, in addition to Norway, Iceland and Lichtenstein.

European Medicines Agency Recommends Market Approval of AVT06, Alvotech’s Proposed Biosimilar to Eylea® (aflibercept)

REYKJAVIK, ICELAND and LONDON, UK (June 23, 2025) — Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide and Advanz Pharma, a UK headquartered global pharmaceutical company with a strategic focus on specialty, hospital, and rare disease medicines in Europe, today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human use (CHMP) adopted a positive opinion recommending approval for AVT06, Alvotech’s proposed biosimilar to Eylea® (aflibercept 2 mg). Based on a positive recommendation by CHMP, biosimilar medicines can be approved by the European Commission for marketing in the European Economic Area, that includes the 27 member states of the European Union, in addition to Norway, Iceland and Lichtenstein.

Galapagos Appoints Aaron Cox as Chief Financial Officer

Former Horizon CFO joins Galapagos with deep expertise in international corporate finance, M&A, business development and strategic leadership 

Novogene Establishes New Subsidiary in Korea to Accelerate Multi-Omics Research

SEOUL, South Korea, June 23, 2025 /PRNewswire/ -- Novogene, a global leader in next-generation sequencing (NGS) and multi-omics solutions, today announced the establishment of...

Saudi Arabia Concludes Landmark BIO 2025 Debut as Kingdom Opens Doors to Global Biotech Collaboration

From genomics to regulatory innovation, the Kingdom’s presence in Boston establishes it as a major partner in global health science
From genomics to regulatory innovation, the Kingdom’s presence in Boston establishes it as a major partner in global health science

PharmAla Files Preliminary Base Shelf Prospectus

Pharmala files short form prospectus

OSE Immunotherapeutics Reaffirms Commitment to Holding a Transparent and Serene General Meeting in Compliance with Market Rules

OSE Immunotherapeutics Reaffirms Commitment to Holding a Transparent and Serene General Meeting in Compliance with Market Rules

Weekly Recap: 11 Tech Press Releases You Need to See

A roundup of the most newsworthy tech announcements from PR Newswire this week, including Skypoints's AI agents, Bybit's new platform & Synopsys advancements in...

Parataxis Holdings LLC Announces Definitive Agreement with Bridge Biotherapeutics, Inc. (KOSDAQ: 288330), to Bring Institutionally-Backed, Bitcoin Treasury Company to the South Korean Public Markets:

SEOUL, South Korea and NEW YORK, June 20, 2025 /CNW/ -- Parataxis Holdings LLC ("Parataxis Holdings"), an affiliate of Parataxis Capital Management LLC ("Parataxis Capital"...

Parataxis Holdings LLC Announces Definitive Agreement with Bridge Biotherapeutics, Inc. (KOSDAQ: 288330), to Bring Institutionally-Backed, Bitcoin Treasury Company to the South Korean Public Markets:

SEOUL, South Korea and NEW YORK, June 20, 2025 /PRNewswire/ -- Parataxis Holdings LLC ("Parataxis Holdings"), an affiliate of Parataxis Capital Management LLC ("Parataxis Capital"...

NurExone Advances U.S. Growth Strategy with Acceptance into Prestigious ARMI HealthTech Hub Accelerator and Provides Corporate Update

TORONTO and HAIFA, Israel, June 20, 2025 (GLOBE NEWSWIRE) -- NurExone Biologic Inc. (TSXV: NRX) (OTCQB: NRXBF) (FSE: J90) (“NurExone” or the “Company”), a biotech company developing exosome-based therapies for central nervous system injuries, announced today that it has been accepted into the HealthTech Hub (“HTH”) Accelerator Program. Based in Boston, Massachusetts, home to more than 1,000 biotech companies1, HTH is operated by the Advanced Regenerative Manufacturing Institute (“ARMI”) and its BioFabUSA initiative.

Delta-like Ligand 3 Targeted Therapies Market is Predicted to Heat Up During the Forecast Period (2025-2034) Across 7MM Owing to a Robust Pipeline |...

The delta-like ligand 3 targeted therapies market is witnessing significant growth, driven by the rising incidence of small cell lung cancer (SCLC) and neuroendocrine...

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