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Tag: biotech company

Hemispherian Receives U.S. FDA Orphan Drug Designation for GLIX1 for the Treatment of Malignant Glioma

OSLO, Norway, July 1, 2025 /PRNewswire/ -- Hemispherian AS, a pioneering biotech company developing next-generation therapeutics for aggressive cancers, announced today that the U.S....

Cancer Therapeutics Market Forecast to Reach $168 Billion by 2029, Highlighting Recurrent and Metastatic Innovations

"Metastatic Cancer: A Significant Therapeutic Challenge as Pharmaceutical Companies Leverage Digital Platforms and Data to Enhance Engagement with Patients, Providers, and Regulators in the...

Scinai Highlights Award-Winning Science Behind PC111 as Key Pincell Researcher Receives “Oscar of Italian Dermatology”

Dr. Roberta Lotti honoured for a pioneering work on PC111, reinforcing Scinai's strategic option agreement to acquire the Italian biotech company Pincell srl. JERUSALEM, June 26,...

Positive Top Line Results from Confirmatory Efficacy Study for Proposed Biosimilar to Xolair® (omalizumab)

REYKJAVIK, ICELAND, PISCATAWAY, NEW JERSEY AND LONDON, UK (June 25, 2025) — Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacturing of biosimilar medicines for patients worldwide, Kashiv Biosciences LLC (“Kashiv”), a fully integrated biopharmaceutical company headquartered in New Jersey, US, and Advanz Pharma Holdco Limited (“Advanz Pharma”), a UK-headquartered global pharmaceutical company with a strategic focus on specialty, hospital, and rare disease medicines, today announced positive topline results from a confirmatory efficacy study comparing AVT23 (ADL-018), a proposed biosimilar to Xolair® (omalizumab), with the reference biologic.

OSE Immunotherapeutics provides an update on ongoing proceedings

OSE Immunotherapeutics provides an update on ongoing proceedings

Zymo Research Unveils MultiOmiX Workstation with Show-Stopping Launch at ASM Microbe 2025

IRVINE, Calif., June 24, 2025 /PRNewswire/ -- Zymo Research stole the spotlight at the American Society for Microbiology (ASM) Microbe 2025 conference with the official...

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.

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

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.

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