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Tag: pharmaceuticals

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.

141,959 Orion Corporation A shares converted into B shares

ORION CORPORATION 
STOCK EXCHANGE RELEASE – OTHER INFORMATION DISCLOSED ACCORDING TO THE RULES OF THE EXCHANGE
23 June 2025 at 9.30 EEST
        

Navamedic ASA expands into addiction treatment through the acquisition of the business of dne pharma and announces a partially underwritten rights issue

NOT FOR DISTRIBUTION OR RELEASE, DIRECTLY OR INDIRECTLY, IN OR INTO THE UNITED STATES, CANADA, AUSTRALIA, THE HONG KONG SPECIAL ADMINISTRATIVE REGION OF THE...

XtalPi Announces Strategic Collaboration with Harvard Professor Gregory Verdine’s DoveTree LLC to Advance Novel Therapeutics Using AI+Robotics Drug Discovery Platform

CAMBRIDGE, Mass. , June 23, 2025 /PRNewswire/ -- XtalPi, a global leader in AI- and robotics-powered drug and materials discovery, today announced it has signed...

Everest Medicines Announces Official Publication of the Specifications for Antimicrobial Susceptibility Testing of Eravacycline (2025)

SHANGHAI, June 23, 2025 /PRNewswire/ -- Everest Medicines (HKEX 1952.HK, "Everest", or the "Company"), a biopharmaceutical company focused on the discovery, clinical development, manufacturing,...

INVESTOR ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Rocket Pharmaceuticals, Inc. – RCKT

NEW YORK, June 22, 2025 /PRNewswire/ -- Pomerantz LLP is investigating claims on behalf of investors of Rocket Pharmaceuticals, Inc. ("Rocket" or the "Company")...

ROSEN, A LEADING INVESTOR RIGHTS LAW FIRM, Encourages Rocket Pharmaceuticals, Inc. Investors to Secure Counsel Before Important Deadline in Securities Class Action – RCKT

NEW YORK, June 22, 2025 (GLOBE NEWSWIRE) --

WHY: Rosen Law Firm, a global investor rights law firm, reminds purchasers of securities of Rocket Pharmaceuticals, Inc. (NASDAQ: RCKT) between February 27, 2025 and May 26, 2025, both dates inclusive (the “Class Period”), of the important August 11, 2025 lead plaintiff deadline.

Gan & Lee Pharmaceuticals Presented Multiple Results in Novel Diabetes Therapies at the American Diabetes Association’s 85th Scientific Sessions

In a Phase 2a clinical trial, the GLP-1 RA bofanglutide injection demonstrated a favorable safety and tolerability profile after 23 weeks of once weekly...

Gan & Lee Pharmaceuticals Presented Multiple Results in Novel Diabetes Therapies at the American Diabetes Association’s 85th Scientific Sessions

In a Phase 2a clinical trial, the GLP-1 RA bofanglutide injection demonstrated a favorable safety and tolerability profile after 23 weeks of once weekly...

Gan & Lee Pharmaceuticals Presented Multiple Results in Novel Diabetes Therapies at the American Diabetes Association’s 85th Scientific Sessions

In a Phase 2a clinical trial, the GLP-1 RA bofanglutide injection demonstrated a favorable safety and tolerability profile after 23 weeks of once weekly...

Gan & Lee Pharmaceuticals Presented Multiple Results in Novel Diabetes Therapies at the American Diabetes Association’s 85th Scientific Sessions

In a Phase 2a clinical trial, the GLP-1 RA bofanglutide injection demonstrated a favorable safety and tolerability profile after 23 weeks of once weekly...

Gan & Lee Pharmaceuticals Presented Multiple Results in Novel Diabetes Therapies at the American Diabetes Association’s 85th Scientific Sessions

In a Phase 2a clinical trial, the GLP-1 RA bofanglutide injection demonstrated a favorable safety and tolerability profile after 23 weeks of once weekly...

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