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FDA Accepts Telix NDA for New Prostate Cancer Imaging Agent
By Dr. Matthew Watson
MELBOURNE, Australia, July 24, 2024 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces that the United States (U.S.) Food and Drug Administration (FDA) has accepted the filing of its New Drug Application (NDA) for TLX007-CDx, a new and proprietary cold kit (“Kit”) for the preparation of PSMA-PET imaging1 for prostate cancer. The PDUFA2 goal date is March 24, 2025.
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FDA Accepts Telix NDA for New Prostate Cancer Imaging Agent
NewGenIvf Provides Update on Potential Reverse Merger with COVIRIX
By Dr. Matthew Watson
BANGKOK, July 24, 2024 (GLOBE NEWSWIRE) -- NewGenIvf Group (NASDAQ: NIVF) (“NewGen” or the “Company”), a comprehensive fertility services provider in Asia helping couples and individuals obtain access to fertility treatments, today announced an update on its proposed reverse merger (the “Proposed Transaction”) with pharmaceutical company COVIRIX Medical Pty Ltd ("COVIRIX"). The Company reports steady progress in its due diligence efforts and, contingent upon meeting all regulatory requirements, anticipates completing the Proposed Transaction by the end of August 2024.
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NewGenIvf Provides Update on Potential Reverse Merger with COVIRIX
Kronos Bio Announces First Patient Dosed with KB-0742 in an Expansion Cohort Focused on Platinum-Resistant High-Grade Serous Ovarian Cancer
By Dr. Matthew Watson
— KB-0742 cleared 80mg four-days-on, three-days-off dosing schedule in dose escalation —
Assembly Biosciences Presents New Preclinical Data Highlighting Investigational Helicase-Primase Inhibitors at International Herpesvirus Workshop
By Dr. Matthew Watson
– Data from both ABI-5366 and ABI-1179, novel long-acting helicase-primase inhibitor candidates for recurrent genital herpes, to be presented –
GRI Bio (NASDAQ: GRI) to Participate in the Virtual Investor Lunch Break Series
By Dr. Matthew Watson
Live video webcast on Wednesday, July 17th at 12:00 PM ET
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GRI Bio (NASDAQ: GRI) to Participate in the Virtual Investor Lunch Break Series
Monthly information related to total number of voting rights and shares composing the share capital – July 1, 2024
By Dr. Matthew Watson
Article 223-16 of general regulation of French Autorité des Marchés Financiers
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Monthly information related to total number of voting rights and shares composing the share capital – July 1, 2024
Inventiva provides an update on its NATiV3 clinical program evaluating lanifibranor in patients with MASH/NASH and its financial position
By Dr. Matthew Watson
Daix (France), Long Island City (New York, United States), July 5, 2024 – Inventiva (Euronext Paris and Nasdaq: IVA) (“Inventiva” or the “Company”), a clinical-stage biopharmaceutical company focused on the development of oral small molecule therapies for the treatment of patients with metabolic dysfunction-associated steatohepatitis (“MASH”), also known as non-alcoholic steatohepatitis (“NASH”), and other diseases with significant unmet medical needs, today provided an update on its clinical program evaluating lanifibranor for the treatment of MASH/NASH and its financial position.
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Inventiva provides an update on its NATiV3 clinical program evaluating lanifibranor in patients with MASH/NASH and its financial position
Bioxodes meets first Phase 2a patient enrollment milestone with BIOX-101 in intracerebral hemorrhagic stroke
By Dr. Matthew Watson
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
European Commission approves Roche’s Alecensa as the first and only targeted adjuvant treatment for people with ALK-positive early-stage lung cancer
By Dr. Matthew Watson
European Commission approves Roche’s Alecensa as the first and only targeted adjuvant treatment for people with ALK-positive early-stage lung cancer
Mainz Biomed Reports Results of 2024 Annual General Meeting
By Dr. Matthew Watson
BERKELEY, Calif. and MAINZ, Germany, May 31, 2024 (GLOBE NEWSWIRE) -- Mainz Biomed N.V. (NASDAQ: MYNZ), a molecular genetics diagnostic company specializing in the early detection of cancer, held its annual general meeting (“Annual General Meeting”) on Friday, May 31, 2024 in Amsterdam, The Netherlands. Holders of 2,431,947 ordinary shares, representing approximately 10.9% of our outstanding shares on May 3, 2024, the record date for the Annual General Meeting, were present at such meeting, which constituted a quorum under Dutch law. Each of the matters presented at the Annual General Meeting received the requisite shareholder approval as set below:
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Mainz Biomed Reports Results of 2024 Annual General Meeting
CENTOGENE Announces Adoption of All Resolutions Tabled at 2024 Annual General Meeting
By Dr. Matthew Watson
CAMBRIDGE, Mass. and ROSTOCK, Germany and BERLIN, May 31, 2024 (GLOBE NEWSWIRE) -- CENTOGENE N.V. (Nasdaq: CNTG) (the “Company”), the essential life science partner for data-driven answers in rare and neurodegenerative diseases, today announced the voting results of the Company’s 2024 Annual General Meeting. Shareholders voted in favor of all proposals.
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CENTOGENE Announces Adoption of All Resolutions Tabled at 2024 Annual General Meeting
Immunocore reports updated Phase 1 data of brenetafusp (IMC-F106C), an ImmTAC bispecific targeting PRAME, in immune checkpoint pre-treated cutaneous…
By Dr. Matthew Watson
Immunocore reports updated Phase 1 data of brenetafusp (IMC-F106C), an ImmTAC bispecific targeting PRAME, in immune checkpoint pre-treated cutaneous melanoma patients at ASCO 2024
Ultimovacs Announces Poster Presentation at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting
By Dr. Matthew Watson
Sobi to present new myelofibrosis data at the ASCO 2024 Annual Meeting
By Dr. Matthew Watson
WALTHAM, Mass., May 24, 2024 (GLOBE NEWSWIRE) -- Sobi North America, the North American affiliate of Swedish Orphan Biovitrum AB (Sobi®), today announced the presentation of three abstracts that highlights data from its myelofibrosis treatment option at the American Society of Clinical Oncology (ASCO) Annual Meeting taking place in Chicago from May 31 – June 4, 2024.
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Sobi to present new myelofibrosis data at the ASCO 2024 Annual Meeting
QuTEM Receives GMP Certificates and Manufacturing Permits for Transmission Electron Microscopy Laboratory from the Swedish Medical Products Agency
By Dr. Matthew Watson
STOCKHOLM, Sweden, May 17, 2024 (GLOBE NEWSWIRE) -- QuTEM AB (formerly Vironova BioAnalytics AB), a leading provider of transmission electron microscopy (TEM) services, proudly announces the receipt of GMP (Good Manufacturing Practice) Certificates and Manufacturing Permits for Independent Quality Control Laboratories issued by the Swedish Medical Products Agency (Läkemedelsverket). QuTEM is thereby authorized to perform critical quality control analysis essential for the release of medicines to the market. The GMP Certificates and Manufacturing Permits cover medicinal and investigational medicinal products for both human and veterinary use.
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QuTEM Receives GMP Certificates and Manufacturing Permits for Transmission Electron Microscopy Laboratory from the Swedish Medical Products Agency
Erasca Announces Strategic In-Licensing of RAS-Targeting Franchise
By Dr. Matthew Watson
Pan-RAS molecular glue ERAS-0015 and pan-KRAS inhibitor ERAS-4001 are potent, oral inhibitors with potential best-in-class profiles in RASm solid tumors
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Erasca Announces Strategic In-Licensing of RAS-Targeting Franchise
HUTCHMED Highlights Sovleplenib Phase III ESLIM-01 Study and Hematological Malignancy Programs Data to be Presented at the upcoming EHA2024 Congress
By Dr. Matthew Watson
HONG KONG, SHANGHAI and FLORHAM PARK, N.J., May 17, 2024 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) today announces that topline and subgroup results from the ESLIM-01 Phase III study of sovleplenib, as well as new and updated data related to novel investigational hematological malignancy therapies HMPL-306, HMPL-760 and tazemetostat, will be presented at the upcoming European Hematology Association (“EHA”) Hybrid Congress, taking place on June 13-16, 2024 in Madrid, Spain and online.
Ultimovacs – Invitation to Business Update on April 17, 2024
By Dr. Matthew Watson
Notable Labs Presents the Design Plan for the PPMP-Enabled Phase 2 Trial with Volasertib for Relapsed/Refractory AML at AACR 2024
By Dr. Matthew Watson
FOSTER CITY, Calif., April 09, 2024 (GLOBE NEWSWIRE) -- Notable Labs, Ltd. (Nasdaq: NTBL) (“Notable” or the “Company”), a clinical-stage precision oncology company developing a new class of cancer therapies identified by its Predictive Precision Medicine Platform (PPMP), today presented the design for the PPMP-enabled Phase 2 trial with volasertib, in combination with decitabine, in patients with relapsed/refractory (R/R) acute myeloid leukemia (AML) at the American Association for Cancer Research (AACR 2024) being held in San Diego, CA (Poster abstract 5178).
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Notable Labs Presents the Design Plan for the PPMP-Enabled Phase 2 Trial with Volasertib for Relapsed/Refractory AML at AACR 2024
Gedeon Richter Selects Trial Interactive for Clinical Trial Management
By Dr. Matthew Watson
Specialty Pharmaceutical Company Deploys TransPerfect Technology to Streamline TMF Operations Specialty Pharmaceutical Company Deploys TransPerfect Technology to Streamline TMF Operations
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Gedeon Richter Selects Trial Interactive for Clinical Trial Management