Pharmaceuticals
First Patient Treated in Phase 2 GvHD Trial
MELBOURNE, Australia, March 5, 2024 /PRNewswire/ -- Cynata Therapeutics Limited (ASX: "CYP", "Cynata", or the "Company"), a clinical-stage biotechnology company specialising in cell therapeutics, confirms that the first patient has been enrolled and treated in its Phase 2 clinical trial ofCYP-001...
Telix to Acquire ARTMS, Inc. and its Advanced Isotope Production Platform
MELBOURNE, Australia, March 5, 2024 /PRNewswire/ -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces it has entered into an agreement to acquire radioisotope production technology firm ARTMS Inc. (ARTMS), its advanced cyclotron-based isotope production platform, manuf...
Formosa Pharmaceuticals and AimMax Therapeutics Receive FDA Approval for Clobetasol Propionate Ophthalmic Suspension 0.05%, for the Treatment of Post-Operative Inflammation and Pain Following Ocular Surgery
TAIPEI, March 4, 2024 /PRNewswire/ -- Taiwan-based Formosa Pharmaceuticals (6838.TWO) and AimMax Therapeutics (United States) announced today that the U.S. Food and Drug Administration (FDA) has approved clobetasol propionate ophthalmic suspension 0.05% (APP13007), for the treatment of post-opera...
ACROBiosystems Launches New Initiative to Support Cell and Gene Manufacturers
NEWARK, Calif., March 4, 2024 /PRNewswire/ -- ACROBiosystems, one of the leading providers of innovative tools and solutions used from discovery to the clinic, has announced a new corporate initiative to supportex vivo cell manufacturing and manufacturers of innovative cell and gene therapies. I...
Henlius Forecasts Profit in 2023: Achieving first full year of profitability, and ushering in a new phase of high-quality development
SHANGHAI, March 4, 2024 /PRNewswire/ -- Henlius (2696.HK) released a positive profit forecast. Based on the preliminary assessment of the unaudited consolidated management accounts for the year ended31 December, 2023 (the "Reporting Period") and the information currently available to the Board,it...
Henlius Forecasts Profit in 2023: Achieving first full year of profitability, and ushering in a new phase of high-quality development
SHANGHAI, March 4, 2024 /PRNewswire/ -- Henlius (2696.HK) released a positive profit forecast. Based on the preliminary assessment of the unaudited consolidated management accounts for the year ended31 December, 2023 (the "Reporting Period") and the information currently available to the Board,it...
Landmark Clinical Approval for YOLT-201 Obtained by the NMPA
SHANGHAI, March 4, 2024 /PRNewswire/ -- YolTech Therapeutics, a biotech company developing in vivo gene editing therapies to treat rare genetic diseases, today announced the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) has officially approved the YOLT-2...
Results from the Clinical Trial of Qilu Pharmaceutical's Novel Anticancer Agent Iparomlimab and Tuvonralimab (QL1706) Featured in Oral Presentation at the ESGO Annual Meeting
JINAN, China, March 4, 2024 /PRNewswire/ -- The European Society of Gynecological Oncology (ESGO) 2024 Conference has recently made selected abstracts available online. The abstract (abstract # 251) that details results from the Phase II clinical trial (DUBHE-C-206) evaluating the efficacy and s...
Caliway Announced Orphan Drug Designation Granted to CBL-514 for the Treatment of Dercum's Disease
* CBL-514 is the first and only drug to receive both Orphan Drug Designation and Fast Track designation for Dercum's disease treatment. NEW TAIPEI CITY, March 4, 2024 /PRNewswire/ -- Caliway Biopharmaceuticals (Caliway) announced that the U.S. Food and Drug Administration (FDA) granted Orphan D...
Caliway Announced Orphan Drug Designation Granted to CBL-514 for the Treatment of Dercum's Disease
- CBL-514 is the first and only drug to receive both Orphan Drug Designation and Fast Track designation for Dercum's disease treatment. NEW TAIPEI CITY, March 3, 2024 /PRNewswire/ -- Caliway Biopharmaceuticals (Caliway) announced that the U.S. Food and Drug Administration (FDA) granted Orp...
Mezzion Pharmaceuticals Announces Dr. Rahul Rathod of Boston Children's Hospital and Harvard Medical School as the Global Principal Investigator for the Confirmatory Pivotal Phase 3 Trial FUEL-2
FORT LEE, N.J., March 2, 2024 /PRNewswire/ -- Mezzion Pharmaceuticals is a rare disease company conducting the confirmatory pivotal phase 3 clinical trial in Fontan subjects: The Fontan Udenafil Exercise Longitudinal Assessment Trial- 2, or FUEL-2 trial. The company is pleased to announce Dr.Rahu...
The 16th Zhang Zhongjing Medicine Culture Festival & Forum on High-quality Development of TCM Takes Place in Nanyang, China
NANYANG, China, March 2, 2024 /PRNewswire/ -- Co-hosted by the Nanyang Chinese Medicine Development Bureau, the China Association of Chinese Medicine (CACM) and the China Association of Traditional Chinese Medicine (CATCM), the Zhang Zhongjing Medicine Culture Festival & Forum on High-quality Dev...
NMPA Approves the NDA for CARsgen's BCMA CAR-T Therapy Zevorcabtagene Autoleucel for Relapsed or Refractory Multiple Myeloma
SHANGHAI, March 1, 2024 /PRNewswire/ -- CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on innovative CAR T-cell therapies for the treatment of hematologic malignancies and solid tumors, announces that today the National Medical Products Administration ("NMPA") ofChi...
Kinnate Biopharma Inc. Sells Its Investigational Pan-RAF Inhibitor, exarafenib, to Pierre Fabre Laboratories
* Kinnate has entered into an Asset Purchase Agreement (the "APA") with Pierre Fabre Laboratories for global rights to exarafenib and other pan-RAF program assets. * The transaction is in furtherance of Kinnate's previously announced pursuit of strategic alternatives. * This acquisition is ...
111 to Announce Fourth Quarter and Fiscal Year 2023 Unaudited Financial Results- Conference Call to Follow
SHANGHAI, March 1, 2024 /PRNewswire/ -- 111, Inc. (NASDAQ: YI) ("111" or the "Company"), a leading tech-enabled healthcare platform company committed to digitally connecting patients with medicine and healthcare services inChina, today announced that it will report its unaudited financial results...
Jacobio Pharma Receives IND Approval for P53 Y220C Activator JAB-30300 in the U.S.
BEIJING, SHANGHAI and BOSTON, March 1, 2024 /PRNewswire/ -- Jacobio Pharma (1167.HK), a clinical-stage oncology company drugging the undruggable targets, today announced it received IND (Investigational New Drug) approval of its self-developed drug JAB-30300 (P53 Y220C activator) from the FDA of ...
Innovent Announces First Participant Dosed in a Phase I Study of IBI3002 (an anti-IL-4Rα/TSLP bispecific antibody) in Australia
ROCKVILLE, Md. and SUZHOU, China, March 1, 2024 /PRNewswire/ -- Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncology, metabolic, autoimmune, ophthalmology and ...
SN BioScience received US FDA Orphan Drug Designation for its Nano Anti-Cancer Drug 'SNB-101' on Pancreatic Cancer
SEOUL, South Korea, Feb. 29, 2024 /PRNewswire/ -- SN Bioscience Co. Ltd. (CEO Park Young-hwan) announced onFeb 27 that the US FDA had granted an orphan drug designation for pancreatic cancer for SNB-101 (API: SN-38), a new polymer nanoparticle drug under development, based on the pre-clinical dat...
Medidata and Sanofi Vaccines Extend Collaboration to Improve Patient Centricity and Trial Efficiency
Collaboration will harness Medidata Electronic Clinical Outcome Assessment
(eCOA) for remote patient engagement and real-time data capture
SINGAPORE, Feb. 29, 2024 /PRNewswire/ -- Medidata
Skyhawk Therapeutics Has Advanced to the Multiple Ascending Dose Portion of its Phase 1 Study evaluating SKY-0515, a RNA-Targeting Small Molecule for Huntington's Disease
SKY-0515 is a small molecule RNA splicing modifier developed through the company's novel SKYSTAR® platform. Having successfully advanced through single asending dose, SKY-0515 is advancing into the Multiple Ascending Dose portion of its phase 1 study. Huntington's disease is a fatal neurological ...
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