Pharmaceuticals
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...
PharmAust announces positive Phase 1 MEND Study Top-Line Results in MND / ALS
Highlights: * Monepantel displays a superior safety, tolerability to the leading FDA approved drug Relyvrio® * Preliminary efficacy data shows a 58% reduction in the rate of disease progression for Cohort 2 (High Dose) using the FDA primary efficacy endpoint, ALSFRS-R * Confirmation that m...
The promising results of a phase II clinical study for Akeso's Cadonilimab (PD-1/CTLA-4) combined standard treatment for first-line treatment of R/M cervical cancer has been published in Clinical Cancer Research
HONG KONG, Feb. 28, 2024 /PRNewswire/ -- Akeso (9926.HK) announced that the results of a phase II clinical trial for PD-1/CTLA-4 bispecific antibody(cadonilimab)combined with standard treatment (chemotherapy +/- bevacizumab) as first-line treatment for recurrent/metastatic cervical cancer had be...
FDA Grants Fast Track Designation to 9MW2821
SHANGHAI, Feb. 27, 2024 /PRNewswire/ -- Mabwell (688062.SH), an innovative biopharmaceutical company with entire industry chain, announces that its self-developed novel ADC drug targeting Nectin-4 (R&D Code: 9MW2821) has been granted Fast Track Designation (FTD) by the U.S. Food and Drug Administ...
111 Announces Receipt of Withdrawal of Going Private Proposal
SHANGHAI, Feb. 27, 2024 /PRNewswire/ -- 111, Inc. ("111" or the "Company") (NASDAQ: YI), a leading tech-enabled healthcare platform company committed to digitally connecting patients with medicine and healthcare services inChina, today announced that it has received a notice dated Feburary 27, 20...
Nona Biosciences Enters into Collaboration Agreement with Boostimmune in Antibody-Drug Conjugate Development
CAMBRIDGE, Mass., Feb. 26, 2024 /PRNewswire/ -- Nona Biosciences, a wholly-owned subsidiary of HBM Holdings Limited committed to cutting-edge technology innovations and providing a total solution from "Idea to IND" ("I to ITM"), announced today that it has entered into a collaboration agreement w...
BioCity Announces Enrollment Completion of the IgA Nephropathy (IgAN) Cohort in the Randomized, Placebo-controlled Phase II Clinical Trial of the ETA Receptor Antagonist SC0062
WUXI, China, Feb. 25, 2024 /PRNewswire/ -- BioCity Biopharma is pleased to announce the completion of enrollment of all 120 participants in the IgA nephropathy (IgAN) cohort in a randomized, double-blind, placebo-controlled Phase 2 clinical study of the novel, oral endothelin A (ETA)-receptor sel...
TransThera initiates IND-Enabling studies for TT-02332, a novel, highly potent and CNS-penetrating NLRP3 inhibitor
NANJING, China and GAITHURSBURG, Md., Feb. 26, 2024 /PRNewswire/ -- TransThera, a clinical-stage biopharmaceutical company dedicated to innovating differentiated drugs globally, today announced the initiation of IND-enabling studies for TT-02332, a potent, selective and highly CNS-penetrating NLR...
Aucta Pharmaceuticals, Inc. ("Aucta Pharmaceuticals") launches MOTPOLY XR™ (lacosamide) extended-release capsules C-V, the first, and only once-daily formulation of lacosamide
PISCATAWAY, N.J., Feb. 26, 2024 /PRNewswire/ -- Aucta Pharmaceuticals, Inc., a private specialty pharmaceutical company focused on niche generic and branded specialty products, today announced the commercial launch of MOTPOLY XR (lacosamide) extended-release capsules C-V (100, 150 and 200 mg). M...
Groundbreaking! Phase II Data of LP-003 Unveiled by Longbio Pharma at AAAAI2024
WASHINGTON, Feb. 25, 2024 /PRNewswire/ -- Longbio Pharma (Suzhou) Co., Ltd. (referred to as "Longbio Pharma"), a leading biotech company dedicated to developing innovative protein treatments for allergy, respiratory, dermatology, hematology, ophthalmology, and other autoimmune and rare diseases, ...
Oscotec/ADEL Initiates First-in-Human Dosing in Ph1 of Anti-MTBR Tau Antibody ADEL-Y01 In Alzheimer's Disease
PANGYO, South Korea, Feb. 23, 2024 /PRNewswire/ -- Oscotec Inc. and ADEL Inc. announced the dosing of the first healthy participant in its first-in-human study of ADEL-Y01 for the treatment of Alzheimer's disease (AD). Oscotec and ADEL are jointly developing a novel disease-modifying immunothera...
Immunofoco Announces the Dual Approval of IND Applications by the U.S. FDA and China CDE for the First EpCAM CAR-T Targeted at Advanced Solid Tumors
- The first EpCAM targeted CAR-T product obtained US/CN IND approval. - Acceptable safety profiles and preliminary efficacy were observed in Investigator-Initiated Trial (IIT) clinical studies of IMC001. SHANGHAI, Feb. 22, 2024 /PRNewswire/ -- Immunofoco, a company dedicated to developing cell ...
CATUG and Crystal Bio Establish Strategic Partnership, Launching "CATUG-Crystal" Joint Lab Dedicated to Advanced Nucleic Acid Analytical Services
CAMBRIDGE, Mass. and CRANBURY, N.J., Feb. 22, 2024 /PRNewswire/ -- CATUG Inc. (CATUG) andCrystal Bio, a member of Crystal Pharmatech, announced today a long-term strategic partnership to provide advanced nucleic acid-based drug analytical services. CATUG, a distinguished global entity specializin...
Mabwell Publishes the Phase III Study Results on Its Denosumab Biosimilar (MW032) in the journal JAMA Oncology
SHANGHAI, Feb. 21, 2024 /PRNewswire/ -- Mabwell (688062.SH), an innovative biopharmaceutical company with entire industry chain, recently published the phase III study results of denosumab biosimilar (MW032) online in the international top journal of JAMA Oncology. This is the first recorded tria...
Ono Enters into a Research Collaboration Agreement with InveniAI to Identify Novel Therapeutic Targets
OSAKA, Japan, Feb. 20, 2024 /PRNewswire/ -- Ono Pharmaceutical Co., Ltd. ( Osaka, Japan; President and CEO: Gyo Sagara; "Ono") today announced that it has entered into a research collaboration agreement with InveniAI® LLC (Guilford, Connecticut, USA; President and CEO: Krishnan Nandabalan; "Inveni...
Hox Therapeutics and Vernalis announce a drug discovery collaboration in oncology
CHENGDU, China, Feb. 20, 2024 /PRNewswire/ -- Hox Therapeutics Ltd ("Hox") a private biotechnology company developing highly targeted cancer therapies and Vernalis (R&D) Ltd ("Vernalis"), a fully owned subsidiary of HitGen Inc., are pleased to announce a collaboration to identify inhibitors again...
Mabwell Receives IND Approval from FDA for Novel B7-H3 ADC 7MW3711
SHANGHAI, Feb. 20, 2024 /PRNewswire/ -- Mabwell (688062.SH), an innovative biopharmaceutical company with entire industry chain, announced that its clinical trial application of B7-H3 targeting ADC (R&D code: 7MW3711) for advanced malignant solid tumor was approved by the U.S. Food and Drug Admi...
FDA Grants Orphan Drug Designation to 9MW3011
SHANGHAI, Feb. 20, 2024 /PRNewswire/ -- Mabwell (688062.SH), an innovative biopharmaceutical company with entire industry chain, announced that FDA has granted Orphan Drug Designation (ODD) to 9MW3011 (R&D code in the US: MWTX-003/DISC-3405) for the treatment of patients with polycythemia vera (P...
WuXi Advanced Therapies Receives FDA Approval to Manufacture Iovance's AMTAGVI™ (lifileucel) for Advanced Melanoma
AMTAGVI is the first and only one-time, individualized T cell therapy to receive U.S. FDA approval fora solid tumor cancer. PHILADELPHIA, Feb. 20, 2024 /PRNewswire/ -- WuXi Advanced Therapies (WuXi ATU), a wholly owned subsidiary of WuXi AppTec, today announced that the U.S. Food and Drug Admini...
Kangpu Biopharmaceuticals to Present Preclinical Efficacy Data of KPG-818 in Crohn's Disease at the 19th Congress of ECCO (IND Application for Phase II in Progress)
HEFEI, China, Feb. 20, 2024 /PRNewswire/ -- Kangpu Biopharmaceuticals, a clinical-stage company dedicated to the discovery and development of novel therapeutics for the treatment of cancer, autoimmune diseases, and inflammation, through targeted protein degradation technology, today announced th...
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