Biotechnology
Everest Medicines and Kezar Life Sciences Receive IND Approval from China NMPA for PALIZADE Trial in Lupus Nephritis
SHANGHAI, China and SOUTH SAN FRANCISCO, Calif., Feb. 27, 2024 /PRNewswire/ -- Everest Medicines (HKEX 1952.HK) and Kezar Life Sciences, Inc. (Nasdaq: KZR) announced today that the Center for Drug Evaluation (CDE) ofChina's National Medical Products Administration (NMPA) approved Kezar's investig...
Neomorph Announces Multi-Target Collaboration with Novo Nordisk to Discover Novel Molecular Glue Degraders for Cardiometabolic and Rare Diseases
* Collaboration leverages Neomorph's leading molecular glue discovery platform and Novo Nordisk's extensive expertise in cardiometabolic and rare diseases * Total potential deal value of $1.46B across multiple targets SAN DIEGO, Feb. 27, 2024 /PRNewswire/ -- Neomorph, Inc. today announced it ...
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...
GC Cell and BioCentriq® Execute Process Transfer Agreement in Anticipation of the U.S. entry of Immuncell-LC Inj.
* Immuncell-LC Inj. is an autologous Cytokine Induced Killer (CIK) cell therapy approved for Commercial use inSouth Korea as an adjuvant cell therapy for the treatment of Hepatocellular Carcinoma (HCC) after curative resection and has receivedFDA Orphan Drug Designations (ODDs) for liver, brain...
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...
J INTS BIO, Phase 1/2 study of 'JIN-A02', a Novel Oral 4th Generation EGFR TKI, accepted for presentation at the upcoming American Association for Cancer Research 2024 meeting in USA (AACR 2024)
SEOUL, South Korea, Feb. 26, 2024 /PRNewswire/ -- J INTS BIO announced on the 26th of month that the Phase 1/2 clinical study of its Novel Oral 4th Generation EGFR TKI "JIN-A02" for the treatment of NSCLC has been accepted for poster presentation at the upcoming American Association for Cancer Re...
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...
Everest Medicines' Partner Pfizer Announces European Commission Approves VELSIPITY® for Patients with Moderately to Severely Active Ulcerative Colitis
--VELSIPITY is the first and only oral advanced ulcerative colitis therapy approved for use in patients 16 years of age or older in the EU-- SHANGHAI, Feb. 22, 2024 /PRNewswire/ -- Everest Medicines (HKEX 1952.HK, "Everest", or the "Company")'s partner Pfizer Inc. (NYSE: PFE) announced that the ...
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...
WuXi Biologics Recognized as Both Industry and Regional ESG Top-Rated Company by Morningstar Sustainalytics
* Named Top-Rated for fourth consecutive year * Committed to generating long-term value for all stakeholders SHANGHAI, Feb. 21, 2024 /PRNewswire/ -- WuXi Biologics ("WuXi Bio") (2269.HK), a leading global Contract Research, Development and Manufacturing Organization (CRDMO), announced it has ...
Findings of a Phase III Clinical Study of Sanbexin® Sublingual Tablets Published in JAMA
NANJING, China, Feb. 21, 2024 /PRNewswire/ -- On February 19, 2024, the Journal of American Medical Association•Neurology (JAMA NEUROLOGY, IF: 29.0) published online the key findings of a phase III clinical study (NCT04950920) (the "TASTE-SL Study") investigating Sanbexin® (a combination of edara...
Everest Medicines' Licensing Partner Venatorx Pharmaceuticals Announces Publication of Positive Results from Cefepime-Taniborbactam's Phase 3 CERTAIN-1 Study in New England Journal of Medicine
--Cefepime-taniborbactam was superior to meropenem for the composite efficacy endpoint with composite efficacy sustained at late follow-up visit-- SHANGHAI, Feb. 21, 2024 /PRNewswire/ -- Everest Medicines (HKEX 1952.HK)'s licensing partner, Venatorx Pharmaceuticals announced that The New England ...
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...
Origin Agritech Regains Compliance with Nasdaq Listing Standards
BEIJING, Feb. 20, 2024 /PRNewswire/ -- Origin Agritech Ltd. (NASDAQ: SEED) (the "Company" or "Origin"), a leading Chinese agricultural technology company, today announced that it has regained compliance with Nasdaq's market value of listed securities requirement as set forth in Listing Rule 5550(...
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