Pharmaceuticals

Bambusa Therapeutics Announces First Subject Dosed in Phase 1 Clinical Trial of BBT002, A Novel Platform-In-A-Molecule Bispecific Antibody for Broad I&I Conditions and U.S. FDA Clearance of IND Application for BBT001

* Preclinical data with BBT002 demonstrate its best-in-disease potential for improved efficacy and dosing convenience across respiratory, dermatology, and gastroenterology indications * Interim safety and pharmacokinetic data from BBT002-01 study anticipated in Q1 2026 * The clearance of BB...

2025-05-30 21:30 2923

GC Biopharma's Phase 3 Clinical Trial Results for Hunterase Published in SCIE-Indexed Journal

YONGIN, South Korea, May 30, 2025 /PRNewswire/ -- GC Biopharma, a South Korean pharmaceutical company, announced that the Phase 3 clinical trial results for Hunterase (idursulfase beta), its investigational drug for Hunter Syndrome (MPS II), have been published in Genetics in Medicine, an SCIE-in...

2025-05-30 15:02 2113

Teddy Laboratory (GuanHe Pharmaceuticals) Signs Strategic Cooperation Agreement with LabConnect to Forge a New Landscape in Laboratory Services Collaboration

JOHNSON CITY, Tenn., May 30, 2025 /PRNewswire/ -- Teddy Laboratory, a subsidiary of Tigermed, officially signed a strategic cooperation agreement with LabConnect, LLC, a global leader in central laboratory services. The two parties will jointly build a full-chain laboratory service system covering...

2025-05-30 05:05 2219

NEW THERAPY FOR CHILDREN WITH GROWTH HORMONE DEFICIENCY APPROVED IN AUSTRALIA

SKYTROFA® (lonapegsomatropin) is now registered by the Therapeutic Goods Administration (TGA) for the treatment of paediatric growth hormone deficiency.[ 1] SINGAPORE, May 29, 2025 /PRNewswire/ -- Independent biopharmaceutical company Specialised Therapeutics (ST) is pleased to announce the Austr...

2025-05-30 00:01 2283

First patient imaged in Phase III AMPLIFY trial with 64Cu-SAR-bisPSMA PET/CT

SYDNEY, May 29, 2025 /PRNewswire/ -- Clarity Pharmaceuticals (ASX: CU6) ("Clarity" or "Company"), a clinical-stage radiopharmaceutical company with a mission to develop next-generation products that improve treatment outcomes for patients with cancer, is pleased to announce that it has imaged the...

2025-05-29 21:04 1980

Dx&Vx Accelerates Development of Universal COVID-19 Vaccine

* Emerging as a next-generation vaccine amidst global resurgence of COVID-19 * Expanding v arious pipelines other than universal COVID vaccine SEOUL, South Korea, May 29, 2025 /PRNewswire/ -- Bio-healthcare company Dx&Vx (DXVX) has officially announced the acceleration of its development progr...

2025-05-29 21:03 2115

Medicilon Passes FDA Inspection, Reinforcing Global R&D Excellence

BOSTON, May 29, 2025 /PRNewswire/ -- On May 20, Medicilon Preclinical Research ( Shanghai) LLC ("Medicilon") announces that it has successfully passed an on-site inspection by the FDA. The company receives an official Establishment Inspection Report (EIR) reaffirming its position as a trusted lead...

2025-05-29 20:30 1663

Rona Therapeutics Announces Breakthrough Data on Potential Annual Dosing RNAi Therapy RN026 Targeting Lipoprotein(a) in The National Lipid Association (NLA) Scientific Sessions 2025

SHANGHAI, May 29, 2025 /PRNewswire/ -- Rona Therapeutics, a global leading RNA therapy company, today announced preclinical data for its self-developed RNA interference (RNAi) therapy RN026 at the National Lipid Association (NLA) Annual Scientific Sessions. Preclinical studies revealed that the t...

2025-05-29 20:00 2751

AccurEdit Therapeutics' ART001 Becomes China's First Gene Editing Therapy to Receive FDA Regenerative Medicine Advanced Therapy (RMAT) Designation

RMAT designation expected to expedite development; 72 weeks interim clinical trial data showing sustainable reduction of TTR over 90% with no significant adverse events. SUZHOU, China, May 29, 2025 /PRNewswire/ -- AccurEdit Therapeutics today announced that its internally developed in vivo gene ...

2025-05-29 20:00 1679

Neuronata-R® Stem Cell Therapy Shows Promise in ALS Phase 3 Subgroup Analysis, Moves Toward FDA Accelerated Approval

Meaningful efficacy observed in slow-progressor subgroup; NfL biomarker improvements support potential for accelerated regulatory pathway SEOUL, South Korea, May 29, 2025 /PRNewswire/ -- Neuronata-R®, an autologous bone marrow-derived mesenchymal stem cell (MSC) therapy for amyotrophic lateral s...

2025-05-29 20:00 2309

AI Meets Audit Powerhouse: Qualifyze Launches Quality Insights Platform to Help Global Pharma Manage Supplier Site Risk

FRANKFURT, Germany, May 29, 2025 /PRNewswire/ -- Qualifyze, already the global leader in third-party audit services for the pharmaceutical industry, announces the launch ofQuality Insights Platform, an AI-powered platform that transforms the world's largest pharmaceutical audit database into a st...

2025-05-29 18:23 2236

CPHI & PMEC China Sees Surge in International Attendance as Global Pharma Trade Outlook Strengthens

Record international participation reflects renewed momentum in pharma manufacturing and global sourcing, as easing tariffs fuel growth SHANGHAI, May 29, 2025 /PRNewswire/ -- CPHI & PMEC China  (June 24-26th) returns to the Shanghai New International Expo Center am...

2025-05-29 12:43 2236

Kexing Biopharm's GB18 project received clearance of IND application from NMPA and FDA

SHENZHEN, China, May 28, 2025 /PRNewswire/ -- On May 26th, Kexing Biopharm (688136.SH) announced that the National Medical Products Administration (NMPA) has approved the Investigational New Drug (IND) application for its independently developed innovative product, GB18. Moreover, GB18 has previo...

2025-05-29 11:47 1462

Innovent Announces a Phase 3 Study of Picankibart (Anti-IL-23p19 Antibody) Completes First Participant Dosing, Exploring Biologics Switching Treatment for Psoriasis Patients with Prior Inadequate Response to Anti-IL-17 Antibodies

SAN FRANCISCO and SUZHOU, China, May 29, 2025 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncologic, autoimmune, cardiovascular and metabolic...

2025-05-29 10:23 2764

Formosa Pharmaceuticals and Adalvo Limited Announce Licensing Agreement for Clobetasol Propionate Ophthalmic Suspension for the Treatment of Ocular Inflammation and Pain

TAIPEI, May 28, 2025 /PRNewswire/ -- Taiwan-based Formosa Pharmaceuticals ("Formosa", 6838.TW) announced that the company has entered into an exclusive licensing agreement with Adalvo Limited ("Adalvo") in the European and Brazilian markets for exclusive rights to the commercialization of clobeta...

2025-05-28 20:00 1803

EpiVax Appoints Dr. Vibha Jawa to Lead Scientific Strategy as CSO

PROVIDENCE, R.I., May 28, 2025 /PRNewswire/ -- EpiVax, Inc., a leader in preclinical immunogenicity assessment for biologic therapeutics and vaccines, is pleased to announce the appointment ofVibha Jawa, PhD, FAAPS as Chief Scientific Officer. Dr. Jawa succeeds EpiVax founder and Executive Chairw...

2025-05-28 14:13 2267

Experimental Drug Development Centre Granted U.S. FDA Fast Track Designation for Antibody-Drug Conjugate EBC-129 to Treat Pancreatic Ductal Adenocarcinoma

* EBC-129 is the first made-in-Singapore antibody-drug conjugate (ADC) to enter clinical development. It selectively targets a tumour-specific N-glycosylated epitope on both CEACAM5 and CEACAM6.  * The Fast Track Designation highlights the potential of EBC-129 to address critical unmet needs ...

2025-05-28 14:00 1981

CARsgen's Satri-cel Granted Priority Review by the NMPA

SHANGHAI, May 28, 2025 /PRNewswire/ -- CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on developing innovative CAR T-cell therapies, announces that the Center for Drug Evaluation (CDE) ofChina's National Medical Products Administration (NMPA) has granted Priority R...

2025-05-28 12:10 1966

Exclusive Global 20 Seats, China's Sole One! KT-939 Was Successfully Selected for 2025 NYSCC Inspiration Hive Zone

SUZHOU, China, May 28, 2025 /PRNewswire/ -- In the newly announced entry list of the Inspiration Hive zone at the 2025 New York Society of Cosmetic Chemists (NYSCC) exhibition, Kintor's innovative ingredient KT-939 has been selected as the only "Chinese Ingredient" among the numerous global ones....

2025-05-28 11:08 2101

HKSH Fosters Collaboration for Innovation at Asia Summit on Global Health 2025, Through Partnership with United Imaging to Elevate Medical Imaging Excellence

HONG KONG, May 27, 2025 /PRNewswire/ -- The HKSH Medical Group (HKSH) has for over a century been committed to acquiring the state-of-the-art, world-class technology and facilities to deliver excellent and advanced medical services. Mr. Wyman LI, Chief Operating Officer of HKSH Medical Group, Dire...

2025-05-27 21:00 2914
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