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Eisai Completes FDA Submission for LEQEMBI® IQLIK™ Subcutaneous Starting Dose.

Eisai Co., Ltd. and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, "Biogen") announced that Eisai has completed the rolling submission of the Supplemental Biologics License Application...

Phase 2 Data of GC Biopharma's Recombinant Anthrax Vaccine, BARYTHRAX, Demonstrates Safety and Immunogenicity, Published in 'Vaccine

GC Biopharma, a leading global pharmaceutical company based in South Korea, announced that the Phase 2 clinical trial results for its anthrax vaccine 'BARYTHRAX inj. (GC1109)' have been published in the international journal Vaccine. BARYTHRAX is...

Samsung Epis Holdings, Newly Established, to Drive Growth for Samsung Bioepis and Its New Subsidiary

Samsung Epis Holdings Co., Ltd. announced its establishment as a new investment holding company, following the spin-off of Samsung Bioepis Co., Ltd. from Samsung Biologics (KRX: 207940.KS). Samsung Epis Holdings will be listed on Korea Exchange...

European Commission Approves Alteogen’s Aflibercept Biosimilar, EYLUXVI® (ALT-L9)

Alteogen Inc. announced today that the European Commission (EC) has granted marketing authorization for EYLUXVI® (code name: ALT-L9), an Eylea® biosimilar co-developed by its subsidiary, Alteogen Biologics. EYLUXVI® is Alteogen's second approved...

In the IDeate-Lung01 Phase 2 trial, Ifinatamab Deruxtecan demonstrated clinically meaningful response rates in patients with extensive-stage small cell lung cancer

Results from the IDeate-Lung01 phase 2 trial showed that ifinatamab deruxtecan (I-DXd) demonstrated clinically meaningful response rates in patients with previously treated extensive-stage small cell lung cancer (ES-SCLC). These data were...

VASTHERA Receives U.S. FDA Clearance to Begin Phase 1 Clinical Trial of Pulmonary Arterial Hypertension Drug Candidate, VTB-10

VASTHERA to formally begin global clinical development. The program has been supported by national funding from the Korea Drug Development Fund (KDDF). Dr. Sang Wong Kang, Ph.D., CEO of VASTHERA, stated, “The U.S. clinical entry of VTB-10 marks a...

Proving the strength of its drug-delivery platform, the Daewoong Therapeutics Microneedle Patch achieves best-in-class bioavailability

Daewoong Pharmaceutical (Co-CEOs Seong-Soo Park and Chang-Jae Lee) and Daewoong Therapeutics (CEO Bok-Ki Kang) announced that their proprietary semaglutide microneedle patch achieved more than 80%relative bioavailability compared to the injectable...

Made Scientific and Sentinel BioTherapeutics Announce a Strategic Manufacturing Partnership to Advance the Phase I/II Allogeneic ePP Encapsulated Cell Therapy Program

Made Scientific, a leading U.S.-based cell therapy contract development and manufacturing organization (CDMO), and Sentinel BioTherapeutics, a clinical-stage biotechnology company advancing encapsulated cell-based immunotherapies for solid tumors,...

Samsung Biologics introduces 'Samsung Organoids'—a novel drug screening service utilizing lab-grown human organ models to enhance oncology research

Samsung Biologics a leading contract development and manufacturing organization (CDMO), today announced the launch of Samsung Organoids – advanced drug screening services to support clients in drug discovery and development. Organoids are...

SK Life Science Labs Announces Nature Communications Publication of Breakthrough Molecular Glue Research Advancing Cancer Immunotherapy

SK Life Science Labs, a subsidiary of SK Biopharmaceuticals Co., Ltd., a global biotech focused on the research, development, and commercialization of treatments for cancer and disorders of the central nervous system (CNS), announced the...

S&E Bio Secures Korea’s First Approval for a Clinical Trial of Exosome-Based Therapy

S&E bio Co., Ltd., a biotechnology company specializing in exosomal microRNA-based therapies, has received approval from Korea's Ministry of Food and Drug Safety (MFDS) to initiate a Phase 1b clinical trial of its investigational stroke therapy,...

Hanmi Pharmaceutical Launches 'Aditams' in Mexico, Expanding into Latin America

Hanmi Pharmaceutical's combination therapy for Obstructive Prostatic Growth (OPG) caused by Benign Prostatic Hyperplasia (BPH) and Erectile Dysfunction (ED), Gugutams, is entering the Mexican market under the local brand name "Aditams." Hanmi...

Pint Pharma secures ANVISA approval for BESREMi® to treat Polycythemia Vera

Pint Pharma and PharmaEssentia announced that ANVISA (Brazilian Health Regulatory Agency) has approved BESREMi® (ropeginterferon alfa-2b) for the treatment of adult patients with Polycythemia Vera (PV). Polycythemia Vera (PV) is a rare, chronic,...

"Grindeks, the leading pharmaceutical company in the Baltics, expands to new export markets worldwide

The leading pharmaceutical company in the Baltics, Grindeks, continues to strengthen its global presence by entering new export markets. This year, for the first time, Grindeks products will be delivered to Panama. The company's export markets...

Leqembi® approved in Mexico

BioArctic AB's partner Eisai announced that the Federal Commission for the Protection Against Sanitary Risk (COFEPRIS) in Mexico has approved Leqembi (lecanemab) for the treatment of early Alzheimer's disease (AD)1. Leqembi selectively binds to...

LEQEMBI® (lecanemab), a treatment for Alzheimer's disease, is now available in South Korea, expanding access to innovative care

Eisai Co., Ltd. and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, "Biogen") announced that the humanized anti-soluble aggregated amyloid-beta (Aβ) monoclonal antibody "LEQEMBI®" has...

Hanmi Pharmaceutical and Beijing Hanmi advance clinical trials for BH3120, their co-developed next-generation cancer immunotherapy

The latest progress in the clinical trial of BH3120, an innovative immunotherapy jointly developed by Hanmi Pharmaceutical and Beijing Hanmi Pharmaceutical, was recently presented at a major global academic conference, drawing significant...

GC Biopharma and Novelty Nobility sign an R&D agreement to develop therapies for geographic atrophy

GC Biopharma announced that it has signed an agreement with Novelty Nobility, a biotech company specializing in the development of antibody-based therapeutics, for the joint research and development of a novel treatment for geographic atrophy...

Leqembi Secures Approval for Alzheimer's Disease Treatment in Hong Kong

BioArctic AB's partner Eisai announced that the Department of Health in Hong Kong has approved Leqembi® (brand name in Hong Kong, generic name: lecanemab) for treatment of Alzheimer's disease (AD). Treatment with Leqembi should be initiated in...

PharmAbcine's Phase 1 Trial of PMC-403 for Neovascular Age-Related Macular Degeneration Advances to Single-Dose (4mg) and Multiple-Dose (3mg)

PharmAbcine, Inc. a clinical-stage public company developing next generation therapeutics to treat medical unmet needs, announced today the decision to advance PMC-403, its candidate treatment for neovascular age-related macular degeneration...

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