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EpiVax and FDA Scientists Publish New Insights on Immunogenicity Risks of Peptide-Related Impurities in Generic Teriparatide

PROVIDENCE, R.I., Dec. 9, 2025 -- EpiVax, Inc., with U.S. Food and Drug Administration (FDA) and CUBRC, Inc. (Buffalo, NY) scientist collaborators, announces the publication of a study titled "Immunogenicity Risk Assessment of Peptide-Related Impurities Identified in Generic Teriparatide Products." The study uses a series of different tools to evaluate whether peptide-related impurities may influence unwanted immune responses in generic teriparatide (TPT)—an important consideration for ensuring the safety and comparability of generic peptide drugs. Teriparatide, a rec
- 김갑성 기자
- 2025-12-09 03:11
Menarini Group Presents Elacestrant (ORSERDU®) Phase 2 Combination Data in Patients with ER+, HER2- Metastatic Breast Cancer (mBC) at the 2025 San Antonio Breast Cancer Symposium

In addition, the expansive elacestrant clinical development program updates reinforce its potential as a backbone endocrine therapy in combination settings, as well as in both metastatic and early stage breast cancer. FLORENCE, Italy and NEW YORK, Dec. 8, 2025 -- The Menarini Group ("Menarini"), a leading international pharmaceutical and diagnostics company, and Stemline Therapeutics, Inc. ("Stemline"), a wholly-owned subsidiary of the Menarini Group, focused on bringing transformational oncology treatments to cancer patients, will present updated mean
- 김갑성 기자
- 2025-12-09 03:05
Convergen Secures $10 Million Seed Funding to Advance TrimTAC Platform for Neurodegeneration & beyond

SUZHOU, China, Dec. 8, 2025 -- Convergen, a biotech company pioneering targeted protein degradation (TPD) therapies for diseases driven by pathological protein aggregates, today announced the closing of a $10 million Seed financing round. The round was invested by Qiming Venture Partners, a leading global venture capital firm focused on life sciences and healthcare innovation. Funds from the financing will accelerate the development of Convergen's proprietary TrimTAC platform—next-generation bifunctional degraders leveraging the E3 ubiquitin ligase TRIM21—and advance its early
- 김갑성 기자
- 2025-12-08 23:00
Halia Therapeutics Announces Positive Phase 2a Data for Ofirnoflast in Lower-Risk MDS at ASH 2025

– New findings demonstrate a 72% HI-E response rate at Week 16 with meaningful hemoglobin improvement –– Strong activity observed across ESA-refractory and ESA-intolerant patients, and across mutation and morphology subtypes –– Favorable safety profile with no treatment-related serious adverse events – LEHI, Utah, Dec. 8, 2025 -- Halia Therapeutics, a clinical-stage biopharmaceutical company, today presented new clinical data from its Phase 2a study of ofirnoflast (HT-6184) at the 67th American Society of Hematology (ASH) Annual Meeting. The data show that ofirnoflast, a first-
- 김갑성 기자
- 2025-12-08 22:22
ALR TECHNOLOGIES TO RELAUNCH THE GLUCURVE PET CGM IN JANUARY 2026

SINGAPORE, Dec. 8, 2025 -- ALR Technologies SG Ltd ("ALRT" or the "Company") (OTC: ALRTF), the diabetes management company, announces the successful completion of internal manufacturing testing on the GluCurve Pet CGM ("GluCurve") showing accuracy results comparative to the leading veterinary Blood Glucose Meter ("BGM") and scheduling of its relaunch into the Canadian market for January 2026. GluCurve is the first and only diabetic monitoring system built specifically for veterinary use on cats and dogs. A pet-friendly Continuous Glucose Monitor
- 김갑성 기자
- 2025-12-08 22:14
Zymedi Announces "rapaprutug" as the International Nonproprietary Name (INN) for ZMA001

INCHEON, South Korea, Dec. 8, 2025 -- Zymedi (CEO Sunghoon Kim) announced that the World Health Organization (WHO) has assigned rapaprutug as the International Nonproprietary Name (INN) for the company's first-in-class antibody therapy ZMA001, being developed as a treatment for pulmonary arterial hypertension (PAH). The assignment of the name rapaprutug (development code: ZMA001) marks a key global milestone and establishes a unified scientific identity for Zymedi's lead candidate as it advances through development. The antibody is currently being evaluated in an ongoing Phase 1 clinic
- 김갑성 기자
- 2025-12-08 22:00
Lunit Submits 510(k) Application for Image-Based Breast Cancer Risk Prediction Model

Submission marks a key regulatory milestone toward bringing SEER-calibrated, imaging-based risk assessment to U.S. screening programs SEOUL, South Korea, Dec. 8, 2025 -- Lunit (KRX:328130), a leading provider of AI for cancer diagnostics and precision oncology, today announced that it has submitted a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) for Lunit INSIGHT Risk, a mammography-based five-year breast cancer risk prediction model. Potential clearance is expected in 2026. Lunit INSIGHT Risk estimates a woman's five-year bre
- 김갑성 기자
- 2025-12-08 22:00
PT Fapon and PT Bio Farma Forge Strategic Partnership to Advance IVD Localization and Innovation in Indonesia

DONGGUAN, China, Dec. 8, 2025 -- PT Fapon Bioindustries Indonesia (referred to as "PT Fapon") and the Indonesian state-owned pharmaceutical holding company PT Bio Farma (Persero) (referred to as "Bio Farma") officially signed a cooperation agreement at Fapon's headquarters in Dongguan. The partnership is centered on the local manufacturing, and commercialization of IVD products in Indonesia. Mrs. Dyah, Chief Executive Officer of Fapon Indonesia Market, and Mr. Dicky, Head of the Business Development Division at Bio Farma, formally executed the agreement on behalf of their respe
- 김갑성 기자
- 2025-12-08 20:47
Servier's Voranigo® (vorasidenib) Receives Prix Galien Awards Across Multiple Regions

Voranigo® has been awarded the Prix Galien USA, the Prix Galien Poland and the Prix Galien Bridges Awards for Best Product for Orphan/Rare Diseases. These awards across several geographies recognize the progress represented by Voranigo® for patients living with glioma. SURESNES, France, Dec. 8, 2025 -- Servier, an independent international pharmaceutical group governed by a foundation, today announced that Voranigo® (vorasidenib) has been awarded the inaugural 2025 Prix Galien Bridges Award for Best Product for Orphan/Rare Diseases, during a ceremony held in
- 김갑성 기자
- 2025-12-08 20:24
Aurora Names Seasoned Global CPG Executive to Lead Australia and New Zealand

NASDAQ | TSX: ACB EDMONTON, AB, Dec. 8, 2025 -- Aurora Cannabis Inc. (NASDAQ: ACB) (TSX: ACB), the Canadian-based leading global medical cannabis company, announces Kerry Miller, a 35-year consumer packaged goods executive, as Managing Director for Australia and New Zealand, effective January 15, 2026. Kerry will be instrumental in driving growth in these key markets, drawing on decades of global experience in fast moving, regulated industries. "I'm excited to join Aurora at an inflection point in the company's global leadership and to work alongside a team dedicate
- 김갑성 기자
- 2025-12-08 20:00

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