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Jan 09, 2026, 02:29 ET No serious adverse events to date in ongoing phase 1/2a clinical study of SYN321
candidate drug SYN321, a novel intra-articular treatment for knee osteoarthritis, through a phase 1/2a clinical study focused on safety, tolerability, PK, and early efficacy signals. The study was initiated in August 2025 following approval from the Swedish Medical Products Agency (MPA) and the Swedish
More news about: Synartro AB
Jan 08, 2026, 12:40 ET PointsKash Signs Exclusive ISV Agreement with Global Fintech Leader Paysafe -- Paving the Way for a Next‑Generation Rewards, Loyalty, and Payments Ecosystem
competitive pricing and sophisticated processing across multiple payment channels. The integration will also underpin PointsKash's groundbreaking "PK Kash" universal rewards currency and the first industry‑wide Rewards and Loyalty redemption engine that seamlessly connects loyalty, payments,
More news about: PointsKash Inc.
Jan 08, 2026, 09:22 ET Florida Cancer Specialists & Research Institute Expand Global Impact in Gastrointestinal Cancer Research
ASP3082, a first-in-class selective protein degrader, in patients (pts) with KRAS G12D-mutant pancreatic ductal adenocarcinoma (PDAC): Pharmacokinetics (PK) and biomarker insights."Early-phase clinical research, including Phase 1 and Phase 2 studies, is essential for advancing cancer treatment.
More news about: Florida Cancer Specialists & Research Institute
Jan 07, 2026, 07:00 ET AL-S Pharma to present at the upcoming J. P. Morgan 2026 Annual Healthcare Conference on Thursday, January 15
drug designations from FDA, EMA and Swissmedic. The Phase 2 study evaluated safety, tolerability, pharmacodynamic (PD) markers, and pharmacokinetics (PK) of AP-101 in patients with sporadic ALS and in patients with mutations in the SOD1 gene.About AL-S Pharma AG AL-S Pharma is a
More news about: AL-S Pharma AG
Jan 06, 2026, 20:30 ET 亞盛醫藥BTK降解劑APG-3288的新藥臨床申請（IND）獲美國FDA許可
是公司在BTK靶向治療領域的重要臨床佈局, 其在多個BTK耐藥模型中展現出的高選擇性、強效和一致的 PK/PD特徵，充分驗證了其差異化PROTAC設計理念。此次APG-3288的IND獲美國FDA許可，是我們在這一領域的重大里程碑。這一重要策略和規劃不僅體現亞盛醫藥在血液腫瘤領域的持續深耕，同時也為進一步挖掘該藥物與公司已有小分子靶向藥之間的聯合治療潛力奠定了基礎。我們將快速推進APG-3288的全球臨床開發，積極探索蛋白降解劑這一新分子實體在血液腫瘤及其他BTK相關疾病中的治療潛力，早日惠及更多患者。」
More news about: 亞盛醫藥
Jan 05, 2026, 08:30 ET MetaVia Reports Positive Statistically Significant Results from Its Phase 1b Clinical Trial of DA-1726 In Metabolic Disease - Demonstrating Strong Glycemic Response, Significant Direct Hepatic Effects, Robust Weight Loss and Favorable Safety Profile
later-stage development."The Phase 1 trial was a randomized, double-blind, placebo-controlled study designed to evaluate the safety, tolerability, PK, and pharmacodynamics (PD) of single and multiple ascending doses of DA-1726 in obese but otherwise healthy adults with a body mass index (BMI) of 30–45
More news about: MetaVia Inc.
Jan 05, 2026, 08:00 ET Avista Healthcare Partners Announces Promotions
equity at Partners Group. Elaine received a B.A. from Wellesley College and an M.B.A. from Harvard Business School. She currently serves as a Director of PK Benelux and Probo Medical.About Avista Healthcare PartnersAvista Healthcare Partners, founded in 2005 by
More news about: Avista Healthcare Partners
Jan 05, 2026, 07:00 ET Kelun-Biotech Receives Investigational New Drug Approval for ITGB6-Targeted ADC SKB105 from the NMPA
tumor-specific payload delivery while reducing adverse effects. In preclinical models, SKB105 demonstrated a favorable efficacy, safety, and pharmacokinetic (PK) profile.About SKB118(also known as CR-001)SKB118/CR-001 is a tetravalent bispecific antibody being developed for the treatment
More news about: Kelun-Biotech
Jan 05, 2026, 07:00 ET RedHill's RHB-102 Progresses in Multiple GI Indications Including GLP-1 Therapy-Related GI Side Effects
U.S. Phase 3 & 2 results in gastroenteritis/gastritis and diarrhea-predominant irritable bowel syndrome (IBS-D) respectively, a positive comparative PK clinical study as part of the oncology support (CINV/RINV) program2, plus decades of ondansetron clinical use (>22 million
More news about: RedHill Biopharma Ltd.
Dec 30, 2025, 12:00 ET Lumos Infinitas to Showcase Silicon-Photonics Sensing at CES 2026: CITEYE™ Smart-City LiDAR, Kimo Bloodspeed Pro™ PWV, and High-Precision Range Finder
https://ces26.mapyourshow.com/8_0/exhibitor/exhibitor-details.cfm?exhid=001Pp00001L2Pk5IAF.
More news about: Lumos Infinitas USA Inc.
Dec 29, 2025, 01:27 ET Adventures in DMPK: Viva Biotech's One-Stop Pharmacology Platform Cross New Modalities
roughly share a common ADME/PK logic: physicochemical profiling and metabolic stability (e.g., microsomes, hepatocytes, S9/UGT, whole blood/plasma), permeability/transport (MDCK/Caco-2), DDI risk (CYP inhibition), and tailored exploratory assays, followed by multispecies PK with formulation screening.
More news about: Viva Biotech
Dec 29, 2025, 01:13 ET Adventures in DMPK: Viva Biotech's One-Stop Pharmacology Platform Cross New Modalities
roughly share a common ADME/PK logic: physicochemical profiling and metabolic stability (e.g., microsomes, hepatocytes, S9/UGT, whole blood/plasma), permeability/transport (MDCK/Caco-2), DDI risk (CYP inhibition), and tailored exploratory assays, followed by multispecies PK with formulation screening.
More news about: Viva Biotech
Dec 28, 2025, 21:24 ET Senhwa Biosciences Aims at Multi-Billion Dollar Global Market with CX-5461 Combined with ADC "Blockbuster" Therapy
1. Safety and DLT evaluation on CX-54612. RP2D for on CX-54613. ORR4. CX-5461 PK5. Effect on MYC-aberrant lymphoma gene expression2024:
More news about: Senhwa Biosciences, Inc.
Dec 19, 2025, 11:23 ET Presidential Executive Order Validates DeFloria's Strategy in Pharmaceutical Cannabinoid Drug Development
already achieved:A cleared botancial IND application and "Study May Proceed" letter from the FDA;Completion of a Phase 1 PK/PD clinical trial, demonstrating safety and a well-tolerated dosing profile; andFDA authorization to initiate a Phase 2 clinical program evaluating
More news about: Charlotte's Web Holdings, Inc.
Dec 18, 2025, 07:00 ET U.S. FDA Approves RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj) Co-Formulated with ENHANZE® for the Treatment of Advanced EGFR-mutated Non-Small Cell Lung Cancer
3 PALOMA-3 study (NCT05388669), RYBREVANT FASPRO™ delivered consistent results to RYBREVANT®, meeting both co-primary pharmacokinetic (PK) endpoints as measured by amivantamab levels in the blood [Ctrough on Cycle (C) 2 Day (D) 1 or C4D1 and C2 area under the curve (AUCD1-D15)].1,2For
More news about: Halozyme Therapeutics, Inc.
Dec 17, 2025, 18:49 ET U.S. FDA Approval of RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj) Enables the Simplest, Shortest Administration Time for a First-Line Combination Regimen when Combined with LAZCLUZE® (lazertinib)
NCT05388669), RYBREVANT FASPRO™ delivered consistent results to RYBREVANT®, meeting both co-primary pharmacokinetic (PK) endpoints as measured by amivantamab levels in the blood [Ctrough on Cycle (C) 2 Day (D) 1 or C4D1 and C2 area under the curve (AUCD1-D15)].1,7
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Dec 17, 2025, 09:00 ET Thryv Therapeutics Announces Positive Phase 1 Results of THRV-1268 in Obese Participants
ascending doses (SAD) in obese participants. THRV-1268 appeared to be well tolerated with no serious adverse events (SAEs) reported. Pharmacokinetics (PK) demonstrated that therapeutic exposures were maintained throughout the dosing interval and support twice daily dosing.The study included a comparative
More news about: Thryv Therapeutics Inc.
Dec 15, 2025, 11:07 ET Nonprofits, Closegap and Koko, partner to scale evidence-based interventions in K-12 schools
improve youth mental health by transforming the way kids are cared for in school. Our comprehensive mental health check-ins and intervention library help PK-12 students build key social-emotional skills while equipping schools with data for real-time monitoring and intervention. Closegap is trusted by thousands
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Dec 12, 2025, 07:00 ET Insilico Medicine and TaiGen Achieves License Agreement to Develop and Commercialize AI-driven PHD Inhibitor for Anemia of Chronic Kidney Disease (CKD)
lower effective doses in CKD rat models; promising oral drug-like properties featuring favorable in vitro ADME and promising pharmacokinetic (PK) profiles across animal models; and a safety profile characterized by higher maximum tolerated doses and broad safety margins. The program received IND
More news about: Insilico Medicine
Dec 11, 2025, 08:00 ET HanchorBio Announces Oral Presentation of HCB101 at the ESMO Immuno-Oncology Congress 2025
mg/kg QWNo bleeding events or immune-related toxicities, with the majority of treatment-related adverse events being Grade 1-2Linear PK (T1/2 ~3 days) with receptor occupancy (RO) >99% at ≥8 mg/kgDurable antitumor activity, including confirmed PRs in:HNSCC
More news about: HanchorBio Inc.
Dec 08, 2025, 14:45 ET Hemab Therapeutics Announces Positive Complete Phase 2 Data for Sutacimig in Glanzmann Thrombasthenia at ASH 2025; Plans to Advance to Pivotal Phase 3 Study
patients with GT, with a single related serious adverse event (grade 2 DVT) occurring at the highest dose level (0.9 mg/kg). Anti-drug antibodies impacting PK/PD were observed in five participants; however, titers resolved in one participant with continued dosing, and no associated safety events were reported.Retention:
More news about: Hemab Therapeutics
Dec 08, 2025, 10:30 ET Taiho Oncology Presents Data on All-Oral Regimens Azacitidine and Cedazuridine, and Decitabine and Cedazuridine at the 2025 American Society of Hematology Annual Meeting and Exposition
subset of patients with a high BSA had a GMR of 0.700 (90% CI: 0.55, 0.89) and further simulations suggested that BSA-adjusted dosing will help ensure the PK exposure of the oral combination approximates that of subcutaneous azacitidine.Summary of Preliminary Safety and TolerabilityAdverse
More news about: Taiho Oncology
Dec 05, 2025, 17:45 ET AL-S Pharma Reports Positive Results from Phase 2 Study of AP-101 for the Treatment of ALS, Supporting Plans for a Confirmatory Phase 3 Study
drug designations from FDA, EMA and Swissmedic. The Phase 2 study evaluated safety, tolerability, pharmacodynamic (PD) markers, and pharmacokinetics (PK) of AP-101 in patients with sporadic ALS and in patients with mutations in the SOD1 gene.About AL-S Pharma AGAL-S Pharma is a
More news about: AL-S Pharma AG
Dec 05, 2025, 09:00 ET Jazz Pharmaceuticals to Present Extensive New Data and Real-World Evidence Highlighting Epidiolex® (cannabidiol) Outcomes in Treatment-Resistant Epilepsies at the American Epilepsy Society 2025 Annual Meeting
late-breaking poster featuring results from a Phase 1 clinical study evaluating bidirectional pharmacokinetic (PK) drug-drug interactions between Epidiolex and cenobamate, which did not find PK interactions between cannabidiol and cenobamate parent molecules when concomitantly administered at clinically
More news about: Jazz Pharmaceuticals plc
Dec 05, 2025, 09:00 ET NEURELIS TO PRESENT CLINICAL DATA AT AMERICAN EPILEPSY SOCIETY ANNUAL MEETING
Six of Neurelis' posters include analyses of data from the completed Stellina study, which was a long-term, Phase 1/2a, open-label pharmacokinetics (PK) and safety study that investigated diazepam nasal spray for the treatment of episodes of frequent seizures in patients with epilepsy aged 2-5 years,
More news about: Neurelis, Inc.