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GSK
GSK Receives the US FDA Approval of Arexvy to Prevent Respiratory Syncytial Virus (RSV) Disease
Shots: The US FDA has approved Arexvy RSV vaccine for adults (18-49yrs.) at increased risk for lower respiratory tract disease, expanding its use beyond those aged ≥50yrs. Approval was based on P-IIIb trial (n=1458) assessing immune response & safety of Arexvy RSV vaccine in individuals (18-49yrs.; n=426) compared to adults (≥60yrs.; n=429); an additional cohort (18-49yrs.; n=603) was…
1 day ago
Otsuka Pharmaceutical Reports OLE Study Data on Repinatrabit in Phenylketonuria
Shots: OLE study assessed repinatrabit (JNT-517) in adolescents with PKU. Early time-point data remain embargoed to preserve parent-study blinding, with additional randomized-period results to be presented later First cohort receiving repinatrabit (75mg, PO, BID) showed a 67% mean reduction in Phe from baseline (Day 56/OLE Month 1), with responses seen in all pts, incl. prior…
1 day ago
Enodia Acquires Kezar’s Sec61 Program to Advance Targeted Protein Degradation Pipeline
Shots: Enodia has acquired Kezar’s Sec61-based discovery & development program assets, strengthening its understanding of Sec61 selectivity mechanisms & expanding translational insights to accelerate progress toward key clinical milestones As per the deal, Kezar will receive a $1M upfront, ~$127M in development, regulatory, & commercial milestones, plus tiered royalties on future net sales Enodia’s platform…
1 day ago
PRISM BioLab and Receptor.AI Partner to Develop a Drug Discovery Platform
Shots: PRISM has partnered with Receptor.AI to develop an AI-navigated, physics-guided platform for discovering orally available small molecules targeting intracellular protein–protein interactions (PPIs), membrane proteins & complex receptor systems Collaboration will combine PRISM’s PepMetics Tech, 3D small molecules designed to mimic α-helix & β-turn motifs, with Receptor.AI’s AI-driven molecular design engine to identify hit, lead, &…
1 day ago
Natera Launches Zenith Genomics in the US to Diagnose Rare Diseases
Shots: Natera has reported the commercial launch of Zenith genomics, a next-generation whole genome sequencing (WGS) assay designed to enhance the detection of rare diseases in the US The platform combines whole genome sequencing with long-read sequencing confirmation to detect genomic features such as tandem repeat expansions, supporting diagnosis of rare & ultra-rare conditions, &…
2 days ago
Aplagon Doses First Patient in P-IIa (HEALING) Trial of APAC for Peripheral Arterial Occlusive Disease/Chronic Limb Threatening Ischemia
Shots: Aplagon has dosed the first patient with APAC (IV) in its P-IIa (HEALING) trial in Finland for peripheral arterial occlusive disease (PAOD), leading to chronic limb-threatening ischemia (CLTI) Trial will evaluate APAC in ~42 CTLI pts across 4 cohorts to assess safety, efficacy, & effects on thrombo-inflammatory biomarkers. Additionally, an associated PET imaging study with…
2 days ago
J&J
Johnson & Johnson Submits Tecvayli Application to EMA for R/R Multiple Myeloma
Shots: The EMA has received the Type II variation application for Tecvayli monotx. (teclistamab) for the treatment of adults with r/r multiple myeloma (RRMM) who have received ≥1 prior therapy Application was supported by the P-III (MajesTEC-9) trial assessing Tecvayli vs SoC of pomalidomide, bortezomib, & dexamethasone (PVd) or carfilzomib & dexamethasone (Kd) in 614…
2 days ago
George Medicines Partners with Ahngook Pharmaceutical to Commercialize GMRx2 in Korea
Shots: George Medicines has entered into an exclusive licensing & supply agreement with Ahngook Pharmaceutical, granting rights to seek regulatory approval & commercialize GMRx2 in Korea for the treatment of Hypertension As per the deal, George Medicines will receive an upfront licensing fee, potential regulatory & commercial milestone payments, as well as stepped royalties on…
2 days ago
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