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AlzeCure Partners with QuantumCell for NeuroRestore ACD856 in a Deal Worth up to $2.2B
Shots: AlzeCure Pharma has entered into an out-licensing & collaboration agreement with QuantumCell for global rights to AlzeCure’s Alzheimer’s platform NeuroRestore, incl. ACD856 AlzeCure will receive $12M upfront, incl. a $5M investment, & is eligible for development & commercial milestones exceeding $2.2B (excl. royalties), plus tiered single to low double-digit royalties NeuroRestore ACD856 is a…
Inocras and AimedBio Collaborate on Precision Oncology and ADC Development
Shots: Inocras and AimedBio have partnered to integrate Inocras’ whole-genome sequencing (WGS) platform into AimedBio’s ADC clinical programs, alongside AimedBio’s strategic equity investment in Inocras As per the deal, AimedBio will use Inocras’ WGS, cancer intelligence platform, & multi-omics analyses across its ADC trials to enable biomarker discovery, patient selection, and novel target identification The…
Hutchmed
HUTCHMED Reports NMPA Conditional Approval of Orpathys (Savolitinib) for Gastric Cancer Patients with MET Amplification
Shots: The NMPA has granted conditional approval to Orpathys for the treatment of LA/M gastric cancer or gastroesophageal junction (GC/GEJ) adenocarcinoma pts with MET amplification who have failed ≥2 prior systemic treatments Approval was supported by the P-II trial of Orpathys in GC/GEJ adenocarcinoma pts with MET amplification in China, which showed 32.3% ORR (1EP), & improved 2EPs, incl. 63.1% DCR, 1.4mos.…
Novartis’ Itvisma Receives the EC Approval for Spinal Muscular Atrophy
Shots: The EC has approved Novartis' Itvisma (onasemnogene abeparvovec) for the treatment of pts (≥2yrs.) living with 5q spinal muscular atrophy (SMA) harboring a confirmed bi-allelic mutation in the SMN1 gene Approval was based on the P-III (STEER) trial & supportive P-IIIb (STRENGTH) & P-I/II (STRONG) studies, where STEER showed a 2.39-point improvement in the…
Junshi Biosciences Licenses Roconkibart to Fosun Wanbang in Greater China
Shots: Junshi Biosciences has entered into a license agreement with Fosun Wanbang Pharma Group for roconkibart in the Greater China region, incl. Mainland China, Hong Kong SAR, Macao SAR, & Taiwan Companies will cooperate on the development, registration, manufacturing & commercialization of roconkibart, an anti-IL-17A mAb, which showed 91% reached PASI 90 at wk. 16…
Insilico Medicine Collaborates with Takeda to Advance AI Drug Discovery
Shots: Insilico Medicine has entered into a strategic collaboration agreement with Takeda to advance clinically differentiated drug candidates across Takeda's therapeutic areas, using Insilico’s Pharma.AI platform Insilico will lead AI-driven discovery, while Takeda will advance selected candidates through clinical development & hold exclusive worldwide rights to develop, manufacture, & commercialize resulting therapeutics As per the…
Samsung Bioepis and Harrow Relaunch Byooviz (Biosimilar, Lucentis) in the US
Shots: Samsung Bioepis, in partnership with Harrow, has relaunched Byooviz, a biosimilar to Lucentis (ranibizumab), in the US Byooviz was initially commercialized by Biogen beginning in Jun 2022, before Biogen returned the US commercial rights to Samsung Bioepis at the end of 2025 Approved by the FDA in 2021 as the first ophthalmology biosimilar, Byooviz…
RefleXion Seeks FDA Clearance for Anchor Point Tumor Tracking
Shots: The US FDA has received a 510(k) premarket notification for Anchor Point Tracking, a tumor tracking technology designed for use with its new RefleXion X2 radiotherapy platform Filing is backed by extensive system validation & phantom testing, with additional data from academic investigators demonstrating improved target tracking, dose conformity, motion management, & organ-at-risk sparing…