Skip to content Skip to footer

NEWS

Visby Medical Secures FDA Clearance for At-Home Flu & COVID-19 PCR Test
Shots: The US FDA has granted clearance to Flu and COVID-19 Test, an at-home PCR test capable of detecting multiple respiratory viruses, expanding its portfolio of over-the-counter molecular diagnostics The test delivers PCR-quality results in 30min. & detects COVID-19 and influenza A/B at home, enabling earlier diagnosis & timely treatment decisions, incl. access to antiviral…
United Therapeutics Acquires Thymmune Therapeutics for ~$300M
Shots: United Therapeutics has acquired Thymmune Therapeutics, incl. its lead asset THY-100, developed for the treatment of congenital athymia Under the deal, United Therapeutics has acquired Thymmune for $140M upfront, with up to $160M in additional earn-out payments tied to clinical & regulatory milestones through 2031 THY-100 is a preclinical regenerative therapy for congenital athymia…
CSPC Group and AstraZeneca Partner to Develop siRNA Drugs in ~$1.77B Deal
Shots: CSPC & AstraZeneca have entered into a strategic collaboration, option & license agreement to leverage CSPC’s siRNA discovery & extrahepatic targeted delivery platforms to develop novel small nucleic acid therapeutics CSPC & AstraZeneca will jointly discover & develop preclinical candidates for two renal disease targets, with AstraZeneca holding options for global/ex-China rights to each…
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…