Shots:
The US FDA has received the BLA of SkinTE for the treatment of Wagner Grade 1 diabetic foot ulcers (DFUs)
BLA submission follows the P-III (COVER DFUS II) trial assessing SkinTE + SoC vs SoC alone in 120 pts with Wagner 1 DFU, which met its 1EP of complete wound closure
SkinTE is a first-in-class autologous…
NEWS
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…
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…
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…
Shots:
Median Technologies has received CE Mark for eyonis Lung Cancer Screening (LCS) to detect & diagnose lung cancer
In testing eyonis LCS has showed 93.3% sensitivity & 92.4% specificity, with 68% reduction of False Positives & 66% reduction of False Negatives, minimizing unnecessary follow-ups
eyonis Lung Cancer Screening is an AI-powered computer-aided detection & diagnosis…
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…
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…
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.…
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…
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…

