Shots:
Ipsen has reported topline P-III (E-BEOND & C-BEOND) trial results assessing Dysport (abobotulinumtoxinA) vs PBO in a total of 1,510 adults with episodic & chronic migraine, respectively
Both trials met their 1EP, with a reduction in monthly migraine days vs PBO & demonstrated a favorable safety profile; detailed results will be presented at a future…
NEWS
Shots:
Samsung Bioepis & Teva have entered into a license and commercialization agreement to commercialize Opuviz (Biosimilar, Eylea) in Canada
As per the deal, Samsung Bioepis will be responsible for the registration & manufacture of the products, while Teva Canada will hold commercialization rights
Opuviz was approved by Health Canada in October 2025 for wet AMD, CRVO/BRVO-related macular edema, DME, and mCNV. Samsung Bioepis' aflibercept biosimilar is also marketed in EU and South…
Shots:
Roche has received a CE Mark for its Elecsys IGRA TB test, a blood-based assay for detecting tuberculosis infection (latent TB) in routine laboratory settings
Test delivers results in <24hrs., with IGRA assay completed in 19min., & automates result calculation, interpretation, & reporting on Roche immunoassay platforms while integrating with third-party liquid handlers to…
Shots:
The US FDA has approved Dual Energy THERMOCOOL SMARTTOUCH SF (DE STSF) Platform, an integrated catheter ablation system that enables delivery of both radiofrequency (RF) & pulsed field (PF) energy through a single catheter
Built on the THERMOCOOL SMARTTOUCH SF Platform, used in >1M US pts, the dual-energy system integrates with the CARTO ecosystem…
Shots:
The US FDA has granted 510(k) clearance to iPredict-DR, an AI-powered software that automatically detects more than mild diabetic retinopathy (mtmDR) in adults with diabetes who have not been previously diagnosed
iPredict-DR uses AI to analyze retinal fundus images from the iCare DRSplus camera for non-invasive & affordable diabetic retinopathy screening, with clearance backed…
Shots:
Sino Biopharmaceutical has entered into an exclusive license agreement with AstraZeneca for the development, manufacturing & commercialization of TQC3721, an inhaled PDE3/4 inhibitor
As per the deal, AstraZeneca secured exclusive rights to develop, manufacture, & commercialize TQC3721 outside China, along with exclusive global rights to select future development programs
In return, Sino will receive…
Shots:
The US FDA has accepted the NDA for Immunome’s varegacestat for the treatment of adults with desmoid tumors, with a PDUFA target action date of Apr 28, 2027
NDA is supported by the global P-III (RINGSIDE) trial assessing varegacestat (1.2mg, QD) vs PBO until disease progression or death in 156 pts with progressing desmoid…
Shots:
Insilico has initiated a P-III trial assessing Rentosertib vs PBO in ~320 pts with idiopathic pulmonary fibrosis (IPF) over 52wks.
Earlier P-IIa (GENESIS-IPF) trial data showed Rentosertib (30mg, QD or BID, & 60mg, QD) met its 1EP, plus 60mg arm demonstrated a mean FVC change of +98.4mL vs -20.3mL at 12wks.
Rentosertib, an oral…
Shots:
Henlius has dosed the first patient in China in the P-I HLX05-N (HLX05-N-mCRC102), a biosimilar version of Erbitux (cetuximab), for the treatment of metastatic colorectal cancer (mCRC)
The study will compare HLX05-N vs. US & EU sourced Erbitux in mCRC, evaluating PK similarity, efficacy, safety, and immunogenicity in combination with mFOLFOX6 CT
HLX05-N is Henlius' cetuximab biosimilar candidate, developed under global biosimilar guidelines, with analytical and non-clinical studies demonstrating high…
Shots:
Biocytogen has entered into a global collaboration with Whitehawk Therapeutics to develop bispecific antibody-drug conjugates (BsADCs)
Biocytogen will provide ~5 bispecific antibodies from its RenLite platform & Whitehawk will evaluate these in combination with its ADC linker-payload technologies, with Whitehawk holding the option to advance resulting BsADC candidates
Biocytogen will receive an upfront payment,…

