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Genentech
NEWS
Genentech Presents Long-Term Efficacy and Safety Data on Vabysmo for Wet Age-Related Macular Degeneration
Shots: Genentech has reported new data from the open-label AVONELLE-X & P-IIIb/IV (SALWEEN) studies of Vabysmo (faricimab-svoa) at Euretina’25 The 2yr. AVONELLE-X study was an extension of P-III (TENAYA & LUCERNE) trials, showing maintained vision & anatomy in wet AMD, with ~80% pts extending dosing to Q3M/Q4M after ~4yrs. of therapy SALWEEN study in Asia…
September 5, 20250Comments
NEWS
Bluejay Therapeutics Reports First Patient Enrolment in P-III (AZURE-2) Trial of Brelovitug for Chronic Hepatitis D
Shots: Bluejay Therapeutics has enrolled its first patient in the P-III (AZURE-2) trial assessing brelovitug (300mg, SC, QW) vs Hepcludex (bulevirtide) for the treatment of chronic hepatitis D Trial will assess the proportion of participants achieving a composite response at Wk. 48, defined as undetectable hepatitis D virus RNA along with normalization of alanine aminotransferase…
September 5, 20250Comments
NEWS
Pulmovant and Roivant’s Mosliciguat Receives MHLW’s Orphan Drug Designation for Pulmonary Hypertension Associated with Interstitial Lung Disease
Shots: Japan’s MHLW has granted ODD to mosliciguat for the treatment of pulmonary hypertension associated with interstitial lung disease (PH-ILD) Mosliciguat (dry powder inhaler) is being evaluated in an ongoing global P-II (PHocus) trial against PBO among ~120 PH-ILD adults, with trial design to be presented at ERS Congress 2025 Mosliciguat is an sGC activator that…
September 5, 20250Comments
Eli lilly
NEWS
The US FDA Grants Breakthrough Therapy Designation to Eli Lilly’s Olomorasib for KRAS G12C-Mutant NSCLC
Shots: The US FDA has granted BTD to olomorasib + Keytruda for the 1L treatment of pts with unresectable advanced or metastatic NSCLC harboring KRAS G12C mutation & PD-L1 expression ≥ 50% Designation was based on P-I/II (LOXO-RAS-20001) trial of olomorasib monotx. & dose optimization portion from P-III (SUNRAY-01) trial of olomorasib + Keytruda ±…
September 5, 20250Comments
Roche
NEWS
Roche Reports the European CE Mark Approval of Contivue to Treat Neovascular Age-Related Macular Degeneration
Shots: Roche has received the European CE Mark approval for Contivue, a port delivery platform containing Susvimo (Lucentis) for the treatment of neovascular age-related macular degeneration (nAMD); Susvimo (100mg/mL) is under the EMA’s review Approval was backed by P-III (Archway) trial & additional studies, a P-II (LADDER) trial, & Portal OLE long-term study, with Archway showing…
September 5, 20250Comments
INSIGHTS+
Know Your Investor: Cormorant Asset Management (September’25 Edition) 
Shots:  Welcome to the September edition of Know Your Investor, featuring leading investors fuelling healthcare & life sciences  This edition spotlights Cormorant Asset Management, an investment firm focused on biotechnology and healthcare companies  In 2024, Cormorant completed 31 investments ~$3.88B, spanning PIPEs, private financings, IPO, and venture rounds. For the full report, contact us at…
September 4, 20250Comments
NEWS
AliveDx Reports the US FDA’s 510(k) Submission for MosaiQ AiPlex VAS Assay to Diagnose Autoimmune Vasculitis
Shots: The US FDA has received 510(k) premarket notification for MosaiQ AiPlex Vasculitis (VAS) assay to improve & accelerate diagnosis of Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitides & Anti-GBM (Goodpasture's) disease; available in IVDR CE-marking countries since Jul 2025 VAS assay diagnoses autoimmune vasculitis using just 10μL of sample in a single test, with 3 key autoantibody markers: MPO, PR3, & GBM…
September 4, 20250Comments
NEWS
Biocytogen Partners with Merck KGaA to Develop Antibody-Conjugated Lipid-Based Delivery Solutions
Shots: Biocytogen has entered into an evaluation & option agreement with Merck KGaA to develop antibody-conjugated lipid-based delivery solutions for nucleic acid payloads, incl. antibody-conjugated lipid nanoparticles As per the deal, Biocytogen will provide fully human antibodies from its RenMice platform for evaluation to Merck KGaA’s antibody-conjugated LNP services, with Merck KGaA holding an exclusive…
September 4, 20250Comments