Shots:
The US FDA has granted IDE approval to initiate RESONATE Early Feasibility Study of Motif XCS System in pts with treatment-resistant depression, who have received ≥2 medications
The trial will assess 12mos. safety of Motif XCS System & procedure post-implantation & measure symptom reduction, quality of life, anxiety, & cognitive function using standard assessments…
NEWS
Shots:
The US FDA has approved AstraZeneca’s Saphnelo pen (anifrolumab; 120mg, SC, QW, autoinjector) for the treatment of adults with SLE in combination with SoC
Approval was based on the P-III (TULIP-SC) trial assessing Saphnelo pen vs PBO in 367 pts (18-70yrs.) with mod. to sev. SLE while receiving SoC, which showed Saphnelo reduced disease activity (1EP); full…
Shots:
The CHMP has recommended Sanofi's Cenrifki for the treatment of SPMS without relapses in the last 2yrs.; regulatory submissions are ongoing in other regions
Opinion was backed by P-III (HERCULES) trial in non-relapsing SPMS & supporting data from P-III (GEMINI 1 & 2) studies in relapsing multiple sclerosis, with HERCULES demonstrating delayed onset of…
Shots:
The CHMP has recommended 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
Opinion was based on the P-III (STEER) trial & P-IIIb (STRENGTH) study, where STEER showed a 2.39-point improvement in the HFMSE with effects sustained…
Shots:
Sun Pharma has entered into a definitive agreement to acquire Organon, growing Sun Pharma’s Innovative Medicines business & supporting its entry into biosimilars as a top-10 global player
As per the deal, Sun Pharma will acquire Organon for $14/share in an all‑cash transaction with an enterprise valuation of $11.75B; closing is expected in early…
Shots:
The CHMP has recommended Arrowhead's Redemplo as an adjunct to diet to reduce triglycerides (TGs) in adults with FCS; EC’s decision is expected in Q2’26
Opinion was supported by the P-III (PALISADE) trial assessing Redemplo (25mg & 50mg, SC, Q3M) vs PBO in 75 adults with genetically confirmed/clinically diagnosed FCS. Pts could join a…
Shots:
Cumberland has entered into an agreement to sell its portfolio of branded US products to an affiliate of Apotex for $100M in cash, which will create a platform to deliver specialty medicines
The move separates Cumberland’s commercial business from its R&D operations, allowing the company to focus on advancing its pipeline product candidates post-closing,…
Shots:
Mabwell has initiated a P-III trial of 9MW2821 in triple-negative breast cancer (TNBC), marking the fourth pivotal study for 9MW2821
The trial will assess the efficacy of 9MW2821 vs the investigator’s choice chemotherapy in locally advanced or metastatic TNBC pts previously treated with taxane-based CT ± immunotherapy & a topoisomerase inhibitor-based ADC
9MW2821, a…
Shots:
FLEX Vascular reported 12mos. results from the FLEX FIRST AV Registry at Charing Cross Symposium 2026, showing strong safety with 0% serious adverse events at 30 days & durable performance in hemodialysis access patients
The study (n=130) demonstrated 40% primary patency in cephalic arch lesions & 100% secondary patency in AV grafts at 12mos.,…
Shots:
J&J has reported data from the P-III (Vivacity-MG3) trial assessing Imaavy + SoC (n=77) vs PBO + SoC (n=76) in gMG pts (N=199; 153 were Ab +ve), plus from an ongoing OLE trial. Also, enrolment is ongoing in the EPIC trial of Imaavy against efgartigimod
The 24wk. Post-hoc analysis data showed adults receiving Imaavy…

