Shots:
Thermo Fisher Scientific has agreed to sell its microbiology business to Astorg for ~$1.075B, incl. cash & a $50M seller note, as part of its portfolio optimization strategy
The divested unit, which offers antimicrobial susceptibility testing and culture media solutions, generated $645M in revenue in 2025 and operates within Thermo Fisher’s Specialty Diagnostics segment…
J&J Receives the US FDA Priority Review for Imaavy to Treat Warm Autoimmune Hemolytic Anemia (wAIHA)
Shots:
The US FDA has accepted sBLA & granted priority review to J&J's Imaavy (nipocalimab-aahu) for the treatment of warm autoimmune hemolytic anemia (wAIHA)
sBLA was supported by P-II/III (ENERGY) trial assessing the efficacy & safety of Imaavy vs PBO in adults with wAIHA, followed by an OLE period
Trial showed that pts treated with Imaavy…
Shots:
Eli Lilly has entered into a definitive agreement to acquire Ajax Therapeutics, incl. its lead asset AJ1-11095, strengthening Lilly's capabilities in blood cancers
As per the deal, Lilly will acquire Ajax for ~$2.3B in cash, inclusive of an upfront payment & subsequent clinical & regulatory milestone payments
AJ1-11095 (PO, QD), a Type II JAK2…
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…
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,…

