Novartis to acquire Excellergy, adding Phase 1 anti-IgE program
Deal brings Exl-111 into Novartis’s allergy portfolio, targeting IgE-driven diseases including food allergy and asthma.
Kali licenses KT501 to Sanofi in autoimmune disease deal
Sanofi will obtain exclusive worldwide rights to Kali Therapeutics’ KT501 under an agreement covering a tri-specific T-cell engager for B cell-mediated autoimmune diseases.
India semaglutide market sees new moves from Lupin, Zydus, and Sun Pharma
Lupin gained semi-exclusive rights to co-market Zydus’ semaglutide injection in India, while Sun Pharma launched Noveltreat and Sematrinity for chronic weight management and type 2 diabetes.
FDA expands IMCIVREE label to acquired hypothalamic obesity as EMANATE misses primary endpoints
Rhythm Pharmaceuticals said the FDA approved IMCIVREE for acquired hypothalamic obesity, making it the first FDA-approved therapy for the condition.
Abbott completes Exact Sciences deal, expanding diagnostics portfolio in cancer screening
The deal increases Abbott’s exposure to a U.S. cancer screening and precision oncology diagnostics market the company sizes at $60 billion.
Aldeyra receives FDA complete response letter for Reproxalap
The FDA issued a Complete Response Letter for Aldeyra’s reproxalap application in dry eye disease, citing insufficient evidence of efficacy and inconsistent trial results.
Novartis expands Cosentyx label with FDA approval in adolescent Hidradenitis Suppurativa
The FDA approval extends Cosentyx into pediatric hidradenitis suppurativa, with use supported by adult studies, pharmacokinetic modeling, and pediatric data from other approved indications
China approves commercial BCI system for cervical spinal cord injury patients
The approved NEO system is designed to restore hand-grasping ability through neural signal decoding and a robotic glove.
Lilly escalates compounding challenge after finding impurity in Tirzepatide-B12 products
Eli Lilly said testing found an impurity in compounded tirzepatide products mixed with vitamin B12 and urged FDA action.
Bristol Myers Squibb’s Mezigdomide Delivers Progression-Free Survival Benefit in Phase 3 SUCCESSOR-2 Trial
SUCCESSOR-2 is mezigdomide’s first positive Phase 3 study and the CELMoD program’s second. The trial showed a progression-free survival benefit over carfilzomib and dexamethasone alone.
BioNTech sets leadership transition as Sahin and Türeci plan move to new mRNA company
BioNTech said its pipeline and COVID-19 vaccine franchise remain unaffected as its co-founders prepare to move to a new independent mRNA company.
Vertex posts positive week 36 phase 3 IgAN data for Povetacicept
Vertex reported positive Week 36 interim Phase 3 data for povetacicept in IgAN and said it will complete its BLA by the end of March.
Agilent Technologies targets pathology growth with $950 million Biocare Medical acquisition
Agilent’s planned acquisition of Biocare Medical would expand its pathology capabilities and place the business inside its Life Sciences and Diagnostics Markets Group.
FDA updates biosimilar development guidance as review experience accumulates
FDA’s March 9 draft biosimilar guidance could eliminate some three-way PK studies and cut related development costs by up to 50%, or about $20 million.
Xenon’s azetukalner meets Phase 3 endpoint in treatment-resistant focal onset seizures
Xenon Pharmaceuticals reported a 42.7% placebo-adjusted reduction in focal onset seizures at the 25 mg dose of azetukalner in Phase 3, lifting shares to an all-time high.
FDA proposes “plausible mechanism” route for individualized ultra-rare disease drugs
The agency’s “plausible mechanism” framework targets genome editing and RNA-based approaches, and outlines how sponsors can build substantial evidence using clinical data, supported by disease biology, natural-history data, and target confirmation, when randomized trials are not feasible.