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M&A moves reshaping autoimmune strategy at Eli Lilly
Eli Lilly agreed to buy Merida Biosciences for up to about $2.875 billion, extending Lilly’s acquisition streak and expanding its immunology pipeline beyond obesity-focused offerings. Merida’s...
Federal funding for custom RNA medicines on demand (ARPA-H GIVE)
ARPA-H awarded up to $125 million under its Genetic Medicines and Individualized Manufacturing for Everyone (GIVE) program to build a domestic, automated network for producing individualized,...
Biopharma pricing and access policy expands under MFN deals
The White House announced nine additional most-favored-nation (MFN) pricing agreements with midsized drugmakers, bringing the total to 26 participating manufacturers that the government says cover...
Clinical-trial safety stops in autoimmune CAR-T (Novartis and BMS)
Novartis and Bristol Myers Squibb paused autoimmune CAR-T programs after reports of serious adverse events and immune-related safety concerns. Fierce reported Novartis halted rap-cel trials across...
Gene therapy manufacturing scale-up for AAV diabetes program
Genprex selected Andelyn Biosciences to support manufacturing scale-up for its AAV-based diabetes gene therapy program delivered via the pancreatic duct. Under the agreement, Andelyn will...
Late-stage regulators align on DLL3 ADC Phase 3 (Ideaya)
Ideaya Biosciences received FDA alignment on a Phase 3 study design for IDE-849, its DLL3-targeted antibody-drug conjugate, moving the program into a late-stage development race. The alignment was...
Cancer precision diagnostics score insurance coverage milestone (Guardant Shield CRC)
Guardant Health said Carelon Healthcare Services will cover its Guardant Shield blood test for colorectal cancer screening starting Nov. 15. The coverage update is expected to extend total covered...
R&D infrastructure for faster drug discovery via large-scale virtual screening (AdaptiveFlow)
Researchers published an open-source AI-informed platform, AdaptiveFlow, designed to enable virtual screening at ultra-large scale with reduced computational cost. The approach is described as...
Liquid biopsy financing boosts RBC-bound nucleic acids platform (Senticell)
Senticell closed an oversubscribed seed financing approaching $7 million to advance its red blood cell (RBC)-bound nucleic acid liquid biopsy platform licensed from the University of Pennsylvania....
Biotech funding and stealth launches
K2 Therapeutics emerged from stealth, raising a $50 million seed round led by MPM BioImpact, with the firm positioned to expand its portfolio across antibody-drug conjugates and T-cell engager...
Clinical success and pivotal trial readouts
Genentech reported new results from two positive Phase III studies of fenebrutinib (FENhance 1 and FENhance 2) in relapsing multiple sclerosis, citing superiority versus teriflunomide on...
Clinical setbacks in autoimmune drug development
Alumis disclosed that its TYK2 inhibitor envudeucitinib failed to meet efficacy goals in a mid-stage systemic lupus erythematosus (SLE) study, according to the company’s Phase IIb Lumus trial...
Autoimmune CAR-T pauses and safety signals
Novartis paused development of its CD19-directed autoimmune CAR-T program after three patient deaths following a dangerous immune response, according to reporting on trial safety. Bristol Myers...
Biopharma policy and drug pricing initiatives
The White House announced nine additional voluntary most-favored-nation (MFN) drug pricing deals with mid-sized and large pharma companies, expanding coverage beyond the initial group previously...
Manufacturing scale-up for gene therapy
Genprex selected Andelyn Biosciences to support manufacturing scale-up for its diabetes gene therapy program, the company said in a collaboration focused on AAV process development and...
R&D platform leap for automated genetic medicines
ARPA-H awarded up to $125 million under its Genetic Medicines and Individualized Manufacturing for Everyone (GIVE) program to build a domestic automated network for RNA-based genetic medicines....
Strategic partnerships in ADCs and oncology targets
Roche moved into ADC licensing with Genentech’s collaboration and license deal with Dualitybio centered on the DUPAC (DualityBio Unique Payload Antibody Conjugate) payload platform. The deal...
Big pharma M&A in immunology
Eli Lilly agreed to acquire Merida Biosciences for up to $2.875 billion, extending its immunology push with a precision approach aimed at eliminating pathogenic autoantibodies. The deal adds...
Regulatory and reimbursement: expanding diagnostic access
Fujirebio said Health Canada cleared two neurological blood-based diagnostics for the Canadian market, both using its Lumipulse G platform. The approvals include a Class II Medical Device license...
Immunology clinical outcomes and trial pauses
Novartis halted multiple autoimmune CAR-T programs after three patient deaths tied to rap-cel, while Bristol Myers Squibb also paused development of zola-cel programs to review immune-related...