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Regulatory approvals – gene therapy for ultra-rare immune disease
The FDA has granted accelerated approval to Rocket Pharmaceuticals’ Kresladi (marnetegragene autotemcel), positioning it as the first gene therapy option for severe leukocyte adhesion deficiency-I...
Phase 3 readouts – lupus immunology pipeline signal
Biogen reported Phase 2 efficacy in lupus with litifilimab, its anti-BDCA2 antibody being positioned as a pillar of its immunology pipeline. In the company’s program update for skin involvement,...
Phase 3 results – COPD antibody reaches late-stage success
AstraZeneca said its experimental antibody tozorakimab met primary goals in two Phase 3 trials in chronic obstructive pulmonary disease, delivering flare-up reductions across a broad population....
M&A – Otsuka acquires Transcend Therapeutics for neuropsychiatric pipeline
Otsuka agreed to acquire Transcend Therapeutics in a deal valued at roughly $1.2 billion, including a $700 million upfront payment, to expand its neuropsychiatric drug portfolio. The target is...
M&A – Novartis expands allergy platform with Excellergy
Novartis agreed to buy Excellergy in a transaction valued at up to $2 billion, betting on next-generation anti-IgE immunology to extend and defend its allergy franchise. Excellergy’s trifunctional...
Diagnostics – expanded multi-cancer early detection testing in the U.S.
Maryland has awarded more than $520,000 to 18 fire-department groups to run multi-cancer early detection (MCED) screening using 20/20 BioLabs’ OneTest blood assay. The funding, routed through the...
Clinical pipeline – checkpoint-free cancer drug exposure update (RET fusion NSCLC)
Authors disclosed final efficacy and safety details from the Phase I/II ARROW study of pralsetinib in patients with advanced RET fusion–positive non–small cell lung cancer. The update provides...
Biotech financing – VC push tied to clinical milestones
Pinnacle and Immutrin moved toward clinical goals with new venture financing rounds as part of a broader “finance report” tally of biotech cash infusions. The reported rounds underscore how...
Regulatory/IP – CRISPR/Cas9 patent priority reaffirmed
Editas Medicine said the U.S. Patent and Trademark Office reaffirmed an earlier Patent Trial and Appeal Board decision that certain foundational CRISPR/Cas9 genome-editing patents belong to a...
Biology breakthrough – gut-epithelial antigen presentation links to MS neuroinflammation
Researchers led by Shohei Suzuki, MD, PhD, and Tomohisa Sujino, PhD at Keio University reported a mechanistic link between intestinal epithelial cells and multiple sclerosis–related...
US regulators approve first-in-class weekly insulin
The FDA approved Novo Nordisk’s once-weekly basal insulin Awiqli (insulin icodec) injection for type 2 diabetes, making it the first longer-acting alternative to daily basal insulin in the US. The...
EMA moves on oncology and label expansions
The EMA’s Committee for Medicinal Products for Human Use (CHMP) recommended approval of four new medicines in March, including specific actions around cancer therapies and label changes. CHMP...
US FDA grants first gene therapy for ultra-rare immune deficiency
The FDA granted accelerated approval to Rocket Pharmaceuticals’ Kresladi (marnetegragene autotemcel), the first gene therapy option for severe leukocyte adhesion deficiency-I (LAD-I). The approval...
Biogen advances lupus immunology with Phase 2 results
Biogen reported Phase 2 success for litifilimab, its anti-BDCA2 antibody program in lupus, positioning the drug as a potential pillar in its immunology pipeline. In 24 weeks, the company said...
New Phase 3 milestone for Bain-backed rare-disease oral therapy
Tanabe Pharma announced positive Phase 3 data for an oral drug targeting two rare diseases, marking its first major clinical milestone since Bain Capital acquired the company. The update advances...
Otsuka buys Transcend Therapeutics for PTSD drug development
Otsuka will acquire Transcend Therapeutics in a deal valued at $700 million upfront (up to $1.2 billion including milestones), gaining an experimental neuroplasticity-focused candidate for PTSD...
Novartis expands allergy immunology with Excellergy acquisition
Novartis agreed to acquire Excellergy for up to $2 billion in upfront and milestone payments, aiming to bolster its IgE-focused immunology strategy. Excellergy’s trifunctional allergic effector...
Clinical readout support for pralsetinib in RET fusion NSCLC
Authors disclosed final efficacy and safety data from the Phase I/II ARROW study of pralsetinib in patients with advanced RET fusion-positive non–small cell lung cancer. The manuscript provides...
Multi-drug “living pharmacy” implant advances in animals
Northwestern University led new work toward implantable “living pharmacies,” reporting a wireless hybrid oxygenation platform (HOBIT) that supports engineered cells producing multiple therapeutics...
Personalized cancer detection scales in Maryland
Maryland’s Department of Health awarded more than $520,000 to expand multi-cancer early detection (MCED) screening for firefighters using 20/20 BioLabs’ OneTest blood assay. The funding supports...