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Regulatory approvals
The FDA cleared Rocket Pharmaceuticals’ gene therapy Kresladi (marnetegragene autotemcel) for severe leukocyte adhesion deficiency-I (LAD-I), marking the first approved gene therapy option for...
US insulin market milestone
Novo Nordisk secured the long-awaited U.S. FDA approval for Awiqli (insulin icodec) injection, the first and only once-weekly, long-acting basal insulin for type 2 diabetes. The decision follows a...
Biogen lupus trial readout
Biogen reported Phase 2 success for litifilimab in lupus, highlighting improvements in cutaneous manifestations after 24 weeks. The company’s #AAD26 update underscores its push to build a pillar...
European regulatory label updates
The EMA’s CHMP recommended four new medicines in March, including opinions affecting oncology and rare-disease indications. Among the guidance, the committee backed two therapies already approved...
M&A: Otsuka buying Transcend for PTSD and psychiatric pipeline
Otsuka moves to broaden its neuropsychiatric portfolio with an acquisition of Transcend Therapeutics. The deal is valued at about $1.2 billion, including a $700 million upfront payment and up to...
M&A: Novartis expands allergy immunology with Excellergy
Novartis agreed to acquire Excellergy for up to $2 billion, adding a next-generation anti-IgE platform to bolster its allergy pipeline. Excellergy’s lead candidate, Exl-111, is in Phase 1 with a...
Clinical oncology: pralaet? pralsetinib ARROW final data
Final efficacy and safety disclosures from the Phase I/II ARROW study of pralsetinib in advanced RET fusion–positive non–small cell lung cancer provide an endpoint-complete readout for the...
Late-stage immunology: AstraZeneca COPD antibody surprise
AstraZeneca said its investigational antibody tozorakimab met key goals in two Phase 3 COPD trials, Oberon and Titania, delivering results across a broader patient mix than many...
Rare disease cell/gene therapy pipeline: Wave obesity shock and trial-linked context
Wave Life Sciences’ earlier obesity trial disappointment—described as debated and ultimately stock-denting—continued to reverberate in sector conversations about INHBE and activin E pathway...
Diagnostics and coverage push: 20/20 BioLabs OneTest for MCED
Maryland awarded more than $520,000 for multi-cancer early detection screening using 20/20 BioLabs’ OneTest blood-based assay, funding testing for over 1,400 firefighters. The program expands the...
Regulatory approvals in rare disease gene therapy
The U.S. FDA granted accelerated approval to Rocket Pharmaceuticals’ gene therapy Kresladi (marnetegragene autotemcel) for severe leukocyte adhesion deficiency-I (LAD-I), marking the first gene...
EU regulator backs new cancer and label changes
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) backed four new medicines in March, including a new subcutaneous formulation of Sanofi’s Sarclisa in multiple...
Big pharma M&A reshapes next-gen immunology
Novartis agreed to acquire Excellergy, an early-stage allergy biotech, in a deal valued at up to $2 billion including upfront and milestone payments. The purchase brings Excellergy’s trifunctional...
Psychiatry M&A: Otsuka moves into neuroplasticity drug development
Otsuka is buying Transcend Therapeutics in a transaction worth about $1.2 billion, including $700 million upfront, to acquire TSND-201, a neuroplasticity-focused experimental psychiatric medicine....
Clinical pipeline setback turns into market signal for Wave obesity program
Wave Life Sciences’ obesity readouts pushed the company’s shares sharply lower, as investors digested data suggesting limited additional benefit from higher dosing of its INHBE-targeted program....
Late-stage success expands COPD biologics competition
AstraZeneca reported “surprise” Phase 3 wins for its investigational COPD antibody tozorakimab, showing success in two late-stage trials after mixed results earlier in development. The studies,...
Diagnostics reimbursement push for multi-cancer early detection
Maryland awarded more than $520,000 to fire departments to run multi-cancer early detection screening using 20/20 BioLabs’ OneTest blood assay, covering testing for more than 1,400 firefighters....
Cancer pipeline risk and immunology platform investment via VC funding
Pinnacle Medicines raised $89 million in a Series B to advance its oral peptide programs, bringing total funding to $134 million. The round was co-led by LAV and Foresite Capital, strengthening...
Precision immunology discovery: gut-immune mechanism in MS
Researchers at Keio University (including Shohei Suzuki and Tomohisa Sujino) reported a mechanistic link between intestinal epithelial cells and multiple sclerosis-related neuroinflammation. In...
Patent landscape in genome editing: Broad CRISPR/Cas9 priority reaffirmed
Editas Medicine said the USPTO reaffirmed an earlier Patent Trial and Appeal Board decision supporting Broad Institute inventorship priority for foundational CRISPR/Cas9 genome editing patents in...