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Acquisitions & pipeline expansion in rare bone disease
BioMarin agreed to acquire Alesta Therapeutics’ lead program ALE1 in a deal valued at $275 million upfront with up to $490 million total, expanding BioMarin’s rare disease portfolio around...
FDA approvals for ultra-rare conditions targeting activin A
The FDA approved Regeneron’s garetosmab (branded Pasatru) for fibrodysplasia ossificans progressiva (FOP), giving patients a second cleared therapy for an ultrarare disorder that turns soft tissue...
Late-stage win for personalized mRNA neoantigen vaccines
Merck and Moderna announced a pivotal Phase 3 success for intismeran autogene, a personalized mRNA neoantigen vaccine given with Merck’s Keytruda in resected high-risk melanoma. The companies said...
Phase 3 confirmation in EGFR exon 20 insertion NSCLC
Sunvozertinib outperformed chemotherapy as first-line treatment for advanced non–small-cell lung cancer with EGFR exon 20 insertions in a Phase 3 trial. In NEJM data (published May 29, 2026),...
Antibody engineering & diagnostics: liquid biopsy genomics in Japan
Pillar Biosciences said it will contribute its oncoReveal Essential+ next-generation sequencing assay to a Japan-based liquid biopsy screening partnership for non–small cell lung cancer. The...
FDA policy & regulatory oversight: appointment path for FDA commissioner
Multiple outlets reported that President Donald Trump plans to nominate Heidi Overton to lead the FDA as commissioner. If confirmed, Overton would take over a regulator that has been without a...
Gene therapy patent litigation victory in single-cell genomics
The U.S. Court of Appeals for the Federal Circuit upheld a patent validity decision in a dispute between Parse Biosciences and 10x Genomics. The appeals court affirmed that three 10x Genomics...
Regulatory risk: AI devices cleared without patient-outcome evidence
A sweeping review found that most AI-enabled medical devices authorized for patient care by the FDA had not been tested for patient outcomes. Researchers identified 1,357 AI-enabled devices...
Cell therapy manufacturing: scaling analytics automation for small-batch workflows
BlueRock Therapeutics said it developed an automated system for high-throughput auditing in cell therapy workflows, built to handle cell culture, liquid handling, and small-volume sample...
Biotech investing: Network Bio launches with $50M and Nvidia partnership
Network Bio launched with $50 million in financing and a collaboration valued at $30 million with Nvidia to develop a cell-free RNA (cfRNA) foundation model. The startup plans to train models...
Regulatory approvals in rare bone disease
The FDA has approved Regeneron’s activin A-targeting monoclonal antibody garetosmab (Pasatru) for fibrodysplasia ossificans progressiva (FOP), completing a decades-long development effort and...
Personalized mRNA cancer vaccines gain Phase 3 milestone
Merck and Moderna announced a randomized Phase 3 success for their personalized neoantigen mRNA vaccine intismeran autogene (intismeran) combined with Keytruda in adjuvant melanoma. The companies...
First-line targeted therapy for EGFR exon 20 insertions clears Phase 3 hurdle
In a pivotal Phase 3 trial, sunvozertinib outperformed chemotherapy as first-line treatment in advanced non–small-cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations. The study...
Big deal in rare bone disease – BioMarin buys Alesta’s ALE-1
BioMarin agreed to acquire Alesta Therapeutics BV’s lead oral small-molecule candidate ALE-1 in a transaction valued at $275 million upfront and up to $490 million with milestones. The asset...
Car T development pivot after toxicity in solid-tumor program
Chimeric Therapeutics halted its phase I/II study of CHM-2101, an autologous cadherin-17-targeted CAR T for gastrointestinal cancers, after a second patient at the highest dose level experienced...
AI in clinical devices – FDA-cleared products lacked outcome testing
A sweeping review of AI-enabled medical devices authorized by the FDA found that most were cleared without evidence tied to improved patient outcomes. Using a dataset of 1,357 AI-enabled devices...
FDA oversight for generative AI-enabled medical devices
The FDA solicited public input on approaches to regulating generative AI-enabled medical devices, focusing on how to assess risk and what evidence should support premarket evaluation and...
Business and litigation: Parse wins appellate IP dispute vs 10x Genomics
The U.S. Court of Appeals for the Federal Circuit upheld a Patent Trial and Appeal Board decision invalidating three patents asserted by 10x Genomics against Parse Biosciences. The ruling affirms...
Startup launch with large-scale cfRNA model ambitions
Network Bio launched with $50 million in financing and a strategic collaboration valued at $30 million with Nvidia to develop a cell-free RNA (cfRNA) foundation model. The startup plans to combine...
Clinical tradeoffs and cost pressures in CAR T manufacturing
Industry leaders highlighted CAR T manufacturing constraints as the next bottleneck for broader patient access, focusing on scaling, automation, vector engineering, and consistency across batches....