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Regulatory approvals in Parkinson’s disease
The FDA cleared AbbVie’s next-generation Parkinson’s therapy, tavapadon, branded as Juvmo, expanding treatment options for dopamine-agonist–responsive symptoms. The approval marks a regulatory...
R&D setbacks in lung cancer ADCs
Merck and Daiichi Sankyo withdrew their FDA accelerated-approval submission for their B7-H3 antibody-drug conjugate in small cell lung cancer after FDA pushback on available data. The move erases...
Anticancer licensing—KRAS G12D deals at scale
Merck agreed to a high-profile licensing deal for a KRAS G12D inhibitor, paying SciBrunch Therapeutics $400 million upfront for global rights to a preclinical candidate, with total deal value...
Ophthalmology trial readouts for aflibercept-matched therapies
Kodiak Sciences reported that two vision-focused candidates matched aflibercept in a Phase 3 clinical trial, positioning the company to pursue FDA approval of one eye disease asset during the...
Obesity drug development reversals at Roche
Roche stopped work on emugrobart (GYM329) and returned the muscle-building obesity program to Chugai, ending a trial that tested the experimental medicine with an anti-obesity injectable. The...
Hepatitis delta—Phase 3 win to challenge Gilead
Mirum Pharmaceuticals posted a Phase 3 result for its chronic hepatitis delta program, reporting that the trial hit its primary endpoint. The readout advances Mirum’s effort to establish a...
Rare disease—FDA approval for fibrodysplasia ossificans progressiva
Mirum Pharmaceuticals’ oral therapy, Atebrioz, received FDA approval for fibrodysplasia ossificans progressiva (FOP), making it the third approved drug for the ultra-rare bone growth disorder....
Public-private R&D funding—BARDA contract for antifungals
BARDA awarded Scynexis a $214 million contract to develop a treatment for invasive fungal infections. The award supports continued development in a segment where resistant and hard-to-treat...
AI in clinical trials—automation with cost impact signals
Medable introduced evidence from a Tufts Center for the Study of Drug Development analysis indicating its Clinical Monitoring Agent can improve clinical research monitor efficiency and potentially...
Therapeutic innovation—AI-built thermostable mRNA vaccines
Researchers reported an AI-guided approach to engineer thermostable, solid-state mRNA vaccines designed to avoid ultra-cold storage constraints. Using an AGENT framework that couples...
FDA approval for rare disease oral/injectable pipeline
Mirum Pharmaceuticals’ Atebrioz has received FDA approval for fibrodysplasia ossificans progressiva (FOP), extending the company’s rare-disease franchise with a third approved option for the...
Regulatory setback on oncology accelerated approval pathway
Daiichi Sankyo and Merck withdrew a lung cancer antibody-drug conjugate filing after FDA pushback, according to the report. The regulator said the companies lacked sufficient data to support...
Company-level legal outcome impacting capital expectations
Nektar Therapeutics’ stock didn’t surge as investors may have expected following a jury verdict in its favor versus Eli Lilly over the termination of a rezpegaldesleukin (rezpeg) collaboration....
Thermostable RNA vaccine formulation using AI-driven design
Researchers reported an AI-guided approach to rapidly identify thermostable mRNA–lipid nanoparticle vaccine formulations, addressing a key barrier to global distribution of mRNA platforms. Using...
LNP engineering for large RNA cargo and tissue targeting
A Nature Biotechnology report highlighted how incorporating RNA cargo size into lipid nanoparticle design can improve performance for delivery of large gene editors. In parallel, another Nature...
Self-amplifying RNA vaccine resistance to intracellular defenses
A study led by Queen Mary University of London described a viral protein strategy to overcome cellular restrictions on self-amplifying RNA (saRNA). In a Nature Communications paper, adding the...
AI-assisted clinical monitoring to reduce trial cost and inefficiency
Medable reported independent modeling results suggesting its AI-assisted clinical monitoring software can reduce trial costs by improving how monitors handle documentation and site variability....
CRISPR nuclease engineering accelerates genome editing performance
Researchers engineered a compact CRISPR nuclease (CgCas12n) into a high-performance genome-editing platform, reporting a roughly 60-fold power boost in human cells. The work, published in...
Clinical monitoring and decision support for oncology response uncertainty
A new AI-driven clinical monitoring approach aims to identify uncertainty about whether cancer patients will respond to therapy. The report focuses on metastatic non-small cell lung cancer and...
Operational readiness as a bottleneck for moving therapies to market
A commentary piece in the biotech investing ecosystem argued that scientific breakthroughs are not the limiting factor for most new companies; operational execution—GMP production, quality...