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Thyroid eye disease drug approvals
FDA has cleared Viridian Therapeutics’ thyroid eye disease (TED) therapy Lumvoa (veligrotug-vvze), giving the company an entry point to a market long dominated by Amgen’s Tepezza...
Inflammatory drug safety withdrawals in Europe and the US
The European Medicines Agency has moved toward withdrawing marketing authorization for Amgen and Vifor’s inflammatory drug Tavneos, concluding that benefits no longer outweigh risks. The CHMP...
CMS Medicare Advantage payment recalculations
CMS is recalculating select 2026 Medicare Advantage Star Ratings after a court ruled that the original calculation for Clover Health’s rating was improperly determined. The change could boost...
AI drug discovery partnership funding scale
Insilico Medicine and SK Biopharmaceuticals have launched a neuroimmune AI drug discovery collaboration that could generate up to $2.5 billion in value. The partnership assigns Insilico’s...
Progression-stage MS drug development signal
Immunic is advancing its Nurr1 program beyond multiple sclerosis’s inflammation ceiling, with Phase III activity expected to evaluate vidofludimus calcium. The development plan centers on whether...
FDA advisory committee agenda risks and independence scrutiny
Upcoming FDA advisory committee meetings are expected to revisit post-independence governance questions, with specific attention on meetings involving Replimune and Capricor. Coverage also notes...
Cell-free protein manufacturing cost breakthrough
A research team led by POSTECH (Pohang University of Science and Technology) reported a modular, automated approach to assembling reconstituted cell-free systems and said it reduced the cost of...
Bridging lab and market via genetic code expansion
A perspective argues that genetic code expansion (GCE) paired with machine learning can close the lab-to-market gap for engineered proteins and peptides by enabling non-canonical amino acid...
Neurotechnology coverage on BCI innovation
BioWorld reports that brain-computer interface (BCI) systems have advanced enough to prompt renewed attention from investors and clinicians after decades of research and setbacks. The coverage...
US drug pricing and access policy pressure around GLP-1 coverage
A policy analysis says Medicare’s GLP-1 coverage expansion for seniors requires a more holistic approach to weight management to avoid downstream risk. The piece frames the policy shift as...
Regulatory action over Tavneos safety/approval basis
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has joined the US Food and Drug Administration in challenging the approval basis for Amgen’s and Vifor’s...
FDA advisory committee meetings return under renewed scrutiny
The FDA is scheduling renewed advisory committee activity under new leadership, with officials signaling a higher priority for contentious product applications. Two announced meetings highlight...
New entrant wins FDA approval in thyroid eye disease, intensifying competition
Viridian Therapeutics received FDA approval for veligrotug for thyroid eye disease, initiating direct competitive pressure on Amgen’s Tepezza. Viridian’s drug will be marketed as Lumvoa, and the...
Financing: Definium raises $805M to fuel follow-on offerings
Definium launched a large $805 million public offering and is leading a follow-on group raising additional capital, according to the finance report. The quartet structure also includes other...
Startup launch: Bionyra Pharma emerges from stealth with $165M Series A
Bionyra Pharma, a clinical-stage biopharmaceutical company focused on next-generation biologics for severe immunological and inflammatory diseases, emerged from stealth after raising an...
Phase 3 MS strategy: Immunic tests Nurr1 pathway and inflammation ceiling
Immunic is moving forward with Nurr1 program testing aimed at pushing beyond what the company describes as the inflammation ceiling in multiple sclerosis (MS). The Phase III candidate vidofludimus...
Funding and build-time gains: cell-free protein system assembly costs down
A research team led by POSTECH’s Professor Joongoo Lee reported a method to cut the cost of building reconstituted cell-free systems by 95%. The work describes an automated, modular approach for...
AI for oncology discovery challenged by preclinical model gaps
A report warns that AI cannot overcome oncology drug discovery failures when preclinical models do not reflect patient tumor biology. The piece argues that despite growing use of sequencing,...
China biotech policy and investment restriction pressure
A leaders-style argument says US policymakers should not restrict Chinese biotechnology, citing patient access to faster and cheaper treatments as evidence of the practical downside of broad...
Litigation: Natera hit with class action over PGT-A marketing claims
Natera is facing a class action lawsuit in the Northern District of California alleging misleading advertising and marketing claims around its preimplantation genetic test for aneuploidy (Spectrum...