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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...
Regulators pull back on avacopan approvals in Europe and the U.S.
The European Medicines Agency (EMA) has recommended withdrawing marketing authorization for Amgen and Vifor’s Tavneos (avacopan), citing data integrity problems with the basis of approval. A...
FDA approves a new over-the-counter sunscreen ingredient after decades
The FDA approved bemotrizinol as the first new active sunscreen ingredient for over-the-counter consumer use in the US since 1999. The ingredient—already used for decades in Europe and Asia—now...
New drug launches: Viridian’s thyroid eye disease therapy competes with Tepezza
The FDA approved Viridian Therapeutics’ veligrotug for thyroid eye disease, with the drug to be marketed in the US as Lumvoa. The approval immediately sets up competition against Amgen’s Tepezza,...
Clinical-stage company emerges with $165M Series A to build next-gen inflammatory biologics
Bionyra Pharma launched out of stealth after raising $165 million in an oversubscribed Series A to develop next-generation biologics for severe immunological and inflammatory diseases. The...
Healthcare policy: Medicare bills propose major out-of-pocket cost relief tied to beneficiaries’ spending
A new bill led by Democrats, the Medicare Cost Cap Act, would create a $5,000 cap on out-of-pocket costs for traditional Medicare beneficiaries. The proposal would significantly alter patient...
Medicare GLP-1 access expansion triggers a coverage-design debate
A policy change expanding Medicare coverage for GLP-1 treatments would dramatically increase access for seniors, but observers warn the approach needs stronger integration with broader weight...
China biotech and investment restrictions take center stage in US policy and deal strategy
US lawmakers are moving toward a tighter policy posture on China biotech investment and in-licensing restrictions, with a House committee slated to vote on proposals that add BINSA research...
Platform innovation: automated reconstituted cell-free systems cut build cost 95%
Researchers led by Joongoo Lee at POSTECH (Pohang University of Science and Technology) reported an automated, modular assembly method that cuts the cost of building reconstituted cell-free...
Oncology immunotherapy: intravesical CAR T cells show tumor control in bladder cancer model
Weill Cornell Medicine and Roswell Park Comprehensive Cancer Center reported preclinical results showing intravesical CAR T-cell delivery can control bladder tumor growth in mice. The approach...
Diagnostics: BioMérieux files for rapid syndromic vaginitis panel with dual FDA pathway
BioMérieux submitted a rapid multiplex PCR vaginitis panel to the FDA for dual 510(k) clearance and CLIA waiver. The BioFire SpotFire Vaginitis Panel is designed to return results within 20...