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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...
Regulatory action—Tavneos (avacopan) in Europe
The European Medicines Agency (EMA) moved to revoke marketing authorization for Amgen and Vifor’s complement inhibitor Tavneos (avacopan) after concluding the approval basis relied on “incorrect...
FDA advisory momentum—RP1 and next contested product meetings
Replimune’s oncolytic immunotherapy RP1 cleared an FDA regulatory milestone, receiving an early August decision date after a resubmission for advanced melanoma. The FDA set an advisory committee...
Commercial and regulatory—Viridian’s thyroid eye disease launch
The FDA approved Viridian Therapeutics’ thyroid eye disease drug veligrotug, initiating a new competitive cycle for Amgen’s Tepezza franchise. Viridian will market the therapy as Lumvoa, with...
Immunotherapy—Intravesical CAR T-cell approach in bladder cancer
Weill Cornell Medicine and Roswell Park Comprehensive Cancer Center reported preclinical data supporting an intravesical CAR T-cell strategy for bladder cancer. In a Journal of Experimental...
Neuroinflammation—Immunic pushes Nurr1 test for multiple sclerosis progression
Immunic is advancing a Phase III test for vidofludimus calcium with a regulatory and clinical objective aimed at moving beyond what the company describes as multiple sclerosis’s inflammation...
Funding—Bionyra Pharma launches with Series A to build inflammatory disease biologics
Bionyra Pharma emerged from stealth with a clinical-stage focus on inflammatory and immune-mediated diseases after raising $165 million in an oversubscribed Series A. The round was co-led by Jeito...
Regulatory and pipeline—Otsuka’s centanafadine posts Phase IIIb ADHD win
Otsuka reported top-line Phase IIIb results for centanafadine in patients with ADHD and comorbid anxiety, marking another clinical development milestone for its non-stimulant program. The company...
Diagnostics—BioMérieux submits rapid syndromic vaginitis test to FDA
BioMérieux filed for dual 510(k) clearance and CLIA waiver with the FDA for a rapid, point-of-care vaginitis molecular panel. The company submitted its BioFire SpotFire Vaginitis Panel (VG),...
Deals and corporate strategy—Agilent acquires Biocare
Agilent completed its acquisition of Biocare Medical, a deal originally announced in March and valued at $950 million. The move expands Agilent’s pathology offerings with Biocare’s...
Research integrity—Nature Medicine retracts Chinese lung cancer timing study
Nature Medicine retracted a widely publicized Chinese lung cancer study—Lungtime-C01—after the journal found issues that undermined confidence in the reported results. The paper claimed that...