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Regulatory action: Tavneos withdrawal escalates in Europe
European regulators moved to revoke Amgen and Vifor’s complement inhibitor Tavneos (avacopan) after a review concluded the original marketing authorization evidence could no longer be relied upon....
FDA advisory momentum: Replimune’s RP1 heads toward a key decision date
Replimune won an early August decision timeline for its twice-rejected melanoma candidate RP1, after the FDA accepted a resubmission for accelerated approval. The regulator is expected to schedule...
New FDA approval: Viridian’s veligrotug sparks competition for thyroid eye disease
The FDA approved Viridian Therapeutics’ thyroid eye disease drug veligrotug for the condition’s treatment, launching a new competitive chapter alongside Amgen’s Tepezza. Viridian said the product...
Clinical pipeline: Intravesical CAR T preclinical data targets bladder cancer
Weill Cornell Medicine and Roswell Park Comprehensive Cancer Center reported preclinical evidence that intravesical CAR T-cell delivery can control bladder tumors in mice. In a Journal of...
Company launch and funding: Bionyra emerges from stealth after a Series A raise
Bionyra Pharma launched from stealth after raising an oversubscribed $165 million Series A to develop next-generation biologics for severe immunological and inflammatory diseases. The round was...
FDA/clinical development shift: Centanafadine posts another Phase 3b win in ADHD with anxiety
Otsuka reported top-line Phase IIIb results for centanafadine, its once-daily non-stimulant candidate for ADHD with comorbid anxiety. In the study, centanafadine met the primary endpoint defined...
Diagnostic innovation: BioMérieux submits rapid vaginitis panel to FDA
BioMérieux submitted a rapid multiplex PCR assay for vaginitis causes to the FDA for dual 510(k) clearance and CLIA waiver. The BioFire SpotFire Vaginitis Panel (VG) is designed to deliver results...
Regulatory and workflow strategy: SEC-approved science case—US research funding under new proposed rules
A proposed OMB rule has raised concerns among scientists that U.S. research funding could be undermined through reduced reliance on peer review and expanded influence for political appointees. The...
Dealmaking: Merck KGaA agrees to acquire Bio-Techne for $11.3B
Merck KGaA agreed to buy Bio-Techne for approximately $11.3 billion, positioning the combined group to expand life sciences tools, multiomics capabilities, and analytical workflow offerings. The...
Branded platform and growth: ARPA-H bankrolls fetal monitoring and rapid diagnostics projects
ARPA-H, the U.S. Department of Health and Human Services advanced research agency, committed $90.7 million over four years under its Making Obstetrics Care Smart (MOCS) program to support...
Regulatory action – Tavneos withdrawal and CHMP escalation
The EMA has joined the FDA in moving toward withdrawal of Amgen’s Tavneos (avacopan) after both agencies flagged data integrity problems. A CHMP review recommended revoking the drug’s EU marketing...
FDA advisory pressure – Replimune and peptide controversy return to adcomms
FDA advisory committees are set to revisit contested applications under renewed emphasis on adcomms, with meetings scheduled that will test the agency’s post-leadership-shakeup approach....
Clinical/regulatory – Replimune’s third RP1 try gets new FDA decision timeline
Replimune has received an early August decision date for its resubmission of RP1, setting up a potential regulatory inflection after two prior FDA rejections for advanced melanoma. The FDA...
FDA approvals – Viridian’s veligrotug launches competition with Amgen’s Tepezza
The FDA approved Viridian Therapeutics’ thyroid eye disease drug veligrotug, to be marketed as Lumvoa, setting up direct competition with Amgen’s Tepezza. The approval opens a new pricing and...
FDA approval – Ionis expands Tryngolza beyond rare disorder
Ionis Pharmaceuticals’ Tryngolza (olezarsen) gained wider U.S. approval for severe hypertriglyceridemia, moving the therapy from a rare formulation into a more prevalent-market label. The FDA...
Market access and pricing policy – 340B reform pressure returns
Sen. Bill Cassidy introduced a bill aimed at restricting the 340B drug discount program amid renewed scrutiny of how the program is used by nonprofit hospitals. Cassidy’s proposal follows years of...
Oncology competition – Gilead’s Trodelvy expands first-line TNBC positioning
The FDA expanded Gilead’s Trodelvy label in first-line triple-negative breast cancer, allowing use regardless of PD-L1 status and intensifying the TROP2 ADC competitive set. The new approval...
Dealmaking and consolidation – Merck KGaA to acquire Bio-Techne for $11.3B
Merck KGaA agreed to buy Bio-Techne in a roughly $11.3 billion deal, positioning the German conglomerate to expand life science tools and multi-omics capabilities across discovery and...
Antibody discovery collaboration – Immunai and Boehringer Ingelheim expand T-cell target search
Immunai signed a research collaboration with Boehringer Ingelheim valued at up to $15 million to identify T-cell dysfunction patterns for oncology and autoimmune target discovery. The multi-year...
Scientific integrity – Nature Medicine retracts China lung cancer timing study
Nature Medicine retracted a high-profile Chinese lung cancer paper that reported survival gains when immunotherapy was administered before 3 p.m., citing loss of confidence in the integrity of the...