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Regulatory action: Tavneos revocation trajectory expands across agencies
Europe’s drug regulator moved closer to pulling Tavneos (avacopan) after the CHMP joined the FDA in challenging the approval basis for Amgen and Vifor’s rare-disease treatment. The recommendation...
FDA approvals: Viridian’s veligrotug launches competition against 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 expands treatment options...
Oncology pipelines: Replimune seeks third FDA try with RP1 advisory decision in August
Replimune’s resubmission for oncolytic immunotherapy RP1 in advanced melanoma has cleared an FDA administrative step, with a potential advisory committee timeline in late July and a decision date...
New therapies entering broader markets: Ionis’ Tryngolza gains prevalent-market label
Ionis’ Tryngolza has received an approval expansion that moves the therapy from rare FCS into severe hypertriglyceridemia—a step that gives Ionis its first widespread cardiometabolic-market...
Cell therapy innovation: intravesical MUC16 CAR T controls bladder tumors in mice
Weill Cornell Medicine and Roswell Park Comprehensive Cancer Center reported preclinical results for intravesical CAR T therapy targeting MUC16 in bladder cancer. In a Journal of Experimental...
Diagnostic innovation and FDA path: BioMérieux submits rapid vaginitis panel for dual review
BioMérieux filed with the FDA for a rapid multiplex vaginitis test designed to detect common causes of vaginitis in about 20 minutes at the point of care. The submission targets both 510(k)...
Biotech M&A: Boundless Bio merges into Serapha Bio in $230M deal
Boundless Bio agreed to merge with Serapha Bio in an all-stock transaction valued at $230 million, with the combined company expected to trade on Nasdaq under a Serapha Bio ticker. The deal is...
Big deal in life-science tools: Merck KGaA to acquire Bio-Techne for $11.3B
Merck KGaA announced an agreement to acquire Bio-Techne for about $11.3 billion, extending its footprint across the life-science workflow from discovery through advanced therapeutics and...
New funding for immune and inflammatory biologics: Bionyra Pharma launches with $165M Series A
Bionyra Pharma emerged from stealth after raising $165 million in an oversubscribed Series A to develop next-generation biologics for severe immunological and inflammatory diseases. The round was...
Policy and research ecosystem: scientists warn proposed U.S. grant-rule changes could weaken peer review
A proposed Office of Management and Budget rule is raising alarms among U.S. scientists that federal research funding could be undermined, with fears centered on reducing the role of peer review...
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...