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Regulatory action – Tavneos integrity concerns (EU and FDA alignment)
European regulators moved to withdraw Tavneos in a formal escalation of the drug’s data-integrity controversy. The EMA’s CHMP recommended revoking marketing authorization after it said it could...
FDA advisory panels return – contested oncology and cellular therapy reviews
FDA advisory panels are set to resume with fresh meetings tied to previously contested applications. Under new leadership, the agency indicated it would place renewed emphasis on advisory meetings...
Clinical validation – intravesical CAR T approach targets MUC16 in bladder cancer
Weill Cornell Medicine and Roswell Park reported preclinical evidence that directly delivering CAR T cells into the bladder can control bladder tumors. In a Journal of Experimental Medicine study,...
Funding – Bionyra Pharma launches with $165M Series A for inflammatory disease biologics
Bionyra Pharma emerged from stealth after raising $165 million in an oversubscribed Series A to develop next-generation biologics for severe inflammatory and immune-driven diseases. The new...
Regulatory and reimbursement – US FDA submits rapid vaginitis PCR for dual 510(k)/CLIA waiver
BioMérieux filed with the FDA seeking clearance and CLIA waiver for a rapid multiplex PCR vaginitis panel designed to return results in about 20 minutes at the point of care. The submission covers...
Therapy pipeline – Otsuka’s centanafadine hits endpoint in ADHD with comorbid anxiety Phase IIIb
Otsuka reported a clinical win for centanafadine in patients with ADHD and comorbid anxiety. Top-line results from a dedicated Phase IIIb study met the primary endpoint, defined as symptom score...
Transactions – 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, consolidating the combined entity under the Serapha Bio name. After completion, the company is...
Policy and politics – House committee to vote on China investment and in-licensing restrictions
A House committee is scheduled to vote on proposals that would tighten China-related investment and in-licensing restrictions for US biomedical activity. The package would consider additions such...
Platform science – AI human-in-the-loop framework proposes GPNMB CAR T target in solid tumors
Researchers used an AI human-in-the-loop framework to nominate CAR T targets and reported preclinical activity for a GPNMB-directed construct across multiple cancer models. In a Cell paper, a...
Research integrity – Nature Medicine retracts China-led immunotherapy-before-3-p.m. lung cancer study
Nature Medicine retracted a high-profile Chinese lung cancer paper that claimed immunotherapy timing—before 3 p.m.—could dramatically improve survival. The journal cited unresolved concerns about...
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...