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EU regulatory move against Amgen’s Tavneos
The European Medicines Agency has recommended revoking the marketing authorization for Amgen’s rare-disease drug Tavneos, citing “incorrect and misleading” clinical data. The action escalates a...
EU drug policy overhaul and timelines under the EU Biotech Act
Biotech stakeholders are bracing for major operational changes as the EU Biotech Act is expected to reduce clinical trial timelines, boost biomanufacturing capacity, and improve investment...
EU payor and access pressure around 340B drug discount transparency
A new wave of scrutiny is building around the US 340B drug discount program, with Sen. Bill Cassidy preparing legislative action and advocates calling for patient-focused reforms and greater...
FDA workforce rebuilding after DOGE-era cuts
FDA leadership says the agency is hiring to rebuild capacity after more than a year of workforce attrition tied to DOGE-era cuts and leadership turnover. Acting chief of staff and deputy...
FDA expands Ionis’ Tryngolza label for severe hypertriglyceridemia
Ionis Pharmaceuticals has received FDA approval to expand Tryngolza (olezarsen) to a broader hypertriglyceridemia label, increasing the therapy’s commercial scope beyond an earlier rare...
Next-gen cell therapy engineering without viral vectors: Circio and Tcelltech
Circio and Tcelltech have agreed to collaborate on engineering next-generation in vivo CAR-T and TCR-T therapies using a non-integrating, non-viral vector strategy. The partners will combine...
AI-assisted CAR-T target discovery with human-in-the-loop screening
Researchers at the University of Pennsylvania and Abramson Cancer Center unveiled an AI-driven, human-in-the-loop framework to nominate CAR T cell antigens across solid-tumor contexts. In a study...
Large biopharma transactions: Merck KGaA to acquire Bio-Techne for $11.3B
Merck KGaA agreed to acquire Bio-Techne for approximately $11.3 billion, expanding the German company’s life science tools footprint across multiomics, spatial biology, cell and gene therapy, and...
Transatlantic M&A in gene therapy: Boundless Bio merges into Serapha Bio
Boundless Bio agreed to merge with Serapha Bio in an all-stock deal valued at $230 million, with the combined company expected to trade on Nasdaq under Serapha Bio’s name. The merger is designed...
M&A expands life-science tools and cell-therapy enablers
Merck KGaA agreed to acquire Bio-Techne for about $11.3 billion, a deal positioned to deepen the German company’s presence across the life-science value chain. The transaction adds Bio-Techne’s...
FDA label expansion boosts Ionis antisense franchise
Ionis said the U.S. FDA approved a wider label for Tryngolza (olezarsen), expanding the drug’s use to a broader set of patients with severe hypertriglyceridemia and related risk of pancreatitis....
Big FDA policy pressure point: 340B faces new transparency and reform push
At BIO 2026, biotech and policy leaders escalated scrutiny of the 340B drug pricing program, arguing it lacks transparency and has drifted from its original goal of supporting access for...
Regulatory staffing and operational recovery at FDA after workforce cuts
FDA leadership told BIO 2026 attendees it is accelerating hiring to rebuild capacity after last year’s workforce disruptions. Acting chief of staff and deputy commissioner Lowell Zeta said the...
Next-gen CAR T target discovery using human-in-the-loop AI
Researchers at the University of Pennsylvania and Abramson Cancer Center reported an AI-enabled, human-in-the-loop framework for nominating CAR T targets, then validated the top pick in...
Venture and platform capital: RQ Bio lands $115M for long-acting flu prevention
RQ Bio closed an oversubscribed $115 million Series A financing to advance RQB01, a long-acting antibody strategy for seasonal influenza prevention in high-risk and immunocompromised populations....
Clinical validation of a T-cell engagement asset for autoimmune disease
Oblenio Bio secured $62 million in a Series B to move its trispecific T-cell engager LBL-051 into first-in-human testing for chronic autoimmune diseases. The funding came roughly a year and a half...
Oncology: Revolution’s second RAS blocker posts strong PDAC combination response signals
Revolution Medicines shared early Phase 1/2 results for zoldonrasib combination regimens in RAS-G12D metastatic pancreatic ductal adenocarcinoma. In the report, the company’s zoldonrasib plus...
Data and diagnostics: Natera Prospera dd-cfDNA becomes exclusive monitoring tool in Phase III kidney transplant trial
Natera and Eledon Pharmaceuticals partnered to incorporate Prospera, Natera’s donor-derived cell-free DNA test, as the exclusive dd-cfDNA monitoring assay in Eledon’s planned Phase III kidney...
Immuno-oncology discovery partnerships: Immunai and Boehringer Ingelheim expand AI-enabled T-cell target search
Immunai entered a research collaboration with Boehringer Ingelheim valued at up to $15 million through 2027, using Immunai’s single-cell immune profiling platform to identify novel T-cell targets...
Regulatory approvals and label expansions
Ionis Pharmaceuticals secured an FDA label expansion for Tryngolza (olezarsen), extending use in hypertriglyceridemia beyond its prior, narrower indication. The broadened approval targets patients...