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Two new oral antibiotics win FDA approval for gonorrhea — expands limited treatment options
Regulators approved two new oral treatments for uncomplicated gonorrhea, adding zoliflodacin (Nuzolvence) and gepotidacin (Blujepa) to the antibiotic armamentarium. Both agents received priority...
House passes INVEST Act — bipartisan bill to ease capital for small biotechs
The U.S. House of Representatives passed the INVEST Act, a BIO‑backed bipartisan bill designed to unlock capital for small, innovative firms by removing regulatory hurdles for companies and...
Disco closes €36M seed to back surfaceome platform — €42M final close fuels target discovery
Disco Pharmaceuticals closed a €36 million seed round (final close) to advance its surfaceome discovery platform toward preclinical development. The funding will support target validation and...
Lilly triple-agonist: 28.7% weight loss, tolerability concerns
Eli Lilly reported jaw-dropping Phase 3 data showing its triple-agonist retatrutide produced mean weight losses approaching 29% in a late-stage study, while trial documents and follow-up reports...
TIGIT programs unravel: Arcus halts late‑stage trials
Arcus Biosciences and partners reported a Phase 3 failure for the anti‑TIGIT antibody domvanalimab when added to PD‑1 blockade and chemotherapy, prompting the company to pause multiple...
AC Immune vaccine: biomarker wins open regulator conversations
Swiss biotech AC Immune released interim Phase II biomarker data from its active immunotherapy Vacsyn (ACI‑7104) that the company says show consistent α‑synuclein, neurofilament light (NfL) and...
ctDNA stakes rise: Exact Sciences and Natera push MRD strategies
Two separate initiatives this week underscored the commercial and clinical push to embed circulating tumor DNA (ctDNA) minimal residual disease (MRD) assays into oncology care. Exact Sciences...
Investors pour cash: China mega‑rounds and European seed fuel discovery startups
Venture financing remained active this week with large rounds and strategic seed closes across geographies. Chinese innovators D3 Bio and Sanegene each secured rounds exceeding $100 million,...
Big‑pharma tie‑ups: Novartis, Relation and Zealand’s $2.5bn metabolic pact
Major industry collaborations continued to shape pipelines: Novartis struck a discovery and development alliance with UK biotech Relation Therapeutics that could deliver up to $1.7 billion in...
FDA vaccine frictions: internal review lands amid public pushback
Regulatory tensions intensified as an FDA staff analysis on pediatric COVID‑19 vaccine safety was circulated internally and triggered media reports that the agency is weighing unprecedented...
CRISPR momentum: in vivo successes and a field‑wide reckoning
CRISPR and gene‑editing took center stage as leaders framed 2025 as a landmark year of in vivo and personalized editing advances. In a wide‑ranging interview, Jennifer Doudna reflected on recent...
Scaling biology: 300M‑cell atlas and AI multi‑omics deals accelerate discovery
Two collaborations signaled rapid scaling of data and AI infrastructure in discovery research. Parse Biosciences and Tahoe Therapeutics agreed to generate a 300 million cell perturbation atlas to...
Rezolute collapses after pivotal miss — stock implodes
Rezolute’s Phase 3 Sunrize study of ersodetug failed to meet its primary and key secondary endpoints in congenital hyperinsulinism, prompting the company to signal program uncertainty and to plan...
Arcus–Gilead halt TIGIT program: Phase 3 failure forces R&D reset
Arcus Biosciences and Gilead reported that the Phase 3 program for the anti‑TIGIT antibody domvanalimab missed its primary endpoints, prompting an immediate pause and strategic refocus. The...
Lilly’s triple agonist smashes weight‑loss records…but tolerability clouds outlook
Eli Lilly’s triple‑agonist retatrutide delivered unprecedented weight loss in a Phase 3 study—averaging roughly 28.7% at 68 weeks—while also improving knee osteoarthritis pain. The high efficacy...
AC Immune shows biomarker wins in Parkinson’s vaccine: regulators next
AC Immune released interim biomarker results from its Phase II Vacsyn trial of the active α‑synuclein vaccine ACI‑7104, reporting changes in cerebrospinal fluid α‑synuclein and supportive...
Rezolute’s pivotal miss: ersodetug fails Phase 3, shares implode
Rezolute disclosed that its Phase 3 Sunrize study of ersodetug for congenital hyperinsulinism missed primary and key secondary endpoints, prompting management to halt investor guidance and plan...
MRD and ctDNA move toward clinic: Exact Sciences, Natera push trials and coverage
Exact Sciences presented first data showing its Oncodetect MRD test stratified distant‑recurrence risk in triple‑negative breast cancer in an NSABP B‑59 sub‑study; MRD‑positive patients after...
Regulatory shifts: FDA diagnostics reclassification and House moves to free biotech capital
The FDA proposed reclassifying some companion diagnostic nucleic‑acid tests from Class III to Class II, which would allow select tests to follow the 510(k) pathway instead of the more burdensome...
Big rounds, seed deals: China megafunds and European surfaceome startup raise capital
China’s D3 Bio and Sanegene each closed financing rounds topping $100 million, underscoring continued deep venture activity in Chinese biotech despite geopolitical headwinds. The financings...