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Natera and MEDSIR launch MiRaDoR trial using Signatera to tailor adjuvant therapy
Natera announced a collaborative Phase II MiRaDoR trial with MEDSIR and Roche funding to evaluate Signatera ctDNA monitoring in HR+/HER2‑ early breast cancer. The study will enroll up to 60...
Disco closes €36M seed to advance surfaceome target discovery
Disco Pharmaceuticals announced a €36 million (≈US$42 million) final close on a seed round to fund development of its surfaceome discovery platform and push identified targets toward formal...
House passes INVEST Act to widen capital access for small biotech
The U.S. House of Representatives approved the INVEST Act, a bipartisan package designed to free up capital for small innovative firms by removing regulatory barriers and expanding investor...
Lilly’s triple-agonist sets new weight-loss bar – phase 3 data
Eli Lilly reported landmark Phase 3 data showing its triple-agonist retatrutide delivered unprecedented long-term weight loss in people with obesity. Company and industry coverage show high-dose...
Gene‑edited cell transplant restores insulin production – first human case
Scientists reported a first-in-human case in which gene‑edited insulin-producing cells were transplanted into a man with type 1 diabetes and produced endogenous insulin without the need for...
Arcus and Gilead’s TIGIT program collapses – late‑stage trials halted
Arcus Biosciences and partner Gilead reported a Phase 3 failure for their anti‑TIGIT antibody domvanalimab in upper gastrointestinal cancers, prompting an immediate halt to the program and a...
FDA weighing boxed warning for Covid vaccines — experts push back
Multiple outlets reported that FDA officials are considering adding a boxed (boxed/’black‑box’) warning to Covid‑19 vaccine labeling, a move that has drawn immediate criticism from public health...
AC Immune posts biomarker gains in Parkinson’s vaccine – regulator talks next
AC Immune released Phase II biomarker data for its anti‑alpha‑synuclein active immunotherapy showing coherent changes across cerebrospinal and imaging markers (α‑syn, NfL, GFAP, DaT‑SPECT) that...
FDA clears two oral drugs for gonorrhea – new antibiotic options expand
Regulators have approved new oral therapies for uncomplicated gonorrhea, adding zoliflodacin (Nuzolvence) and gepotidacin (Blujepa/GSK) to treatment options for Neisseria gonorrhoeae. Regulatory...
EU clinches sweeping pharma reform deal – legislative overhaul agreed
European institutions reached political agreement on a major package of pharmaceutical reforms — the first comprehensive update in two decades — according to industry reports. The deal covers...
Disco closes €36M seed to advance surfaceome discovery platform
Disco Pharmaceuticals closed a €36 million (≈US$42M) seed financing to accelerate its surfaceome platform toward formal preclinical development, the company said in a funding announcement....
Inotiv taps Vugene AI for multiomics-assisted drug discovery
Contract research organization Inotiv announced a partnership with Vugene to integrate the Lithuanian firm’s multiomics AI platform into early discovery workflows, aiming to improve efficacy and...
FDA proposes down‑classifying some companion diagnostics – 510(k) route opened
The FDA proposed reclassifying certain nucleic acid‑based companion diagnostics from Class III to Class II, which would allow affected devices to seek clearance via the 510(k) pathway rather than...
Gene-edited cell transplant restores insulin—no immunosuppression
Scientists reported the first successful transplantation of gene-edited, insulin-producing cells into a patient with type 1 diabetes, restoring endogenous insulin production without chronic...
Lilly’s triple agonist raises the bar — blockbuster weight loss readouts
Eli Lilly’s triple agonist retatrutide produced industry-leading weight-loss results in late-stage testing, with Phase 3 readouts showing roughly mid-to-high‑20s percent mean body-weight reduction...
AC Immune’s Parkinson vaccine posts biomarker gains…regulatory talks next
AC Immune reported interim data from its Phase II Vacsyn program showing coherent biomarker changes — reductions in aggregated α‑synuclein measures and supportive NfL and GFAP signals — that the...
FDA weighs boxed warning for Covid shots — experts sound alarm
Two news outlets reported that FDA officials are considering adding a boxed (black‑box) warning to COVID‑19 vaccines, citing internal deliberations at the agency and a leaked staff memo. Sources...
EMA’s December session backs multiple new drugs — CHMP recommendations roll out
The European Medicines Agency’s CHMP issued multiple favorable recommendations this month, endorsing new medicines from companies such as Hansoh and Cytokinetics and recommending recent filings...
China raises big biotech rounds — venture into surfaceome and diagnostics heats up
Chinese biotech financing accelerated this week as D3 Bio and Sanegene each announced >$100M rounds, and European surfaceome startup Disco closed a €36M seed to advance target discovery. Investors...
Diagnostics consolidation — Natera buys Foresight; Guardant links to trial‑matching AI
Natera announced an acquisition of Foresight Diagnostics to incorporate phased‑variant enrichment technology into Signatera and to expand into hematologic MRD testing, aiming to boost ctDNA...