Get the Daily Brief
Latest Biotech News
FDA proposes lowering companion‑diagnostic bar — Class II pathway eyed
The U.S. Food and Drug Administration proposed a rule to reclassify certain nucleic‑acid–based companion diagnostic assays from Class III to Class II, potentially allowing those tests to use the...
Lilly’s triple agonist shatters expectations — efficacy and tolerability collide
Eli Lilly reported headline-setting Phase 3 weight-loss data for retatrutide, a triple-agonist metabolic candidate, delivering unprecedented mean weight reduction but raising tolerability...
AC Immune’s Parkinson’s vaccine: biomarker wins, clinical benefit still opaque
AC Immune announced positive interim biomarker and safety signals from its Phase II Vacsyn trial of ACI-7104.056, an active immunotherapy targeting alpha‑synuclein in early Parkinson’s disease....
Regulatory chaos: FDA staff alarm and industry confidence wobble
Multiple reports this week documented deep unease inside the FDA and across drug developers as leadership turnover and high‑profile policy moves unsettle established regulatory norms. A BioCentury...
China’s biotech cash surge: multiple $100M rounds reshape dealmaking
Venture activity in China’s life‑science sector accelerated with multiple large financings announced this week, including seven‑figure and nine‑figure rounds that signal continued appetite for...
FDA greenlights nonprofit gene therapy — Waskyra marks precedent
The FDA approved Waskyra, a gene therapy for Wiskott‑Aldrich syndrome developed and sponsored by a nonprofit foundation, marking the first gene therapy authorization awarded to a non‑commercial...
CAR‑T landscape: in vivo delays meet next‑gen constructs in mice
Umoja Biopharma delayed its first clinical readout for an in‑vivo CAR‑T program, citing operational and timeline adjustments, while academic teams disclosed preclinical next‑generation CAR‑T...
AI scales biology: pathology models and 300M‑cell atlas move forward
Two high‑impact AI initiatives this week signalled advancement in computational biology infrastructure. Researchers published a multimodal foundation model tuned for whole‑slide pathology,...
Illumina backs MyOme — WGS, AI and a prospective trial to prove PRS value
Illumina made a strategic investment in MyOme and will supply sequencing for a prospective trial testing whole‑genome sequencing combined with AI risk models to improve population health outcomes....
Rezolute’s phase III failure wipes value — program under review
Rezolute announced its Phase III Sunrize trial of ersodetug failed to meet primary and key secondary endpoints in congenital hyperinsulinism, triggering an immediate market reaction and an 80–90%...
New anti‑infectives advance: GanLum, cholera OmpV inhibitor emerge
Two infectious‑disease advances reported this week could shift treatment paradigms: Novartis and MMV presented positive Phase 3 results for GanLum (ganaplacide + lumefantrine), a novel mechanism...
Lilly’s triple agonist shatters weight-loss records — but tolerability worries surface
Eli Lilly reported phase 3 results showing its triple-agonist retatrutide produced unprecedented mean weight loss in clinical testing. The company disclosed average body-weight reductions reaching...
AC Immune’s Parkison’s vaccine posts biomarker gains — regulator talks next
AC Immune disclosed interim Phase II biomarker results for its active α‑synuclein vaccine that showed coherent changes across CSF and imaging markers, prompting the company to seek early regulator...
Rezolute’s phase‑3 failure wipes out value — stock collapses
Rezolute disclosed that its Phase III Sunrize trial of ersodetug in congenital hyperinsulinism missed primary and key secondary endpoints, triggering an immediate market rout. The company said...
Industry alarm: FDA leadership churn and policy moves rattle biopharma
Industry surveys and op‑eds documented growing unease over regulatory stability and leadership at the U.S. Food and Drug Administration. BioCentury’s survey captured broad investor and developer...
Illumina backs MyOme’s WGS+AI trial — $200B health‑system savings pitched
MyOme announced an Illumina strategic investment and a planned prospective clinical trial — MyOme’s Proactive Health — combining clinical whole‑genome sequencing with AI risk models to evaluate...
Apple Tree Partners files bankruptcy — portfolio startups kept afloat
Venture firm Apple Tree Partners filed for Chapter 11 in the face of a funding dispute with major backers, aiming to restructure and ensure continued financing for its portfolio companies. Court...
FDA greenlights first nonprofit gene therapy — Waskyra clears path
The FDA approved Waskyra, a gene therapy for Wiskott‑Aldrich syndrome developed by a nonprofit foundation, marking the first time an NGO‑led program secured authorization for a genetic medicine....
Novartis’s new malaria combo aces Phase 3 — GanLum posts superior cure rates
Novartis and MMV reported Phase 3 results for GanLum, a combination of ganaplacide and lumefantrine, showing 97.4% cure rates in acute uncomplicated Plasmodium falciparum malaria versus 94% for...
China venture cash and big rounds signal regional firepower — D3, Sanegene lead
Venture financing in China surged with multiple large rounds: D3 Bio closed a $108M series B to advance a KRAS G12C program toward Phase III, while reports showed D3 Bio and Sanegene drew $100M+...