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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+...
In‑vivo CAR‑T readout delayed as next‑gen CARs show safer, persistent responses in mice
Umoja Biopharma delayed its first clinical readout from an in‑vivo CAR‑T trial, citing program timing changes, while academic teams reported preclinical data for next‑generation CAR‑T constructs...
Lilly’s retatrutide posts record weight loss — tolerability questions surface
Eli Lilly’s next‑generation triple‑agonist, retatrutide, delivered unprecedented weight loss in late‑stage testing while prompting new tolerability scrutiny. Company and trial reports show...
AC Immune reports biomarker gains in Parkinson’s vaccine — regulators next
Swiss biotech AC Immune posted interim biomarker and safety data from its Phase II active immunotherapy program targeting alpha‑synuclein in early Parkinson’s disease. The company reported...
Rezolute’s pivotal miss collapses stock — program at inflection
Rezolute’s Phase III Sunrize trial of ersodetug for congenital hyperinsulinism failed to meet primary and key secondary endpoints, the company announced, triggering immediate market fallout. The...
Natera buys Foresight to bolster Signatera and enter hematology
Natera acquired Foresight Diagnostics for $275 million up front to integrate Foresight’s PhaseED‑seq phased‑variant enrichment technology into Natera’s Signatera circulating tumor DNA platform and...
Metagenomic editing inserts large DNA into gut microbes in vivo
A Nature Biotechnology report describes a metagenomic editing breakthrough that enables the integration of large DNA sequences into gut bacteria in vivo. The approach allows researchers to modify...
Novartis’ GanLum wins Phase III — high cure rates against falciparum malaria
Novartis and Medicines for Malaria Venture reported positive Phase III results for GanLum, a next‑generation antimalarial combining ganaplacide with lumefantrine. The KALUMA trial across 34 sites...
FDA clears first at‑home tDCS headset for depression — prescription rollout ahead
Regulators granted clearance for Flow Neuroscience’s wearable transcranial direct current stimulation (tDCS) headset as the first FDA‑cleared device intended for at‑home treatment of major...