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Investors Flood Biotech: Record Follow‑On Deals and Holiday‑Era Offerings
Public markets reopened aggressively for biotech as a wave of follow‑on offerings raised record amounts in a compressed window. Reports show $3.2 billion in follow‑on stock offerings executed over...
AI‑Designed Molecules Advance: Insilico PROTAC and PsiThera’s Oral TNF Play
AI‑driven discovery produced two notable developments: Insilico Medicine reported an AI‑designed PROTAC degrader targeting PKMYT1 with preclinical efficacy across biomarker‑selected models, and...
Roche’s Brainshuttle Antibody Clears Amyloid: 91% Below Threshold in Early Trial
Roche presented Phase I/II Brainshuttle data showing its anti‑amyloid antibody trontinemab achieved rapid, deep amyloid plaque clearance below the positivity threshold in 91% of participants with...
AI Finds Monkeypox Weak Spot — While Surveillance Flags New Recombinant Strain
Researchers used AlphaFold‑3 to predict a monkeypox viral surface protein, OPG153, as a neutralizing antibody target; murine immunizations with OPG153 produced neutralizing antibodies, opening a...
Lipid Nanoparticles and Base Editing Show In Vivo Promise for Blinding and Metabolic Disease
Two preclinical advances demonstrated therapeutic potential for in‑vivo base editing delivered by lipid nanoparticles. Researchers used lipid nanoparticle formulations to mediate base editing of...
FDA Tightens CAR‑T Bar: Randomized Trials Now the Default
The FDA announced a policy shift that will generally require randomized controlled trials (RCTs) to support approvals of CAR‑T cell therapies, raising the evidentiary bar for developers. FDA...
Novartis Plows $1.7B into Relation: AI Targets atopic diseases
Novartis struck a strategic collaboration with London AI‑enabled biotech Relation in a deal worth up to $1.7 billion to discover and advance targets for atopic diseases. Novartis will fund...
ARPA‑H Funds Two Consortia to Replace Animal Toxicology with Human Models
ARPA‑H awarded multi‑million dollar contracts to industrial‑academic consortia developing AI and human biology‑based drug safety models. Inductive Bio won up to $21 million to lead DATAMAP...
Priority Voucher Spurs Fast Approval of US‑Made Amoxicillin
The FDA used its new National Priority Voucher pathway to grant an expedited review and approval to USAntibiotics’ extended‑release amoxicillin, the first clearance under the program. The decision...
D3 Bio Nets $108M to Push KRAS G12C Candidate Into Phase III
Shanghai‑based D3 Bio closed a $108 million Series B to bankroll a planned global Phase III program for its oral KRAS G12C inhibitor, elisrasib (D3S‑001). The financing positions the company to...
Roche’s Brainshuttle Antibody Clears Amyloid in Early Alzheimer’s Readout
Roche reported Phase I/II Brainshuttle AD data showing its anti‑amyloid antibody trontinemab (RG6102) achieved rapid and deep amyloid plaque clearance in 91% of participants, with a favorable...
Novartis’ Ianalumab Extends Disease Control in ITP
Novartis presented Phase III VAYHIT2 data showing ianalumab, added to eltrombopag, extended disease control in primary immune thrombocytopenia (ITP) and reduced treatment failure by 45% at the...
Integrated Continuous Fermentation Platform Readied for Industry
Pow.Bio and Bühler announced a commercialization partnership to deliver an integrated continuous precision fermentation platform, combining Pow.Bio’s AI‑driven continuous fermentation technology...
AI‑Designed PROTAC Targets PKMYT1 in Preclinical Cancer Study
Insilico Medicine disclosed a first‑in‑class AI‑designed PROTAC degrader targeting PKMYT1 (D16‑M1P2) and published preclinical efficacy in Nature Communications. The bifunctional molecule links a...
Kelonia In‑Vivo CAR‑T Data Bolster Single‑Dose Strategy
Kelonia Therapeutics reported in‑vivo CAR‑T data at ASH demonstrating efficacy in multiple myeloma with a single infusion of an off‑the‑shelf in vivo CAR‑T approach. Company presentations...
FDA raises bar for CAR‑T approvals: randomized trials required
The FDA announced a policy shift that will generally require randomized controlled trials (RCTs) with survival or acceptable time‑to‑event end points to support approval of CAR‑T cell therapies...
Tecvayli plus Darzalex... ASH data shows massive PFS gain in myeloma
Late‑breaker data from the Majestec‑3 trial presented at ASH showed the combination of teclistamab (Tecvayli) and daratumumab delivered a dramatic progression‑free survival (PFS) benefit in...
Ianalumab plus Promacta – Phase 3 shows durable control in ITP
Novartis reported Phase 3 VAYHIT2 results showing ianalumab plus eltrombopag (Promacta) significantly extended disease control in immune thrombocytopenia (ITP). The higher ianalumab dose reduced...
Mirum buys Bluejay – $820M deal adds HDV antibody brelovitug
Mirum Pharmaceuticals agreed to acquire Bluejay Therapeutics for $820 million to obtain worldwide rights to brelovitug, a late‑stage monoclonal antibody for chronic hepatitis D virus (HDV). The...
Lilly picks Huntsville: $6B API megasite for GLP‑1 and peptides
Eli Lilly selected Huntsville, Alabama for a $6 billion active pharmaceutical ingredient (API) manufacturing facility to produce peptide and small‑molecule APIs, including the oral GLP‑1 candidate...