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FDA approves Cytokinetics heart drug — company’s first U.S. launch
The U.S. Food and Drug Administration approved Cytokinetics’ first American medicine for obstructive hypertrophic cardiomyopathy, ending a multi‑decade effort by the muscle‑biology focused...
BioMarin to buy Amicus for $4.8B — rare‑disease portfolio expands
BioMarin Pharmaceutical agreed to acquire Amicus Therapeutics in a $4.8 billion all‑cash deal that transfers two approved rare‑disease therapies and late‑stage assets into BioMarin’s portfolio....
FDA places partial hold on Merck–Daiichi ADC trial: safety probe under way
Regulators and sponsors paused a global Phase III program testing an antibody‑drug conjugate (I‑Dxd/ifinatamab deruxtecan) after investigators recorded a higher‑than‑anticipated incidence of fatal...
Moderna lands CEPI backing: $54.3M to push H5 mRNA vaccine into Phase 3
Moderna secured up to $54.3 million from the Coalition for Epidemic Preparedness Innovations (CEPI) to advance its mRNA‑1018 H5 avian influenza vaccine into a Phase 3 program. CEPI’s injection of...
Takeda’s TYK2 drug clears co‑primary endpoints in two Phase 3 psoriasis trials
Takeda reported that zasocitinib met co‑primary and key secondary endpoints in two large Phase 3 studies for plaque psoriasis, delivering clear or almost clear skin for more than half of treated...
Lilly’s oral orforglipron preserves weight loss — maintenance data and expedited review
Eli Lilly disclosed Phase 3 Attain‑Maintain results showing orforglipron, a once‑daily oral GLP‑1 receptor agonist, helped patients maintain weight loss over 52 weeks after prior treatment with...
Epigenovo commercializes scFFPE‑ATAC: single‑cell chromatin profiling for archival tissue
Swedish spinout Epigenovo announced plans to commercialize scFFPE‑ATAC, an assay for high‑throughput single‑cell chromatin accessibility profiling compatible with formalin‑fixed paraffin‑embedded...
Parse Biosciences and Codebreaker Labs partner to map variant effects at single‑cell scale
Parse Biosciences and Codebreaker Labs announced a collaboration to combine Parse’s single‑cell transcriptomics platform with Codebreaker’s engineered variant libraries to experimentally assess...
Orum raises $100M to advance degrader‑ADC platform — AML candidate prioritized
Orum Therapeutics closed a ₩146 billion (≈$100 million) financing to advance its platform of degrader‑antibody conjugates, a hybrid that marries targeted antibodies with protein‑degradation...
CCRM and IonQ partner on quantum computing to accelerate advanced therapies
Canadian cell‑therapy hub CCRM and quantum computing company IonQ announced a strategic collaboration and an initial IonQ investment to explore quantum applications for advanced therapies and...
ADC trial hit by fatal events: FDA places partial hold
The FDA issued a partial clinical hold after a higher-than-anticipated number of deaths surfaced in a global Phase III program testing an antibody-drug conjugate (ADC) for small‑cell lung cancer....
BioMarin shells out $4.8B: buys Amicus to bulk up rare‑disease portfolio
BioMarin Pharmaceutical agreed to acquire Amicus Therapeutics for $4.8 billion in an all‑cash deal that adds two marketed therapies for Fabry and Pompe diseases and U.S. rights to a Phase III...
TYK2 pill clears Phase 3: Takeda eyes 2026 filings
Takeda reported that zasocitinib, a TYK2 inhibitor acquired in a prior deal, met co‑primary and key secondary endpoints in two Phase 3 trials for plaque psoriasis. The company said more than half...
Lilly’s oral GLP‑1 maintains weight: maintenance trial posts positive readout
Eli Lilly announced positive Phase 3 maintenance data for orforglipron, an oral GLP‑1 receptor agonist, showing it helped patients retain weight loss after prior treatment with injectable incretin...
CEPI plugs gap: $54.3M backs Moderna’s H5 pandemic vaccine into Phase 3
The Coalition for Epidemic Preparedness Innovations (CEPI) agreed to provide up to $54.3 million to advance Moderna’s mRNA‑1018 H5 avian influenza vaccine into Phase 3 testing. The funding follows...
AI drugtech fundraising accelerates: IPOs and big seed rounds pile up
Generative‑AI drug companies continued to attract capital as Insilico moved toward a Hong Kong IPO and Edison Scientific closed a large seed round. Insilico filed to raise HK$2.27 billion (about...
Single‑cell genomics pushes clinical samples and variant mapping forward
Parse Biosciences announced a collaboration with Codebreaker Labs to combine engineered variant libraries with high‑throughput single‑cell transcriptomics to experimentally map how genetic...
White House finalizes nine drug‑pricing pacts: largest batch yet
The White House announced pricing agreements with nine major drugmakers—including Amgen, Bristol Myers Squibb, Gilead, Merck and Novartis—aimed at lowering Medicaid prices toward levels paid by...
STAT report: FDA voucher program politicized — workforce strains add pressure
STAT reported that the FDA’s new Commissioner’s National Priority Review voucher program has been used as a vehicle for political influence, with senior officials pressing staff to award vouchers...
Liver‑delivered mRNA rewires aged immunity: boosts vaccines and cancer responses
MIT researchers delivered an mRNA cocktail (DLL1, FLT3L, IL‑7) to hepatocytes using lipid nanoparticles to transiently reconstitute trophic signaling and restore T‑cell diversity in aged mice. The...