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NGS and cancer diagnostics: Sophia Genetics partnerships and Medicare MRD coverage expand access
Sophia Genetics announced partnerships with Complete Genomics and Element Biosciences to integrate its AI analytics into their sequencing platforms for cancer profiling and rare disease workflows,...
AI biotech Iambic raises $100M+ — investors pile into AI‑discovered therapeutics
Iambic announced an oversubscribed financing topping $100 million to advance its AI‑discovered drug pipeline and platform technologies. The round drew strategic and financial investors, including...
Roche’s BTK inhibitor posts two Phase III wins — multiple sclerosis filings loom
Roche reported two Phase III victories for its BTK inhibitor in different multiple sclerosis populations, with the drug meeting primary endpoints and showing efficacy across relapsing and primary...
Pfizer Wins Metsera: $10 Billion Deal Closes the Bidding War
Pfizer agreed to acquire obesity biotech Metsera in a deal valued at up to $10 billion, outbidding Novo Nordisk and securing the company’s next-generation obesity and metabolic pipeline. The...
FDA Strips HRT Black Box: Warning Labels Narrowed
The U.S. Food and Drug Administration announced it will remove or narrow boxed warnings on hormone replacement therapy (HRT) products for menopause after concluding earlier label risks were...
Merck’s Oral PCSK9 Pill Posts Pivotal Wins — Oral Rival to Injectables
Merck reported positive pivotal data for its oral PCSK9 inhibitor, enlicitide, showing LDL‑C reductions similar to injectable PCSK9 blockers in two phase 3 trials presented at AHA 2025. In...
CRISPR Week: Breakthrough Cholesterol Data and a Trial Fatality
The CRISPR field posted mixed news: CRISPR Therapeutics presented early clinical data showing a gene editing therapy halved cholesterol and triglycerides in an initial study, while Intellia...
Lilly Expands Genetic Medicine Arsenal — Eye Gene Therapy and RNAi Pact
Eli Lilly struck multiple genetic‑medicine deals: it secured global rights to MeiraGTx’s AAV‑AIPL1 retinal gene therapy for LCA4 and signed a large collaboration with SanegeneBio worth up to $1.2...
Roche’s BTK Wins in MS: Two Phase 3 Victories Reported
Roche announced positive results from two Phase 3 trials for its BTK inhibitor in multiple sclerosis, showing efficacy across relapsing and primary progressive forms. The outcomes mark a notable...
AAVantgarde Banks $141M to Push Rare Eye Gene Therapies
Italian gene‑therapy company AAVantgarde raised $141 million in a Series B round to advance two pivotal programs for inherited retinal diseases, including an AAV‑8 intein‑mediated therapy for...
Iambic Pads War Chest: $100M Oversubscribed Round for AI‑Drug Engine
Iambic raised over $100 million in an oversubscribed financing round to advance AI‑discovered therapeutics and its platform, attracting heavyweight investors including ARK, Regeneron and Illumina...
Cogent’s Double Win: Phase 3 Successes Propel NDA Timelines
Cogent Biosciences reported two pivotal clinical wins for bezuclastinib, including a Phase 3 trial that halved the risk of progression or death in imatinib‑resistant GIST and supportive data in...
FDA Puts Tenaya’s Heart Gene Therapy on Hold — Immunosuppression Issues
The U.S. Food and Drug Administration placed a clinical hold on a Tenaya Therapeutics gene‑therapy trial while the company standardizes immunosuppression regimens across sites. The pause affects...
Pfizer seals Metsera deal — $10 billion closing ends bidding war
Pfizer reached an amended merger agreement to acquire Metsera for about $10 billion, ending a week-long auction that pitted the pharma against Novo Nordisk. Pfizer submitted a final up-to-$10...
Lilly doubles down on genetic medicines — RNAi and retinal gene therapy deals
Eli Lilly struck two strategic deals this week: a $1.2 billion research collaboration with SanegeneBio to advance tissue‑selective RNAi candidates for metabolic disease, and a separate agreement...
FDA to lift menopause HRT boxed warnings — labeling reversal underway
The U.S. Food and Drug Administration announced it will work with manufacturers to remove boxed warnings from hormone replacement therapies used for menopause, concluding earlier risk estimates...
CRISPR field jolted — Intellia death, CRISPR Therapeutics posts cholesterol wins
The CRISPR sector reported mixed, high‑impact developments: Intellia disclosed a fatality and reported it is awaiting a clinical‑hold letter from the FDA in its MAGNITUDE Phase III trial of...
Merck’s oral PCSK9 pill posts pivotal data — injectable‑level LDL cuts
Merck reported phase 3 results showing its oral PCSK9 inhibitor, enlicitide, reduced LDL‑C by about 59–60% versus placebo at 24 weeks, matching results typically seen with injectable PCSK9...
Cogent’s twin wins clear NDA runway — oncology filings ahead
Cogent Biosciences reported two phase‑trial victories that collectively set up multiple NDA submissions: a Phase III success in imatinib‑resistant gastrointestinal stromal tumors (GIST) and...
CeleCor’s phase 3 win clears path for rapid MI treatment filing
CeleCor Therapeutics reported a positive pivotal CeleBrate Phase 3 trial for a rapid‑onset treatment of myocardial infarction, presented in a late‑breaking session at the American Heart...