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Merck’s oral PCSK9 pill posts near-injectable LDL cuts – data land at AHA
Merck released late-stage results showing its oral PCSK9 inhibitor produced LDL-cholesterol reductions similar to injectable PCSK9 biologics in phase 3 trials, positioning the pill as the first...
Cogent’s bezuclastinib clears phase 3 hurdles – NDA planned for 2026
Cogent Biosciences announced pivotal phase 3 results for bezuclastinib in imatinib-resistant gastrointestinal stromal tumors, meeting the primary endpoint with a 50% reduction in risk of...
Engene posts pivotal bladder gene-therapy data – stock surges
Engene (EnGene/Engene Holdings) released additional pivotal-cohort data from its Legend phase II trial of detalimogene voraplasmid for high-risk, BCG-unresponsive non–muscle-invasive bladder...
Lilly inks gene-therapy, RNAi pacts—expands genetic-medicine footprint
Eli Lilly announced a flurry of genetic-medicine deals: a licensing agreement for MeiraGTx’s AAV-AIPL1 retinal gene therapy and a major collaboration with Sanegene worth up to $1.2 billion to...
MGI to sequence 110,000 genomes in South Africa – national reference aims launched
MGI Tech signed an MoU with South Africa’s SAMRC and DSTI to launch a 110,000-genome program that will establish the country’s first national genomic reference database. The initiative installs...
Iambic raises $100M-plus to advance AI-discovered therapeutics
Iambic Therapeutics closed an oversubscribed financing of over $100 million to accelerate its AI-discovered drug portfolio and platform work, citing new collaborations and clinical advances. The...
FDA taps Richard Pazdur to lead CDER – regulator returns to center stage
The U.S. Food and Drug Administration named veteran regulator Richard Pazdur as director of the Center for Drug Evaluation and Research (CDER) following the sudden resignation of his predecessor....
FDA taps veteran Richard Pazdur—names him CDER director
The FDA appointed long‑time cancer regulator Richard Pazdur as director of the Center for Drug Evaluation and Research (CDER). The agency announced the move after George Tidmarsh's abrupt...
Pfizer clinches Metsera for $10 billion — bidding war ends
Pfizer reached a definitive agreement to acquire obesity developer Metsera for roughly $10 billion after a week‑long auction in which Novo Nordisk declined to increase its bid. Company statements...
CRISPR’s mixed week... breakthrough readouts and a trial fatality
The CRISPR field produced divergent headlines this week: CRISPR Therapeutics reported early clinical data showing substantial reductions in cholesterol and triglycerides with an investigational in...
Neurocrine’s Takeda‑licensed depression drug flunks mid‑stage tests
Neurocrine Biosciences confirmed that NBI‑1070770, an oral NR2B negative allosteric modulator licensed from Takeda, failed to meet the primary endpoint in a Phase 2 trial for major depressive...
Merck’s oral PCSK9 pill posts injectable‑like LDL cuts in phase studies
Merck disclosed late‑stage data showing its oral PCSK9 inhibitor produced LDL cholesterol reductions comparable to current injectable biologics in Phase 3 trials. The company’s CORALreef program...
Engene posts more pivotal bladder‑gene therapy data — stock jumps
Engene (EnGene/Engene Holdings) released additional preliminary results from its pivotal Legend Phase II cohort testing detalimogene voraplasmid in high‑risk, BCG‑unresponsive non‑muscle invasive...
Iambic raises $100M+—AI‑discovered pipeline advances
Iambic Therapeutics closed an oversubscribed financing of more than $100 million to accelerate development of AI‑discovered therapeutics and platform advances. The round drew strategic investors...
MGI and Geneseeq expand national genomics and CDx infrastructure
MGI Tech inked an MoU with South African agencies to launch a 110,000‑genome sequencing initiative aimed at creating the country’s first national genomic reference database. The program installs...
AI tools for single‑cell work: parts lists and chat‑based analysis arrive
Nature Biotechnology published two papers advancing computational tooling for single‑cell research: a comprehensive 'parts list' of promoters and gRNA scaffolds to improve mammalian prime editing...
FDA moves to strip boxed warnings from menopause HRTs
The FDA announced it will work with manufacturers to remove longstanding boxed warnings from hormone replacement therapies used for menopause, following review of evidence that earlier labels...
Pfizer wins Metsera bidding war: $10B deal sealed
Pfizer reached an amended agreement to acquire Metsera for about $10 billion after a week-long competitive auction with Novo Nordisk. The deal gives Pfizer access to Metsera’s obesity and...
Merck’s PCSK9 pill mimics injectables: 59% LDL reduction
Late-stage results presented at a major cardiology meeting show Merck’s oral PCSK9 inhibitor produced LDL‑C reductions on par with existing injectable PCSK9 antibodies. In the CORALreef program...
CRISPR’s mixed week: fatal trial event — gene edit halves lipids
The CRISPR field faced sharp contrasts this week: Intellia disclosed a death in its MAGNITUDE Phase III program and is awaiting FDA communication on the event, while CRISPR Therapeutics reported...