Studies test whether gene-editing can fix high cholesterol. For now, take your medicine
medicalxpress - Scientists are testing an entirely new way to fight heart disease: a gene-editing treatment that might offer a one-time fix for high cholesterol.
AI Summary: Researchers are testing gene‑editing approaches aimed at providing a single‑procedure solution for elevated LDL cholesterol. Early human studies probe safety and durability, but experts urge patients to continue proven lipid‑lowering therapies for now. The line between ambitious science and everyday clinical care remains prudently guarded.
Eli Lilly Expands Its In Vivo Ambitions, Acquiring Cell Therapy Startup Orna for up to $2.4B
Frank Vinluan / medcitynews - Orna Therapeutics brings Eli Lilly an in vivo cell therapy ready for Phase 1 testing as a potential treatment for autoimmune diseases. Lilly is now the latest pharma company to use M&A to enter this growing field, following deals made in the past year by …
AI Summary: Eli Lilly is acquiring Orna Therapeutics for up to $2.4 billion to secure in‑vivo cell‑therapy capabilities and jump‑start its presence in CAR‑T and immune‑resetting platforms. The deal signals big pharma’s move to couple traditional drug development muscle with next‑generation cell‑engineering, accelerating clinical testing and commercialization plans.
Sanofi's Paul Hudson out, with Belén Garijo to step in as new CEO
Reynald Castañeda / endpoints - Paul Hudson is stepping down from his post as CEO of Sanofi, and his last day will be Feb. 17. The French drugmaker's board decided not to renew Hudson's mandate on ...
AI Summary: Sanofi’s board has opted not to renew Paul Hudson’s tenure, installing Belén Garijo as the new chief executive amid mixed reactions. The leadership swap arrives as the French drugmaker faces pipeline pressures and investor impatience—expect strategic shuffles, belt‑tightening and plenty of corporate soul‑searching with a side of investor scrutiny.
Ama launches independent vaccine review after CDC criticism
medicalxpress - Two major medical groups will begin reviewing vaccine safety and effectiveness after major changes at the U.S. Centers for Disease Control and Prevention (CDC) have raised alarms among experts.
AI Summary: The American Medical Association announced an independent review of vaccine safety and effectiveness in response to recent CDC changes and criticism, partnering with external researchers to evaluate evidence and restore public trust. The panel aims to provide transparent, expert analysis free of political noise.
BridgeBio Stands Tall as Phase 3 Data Put Dwarfism Drug on Track for FDA Filing
Frank Vinluan / medcitynews - Infigratinib achieved statistically significant improvement in growth rate and body composition in a Phase 3 clinical trial that tested the BridgeBio Pharma drug in achondroplasia, the most common form of dwarfism. Regulatory submissions are planned for l…
AI Summary: BridgeBio reported statistically significant Phase 3 results for infigratinib in achondroplasia, showing improved growth rates and body composition, moving the program toward an FDA filing. The readout strengthens BridgeBio’s rare-disease momentum and sets the stage for regulatory discussions and potential market entry.
AbbVie sues over selection of Botox for IRA negotiations
Nicole DeFeudis / endpoints - AbbVie is suing CMS for picking Botox for the third round of Medicare negotiations, making it the first drugmaker to challenge the upcoming cycle in court. In a lawsuit filed Wednesday in Washington, DC, AbbVie ...
AI Summary: AbbVie has filed suit challenging the federal decision to include Botox in Medicare’s drug price negotiation program, arguing the selection process was flawed and that the move could imperil innovation and pricing strategies. The lawsuit seeks to block or alter implementation while the industry and regulators brace for legal precedent.
FDA refuses to review Moderna flu vaccine
Ella Jeffries / beckershospitalreview - Moderna has received a refusal-to-file letter from the FDA’s Center for Biologics Evaluation and Research for its biologics license application for mRNA-1010, its investigational seasonal influenza vaccine. The letter, signed by Vinayak Prasad, MD, chief …
AI Summary: Moderna’s mRNA flu vaccine application has been rejected by the FDA—Moderna received a refusal‐to‐file letter while accusing the agency of shifting its review standards. Multiple reports echo this regulatory setback, fueling industry concerns over consistent, transparent decision‐making.
AstraZeneca gets CRL for prefilled pen version of lupus drug Saphnelo
Anna Brown / endpoints - The FDA has handed AstraZeneca a complete response letter for the subcutaneous prefilled, self-injectable pen of Saphnelo for systemic lupus erythematosus (SLE), a month after the asset gained approval in Europe ...
AI Summary: AstraZeneca’s application to market its subcutaneous prefilled pen formulation of Saphnelo for treating lupus has hit a roadblock after the FDA issued a complete response letter. The decision delays the drug’s approval and raises questions about its future in the competitive immunotherapy market.
World Cancer Day: A Global Call to Awareness and Action 2026, Part 2
oncodaily - World Cancer Day is observed annually on February 4 and was established in 2000 at the World Summit Against Cancer for the New Millennium in Paris. The initiative was led […]
AI Summary: World Cancer Day 2026, observed on February 4, serves as a global rallying cry to boost cancer awareness, promote early detection, and improve patient access to care. Healthcare professionals, advocates, and patients united at the event to spotlight the critical need for innovation and coordinated action against cancer.
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HHS to drop 340B rebate pilot after court rulings
Ella Jeffries / beckershospitalreview - HHS will drop its 340B rebate model pilot program following two federal court rulings that blocked its implementation. The program, announced in August 2025, was challenged by the American Hospital Association, the Maine Hospital Association and four safe…
AI Summary: In a twist that no one saw coming (except the federal courts), HHS has scrapped its controversial 340B rebate pilot after two judicial rulings blocked its implementation. Providers, relieved to avoid a potential cash flow nightmare, are quietly celebrating the decision as one less bureaucratic headache to manage.
#ISC26: Bayer’s asundexian reduced ischemic strokes by 26% in Phase 3 trial
Ayisha Sharma / endpoints - Bayer shared more details from its unexpected win in a Phase 3 study testing its next-generation blood thinner for secondary stroke prevention. The factor XIa inhibitor, named asundexian, reduced the occurrence of ischemic stroke by ...
AI Summary: Bayer’s latest Phase 3 study of asundexian has shown a 26% reduction in secondary ischemic stroke risk—without an increased bleeding risk. This compelling data bolsters the drug’s prospects as a blockbuster in stroke prevention and underscores Bayer’s commitment to advancing cardiovascular therapies.
Eikon Therapeutics Raises $381 M in IPO to Advance Live-Cell Imaging in Cancer Drug Discovery
oncodaily - Eikon Therapeutics has raised $381 million through its IPO, pricing at the top of its range in a strong sign of renewed investor appetite for biotech offerings. The South San […]
AI Summary: Eikon Therapeutics successfully raised $381 million in its IPO, reinforcing investor confidence in novel biotechnology approaches for cancer drug discovery. The fundraising milestone is expected to accelerate live‐cell imaging and other innovative oncology research initiatives.
HHS scraps 340B rebate pilot in win for hospitals
Emily Olsen / healthcaredive - The Trump administration agreed to drop a controversial pilot that would have allowed drugmakers to give post-sales rebates on some drugs instead of upfront discounts.
AI Summary: Federal health officials have reversed course on a highly controversial 340B rebate pilot program after federal courts blocked its implementation – a move hailed by providers as a long‐awaited relief from cash flow and administrative burdens.
Statin pills much safer than advertised, major review finds
bbc - The results, in The Lancet journal, come from trials involving more than 120,000 people comparing statins with a dummy drug or placebo.
AI Summary: Multiple large‐scale analyses have debunked the long‐held worries about statin side effects – it turns out that those pesky symptoms listed on package leaflets are no more common than when taking a placebo. In other words, patients can keep calm and lower cholesterol with confidence.
Novo Nordisk vows legal action to protect Wegovy pill
medicalxpress - Novo Nordisk said Thursday it would take legal action against a US chain offering a copycat of the new pill version of its Wegovy weight-loss drug.
AI Summary: Novo Nordisk has vowed to take legal action after discovering that competitors – including Hims & Hers – plan to market a compounded, lower‐priced version of its new Wegovy weight‐loss pill. The company is mobilizing its legal team to protect its intellectual property amid fierce market competition.
FTC deal over insulin prices forces Express Scripts to overhaul policies
Elizabeth Casolo / beckershospitalreview - The Federal Trade Commission reached a settlement with Cigna’s Express Scripts in a case over alleged inflation of insulin prices, according to a Feb. 4 agency news release. Under the settlement, Express Scripts must keep drug manufacturer compensation de…
AI Summary: Federal regulators reached a settlement with Express Scripts amid long‐standing allegations that the pharmacy benefit manager overcharged for insulin. The deal forces sweeping policy revisions to curb price inflation and protect patients from rising costs, following years of regulatory scrutiny over insulin rebate practices.
Letters, Jan. 27, 2026: ‘A Team Canada must be assembled’ to help diversify trade
Jeffrey Morgan / calgarysun - Need to diversify I just watched a video detailing the prior commercial trading practices between Canada and the U.S. It makes me realize there is nothing more important than Canada diversifying its trade with other countries. By ‘nothing,’ I mean all pro…
AI Summary: Summit Therapeutics announced that the U.S. Food and Drug Administration has accepted its Biologics License Application for Ivonescimab—intended for patients with EGFR‑mutated non‑small cell lung cancer who have progressed after TKI therapy. The regulatory nod signals a promising step forward in targeted lung cancer treatment.
FDA lifts hold on one of two Phase 3 gene editing studies by Intellia
Lei Lei Wu / endpoints - The FDA has allowed Intellia Therapeutics to resume one of its two pivotal trials of a gene editing therapy for transthyretin amyloidosis, which is a disease caused by misfolded proteins. Intellia
AI Summary: U.S. regulators have just cleared Intellia Therapeutics’ Phase 3 study of a gene‐editing therapy intended to treat a genetic nerve disorder, effectively rescinding a clinical hold. This development opens the door to renewed patient enrolment and further evaluation of the treatment’s safety and effectiveness.
‘Vertical integration is destroying people’s ability to access care’: Payer CEOs face bipartisan congressional grilling
Jakob Emerson / beckershospitalreview - The CEOs of the nation’s largest health insurers drew the ire of lawmakers on both sides of the aisle during congressional hearings Jan. 22 over industry consolidation, prior authorization practices and executive pay, with members pressing executives to e…
AI Summary: Lawmakers grilled top health insurance executives in a high‐profile congressional hearing over rising healthcare costs, vertical integration and shifting of cost burdens to hospitals and drug makers. The grilling highlighted deep concerns over patient access and systemic inefficiencies in American healthcare.
#JPM26: Day 3 at the JP Morgan Healthcare Conference
ENDPOINTS / endpoints - It’s Wednesday at the JP Morgan Healthcare Conference, and as the sessions wind down, we’ll be keeping an eye on presentations from WuXi AppTec and AbbVie. Yesterday afternoon, our Executive Editor Drew Armstrong spoke with ...
AI Summary: At the JP Morgan Healthcare Conference 2026, top industry leaders unveiled transformative developments—from embedding AI into EHR systems to discussions on GLP‐1 compounding innovations and strategic Q&A sessions with leading pharma CEOs. The event provided a broad overview of emerging trends in healthcare technology and innovation.