Alfasigma Pays $300M for Rights to GSK Rare Liver Disease Drug On Track for FDA Decision
Frank Vinluan / medcitynews - GSK licensed to Alfasigma global rights to linerixibat, a drug developed to treat the rare liver disease primary biliary cholangitis (PBC). The move follows Alfasigma’s 2025 voluntary market withdrawal of Ocaliva, a PBC drug that had sparked safety concer…
AI Summary: GSK has licensed its investigational drug linerixibat to Alfasigma for $300 million upfront, transferring global rights as the therapy nears regulatory decisions for cholestatic liver itch. The deal accelerates Alfasigma’s rare-disease ambitions while allowing GSK to reposition its pipeline — a tidy corporate shuffle with real implications for patients with debilitating pruritus.
Roche’s big hope breast cancer drug fails in crucial first-line trial
Elizabeth Cairns / endpoints - Roche’s breast cancer pill, which the company recently said had the potential to become its biggest-ever selling drug, has failed in what is arguably its most important Phase 3 trial. The persevERA ...
AI Summary: Roche’s experimental breast cancer oral agent failed to meet its primary endpoint in a pivotal first‑line trial, dashing expectations that it would become a major new therapy. The negative readout forces a strategic rethink for the program and raises questions about near‑term prospects for what had been touted as a potential blockbuster.
Antonio Calles: RECITE Trial Findings on Romiplostim for Chemotherapy-Induced Thrombocytopenia
oncodaily - Antonio Calles, Medical Oncologist at Hospital General Universitario Gregorio Marañón and faculty member of the Lung and Other Thoracic Tumours faculty group of the ESMO, shared a post by NEJM, […]
AI Summary: A global phase 3 trial shows romiplostim markedly reduces chemotherapy‑induced thrombocytopenia, cutting severe low‑platelet events and helping patients stay on planned treatment schedules. The finding promises to lower bleeding risk and avoid dose delays, a relief for clinicians and patients alike — and for anyone tired of rescheduled infusions.
Ipsen pulls cancer drug Tazverik from market over safety risks
Nicole DeFeudis / endpoints - Ipsen is pulling its cancer drug Tazverik from the market after an independent data monitoring committee found safety concerns in a confirmatory trial. The committee reported cases of secondary cancers that begin in blood-forming tissue ...
AI Summary: Ipsen has removed its EZH2 inhibitor Tazverik (tazemetostat) from the U.S. market after safety issues flagged by an independent monitoring review. The withdrawal forces clinicians to pivot to alternative therapies and triggers regulatory and clinical re‑examination of the drug’s benefit‑risk profile for patients previously depending on it.
Eliquis may be safer than Xarelto for patients with deep blood clots: Study
Ella Jeffries / beckershospitalreview - Patients taking blood thinner Eliquis had a lower risk of clinically relevant bleeding than those taking Xarelto, a recent study found. Researchers enrolled 2,760 patients with venous thrombosis — blood clots in the veins of the legs or lungs — and random…
AI Summary: A direct comparison trial found apixaban (Eliquis) produced a lower rate of clinically relevant bleeding than rivaroxaban (Xarelto) in patients treated for venous thromboembolism while preserving efficacy against clots. The results offer prescribers clear comparative safety data that could influence anticoagulant selection and guideline recommendations.
Flu vaccines didn't work that well in the US, officials find
medicalxpress - As the U.S. flu season winds down, health officials say the flu vaccine didn't work very well, with one of its worst effectiveness rates in more than a decade.
AI Summary: Health officials report this season’s influenza vaccine performed poorly, with effectiveness among the lowest in recent years. A mismatch between vaccine strains and circulating viruses reduced protection, prompting calls for strain updates ahead of the fall program. Public health leaders still urge vaccination for partial protection and to blunt severe outcomes.
Engineering CAR T cells to secrete VEGF-neutralizing scFvs enhances antitumor activity against solid tumors
Torahito A. Gao, Ryan M. Shih, Justin D. Clubb, Shao-Hsi Hung, Tanya Singh, Laura B. James-Allan, Ga / science - Science Translational Medicine, Volume 18, Issue 839, March 2026.
AI Summary: Researchers engineered CAR‑T cells to secrete VEGF‑neutralizing single‑chain antibodies, improving infiltration and antitumor activity against solid tumors in preclinical models. By locally neutralizing VEGF, the approach remodels the tumor microenvironment and enhances CAR‑T efficacy, offering a plausible strategy to overcome the long‑standing barrier of poor CAR‑T performance in solid cancers.
Elizabeth McKenna: New Cancer Grand Challenges Teams Announced
oncodaily - Elizabeth McKenna, Executive Editor of Cancer Discovery, shared a post on X: “The new Cancer Grand Challenges teams have just been announced! Read about the teams tackling cancer avoidance, mechanisms […]
AI Summary: Global funders announced new Cancer Grand Challenges awards, backing five international teams with large, high‑risk grants to pursue transformative cancer science. The initiative aims to accelerate unconventional, high‑reward projects and foster cross‑disciplinary collaboration — essentially underwriting audacity in hopes that at least one risky bet pays off.
ASCO GU 2026 Highlights: Belzutifan + Lenvatinib and Pembrolizumab in RCC – IUCS
oncodaily - International Urology Cancer Summit shared a post on LinkedIn: “IUCS Journal Club – Highlights from ASCO GU 2026: Targeting HIF-2α in RCC. This Journal Club session reviews the data from […]
AI Summary: At ASCO GU, investigators showcased belzutifan‑based combinations for renal cell carcinoma, including belzutifan with lenvatinib and perioperative belzutifan plus pembrolizumab. Data presented indicate these HIF‑2α‑targeted regimens can extend disease‑free intervals in high‑risk clear‑cell RCC, prompting interest in integrating hypoxia‑axis inhibitors into multimodal kidney‑cancer care.
New FDA bonus pilot to address 'workforce challenges'
Max Bayer / endpoints - A new bonus pilot program meant to reward fast-working FDA reviewers will be funded in part by money from industry user fees, the first details on how Commissioner Marty Makary plans to finance the incentive ...
AI Summary: The FDA has introduced a pilot program offering performance bonuses to expedite regulatory reviews, aiming to tackle reviewer workload and improve timeliness. Funded partly by industry user fees, the initiative seeks to reward faster, high‑quality reviews while balancing independence and efficiency—proof that carrots sometimes replace the endless stick of overtime.
FDA lifts hold on Intellia trial
Ella Jeffries / beckershospitalreview - The FDA has lifted a clinical hold on Intellia Therapeutics’ phase 3 Magnitude trial of nexiguran ziclumeran, or nex-z. The trial was paused Oct. 29 after a patient developed grade 4 liver transaminase elevations and elevated bilirubin following a Sept. 3…
AI Summary: The FDA has lifted clinical holds on Intellia Therapeutics’ Phase 3 gene‑editing trials, allowing the company to resume patient enrollment and advance its nexiguran (nex‑z) development program. Regulators appear satisfied with submitted safety updates, clearing a major regulatory hurdle and moving the gene-editing program back toward its clinical milestones.
Moderna to Pay Up to $2.25B to Settle Patent Suit Over Covid-19 Vaccine Technology
Frank Vinluan / medcitynews - Under the settlement, Genevant Sciences and Arbutus Biopharma will grant Moderna a non-exclusive license to their lipid nanoparticle technology for mRNA delivery in infectious disease vaccines. If Moderna’s full financial payout to the companies is reache…
AI Summary: Moderna has agreed to settle long-running patent disputes over its COVID-19 vaccine technology for up to $2.25 billion, resolving litigation with several claimants. The deal provides Moderna with broad licensing rights and clears a major legal uncertainty, allowing the company to move forward without another courtroom cliffhanger.
Servier Boosts Presence in Rare Cancers With $2.5B Acquisition of Day One Biopharma
Frank Vinluan / medcitynews - Day One Biopharmaceuticals is Servier’s biggest acquisition yet, topping the $2.4 billion it paid to buy Shire’s cancer business in 2018. Day One markets Ojemda, approved for treating pediatric low-grade glioma, the most common type of brain cancer in chi…
AI Summary: Servier is buying Day One Biopharmaceuticals for about $2.5 billion to bolster its rare oncology portfolio, gaining access to promising targeted therapies. The deal expands Servier’s presence in specialty cancer medicines and aligns with its strategic push into rare tumors, with integration and regulatory steps expected to follow.
FDA vaccine chief to step down in April
Ella Jeffries / beckershospitalreview - Vinay Prasad, MD, the FDA’s top regulator of vaccines and cell and gene therapies, will step down at the end of April, an agency spokesperson confirmed to Becker’s. Dr. Prasad joined the agency in 2025 on a one-year sabbatical from the University of Calif…
AI Summary: Vinay Prasad, the FDA’s top regulator for vaccines and cell and gene therapies, will step down at the end of April amid mounting criticism over controversial decisions that reportedly overrode agency scientists and spooked stakeholders. His exit follows prolonged internal and external disputes about regulatory judgment and leadership style.
GLP‑1 drugs may fight addiction across every major substance, according to a study of 600,000 people
medicalxpress - A patient of mine, a veteran who had tried to quit smoking for over a decade, told me that after he started a GLP-1 drug for his diabetes, he lost interest in cigarettes. He didn't use a patch. He didn't set a quit date. He simply lost interest. It happen…
AI Summary: A large observational analysis suggests GLP‑1 receptor agonists — the headline-grabbing diabetes and weight-loss drugs — are linked to reduced risk of developing and dying from substance use disorders across multiple substances. Researchers urge cautious optimism: signals are intriguing, but causality remains unproven and more controlled trials are needed before rewriting addiction treatment playbooks.
Groundbreaking new drug shows promise for treating children with a devastating form of epilepsy
livescience - An experimental treatment reduces seizures and other symptoms in children with a type of epilepsy called Dravet syndrome.
AI Summary: An experimental treatment markedly cut seizures and eased symptoms in children with Dravet syndrome, offering families dramatic improvements where few options existed. Early clinical data show promising safety and efficacy signals, but researchers caution larger, longer trials and regulatory review are needed before this becomes a routine option.
Novo Nordisk inks $2.1B oral obesity drug deal
Ella Jeffries / beckershospitalreview - Novo Nordisk has partnered with Vivtex Corp. to develop next-generation oral biologic medicines for obesity, diabetes and related conditions. Under the agreement, Vivtex will license its proprietary oral drug-delivery technologies to Novo Nordisk and is e…
AI Summary: Novo Nordisk has struck a multibillion‑dollar deal with Vivtex to develop next‑generation oral biologic therapies for obesity and related metabolic diseases. The partnership funnels major R&D resources into oral delivery technology, signaling the company’s bet that pills — not injections — will be the next commercial battleground in weight‑loss medicine.
Antitumour Activity of Rezatapopt Provides Proof of Concept for p53 Reactivation in Patients with TP53 Y220C-mutated Solid Tumours
esmo - Findings from the PYNNACLE study
AI Summary: Clinical results from the PYNNACLE program demonstrate that rezatapopt, an oral small‑molecule p53 reactivator, produces antitumor activity in cancers driven by the TP53 Y220C mutation. Early data validate targeting a previously “undruggable” p53 variant, offering a concrete therapeutic strategy and sparking excitement — and a few warranted caveats — about broader applicability.
Novartis closes Avidity deal as rare heart disease spinout launches
Lei Lei Wu / endpoints - Atrium Therapeutics launched Friday morning as Novartis closed the $12 billion deal to buy Avidity Biosciences and its RNA muscle therapies. The spinout will take on Avidity’s early-stage programs for genetic cardiomyopathies — heart muscle diseases ...
AI Summary: Novartis completed its Avidity Biosciences transaction and backed the launch of Atrium Therapeutics, a newly funded spinout focused on RNA therapies for rare cardiac conditions. Atrium inherits delivery platforms and early programs with substantial capital, as Novartis reshuffles assets to accelerate its RNA strategy — because apparently doubling down on hot modalities never gets old.
Merck Splits Oncology Business Unit as Keytruda Patent Expiry Nears
oncodaily - On February 23, 2026, Merck announced a reorganization of its Human Health structure into two business units: an Oncology Business Unit and a Specialty, Pharma & Infectious Diseases Business Unit. […]
AI Summary: Merck reorganized its Human Health structure to form a separate oncology business unit, positioning the company to defend and optimize its cancer franchise ahead of Keytruda patent pressures and to sharpen focus across therapeutic areas as part of a broader commercial realignment.