Tag Directory / BIOTECH     showing 161–180 of 259   RSS



Updated: Lilly’s triple-G comparable with Mounjaro, first Phase 3 diabetes data suggest

Elizabeth Cairns / endpoints - Eli Lilly’s so-called triple-G reduced blood sugar levels in patients with type 2 diabetes by up to 1.9% in a late-stage trial — a similar margin as Mounjaro achieved in its pivotal diabetes study. The triple-G ...

AI Summary: Eli Lilly’s third‑generation GLP‑1 candidate reported Phase 3 data demonstrating significant weight loss and A1C reductions, with efficacy appearing comparable to existing therapies like Mounjaro. The results sharpen competition in the GLP‑1 market and raise questions about pricing, access and who gets first dibs on the next blockbuster injection.


At clinics: GLP‑1 demand reshaping access, care and pricing

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In labs: oral pills and novel GLP‑1 delivery approaches

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On the ground: Lilly's triple‑G rivaling Mounjaro in trials


Other: clinical oddities, surgical implications and pipeline setbacks

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A liquid biopsy blood test may improve children's survival of cancer in Africa

medicalxpress - In a study published in Nature Medicine, researchers from the University of Oxford and the Muhimbili University of Health and Allied Sciences (MUHAS) in Dar es Salaam, Tanzania have shown that a minimally invasive liquid biopsy test can diagnose Burkitt l…

AI Summary: A blood‑based liquid biopsy for EBV‑positive Burkitt’s lymphoma shows promise for earlier, less invasive diagnosis in endemic regions, potentially improving pediatric survival where tissue biopsies are scarce. Early data indicate actionable sensitivity and feasibility for low‑resource settings, offering a scalable path to faster treatment.

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Engineered tissue offers hope for children born with 'missing' esophagus

medicalxpress - Scientists from Great Ormond Street Hospital (GOSH) and University College London (UCL) have created the first lab‑grown esophagus—the food pipe—shown to safely replace a full section of the organ and restore normal function, including swallowing, in a gr…

AI Summary: Researchers report progress developing lab-grown esophageal tissue to treat children born with congenital absence or severe damage of the esophagus. Early preclinical and surgical work demonstrates that engineered tissue constructs can be implanted and integrated, offering a potential alternative to complex reconstructions — a promising step for tiny patients with very big problems.

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‘Lack of Substantial Evidence’ Leads to FDA Rejection of Aldeyra Dry Eye Disease Drug

Frank Vinluan / medcitynews - Aldeyra said the FDA did not ask for another clinical trial for reproxalap in dry eye disease, but the drug’s mixed record in clinical testing warrants exploration about the reasons for failure, which could identify the appropriate patients for the eye dr…

AI Summary: The FDA has rejected Aldeyra’s reproxalap application, citing a lack of substantial evidence—marking the company’s third setback. Regulators did not demand a fresh, large trial but flagged inconsistent results, prompting investor angst and a slide in the stock. The decision underscores the gap between hopeful early data and regulatory standards.

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'Leaky' brain barrier revealed as driver of chronic brain damage in retired combat and collision sports athletes

medicalxpress - Research, led by teams at Trinity College Dublin and the FutureNeuro Research Ireland Center, has pinpointed the mechanism linking some sports injuries to poor brain health in retired athletes. The research, published in Science Translational Medicine, ha…

AI Summary: New research links repetitive head impacts in contact and combat sports to blood–brain barrier breakdown, which appears to drive chronic traumatic encephalopathy and progressive cognitive decline. The studies identify vascular leakage as a key mechanism and suggest that strategies to bolster the barrier could reduce long-term brain damage in athletes and veterans.

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Neoadjuvant GOLP Prolongs EFS Among Patients with Resectable High-Risk Intrahepatic Cholangiocarcinoma

esmo - Findings from the ZSAB-neoGOLP study

AI Summary: The ZSAB‑neoGOLP trial shows that giving a four‑drug neoadjuvant regimen—gemcitabine, oxaliplatin, lenvatinib and toripalimab—before surgery prolongs event‑free survival for patients with resectable, high‑risk intrahepatic cholangiocarcinoma. The finding suggests preoperative systemic therapy can downstage aggressive tumors and delay recurrence, potentially changing treatment sequencing for this challenging disease.

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NRG-LU005 Trial: Atezolizumab Plus Chemoradiotherapy in Limited-Stage Small Cell Lung Cancer

oncodaily - A major international clinical trial, NRG-LU005, has provided important new insight into how immunotherapy should be used in limited-stage small cell lung cancer (SCLC). While immune checkpoint inhibitors have significantly […]

AI Summary: A major international trial tested whether adding the PD‑L1 inhibitor atezolizumab to concurrent chemoradiotherapy for limited‑stage small‑cell lung cancer would boost outcomes. The study found no significant survival benefit, prompting clinicians to rethink the timing and role of immune checkpoint blockade in curative‑intent SCLC rather than assuming more drugs always means better results.

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A new triple negative breast cancer target: Why HORMAD1 could guide treatment choices

medicalxpress - A gene that is typically active only in reproductive cells may hold the key to new treatments for triple negative breast cancer, according to new research published in the journal Nature Communications. Scientists from the Breast Cancer Now Toby Robins Re…

AI Summary: Researchers have identified HORMAD1, a normally reproductive‑cell gene, as a vulnerability in some triple‑negative breast cancers. Preclinical work suggests exploiting this target could guide patient selection and novel therapies, opening a promising — if early‑stage — route for a tumor type that desperately needs smarter options.


HORMAD1: reproductive gene reveals vulnerability in triple‑negative breast cancer

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New insights into why aggressive breast cancers grow and spread

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OTHER: related cancer research and approvals outside this TNBC angle

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All Other Stories

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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.

3 months / medicalxpress




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.

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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.

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Grail names new CEO as Bob Ragusa retires

Jared Whitlock / endpoints - Grail on Thursday announced that its CEO, Bob Ragusa, will retire and is handing the reins to its current president Josh Ofman. The cancer screening company said the move was the culmination of long-term succession ...

AI Summary: Grail announced a leadership transition as long‑time chief executive Bob Ragusa retires and hands operational control to current president Josh Ofman. The move marks a new chapter for the cancer‑screening company as stakeholders watch for strategic shifts and commentary about the company’s unusual corporate journey and future direction.

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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.




FDA Transparency Push Expands to Monitoring Safety of Vaccines and Other Regulated Products

Frank Vinluan / medcitynews - The FDA said consolidating safety reporting into a single platform, the Adverse Event Monitoring System (AEMS), will increase transparency and reduce costs. But like the legacy systems it replaces, AEMS reports are unverified so causation and frequency of…

AI Summary: The FDA is consolidating multiple safety reporting systems into a single public Adverse Event Monitoring System to centralize reports for drugs, biologics, vaccines, cosmetics and animal products. The move aims to improve transparency, reduce fragmented reporting, and streamline monitoring — a tidy solution if it works as promised.

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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.

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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.

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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.

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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.

4 months / medicalxpress




New AI tool predicts best pancreatic cancer treatment

medicalxpress - A new tool co-developed by investigators from Cedars-Sinai Health Sciences University can predict which of two available chemotherapy options for pancreatic cancer would be more effective for an individual patient.

AI Summary: A Cedars‑Sinai–developed AI platform predicts which of two standard chemotherapy regimens will best suit individual pancreatic cancer patients. The model analyzes clinical and molecular data to guide therapy selection, aiming to personalize treatment and improve outcomes in a disease notorious for poor prognosis—because guesswork is overrated when lives are at stake.

4 months / medicalxpress




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.

3 months / oncodaily

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