Adding Retifanlimab To Chemotherapy Provides OS Benefit over Chemotherapy In First-Line Treatment of Patients with Advanced Squamous Anal Cancer
esmo - Findings from the final overall survival analysis in the POD1UM-303/InterAACT-2 study
AI Summary: A randomized first‑line trial found that adding retifanlimab to standard chemotherapy meaningfully improved overall survival for patients with advanced squamous anal cancer, signaling a new immunotherapy-containing option where few exist. The data from the POD1UM‑303/InterAACT‑2 program offer clinicians a viable strategy to extend life without reinventing the wheel.
Overactive MYC helps tumors fix DNA breaks and resist chemotherapy, study finds
medicalxpress - A protein best known for driving cancer growth also helps damaged tumor cells survive by repairing their DNA, according to a new study that could influence how some cancers are treated.
AI Summary: New research reveals overactive MYC drives tumor cells to repair DNA breaks more efficiently, enabling resistance to chemotherapy. By illuminating the repair pathways MYC hijacks, the study identifies potential targets to reverse resistance and improve treatment responses — because apparently cancers read the manual on how to survive your best shot.
- MYC hijacks DNA repair to enable chemo resistance (4)
- Other molecular drivers of chemoresistance and genome instability (3)
- Tumor cell death and immunity shape chemotherapy outcomes (3)
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MYC hijacks DNA repair to enable chemo resistance
Other molecular drivers of chemoresistance and genome instability
Tumor cell death and immunity shape chemotherapy outcomes
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Data-Driven Decision Support in Obesity Management Commission: enabling more equitable and personalized obesity care
Paul W. Franks / nature - Nature Medicine, Published online: 12 May 2026; doi:10.1038/s41591-026-04363-0Announced in this Comment and in collaboration with Nature Medicine is the convening of the Data-Driven Decision Support in Obesity Management Commission, to promote adequate sc…
AI Summary: A phase 1/2 study of CRISPR‑Cas9 CD33‑deleted allogeneic hematopoietic cell transplantation followed by gemtuzumab ozogamicin maintenance reports encouraging early signals in AML. The gene‑editing approach aims to protect donor cells from CD33‑targeted therapy, potentially enabling safer post‑transplant maintenance and offering a novel strategy to marry cellular engineering with targeted antibody therapy.
- CD33‑targeted transplant and post‑transplant maintenance (4)
- Safety and ethical scrutiny of gene editing and gene therapy (3)
- Scaling cell therapy: accreditation and expanding CAR indications (3)
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CD33‑targeted transplant and post‑transplant maintenance
Safety and ethical scrutiny of gene editing and gene therapy
Scaling cell therapy: accreditation and expanding CAR indications
All Other Stories
Omid Veiseh: First-in-Human Clinical Trial of IL-2 Cytokine Factories in Refractory Ovarian Cancer
oncodaily - Omid Veiseh, Professor and CPRIT Scholar in Cancer Research at Rice University and Co-Founder and Managing Partner of RBL LLC, shared a post on LinkedIn: “Excited to publish the results […]
AI Summary: A first‑in‑human trial of implantable IL‑2 “cytokine factories” in refractory ovarian cancer reported encouraging early safety and biological activity, offering a localized immune‑stimulation strategy that may boost tumor responses while avoiding systemic toxicity. Investigators described the device‑based platform as a potential option for patients with limited alternatives, pending larger efficacy studies.
Antiviral ensitrelvir cuts risk of COVID-19 in household contacts by two-thirds, study finds
medicalxpress - The antiviral drug ensitrelvir prevents infection in household contacts of COVID-19 patients when given within 72 hours after symptom onset in the index patient, according to a Phase III randomized controlled trial published in the New England Journal of …
AI Summary: A randomized trial shows the oral antiviral ensitrelvir, used as post‑exposure prophylaxis, reduced the risk of symptomatic COVID‑19 in household contacts by roughly two‑thirds. The finding suggests a practical option for preventing spread after close exposure, offering public‑health teams a less dramatic but highly useful tool than lockdowns.
BeOne’s next-gen BCL2 inhibitor wins FDA approval, taking aim at Venclexta
Ayisha Sharma / endpoints - BeOne Medicines has clinched US accelerated approval for its drug sonrotoclax in a rare but aggressive form of blood cancer, where AbbVie and Genentech’s Venclexta is used off-label. The FDA greenlit ...
AI Summary: BeOne Medicines secured FDA approval for a next-generation BCL2 inhibitor, positioning the drug as a direct challenge to AbbVie/Roche’s Venclexta franchise. The move reshuffles competitive dynamics in hematology, potentially offering clinicians an alternative and setting the stage for market share battles and payer negotiations. Expect aggressive positioning and head-to-head data requests.
Positive VOLGA Phase III Results for Imfinzi Plus Neoadjuvant EV in MIBC
oncodaily - On May 14, 2026, AstraZeneca announced positive high-level results from a planned interim analysis of the Phase III VOLGA trial, evaluating perioperative Imfinzi with or without Imjudo in combination with […]
AI Summary: Phase III VOLGA trial results reveal that combining durvalumab (Imfinzi) with neoadjuvant enfortumab vedotin improved survival outcomes in muscle‑invasive bladder cancer. Investigators and industry voices highlight potential practice-changing implications for perioperative therapy, while stakeholders weigh regulatory filings and integration into treatment guidelines. Clinicians will want full datasets and toxicity details.
- Clinician reactions, biology and resistance concerns (4)
- Global GU oncology meetings and community coverage (3)
- VOLGA Phase III readout and regulatory landscape (3)
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Clinician reactions, biology and resistance concerns
Global GU oncology meetings and community coverage
VOLGA Phase III readout and regulatory landscape
All Other Stories
Favipiravir for Lassa fever: an open-label, randomized controlled phase 2 trial
Cyril Erameh / nature - Nature Medicine, Published online: 15 May 2026; doi:10.1038/s41591-026-04402-wAn open-label, randomized controlled phase 2 trial comparing favipiravir with ribavirin for the treatment of mild-to-moderate Lassa fever in Nigeria found that favipiravir was s…
AI Summary: An open-label, randomized Phase 2 trial of favipiravir for Lassa fever reported encouraging results, suggesting antiviral benefit where few options exist. The study offers early clinical proof-of-concept, especially important for endemic West African settings, and calls for larger trials to confirm efficacy, optimize dosing, and assess deployment logistics.
Bristol Myers Squibb and Hengrui Forge $15.2 Billion Strategic Alliance, Reshaping China-Out Licensing Landscape
oncodaily - Bristol Myers Squibb (NYSE: BMY) and Jiangsu Hengrui Pharma (600276.SH; 01276.HK) on Tuesday unveiled one of the largest cross-border biopharma collaborations of the year: a global strategic alliance encompassing 13 […]
AI Summary: Bristol Myers Squibb and Hengrui Pharma announced a sweeping strategic alliance covering multiple oncology assets, with potential payments and milestones that could reach roughly $15.2 billion. The deal bundles discovery, development and commercialization rights, reshaping China‑out‑licensing dynamics and signaling continued consolidation and collaboration in global cancer drug development.
Personalized Brain Cancer Vaccine May Help Against Aggressive Glioblastoma
discovermagazine - Discover how a personalized DNA vaccine trained patients’ immune systems to target their own tumors, with one participant remaining cancer-free nearly five years later.
AI Summary: A customized vaccine targeting each patient's tumor has demonstrated encouraging immune responses and signs of clinical benefit against aggressive glioblastoma. Researchers report enhanced T‑cell activity and preliminary survival signals, suggesting personalized neoantigen vaccines may help control this stubborn brain cancer and warrant larger, controlled trials to confirm impact.
- New models and datasets speeding brain tumor research (3)
- Next-gen glioblastoma immunotherapies: CAR T, drugs, stem cells (3)
- Personalized glioblastoma vaccine: early immune and survival signals (3)
- All Other Stories
New models and datasets speeding brain tumor research
Next-gen glioblastoma immunotherapies: CAR T, drugs, stem cells
Personalized glioblastoma vaccine: early immune and survival signals
All Other Stories
F.D.A. Commissioner Marty Makary Resigns After Weeks of Pressure
Christina Jewett / nytimes - The agency’s top food official will step in as acting commissioner, after Dr. Makary’s tumultuous run as the nation’s top food, drug, tobacco and medical device regulator.
AI Summary: F.D.A. commissioner Marty Makary resigned after weeks of intense scrutiny and internal pressure over leadership and policy choices, following reports he faced possible removal. The agency now confronts leadership turbulence as officials rush to steady regulatory priorities, reassure stakeholders and clean up an exit that leaves unfinished reviews and awkward staff memos.
- Firing reports and buildup to Makary's ouster (4)
- Regulatory ripple effects and agency departures (3)
- Resignation announced and immediate leadership vacuum (5)
- All Other Stories
Firing reports and buildup to Makary's ouster
Regulatory ripple effects and agency departures
Resignation announced and immediate leadership vacuum
All Other Stories
A Cancer Driven by Ultra-Rare Mutation Gets Its First FDA-Approved Therapy
Frank Vinluan / medcitynews - Partner Therapeutics’ Bizengri is now FDA approved for treating advanced cases of cholangiocarcinoma driven by NRG1 gene fusions. Partner acquired U.S. rights to this bispecific antibody from Merus in 2024. The post A Cancer Driven by Ultra-Rare Mutation …
AI Summary: The FDA approved zenocutuzumab‑zbco for NRG1‑fusion–positive cholangiocarcinoma, delivering the first cleared therapy for cancers driven by this ultra‑rare genomic alteration. Trial data showed meaningful responses in heavily pretreated patients, prompting regulators to greenlight a precision option that offers targeted benefit where none existed — a small‑population win for genomic oncology.
Study reveals how parenting styles shape babies' willingness to help others
medicalxpress - New research from Durham University shows that the way parents instruct and encourage infants to help plays a key role in how helping behavior develops, and that these approaches vary across cultures.
AI Summary: The RESET‑C trial tested one preoperative dose of pembrolizumab in localized mismatch repair‑deficient colon cancer and recorded unexpectedly high tumor responses, with several patients remaining cancer‑free for nearly three years. The dramatic neoadjuvant activity suggests immune priming could reshape perioperative strategies and raises questions about surgery timing and organ preservation.
UCB bets $2 billion on Candid's T cell engager ambitions
Kyle LaHucik / endpoints - Ken Song has done it again. The biopharma veteran's all-out effort to prove T cell engagers' potential in autoimmune diseases is getting picked up by one of Europe’s oldest pharma companies. UCB is paying $2 ...
AI Summary: UCB has struck a roughly $2 billion deal to acquire Candid, betting heavily on Candid’s T‑cell engager platform to reset immune‑based oncology programs. The acquisition boosts UCB’s immuno‑oncology pipeline and signals intensified competition in T‑cell engager development, with investors and researchers watching closely to see how science translates into clinical wins.
The peptide problem: Hype is outrunning the evidence
medicalxpress - Health Canada recently warned Canadians not to buy or inject unauthorized peptide drugs sold online, naming products that include BPC-157, CJC-1295, ipamorelin, TB-500 and retatrutide.
AI Summary: The booming market for peptide therapies and supplements is racing past the science. Researchers report limited clinical evidence, unclear long-term safety, and weak regulatory oversight, while consumer demand and marketing hype surge. Clinicians urge caution: biological plausibility isn’t the same as proven benefit, and enthusiasm should not substitute for rigorous trials.
Atara, Pierre Fabre's cell therapy to get another shot at FDA approval
Max Gelman / endpoints - There's new life for a twice-rejected T cell therapy from Atara Biotherapeutics and Pierre Fabre Pharmaceuticals. US regulators are willing to reconsider using a Phase 3 study as the basis for an approval, Atara said ...
AI Summary: Regulators have agreed to re-examine a previously rejected cell‑therapy application for a rare lymphoma, giving the Atara‑Pierre Fabre program another opportunity at approval. The decision follows additional data and stakeholder engagement, offering the developer a second bite at the apple and patients a renewed, if cautious, hope for a novel treatment pathway.
Amgen files update to Tavneos label as FDA escalates push to withdraw
Nicole DeFeudis / endpoints - Amgen has taken steps to update its Tavneos label amid an ongoing battle with the FDA. The company filed a supplement on Wednesday that would add more information to the warning ...
AI Summary: Regulators have intensified scrutiny of Amgen’s Tavneos, weighing withdrawal amid safety and efficacy concerns. Amgen responded by filing a label update as the agency evaluates next steps, setting up a regulatory standoff that could alter patient access and the drug’s commercial fate while investigators review supporting trial data.
Vivek Subbiah: F.D.A. Grants Early Access to Promising Drug for Pancreatic Cancer
oncodaily - Vivek Subbiah, Chief of Early-Phase Drug Development at the Sarah Cannon Research Institute, shared a post on LinkedIn: “Wow! It’s Big news on Friday. F.D.A. Grants Early Access to Promising Drug for […]
AI Summary: The FDA has authorized early access to a promising experimental therapy for pancreatic cancer, opening an expanded‑access pathway so eligible patients can receive the drug before full approval. Regulators based the decision on encouraging early clinical signals of activity and manageable safety data, aiming to offer options for a disease with few effective treatments—because pancreatic cancer isn’t known for its patience.
- Daraxonrasib expanded access: FDA opens early pathway (6)
- Research advances: diagnostics and targeted therapies for pancreatic cancer (5)
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Daraxonrasib expanded access: FDA opens early pathway
Research advances: diagnostics and targeted therapies for pancreatic cancer
All Other Stories
Chiesi signs $1.9B deal to acquire KalVista and its approved drug
Kyle LaHucik / endpoints - Chiesi is buying commercial biotech KalVista Pharmaceuticals for about $1.9 billion in an extension of the industry's vigorous spring shopping spree. The Italian pharma will pay $27 per share {$KALV} in cash to buy the ...
AI Summary: Chiesi Group agreed to buy KalVista for $1.9 billion to secure an approved therapy and expand its rare-disease footprint. The deal transfers marketed assets and R&D capacity, positioning Chiesi to scale rare-disease revenues and invest in next-wave therapeutics — essentially a big check for a bigger strategic play.
Avalyn Pharma Takes a Breath to Raise $300M in IPO Cash for Lung Drug Trials
Frank Vinluan / medcitynews - Avalayn Pharma found strong investor interest in its inhalable drugs in development for two types of pulmonary fibrosis, enabling the company to upsize its IPO. Data from two mid-stage studies are expected in 2027. The post Avalyn Pharma Takes a Breath to…
AI Summary: Avalyn Pharma has substantially increased its IPO, targeting roughly $300 million to bankroll late-stage trials of its respiratory drug candidate. The move reflects strong investor enthusiasm for lung‑disease therapeutics and gives the company a bigger war chest to advance programs previously dependent on venture capital and partnerships.