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)
- All Other Stories
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.
Supreme Court preserves access to abortion pill by mail
Sydney Halleman / healthcaredive - The ruling maintains access to mifepristone while litigation continues. The drug can still be prescribed at pharmacies or by mail without requiring in-person visits.
AI Summary: The Supreme Court intervened to maintain access to mifepristone, temporarily restoring telehealth prescribing and preserving mail distribution while litigation proceeds. The decision keeps the pill available nationwide, blocking lower-court restrictions that would have sharply limited remote access and complicated routine clinical care for patients and providers.
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.
Optum Rx unveils new transparent PBM model
fiercehealthcare - UnitedHealth Group's pharmacy benefit manager, Optum Rx, is making the shift to a more transparent model, the company announced Monday.
AI Summary: Optum Rx unveiled a new pharmacy benefit model that separates drug list prices from PBM fees and adopts clearer pass‑through pricing. Aimed at employers and payers fed up with opaque pharmacy economics, the proposal promises simpler contracts and fee clarity — an attempt to make PBMs boringly accountable and maybe slightly less profitable.
- Industry responses to rising drug costs and PBM models (4)
- Lawmakers and states press PBM vertical-integration reform (4)
- Optum Rx unveils transparent PBM model (4)
- All Other Stories
Industry responses to rising drug costs and PBM models
Lawmakers and states press PBM vertical-integration reform
Optum Rx unveils transparent PBM model
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.
A new Medicare option for weight loss drugs is coming: Here's what to know
Jackie Fortiér / npr - Millions of people with Medicare will soon be eligible to get discounted GLP-1 drugs for weight loss. Here's how it will work.
AI Summary: Medicare is introducing a new option to expand access to weight‑loss medications for older Americans, outlining eligibility, coverage mechanics and likely impacts on beneficiaries and budgets. The guidance aims to help clinicians and patients navigate coverage decisions and prepares stakeholders for shifts in prescribing patterns and costs as demand for GLP‑1 class drugs remains high.
- Competition, dosing and long-term weight strategies (4)
- Efficacy and safety of GLP‑1s in older adults (3)
- Medicare expansion and coverage landscape (3)
- All Other Stories
Competition, dosing and long-term weight strategies
Efficacy and safety of GLP‑1s in older adults
Medicare expansion and coverage landscape
All Other Stories
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.
RFK Jr. launches plan to curb antidepressant 'overprescription'
medicalxpress - A new federal initiative aims to curb "overprescribing" of psychiatric medications while emphasizing holistic care.
AI Summary: Robert F. Kennedy Jr. launched a campaign aimed at reducing antidepressant prescribing and helping people taper long-term use, combining policy proposals and public outreach. The initiative challenges current prescribing norms and has provoked debate between advocates for reducing medication dependence and clinicians cautious about abrupt shifts in psychiatric care.
Amazon Pharmacy to offer home delivery for Novo Nordisk's Ozempic pill
fiercehealthcare - Amazon Pharmacy will make Novo Nordisk's Ozempic pill available for home delivery, the company announced Thursday.
AI Summary: Amazon Pharmacy is expanding access to Novo Nordisk’s oral semaglutide (Ozempic) by adding the pill to same‑day prescription kiosks and rolling out home delivery, widening availability beyond clinics and specialty pharmacies. Consumers will now find GLP‑1s via retail logistics — because apparently weight‑loss pills need shipping and curb‑side convenience too.
- Clinical research and future GLP-1 treatments (3)
- Payers and companies reshape access: Medicare, employers, retail programs (4)
- Retail rollout: Amazon kiosks and pharmacy delivery for Ozempic (4)
- All Other Stories
Clinical research and future GLP-1 treatments
Payers and companies reshape access: Medicare, employers, retail programs
Retail rollout: Amazon kiosks and pharmacy delivery for Ozempic
All Other Stories
CVS Health beats the Street with $2.9B in Q1 profit
fiercehealthcare - CVS Health beat the Street on both earnings and revenue in Q1, posting $2.9 billion in profit for the quarter.
AI Summary: CVS Health reported a $2.9 billion Q1 profit, driven by improved performance at Aetna and stronger-than-expected renewals, prompting an upward outlook. Executives point to insurance results and retail stability as drivers — insurance math quietly covering for a retail world that still loves convenience.
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)
- All Other Stories
Daraxonrasib expanded access: FDA opens early pathway
Research advances: diagnostics and targeted therapies for pancreatic cancer
All Other Stories
Court restricts abortion access across US by blocking mailing of mifepristone
abcnews - A federal appeals court has restricted access to one of the most common means of abortion in the U.S. by blocking the mailing of mifepristone
AI Summary: A federal appeals court has imposed new limits on distribution of mifepristone, blocking mail-order shipments and narrowing telehealth-based prescribing. The decision immediately complicates access for patients and clinicians who rely on remote care and pharmacy delivery, forcing last‑minute logistical changes, increased travel, and swift legal and policy responses as providers scramble to adapt.
- Appeals court halts mail and telehealth access (4)
- Clinical pivots and drug alternatives amid disruptions (3)
- Supreme Court temporarily restores mail access (5)
- All Other Stories