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.
6 Things to Know About Medtronic’s Cyberattack
Katie Adams / medcitynews - Medtronic suffered a cyberattack on its corporate IT systems. The incident highlights growing cybersecurity risks in the medtech sector, with cybergangs increasingly using phishing and other human-engineering tactics to gain access to data.The post 6 Thin…
AI Summary: Medtronic reported an IT systems breach following a cyberattack, prompting an internal probe and operational mitigation efforts. The company is assessing clinical and supply impacts, notifying stakeholders, and coordinating with cybersecurity authorities — a reminder that even medtech giants are not immune to the digital snarls that can ripple through patient care and profits.
Centene raises 2026 guidance with strong Q1 revenue, earnings results
fiercehealthcare - Centene kicked off the first quarter with better-than-expected revenue and adjusted earnings results, signaling a recovery from a rough 2025 as the insurer makes progress in managing medical costs.
AI Summary: Centene lifted its 2026 outlook after reporting robust first-quarter revenue and results, signaling confidence in managed care performance and enrollment trends. The company cited favorable operational metrics and market dynamics that supported the guidance bump, reassuring investors even as broader industry headwinds remain in play.
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
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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)
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Appeals court halts mail and telehealth access
Clinical pivots and drug alternatives amid disruptions
Supreme Court temporarily restores mail access
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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.
U.S. Government Will Stop Paying for Test Strips to Detect Deadly Drugs
Jan Hoffman / nytimes - In a letter to states and other grant recipients, the Trump administration says the strips encourage drug use.
AI Summary: Public health officials have declared the South Carolina measles outbreak over after nearly 1,000 people fell ill, attributing containment to intensified vaccination campaigns and contact tracing. Authorities warn that immunity gaps still exist and stressed that preventable outbreaks will recur without sustained immunization efforts — a blunt reminder that vaccines remain the easiest way to avoid headline-making contagions.
AI, face photos may predict cancer survival: Mass General Brigham study
Giles Bruce / beckershospitalreview - Using multiple photos from across a patient’s course of treatment in the FaceAge AI tool may be an even better predictor of survival than a single photo alone, a new Mass General Brigham study found. Researchers behind FaceAge, which uses AI to analyze a …
AI Summary: An AI model trained on clinical cohorts at Mass General Brigham can estimate biological aging from simple facial photos and links accelerated facial aging to poorer cancer survival. The research suggests noninvasive image-based signals could complement standard prognostic markers, offering a surprising, low-cost way to flag higher-risk patients earlier.
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.
Beth Israel Lahey Health taps Heidi for system-wide AI scribe rollout
fiercehealthcare - The scaled deployment follows a six-month trial for 1,000 providers at the Boston-based health system.
AI Summary: Beth Israel Lahey Health is deploying an AI-driven scribe across its network and has appointed a system lead to shepherd the rollout. The initiative aims to reduce clinician documentation burden and streamline workflows, though it also invites debate about accuracy, clinician oversight, and the usual AI-era promises of magical time savings.
- AI leadership, governance and in-house tool strategies (4)
- Ambient AI privacy, nurse concerns and clinical tradeoffs (3)
- Systemwide scribe rollouts and clinical AI deployments (4)
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