AstraZeneca and Ionis report surprise failure of heart disease drug eplontersen, raising questions about silencer drugs
Detailed analysis of the failed TTR cardiomyopathy trial published in NEJM casts doubt on the benefit of RNA silencer therapies beyond standard care, with impli
STAT · +2 outlets
FDA approves Priovant/Roivant's Lisraya (brepocitinib) for rare autoimmune skin disease dermatomyositis
Lisraya is the first approval for the Roivant subsidiary's drug licensed from Pfizer, targeting multiple rare inflammatory conditions.
STAT · +2 outlets
Moderna raises $2.6B in upsized note offering to support cancer vaccine work as FDA clears updated COVID vaccines
The capital raise follows a key study win for Moderna's pipeline, alongside regulatory clearance for new COVID shots.
BioPharma Dive · +1 outlets
Revolution Medicines' pancreatic cancer drug rasonque approved by FDA at $39,800 monthly list price
Rasonque is the first therapy to target a genetic driver of advanced pancreatic cancer, with analysts projecting blockbuster sales.
BioPharma Dive · +2 outlets
Cytokinetics details positive trial results for aficamten (MyQorzo), setting up potential second approval
After 27 years to win its first drug approval, Cytokinetics' new data could bring a second drug to market quickly for heart condition treatment.
STAT
AstraZeneca and Amgen's Tezspire succeeds in eosinophilic esophagitis study, potential third indication
Positive results could unlock a blockbuster opportunity for Tezspire, expanding its use beyond asthma beyond asthma.
BioPharma Dive · +1 outlets
Juul receives FDA clearance for updated vaping device with optional age-gating technology
The clearance covers a redesigned e-cigarette with built-in age verification aimed at preventing underage use.
STAT
Federal autism advisory committee meeting dominated by vaccine misinformation and debunked theories
Members of the federal advisory panel doubled down on long-refuted links between vaccines and autism during discussions on research funding.
STAT
New documents contradict RFK Jr.'s claim that Samoa trip was unrelated to vaccines
Records obtained by AP and The Guardian show the health secretary's trip to Samoa involved MMR vaccine discussions, contradicting his sworn testimony.
STAT · +1 outlets
Cassidy report criticizes FDA oversight of abortion pill manufacturers ahead of Overton confirmation
The senator's report raises scrutiny of mifepristone manufacturing oversight as Heidi Overton faces confirmation for FDA commissioner.
STAT
Former Stanford president Marc Tessier-Lavigne releases emails to rebut fraud and cover-up allegations
Tessier-Lavigne published new details hoping to refute allegations in a book claiming he published fraudulent results while at Genentech and Stanford.
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Michael Polansky launches Outer Bio, a skin-focused biotech that is not a drug company
The new venture aims to avoid typical biotech hurdles by focusing on cosmetic and dermatological data rather than pharmaceutical drug development.
BioPharma Dive · +1 outlets
Startup Generation Lab claims injectable drug can rejuvenate blood, marketed as longevity treatment
The company offered a reporter the chance to receive and write about the treatment, which combines two existing drugs.
Biotechnology and health · +1 outlets
CMS plans launch event for ACCESS Medicare chronic care pilot program
The pilot aims to test new approaches to chronic disease management for Medicare beneficiaries.
STAT · +1 outlets
Opinion: Lindsay Clancy case could deter psychiatrists from treating mothers with mental illness
Reproductive and forensic psychiatrists warn that the high-profile case may create liability fears that reduce access to care for postpartum patients.
STAT
This week in charts: Biotech's rebound is undeniable with XBI near historic highs
Drug companies are pursuing large IPOs and big-ticket M&A as the sector continues its recovery.
BioPharma Dive · +1 outlets
Opinion: Medicare billing code G2211 may not be working as hoped for primary care
A physician argues the code intended to incentivize relationship-based primary care may not be achieving its goals.
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Opinion: Former CDC staff say problems they protested remain one year after resignations
Scientists who resigned from the CDC argue that ideological influence continues to undermine the agency's scientific mission.
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