Clinical Operations Burnout Is Undermining Patient Enrollment
When coordinators are buried in documentation, scheduling, and data reconciliation, patient engagement is the first thing to go. And when engagement drops, retention drops with it.
Eli Lilly’s Triple Combo Obesity Drug Tops 28% Weight Loss in a Pivotal Trial
Eli Lilly’s retatrutide set a high mark in weight loss for obesity drugs, but with clinical trial results that show some new side effects. More detailed data from the Phase 3 study are scheduled for presentation next month during the American Diabetes Association Scientific Sessions meeting.
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Why Patient Engagement Is Clinical Trials’ Next Strategic Frontier
As decentralized trials reduce face time with participants, sponsor organizations that treat engagement as an afterthought will pay for it in dropout rates, missing data and failed endpoints.
BioMarin’s Mixed Bag of Phase 3 Data Dim Prospects for Rare Disease Drug
A BioMarin Pharmaceutical drug met just one of two main goals of a Phase 3 test in a rare inherited enzyme deficiency with no FDA-approved therapies. The drug, a fusion protein, came from BioMarin’s 2025 acquisition of Inozyme Pharma.
FDA Approves AstraZeneca Drug With New Approach to Lowering High Blood Pressure
AstraZeneca’s Baxfendy is the first FDA-approved drug in a new class of medicines called aldosterone synthase inhibitors. The new mechanism of action is important for patients and for AstraZeneca, which has been looking for new drugs with blockbuster potential as its top cardiometabolic medicine faces patent expiration.
This Startup Aims to Upend Biologic Drug Production With Implantable ‘Cell Factories’
Duracyte’s implants employ cells engineered to produce therapeutic protein, bypassing the complexities of traditional biologics manufacturing. The startup’s marriage of biotechnology with electronics comes with on-board sensors that enable clinicians to monitor and control an implant’s drug production process.
The Hidden Administrative Tasks Draining Small Practices
Small practices play a critical role in healthcare delivery, but they cannot continue to absorb ever-increasing administrative demands without consequences.
Under FDA Clinical Hold, Aardvark Therapeutics Seeks Path Forward for Metabolic Drug
The full FDA clinical hold formally halts all tests of Aardvark Therapeutics’ drug for Prader-Willi syndrome, a rare inherited metabolic disorder that leads to excessive eating. Earlier this year, Aardvark voluntarily paused all tests of its small molecule after a cardiovascular problem emerged in a healthy volunteer.
FDA Approval Gives BeOne Medicines a New Challenger to AbbVie, Roche Cancer Drug
BeOne Medicines drug Beqalzi has accelerated FDA approval for treating relapsed or refractory mantle cell lymphoma, a type of blood cancer. The regulatory nod opens the door to potentially compete against Venclexta, a blockbuster cancer drug marketed by AbbVie and Roche.
A Cancer Driven by Ultra-Rare Mutation Gets Its First FDA-Approved Therapy
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.
Windward Bio Secures $165M for Clinical Trials in Asthma, COPD & More
Immunology-focused Windward Bio raised a mega-round of financing to support a lead program in development for respiratory disorders and a second program that could find use in respiratory and dermatological indications. Both drugs are long-acting antibodies that offer a dosing edge over currently available biologic medicines.
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Bayer Sees Opportunity With $300M Acquisition of Eye Drug Biotech
Perfuse Therapeutics brings Bayer an eye drug administered via an implant that controls the release of the therapy. This program is in mid-stage clinical development for glaucoma and diabetic retinopathy.
Madrigal Pharma Adds Another Genetic Medicine to Its Drug Combo Strategy in MASH
Madrigal Pharmaceuticals has licensed rights to an Arrowhead Pharmaceuticals small-interfering RNA therapy designed to address a particular genetic mutation associated with the fatty liver disease MASH. It’s Madrigal’s fourth business development deal of the past year and the company’s second one involving siRNA therapies.
UCB Joins the Chase for Immune System Reset With $2B Acquisition
Candid Therapeutics brings to UCB two clinical-stage T cell engagers in development for autoimmune disorders. To accept UCB’s offer, Candid terminated its reverse merger with Rallybio.
Four Biotech IPOs Raise $1.5B in April, the Biggest Month in Five Years
Hemab Therapeutics and Seaport Therapeutics are the newest biotech companies to join the public markets, each with an upsized IPO. According to IPO research firm Renaissance Capital, April was the biggest month for biotech IPO proceeds in more than five years.
Axsome Drug’s FDA Approval Unlocks New Opportunity in Alzheimer’s Agitation
Axsome Therapeutics’ Auvelity expanded its label to include treating agitation in Alzheimer’s disease patients. It’s just the second FDA-approved drug for this indication, and Axsome’s pill has a safety advantage.