Exclusive Article – Thank You
The newly finalized Variations Regulation has been published in the Official Journal of the E.U., providing a framework for implementing post-authorization changes to medicinal products. Updates aim to streamline the variations process and align with current regulatory practices. A new guideline implementing the changes is open for public consultation until August 23, 2024. The regulation […]
FDA warns of Tandem insulin pump shutdown caused by software glitch
The Food and Drug Administration has announced a recall of Tandem Diabetes Care’s insulin pumps due to a software error that causes the pumps to shut down unexpectedly. This has affected at least 224 diabetes patients, with the potential to be life-threatening if the shutdown occurs while the person is sleeping. The bug in the […]
White House increases tariffs on Chinese-made plastic syringes
The Biden administration has announced an increase in tariffs on imported products from China, including syringes, needles, and surgical gloves. These tariffs are intended to protect American workers and domestic manufacturers from China’s unfair trade practices and artificially low-priced exports. In addition to medical devices, tariffs will also be raised on $18 billion worth of […]
Top FDA Official Overrides Agency Staff to Approve Sarepta Gene Therapy
Sarepta Therapeutics gene therapy, Elevidys, has received traditional FDA approval after failing its confirmatory test, expanding use to a wider group of Duchenne muscular dystrophy patients. The therapy works by producing a smaller version of dystrophin, a protein key to muscle function. The therapy was initially approved based on Phase 2 data showing micro-dystrophin production, […]
New stent from Abbott offers hope for those with peripheral artery disease
Abbott’s dissolvable below-knee stent, originally designed for heart disease patients, is now being used in patients with severe vascular disease. The stent widens clogged blood vessels and then dissolves into the vessel’s walls over three years. It also delivers a drug to prevent scar tissue formation, a common issue with traditional metal stents. Abbott’s first […]
FDA Considers Changing Policy on Study Requirements for Biosimilars Switching
The FDA is considering changes to its biosimilar policy, which could benefit companies that develop complex follow-on biologic drugs, clinicians who prescribe them, and the patients who receive them. Currently, pharmacists cannot substitute lower-cost biosimilars for brand-name products unless they are classified as interchangeable by the FDA. This requires additional clinical trials beyond those needed […]
Healthcare Company GE and MediView XR Collaborate to Launch OmnifyXR – an AR Radiology Suite for Clinical Applications
GE HealthCare and MediView XR have successfully implemented their co-developed OmnifyXR Interventional Suite System in a clinical setting. This system combines GE’s imaging technology with MediView’s augmented reality and surgical navigation platform to improve assessment of patient anatomy, enable informed clinical decision-making, and facilitate remote collaboration among care teams. The platform allows for displaying up […]
Life Sciences Analysis: A Gratitude Message
Alzheimer’s disease (AD) is a devastating condition that affects millions of people worldwide, causing cognitive decline, behavioral changes, and functional impairment. Currently, the FDA has approved several therapies for AD, including medications like Aricept, Namenda, and Rexulti that target cognitive symptoms. Additionally, disease-modifying therapies like Aduhelm and Leqembi have been approved, with a focus on […]
Laboratory trade group files lawsuit against FDA to stop regulation of lab-created tests
The American Clinical Laboratory Association and PCR lab HealthTrackRx have filed a lawsuit against the FDA regarding its plan to regulate lab-developed tests. The FDA’s regulation of these tests has historically been limited, but as tests have become more numerous and complex, unreliable tests have caused harm to patients. The lawsuit argues that the FDA […]
New Monoclonal Antibody Receives Strong Support from Advisory Committee for Early Alzheimer’s Treatment: Exclusive Life Science Analysis
The FDA’s Peripheral and Central Nervous System (PCNS) Advisory Committee recently met to discuss Eli Lilly’s donanemab as a potential treatment for early Alzheimer’s disease. The committee looked at the trial design and safety signals of the drug, ultimately voting unanimously in favor of its risk-benefit profile. If donanemab is approved, it could help alleviate […]