Month: July 2024

Abbott Issues Recall for Freestyle Libre 3 Sensors Over Inaccurate Glucose Measurements

Abbott Issues Recall for Freestyle Libre 3 Sensors Over Inaccurate Glucose Measurements

Abbott, a global healthcare company, recently announced a recal of a limited number of its Freestyle Libre 3 sensors in the United States, specifically those distributed in the first half of May. This action was taken after Abbott’s internal testing revealed that three specific lots of these continuous glucose monitor (CGM) sensors were potentially giving […]

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EMA Committee Cites Safety Concerns in Negative Review of Eisai Alzheimer’s Drug

EMA Committee Cites Safety Concerns in Negative Review of Eisai Alzheimer’s Drug

Eisai, a pharmaceutical company, has encountered significant challenges in introducing its Alzheimer’s drug, Leqembi, to the European market following a negative assessment by the European Medicines Agency (EMA). The EMA’s Committee for Medicinal Products for Human Use (CHMP) advised against granting marketing authorization in Europe, citing that the drug’s benefits do not sufficiently outweigh its […]

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Mid-Year Review: Novel Drug Approvals and Supporting Clinical Trials in 2024

Mid-Year Review: Novel Drug Approvals and Supporting Clinical Trials in 2024

In the first half of 2024, the FDA’s Center for Drug Evaluation and Research (CDER) approved 21 novel drug products, revealing trends in the reliance on single pivotal trials and the racial/ethnic diversity of trial participants. This analysis by AgencyIQ offers a midpoint overview of drug approval processes and characteristics, including drugs’ indications, mechanisms, and […]

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Mid-Year Review: Analyzing Newly Approved Drugs and Their Clinical Trials in 2024 | In-Depth Insights into Life Sciences

Mid-Year Review: Analyzing Newly Approved Drugs and Their Clinical Trials in 2024 | In-Depth Insights into Life Sciences

This text provides a brief insight into a report by AgencyIQ analyzing the drug approvals made by the FDA’s Center for Drug Evaluation and Research (CDER) in the first half of 2024. During this period, CDER approved 21 novel drug products. The analysis focuses on the number of these approvals that were based on a […]

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Autobahn Therapeutics Prepares for Depression Drug Clinical Trials with $100M Funding

Autobahn Therapeutics Prepares for Depression Drug Clinical Trials with $100M Funding

Over the years, there has been a growing awareness of the links between thyroid hormones and mood disorders, particularly depression. Autobahn Therapeutics, a pioneer in this field, is harnessing this relationship by developing a novel treatment aimed at enhancing the efficacy of depression medications when traditional antidepressants fall short. Autobahn’s breakthrough centers around the targeted […]

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CDRH Director Shuren Steps Down Following 15-Year Tenure

CDRH Director Shuren Steps Down Following 15-Year Tenure

Jeff Shuren, the longstanding director of the Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH), announced his decision to retire after a remarkable 15-year tenure. His departure is scheduled for later this year, with the transition of leadership beginning on July 28. Michelle Tarver, currently the deputy director for transformation at […]

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FDA Pushes Forward with Diagnostics Policy Despite Challenges, Amid Congressional, Legal, and Judicial Scrutiny | Exclusive Article from FDA Today

FDA Pushes Forward with Diagnostics Policy Despite Challenges, Amid Congressional, Legal, and Judicial Scrutiny | Exclusive Article from FDA Today

I’m sorry for any confusion, but the text you’ve provided seems to be an introductory snippet or a description of an article rather than the full article itself. It mentions that the FDA issued a final rule in April 2024 to update regulations regarding Laboratory Developed Tests (LDTs) and notes potential impacts from Supreme Court […]

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FDA Issues Two Warning Letters Following Inspection of Syringe Manufacturers in China

FDA Issues Two Warning Letters Following Inspection of Syringe Manufacturers in China

The Food and Drug Administration (FDA) has increased its scrutiny of plastic syringes manufactured in China, issuing additional warnings to two companies, Jiangsu Shenli Medical Production and Jiangsu Caina Medical, for failing to meet quality standards. Jiangsu Shenli, which had previously received a warning in March, was sent another warning following a later inspection of […]

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How the Management of Food Allergies Has Evolved Over the Past 10 Years

How the Management of Food Allergies Has Evolved Over the Past 10 Years

Over the past decade, significant strides have been made in the understanding and treatment of food allergies. This evolution was significantly highlighted through Dr. Kari Nadeau’s pioneering clinical trials at Stanford University with 85 food allergy patients, published by the New York Times 11 years ago. Dr. Nadeau’s work has paved the way for groundbreaking […]

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