Category: FDA

FDA, Pharmaceuticals

Breakthrough Therapy Designation Granted to Bayer’s BAY 2927088 for Non-Small Cell Lung Cancer Treatment

Published February 28, 2024 Bayer’s BAY 2927088, a reversible tyrosine kinase inhibitor (TKI) developed in collaboration with the Broad Institute of MIT and Harvard, is currently undergoing a Phase I trial projected to enroll 460 patients. The US Food and Drug Administration (FDA) has awarded breakthrough therapy designation to Bayer for BAY 2927088 in the treatment of non-small cell lung cancer (NSCLC). This orally administered … Continue reading Breakthrough Therapy Designation Granted to Bayer’s BAY 2927088 for Non-Small Cell Lung Cancer Treatment

Ann Poorboy
FDA, Pharmaceuticals

Roche’s Xolair Shows Promise in Reducing Severe Food Allergies, Earns FDA Approval

The groundbreaking study, also published in The New England Journal of Medicine, heralds a new era in the management of severe food allergies. With FDA approval secured and promising results in hand, Roche’s Xolair emerges as a beacon of hope for millions grappling with the daily challenges posed by food allergies. Continue reading Roche’s Xolair Shows Promise in Reducing Severe Food Allergies, Earns FDA Approval

Ann Poorboy
FDA, Pharmaceuticals

Pharmaceutical Industry Opposes Move as States Seek to Slash Drug Prices through Importation

In a groundbreaking decision, the Food and Drug Administration (FDA) has granted approval to Florida to import medications worth millions of dollars from Canada, marking a significant departure from decades of resistance by the pharmaceutical industry. This move is anticipated to open avenues for other states to follow suit and explore similar initiatives, with supporters hopeful for a breakthrough in the perennial battle against soaring drug prices in the United States. Continue reading Pharmaceutical Industry Opposes Move as States Seek to Slash Drug Prices through Importation

Ann Poorboy
FDA, Lawsuits, Pharmaceuticals

Navigating the Evolving Terrain of False Claims Act: Circuit Splits, Causation Complexities, and Whistleblower Triumphs

Published January 3, 2023 In the ever-evolving landscape of False Claims Act (FCA) cases, recent decisions by the Eighth and Sixth Circuits have ignited a circuit split, particularly concerning the interpretation of the anti-kickback statute. The rulings in United States ex rel. Cairns v. D.S. Medical, LLC, and United States ex rel. Martin v. Hathaway, et al., established that proving “but-for” causation is crucial to … Continue reading Navigating the Evolving Terrain of False Claims Act: Circuit Splits, Causation Complexities, and Whistleblower Triumphs

Ann Poorboy
FDA, Pharmaceuticals

Advancing Pharmaceutical Traceability: FDA Holds Crucial Stakeholders’ Engagement

DSCSA directs the FDA to establish national licensure standards for wholesale distributors and third-party logistics providers, reinforcing the importance of regulatory measures to ensure the safety and security of the drug supply chain. This comprehensive approach aligns with global efforts to fortify pharmaceutical traceability and safeguard public health. Continue reading Advancing Pharmaceutical Traceability: FDA Holds Crucial Stakeholders’ Engagement

Ann Poorboy
FDA, Pharmaceuticals

Revolutionizing Sickle Cell Treatment: Vertex and CRISPR Therapeutics’ Gene Therapy Awaits FDA Approval

The journey towards FDA approval for exa-cel and the potential transformation of sickle cell treatment is poised at a critical juncture. The decisions and developments in the coming months will have a profound impact on the lives of those suffering from this debilitating disease. Continue reading Revolutionizing Sickle Cell Treatment: Vertex and CRISPR Therapeutics’ Gene Therapy Awaits FDA Approval

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FDA, Medical Device

FDA Grants Breakthrough Device Designation to SeaStar Medical’s Innovative Device for Hepatorenal Syndrome

SeaStar Medical Holding Corporation (Nasdaq: ICU), a pioneering medical device company specializing in solutions to combat the impact of hyperinflammation on vital organs, is pleased to announce that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for its groundbreaking Selective Cytopheretic Device (SCD). This patented, first-of-its-kind device is designed for use in the hospital intensive care unit (ICU) to treat patients with acute kidney injury (AKI) and acute on chronic liver failure. This is the third such designation awarded by the FDA to SeaStar Medical for the SCD device, and it is expected to expedite the clinical development and regulatory review process for its use in this specific patient population. Continue reading FDA Grants Breakthrough Device Designation to SeaStar Medical’s Innovative Device for Hepatorenal Syndrome

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FDA, Pharmaceuticals, Rare Diseases

FDA Extends Review for Livmarli’s Expanded Approval, Impacting Mirum Pharmaceuticals

The Food and Drug Administration (FDA) recently made a significant announcement regarding the Supplemental New Drug Application (sNDA) for Mirum Pharmaceuticals’ innovative product, Livmarli (maralixibat). Livmarli is intended for the treatment of patients suffering from cholestatic pruritus associated with progressive familial intrahepatic cholestasis (PFIC). In a strategic move, the FDA has opted to extend the Prescription Drug User Fee Act (PDUFA) date to allow for a thorough review of a submission that was in response to a major FDA information request. This extension has pushed the decision date from December 13 to March 13, 2024, indicating a rigorous evaluation process. Continue reading FDA Extends Review for Livmarli’s Expanded Approval, Impacting Mirum Pharmaceuticals

Ann Poorboy
FDA, Rare Diseases

The FDA’s Regulatory Calendar in Full Swing, Featuring High-Stakes Decisions

In the world of pharmaceuticals and biotechnology, the FDA’s schedule is accelerating rapidly, with a series of pivotal action dates slated for the next two weeks. These critical decisions encompass groundbreaking cancer treatments, sought-after therapies for rare pediatric disorders, and more. Here’s an overview of the notable developments on the horizon. Continue reading The FDA’s Regulatory Calendar in Full Swing, Featuring High-Stakes Decisions

Ann Poorboy