Published March 5, 2024 The landscape of lung cancer treatment is evolving rapidly, with Johnson & Johnson’s Rybrevant at the forefront of groundbreaking advancements. This comprehensive whitepaper delves into the multifaceted dimensions of Rybrevant’s role in reshaping the therapeutic landscape for certain subsets of lung cancer patients. Regulatory Milestones Following recent FDA approval, Rybrevant has been granted access to the first-line treatment arsenal, alongside carboplatin and pemetrexed, for advanced non-small cell lung cancer (NSCLC) harboring EGFR exon 20 insertion mutations ..read more

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 drug selectively targets mutant forms of HER2 and EGFR and is intended for adults with unresectable or metastatic NSCLC harboring HER2 mutations, who have previously n ..read more

Published February 27, 2024 Big pharmaceutical players are making significant investments in nuclear medicine, reshaping the landscape of cancer treatment with targeted approaches. With billions of dollars poured into research and development, these companies are pioneering new therapies designed to combat cancer with precision akin to guided missiles. One of the most prominent avenues of exploration is in antibody-drug conjugates (ADCs), which deliver chemotherapy directly to tumors. Pfizer’s landmark $43 billion acquisition of biotech Seagen Inc. in the field underscores the immense interest ..read more

Published February 26, 2023 A groundbreaking study presented at the American Academy of Allergy, Asthma & Immunology meeting revealed promising results for Roche’s Xolair in the treatment of severe food allergies. Developed over two decades ago as an asthma medication, Xolair, co-marketed with Novartis, demonstrated significant effectiveness in reducing allergic reactions in individuals with multiple severe food allergies. The late-stage trial showcased compelling evidence, leading to the recent approval by the U.S. Food and Drug Administration (FDA) earlier this month. The approval extend ..read more

Published January 30, 2024 Overview: Good news emerged from Vertex Pharmaceuticals (NASDAQ: VRTX) on Tuesday, leading to a surge in the company’s stock. The positive developments center around VX-548, an investigational drug designed to address moderate to severe acute pain. Despite a slight setback in meeting a secondary endpoint, the primary goal of pain reduction was achieved, sparking optimism in the market. Clinical Trial Success: Vertex declared that VX-548 demonstrated effectiveness in meeting its primary endpoint during a phase 3 trial involving patients experiencing various pain condi ..read more

Published January 20, 2024 NovaBay Pharmaceuticals, Inc. (NYSE American:NBY) and Sonoma Pharmaceuticals, Inc. (NASDAQ:SNOA) have joined forces in a groundbreaking agreement for the sale and marketing of Avenova®-branded products within the European Union. This collaboration integrates Sonoma’s acclaimed eye product, Ocudox®, which has already obtained a Class IIB CE mark for European Union sales, with the well-established Avenova branding. The resulting innovative products will be introduced to the European market through Sonoma’s extensive distribution network. This strategic partnership harn ..read more

Published January 9, 2024 Novartis is addressing a temporary shortage of Pluvicto by significantly expanding its manufacturing capabilities. The Swiss pharmaceutical company has unveiled a new commercial radiotherapy facility in Indianapolis, marked as its largest and most advanced globally, receiving FDA approval for the production of commercial doses of Pluvicto. Previously dedicated to Pluvicto production for clinical trials, the 70,000-square-foot facility is designed for radioligand therapies, a focal point for Novartis. This state-of-the-art facility enables continuous line expansion and ..read more

Published January 5, 2024 Protecting Medical Devices from Cyber Threats In the era of interconnected medical devices, such as heart monitors and insulin pumps, the ability to track real-time patient data through connected networks has become a standard practice for healthcare professionals. However, a recent watchdog report from the U.S. Government Accountability Office (GAO) emphasizes the need for federal agencies to update their cybersecurity agreement to safeguard these vital medical tools. The report underscores that while cyber-attacks on medical devices are not common, they have the pot ..read more

Published January 4, 2024 In a significant development, Agios Pharmaceuticals (AGIO.O) has reported positive results from its late-stage study of the drug mitapivat, bringing the company closer to obtaining approval for the first-ever oral treatment for less severe forms of thalassemia, an inherited blood disorder. The study demonstrated a statistically significant increase in hemoglobin response compared with a placebo in patients with either alpha- or beta-thalassemia who were not dependent on transfusion. Mitapivat’s Success in the Late-Stage Study: Mitapivat, the oral drug developed by Agi ..read more

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 establish damages in FCA cases grounded in anti-kickback statute violations. Circuit Split and But-For Causation: While these decisions deepen the divide among circuits, their im ..read more