BY David Lange, Director, Governance, Risk and Compliance Services, Weaver   The pharmaceutical industry is undergoing a fundamental transformation in how drugs are manufactured. As regulatory requirements grow more complex and quality standards become increasingly stringent, companies are reevaluating their manufacturing strategies. The global pharmaceutical contract manufacturing market, projected to exceed $120 billion by 2025, reflects a growing trend toward outsourced manufacturing as a means to enhance quality, ensure compliance and optimize costs.   Current...

In a new paper recently published in Nature, the Translational Research Institute for Space Health (TRISH), a consortium led by Baylor College of Medicine’s Center for Space Medicine with partners California Institute of Technology and Massachusetts Institute of Technology, and its collaborators present spaceflight health data captured from the first all-civilian orbital spaceflight mission in history. Results from a small sample size suggest short-duration spaceflights pose no significant health risks to private astronauts. The research also lays the...

BY Caitie Barkley, UTHealth Houston Charles S. Cox Jr., MD, Professor in the Department of Pediatric Surgery with McGovern Medical School at UTHealth Houston.       Linda Ewing-Cobbs, PhD, Professor in the Department of Pediatrics with McGovern Medical School at UTHealth Houston.         After children experienced severe traumatic brain injury, the infusion of bone marrow mononuclear cells derived from the patient’s own bones led to less time spent in intensive care,...

BY Jaime Pego Curcio – Advisory Principal, Matthew Colford – Advisory Director, Marissa Fremont – Advisory Director, Forensic Practice, KPMG The U.S. Department of Justice (DOJ) has introduced a new Safe Harbor Policy (hereafter referred to as the Policy) for voluntary self-disclosures made in connection with mergers and acquisitions (M&A). The Policy builds on prior DOJ actions, including: The Deputy Attorney General’s September 2022 memorandum (Monaco Memo – see KPMG Regulatory Alert here) Revisions to...

BY Staci Saint-Preux, Industry Manager, StormGeo   It has been a relatively quiet hurricane season – so far. Traditionally the peak of the Atlantic tropical season is September 10th, with two-thirds of activity occurring between August 20th and October 10th. As we move into this period, meteorologists at StormGeo are continuing to see signs of an active hurricane season along the Gulf Coast and Atlantic Seaboard.   When hurricanes make landfall, emergency managers, facility directors,...

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By Courtland Keith, Industry Manager, StormGeo How mature is your hospital’s emergency response plan for severe weather events like hurricanes? One of the toughest jobs in healthcare administration is having to anticipate worst-case scenarios. A massive storm’s impact on a hospital can be widely spread, from protecting current patients to bracing for an influx of storm-related cases. Emergency managers can prepare for and pick up the pieces of these disasters using the right resources and...