The FDA laid out a three-year roadmap to phase out animal toxicity testing in drug research. In addition to organoids and lab-on-a-chip tests, the agency is encouraging drug companies to use computer simulations and artificial intelligence to predict drug behavior.
A look at some of the top law firms that serve companies in the healthcare and life sciences fields, from early stage startups to growth stage businesses.
This webinar will explore how a banking platform approach could be the resource for your company.
As the FDA’s top biologics official, Peter Marks oversaw regulation of cell and gene therapies. The departure of Marks and mass layoffs throughout the FDA raise concerns about the agency’s ability to review and potentially approve such treatments.
BridgeBio Pharma’s approval of Beyonttra comes three months after the drug landed FDA approval for cardiomyopathy caused by transthyretin amyloidosis. Our recap of recent regulatory news also spans approvals in cancer, immunology, vaccines, and more.
Novo Nordisk’s type 2 diabetes drug Ozempic has expanded its label to include chronic kidney disease. The new FDA approval comes as makers of GLP-1 drugs work to expand the uses of these products.
Metabolic medicines dominated life sciences headlines in 2024, a trend expected to continue into the new year. Other things to look for include more widespread adoption of artificial intelligence technologies and the IPO market’s return to normal levels.
Health care professionals can refer patients to the best options for diagnostic imaging covered by Medicare to give more people the medical assistance they need without extra financial stress.
A patient death in a clinical trial usually prompts the FDA to impose a clinical hold. But Neurogene is able to avoid a lengthy clinical trial pause largely because of its participation in an FDA pilot program intended to speed up the development of therapies for rare diseases.
The PTC Therapeutics gene therapy, Kebilidi, treats an enzyme deficiency that affects the body’s ability to produce dopamine, a neurotransmitter important for motor control. FDA approval for the product comes two years after it won its first regulatory approvals in Europe.
Johnson & Johnson is suing the federal agencies overseeing the 340B program that makes discounted medicines more accessible to uninsured and underserved patients. J&J contends the Health Resources Services Administration can’t legally oppose its plan to implement a new rebate plan for certain 340B drugs.
The FDA has proposed removing oral phenylephrine from its guidelines for over-the-counter drugs due to inefficacy as a decongestant. Use of this ingredient in cold and allergy medicines grew after a federal law required that pseudoephedrine-containing products be kept behind pharmacy counters.
The layout of your phlebotomy station can significantly impact efficiency. A well-thought-out setup ensures that every tool is within reach, minimizing unnecessary movement and reducing patient wait times.
Johnson & Johnson stopped short of implementing its proposal to alter the way two drugs are paid for under the 340B drug discount program, but the drugmaker made it clear it still wants changes. In other recent regulatory news, we have drug approvals, clinical holds, and one product withdrawal.
Securities regulators say the role of Ipsen employee Dishant Gupta made him privy to details of the Epizyme acquisition. Gupta allegedly accumulated Epizyme shares while the deal was negotiated, then sold all of them hours after the transaction was announced.
The eBook Femtech Revolution: How Entrepreneurs Are Championing Women’s Health Equity highlights femtech to help track menstruation, how femtech can support access to care, data privacy concerns, and more.
The American Hospital Association sent letters to the Senate and House urging them to support legislation that would prevent the CMS from enforcing its final rule on minimum staffing requirements for long-term care facilities. The organization argued that the mandate could lead nursing homes to reduce capacity or close altogether.
FDA draft guidance eliminates the requirement that biosimilars produce clinical data to show they are interchangeable with their reference drugs. Some lawmakers have said these so-called switching studies add time and expense to the development of biosimilars, delaying them from reaching patients.