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.
As technology advances, AI-powered tools will increasingly reduce the administrative burdens on healthcare providers.
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.
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 future looks bright for the integrated specialty pharmacy model – for health systems, providers, and most importantly, for patients.
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.
Two senators recently introduced a bill that seeks to regulate private equity firms’ involvement in the healthcare industry. If passed, the act would establish a criminal penalty of up to six years in prison for private equity executives whose business decisions result in a patient’s death.
The progress in artificial intelligence (AI) is reshaping patient care, across various dimensions, from facilitating faster discharge to curating treatment plans and suggesting lifestyle changes.
The PTC Therapeutics drug Translarna failed its confirmatory study in Duchenne muscular dystrophy. Analysts say the European Commission’s decision to not adopt the Committee on Medicinal Products for Human Use’s negative opinion on the drug is unusual, if not unprecedented.
Labcorp’s $239 million offer was selected as the winning bid for the assets of genetic testing company Invitae, which filed for bankruptcy protection earlier this year. The acquisition deal, Labcorp's second in the past month, will enable it to expand in oncology and rare diseases.
More than 33,000 Providence employees filed a class-action complaint against the health system in 2021, alleging that it had been withholding their wages by denying them breaks and rounding down their working hours. Last week, Providence was ordered to pay more than $200 million in damages — a decision that “sends a message to healthcare corporations,” according to an attorney representing the workers.
AliveCor CEO Priya Abani argues that Apple has made a habit of taking intellectual property from smaller medical device firms in order to improve the functionalities its Apple Watch. She also believes that Apple has been able to avoid taking accountability for this by “bombarding” smaller companies with litigation it knows they won’t be able to afford — a claim that medical IP lawyers have backed up.
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.