Cervantes Corp Ltd

Myriad Genetics expands access to SneakPeek, a 99% accurate gender test, now available over-the-counter in over 8,800 retail locations, including Walmart, Walgreens, and CVS, allowing expectant parents to learn the baby's sex as early as six weeks into pregnancy. The test involves a simple blood sample collection with the SneakPeek Snap® device, followed by lab analysis with results delivered via text and email. This expansion aligns with a 2024 survey showing 82% of parents prefer to know the baby's sex before delivery, with a preference for in-store purchases over online orders.

The pursuit of convenience in healthcare may lead to shortcuts that don't improve long-term outcomes. For example, the rapid distribution of GLP-1s and CGMs through retail pharmacies, which are closing rapidly, may not ensure patient adherence and satisfaction. Health plans should consider alternative distribution methods, such as collaborating with primary care providers and DMEs, to provide better support and education, ensuring better long-term patient outcomes.

New Chief Editor of Clinical Leader, Dan Schell, shares insights gained over a year, including the evolution of DCTs, DE&I efforts, site payment issues, integration challenges, and retail involvement in trials. He credits networking and interactions with industry experts for his learning journey.

The FDA proposed removing oral phenylephrine from the market due to its ineffectiveness as a nasal decongestant, launching a six-month public comment period. CVS stopped selling phenylephrine products last year after an FDA advisory committee deemed it ineffective. The FDA's proposal targets only oral forms of the drug, not nasal sprays. The Consumer Healthcare Products Association opposes the move, arguing that phenylephrine should remain available as a self-care option.

The FDA proposed removing oral phenylephrine from the market due to its ineffectiveness as a decongestant, launching a six-month public comment period before a final decision. CVS stopped selling products with phenylephrine last year after an FDA advisory committee declared it ineffective, while other major pharmacies still stock it. The FDA's proposal targets only oral forms, not nasal sprays.

FDA approves Journey Medical’s Emrosi (minocycline hydrochloride extended-release capsules) for rosacea treatment, with initial supplies expected in Q1-Q2 2024. FDA also proposes removing oral phenylephrine from OTC nasal decongestants due to lack of efficacy, and mandates mail-back envelopes for opioid disposal under OA REMS program starting March 2025.

Skyrizi surpasses Humira in sales, causing concerns for adalimumab biosimilar market growth. Despite biosimilars capturing 22% market share by Oct 2024, Skyrizi's rise and product hopping complicate biosimilar sustainability. Clinical trials show Skyrizi's superior efficacy in psoriasis treatment, and policy reforms are advocated to enhance biosimilar access and competition.

The FDA proposes to remove oral phenylephrine from cough and cold medicines due to its ineffectiveness as a nasal decongestant, following advisory committee votes against its continued use. The public can comment until May 7, 2024, after which drugmakers may need to reformulate or remove products containing the ingredient.