Pharma Flash for May 26, 2023
The FDA has granted approval for a new drug to treat hot flashes caused by menopause. Approval for Veozah was granted to Astellas Pharma and provides a non-hormonal treatment option for menopausal women experiencing hot flashes. Clinical trials demonstrated the drug's efficacy in reducing the frequency and severity of hot flashes compared to a placebo. The approval of this drug expands the available treatment choices in managing menopause-related hot flashes. Read here.
The FDA has issued two draft guidances aimed at facilitating the approval of pediatric drug products. These guidances provide recommendations and considerations for conducting studies and generating data to support pediatric drug development. The first guidance focuses on pediatric study plans, emphasizing the importance of early planning and collaboration with the FDA. The second guidance addresses extrapolation of efficacy data from adults to pediatric populations. Read more.
The FDA has granted approval to Perrigo for its nicotine-coated mint lozenge as an over-the-counter smoking cessation aid. The lozenge is designed to help individuals quit smoking by providing a controlled release of nicotine to alleviate withdrawal symptoms. Perrigo's product offers an alternative option for smokers looking to quit and adds to the range of available nicotine replacement therapies. The approval was based on clinical data demonstrating the effectiveness and safety of the mint lozenge in helping smokers quit. Read more.
The FDA granted approval for RINVOQ, a once-daily pill, as a treatment for Crohn's disease. RINVOQ, developed by AbbVie, is an oral Janus kinase (JAK) inhibitor that works by targeting inflammation in the body. This approval provides a new treatment option for patients with moderate to severe Crohn's disease who have not responded well to other therapies. The decision was based on positive results from clinical trials demonstrating the drug's efficacy and safety profile. Read more.
Alcami, a CDMO for the pharmaceutical industry, announced the appointment of Laurent Boer as new General Manager for its Biostorage and Pharmaceutical Support Services. Boer brings extensive experience in the pharmaceutical industry, particularly in the areas of biostorage and logistics management. With this appointment, Alcami aims to strengthen its capabilities in biostorage and enhance its support services for pharmaceutical clients. Read more.