This week's FDA news and more! Check out the PharmaFlash for the top five most read news stories
Akorn issued a recall for several of its human and animal drug products. The recall is a result of the company's shutdown, which has led to concerns about the safety and quality of their medications. The recall affects various products, including injectables, ophthalmics, and oral liquids. Customers are advised to discontinue use and return the affected products to avoid potential health risks.
Astellas, announced its acquisition of Iveric Bio, a biotechnology company specializing in ophthalmic diseases. The deal involves Astellas paying approximately $1.3 billion to acquire Iveric Bio, gaining access to their innovative gene therapy and gene editing platforms. This strategic move will expand Astellas' capabilities in the field of gene therapies for retinal diseases. The acquisition is expected to enhance Astellas' pipeline and advance the development of potential treatments for patients with vision-threatening conditions.
Sterling, a contract development and manufacturing organization (CDMO), is set to join a cross-disciplinary partnership aimed at advancing artificial intelligence (AI) flow chemistry techniques. The collaboration includes academic institutions and technology companies focused on leveraging AI to enhance the efficiency and effectiveness of flow chemistry processes. By combining expertise from different fields, the partnership aims to accelerate the development and implementation of AI-driven solutions in chemical manufacturing.
Charles River Laboratories, a provider of research services, has partnered with Wheeler Bio, a biotechnology company, to establish and operate the RightSourceSM Laboratory. This facility will specialize in supporting preclinical research and drug discovery programs. The collaboration aims to provide clients with comprehensive, high-quality laboratory services to accelerate their research and development efforts. The RightSourceSM Laboratory will leverage the expertise and resources of both companies to offer innovative solutions and contribute to advancements in the pharmaceutical and biotechnology sectors.
The FDA issued final guidance regarding nicotine replacement therapy (NRT) drug products. The guidance aims to provide clarity and recommendations for manufacturers seeking approval for over-the-counter NRT products. It addresses various aspects, including study design, labeling requirements, and considerations for specific populations like pregnant and breastfeeding individuals. The FDA intends for this guidance to facilitate the development of safe and effective NRT options, helping individuals quit smoking and reduce nicotine dependence.