Welcome to The Pharma Flash, a weekly countdown of the top 5 news articles on American Pharmaceutical Review and Pharmaceutical Outsourcing's websites.
Akorn, a company that specializes in the development and manufacturing of human and animal drugs, issued a recall of several of its products. The recall comes as a result of the company's shutdown due to quality control issues that led to the suspension of its manufacturing license by the FDA. The affected products include prescription and OTC medications for both humans and animals, such as ophthalmic ointments, injections, and nasal sprays. The company is advising consumers to stop using the products and to contact their healthcare provider or veterinarian for further instructions.
Japanese pharmaceutical company Astellas announced its plans to acquire Iveric Bio, a US-based ophthalmology-focused gene therapy company, for approximately $1.3 billion. The acquisition aims to strengthen Astellas' pipeline in the ophthalmology field by integrating Iveric’s investigational treatments for retinal diseases into Astellas' portfolio. Iveric Bio's pipeline includes gene therapies for conditions such as age-related macular degeneration and inherited retinal diseases. The acquisition is expected to close in the second half of 2023, subject to regulatory approvals and other customary closing conditions.
The FDA issued final guidance on the development of nicotine replacement therapy (NRT) drug products, which are used to help people quit smoking. The guidance aims to provide recommendations for the nonclinical and clinical development of NRT products, including OTC and prescription products. The guidance also provides recommendations on labeling and packaging, as well as postmarketing safety reporting. The FDA hopes that this guidance will help facilitate the development of new and innovative NRT products to help people quit smoking and reduce the public health burden of tobacco-related diseases.
Aldevron, a biotech company that specializes in the production of plasmid DNA and proteins, announced its plans to expand its mRNA production capabilities. The expansion aims to meet the increasing demand for mRNA-based therapies and vaccines, including those developed for COVID-19. The company plans to add a new manufacturing facility to its campus in Fargo, North Dakota, which will be dedicated to mRNA production. The new facility is expected to be operational by the end of 2022 and will create more than 300 new jobs.
The Sandoz division of Novartis entered into an agreement with Adalvo to commercialize six biosimilars in the US. The products include biosimilars for the treatment of cancer and autoimmune diseases such as rheumatoid arthritis and Crohn's disease. The agreement is part of Sandoz's strategy to expand its biosimilars portfolio and improve patient access to these treatments. Adalvo, a biopharmaceutical company based in Spain, will be responsible for the development, manufacturing, and supply of the biosimilars, while Sandoz will be responsible for their commercialization in the US market.