Pharma Flash for May 19, 2023
The FDA issued new guidelines for testing high-risk drug components for diethylene glycol (DEG) and ethylene glycol (EG). DEG and EG are toxic substances that can be harmful if present in pharmaceutical products. The guidance aims to ensure the safety and quality of drugs by implementing rigorous testing protocols to detect these potentially dangerous compounds. By providing clearer instructions and standards, the FDA hopes to prevent future incidents of drug contamination and protect public health.
Perrigo announced the retirement of its CEO, Murray S. Kessler, after serving for four years. The company also unveiled its succession plan, appointing Rich Sorota, the current President of Consumer Self-Care Americas, as the new CEO. Sorota brings experience in the consumer healthcare industry and is expected to lead Perrigo future growth. This leadership transition reflects Perrigo's commitment to strategic planning and ensuring continuity in its executive team.
Adaptive Biotechnologies announced that the FDA has accepted Genentech's Investigational New Drug (IND) application for T-cell therapy. This acceptance signifies that the FDA has agreed to review the proposed clinical trial of the therapy. T-cell therapy is a promising approach that utilizes the body's immune system to target and fight cancer cells. The acceptance of the IND is an important milestone for Adaptive Biotechnologies and Genentech, paving the way for further development and evaluation of this potentially transformative therapy in the treatment of cancer.
Vetter, a CDMO announced the expansion of its production capacities and services at its Austrian site. The expansion aims to meet the growing demand for aseptic manufacturing services and provide additional support to clients in the biopharmaceutical industry. The increased production capabilities will enable Vetter to accommodate larger batch sizes and offer a broader range of services, including fill and finish processes. This expansion reflects the company’s desire to meet the evolving needs of its clients and strengthen its position in the pharmaceutical industry.
AstraZeneca's diabetes drug, Farxiga received approval for expanded use in a broader range of patients. The FDA granted the new indication, allowing Farxiga to be prescribed to patients with chronic kidney disease (CKD) regardless of their type 2 diabetes status. Previously, the drug was approved for use in patients with type 2 diabetes and cardiovascular disease. This expanded approval provides healthcare providers with an additional treatment option for managing CKD in a wider patient population, potentially improving outcomes for those affected by this condition.