This week we highlight a shortage of prescription medication in the United States. In addition, we discuss a Food and Drug Administration committee’s recommendation to approve a new RSV vaccine, comments on the Inflation Reduction Act impact, as well as a major acquisition in the diabetes space. Lastly, we look at new FDA guidance on clinical trials.
Each week we highlight five things affecting the life sciences industry. Here’s the latest.
Major drug shortages lead to rationing
A combination of quality issues, supply chain delays and financial hurdles have led to a shortage of prescription medication in the United States. Oncology drugs are particularly affected and the shortages have forced health care providers to ration treatment. The federal government is working on plans to address this issue and have considered offering tax incentives for generic drug manufacturers.
FDA panel recommends approval of new RSV vaccine
An FDA advisory panel recommended the approval of a monoclonal antibody shot to prevent respiratory syncytial virus, or RSV, in infants and toddlers. Currently, the only RSV vaccine available for infants requires several doses and is prescribed only to high-risk patients. This vaccine would require one dose and would be available to all infants and toddlers.
FDA commissioner addresses IRA and changes in regulatory approval process
FDA Commissioner Rob Califf expressed concerns about high drug prices and misinformation in the pharmaceutical industry. He discussed the need for improved processes and stated that the Inflation Reduction Act is a step toward addressing issues with drug pricing. Califf also highlighted the importance of changes to the accelerated approval process.
Medtronic acquires insulin patch pump manufacturer for $784 million
Medtronic’s diabetes department has been in the spotlight recently with significant developments and expansion. This week the company announced plans to acquire EOFlow, a South Korean manufacturer of an insulin patch pump, for $738 million. The acquisition, which involves acquiring all outstanding shares of EOFlow, is expected to bolster Medtronic’s growth in its diabetes unit.
FDA publishes draft guidance on modernization of clinical trials
The FDA has issued draft guidance with updated recommendations for good clinical practices to modernize clinical trials, making them more efficient without compromising data integrity or participant safety. The guidance incorporates innovative trial designs and encourages the use of digital health technologies. The goal of the new guidance is to improve data quality, security and integrity. Public comments on the draft guidance will be considered before finalization.
