This week we highlight a year-end review of private biopharma financing. We also look at a plan by the federal government to potentially seize patents on certain high-cost drugs. Additionally, we explore a breakthrough in treatment of sickle cell disease, the growing impact of counterfeit drugs on the life sciences industry and renewed efforts to address drug shortages in Europe.
Each week we highlight five things affecting the life sciences industry. Here’s the latest.
Private biopharmaceutical companies are expected to raise approximately $24 billion through 840 transactions by the end of the year, according to Fierce Biotech, marking the lowest amount in four years, down from $36.9 billion last year, which represents a $12.9 billion decrease. Despite the decline, a shift in investment strategy toward fewer but more significant deals suggests a more cautious approach, with investors setting higher benchmarks for clinical data readouts, and the hope for a market correction beginning next year.
The Biden administration has discussed plans to use executive authority to potentially seize patents of government-funded drugs if their prices are deemed to be excessive. This move aims to address the issue of high drug prices and involves a legal argument allowing the government to grant production rights to third parties if a drug is not accessible to the public. According to Pharmaceutical Technology, the pharmaceutical industry has opposed this plan suggesting it could lead to decreased innovation.
The U. S. Food and Drug Administration has approved a groundbreaking treatment for sickle cell disease, NBC News reports. The treatment uses CRISPR gene-editing to genetically modify a patient’s own stem cells, eliminating the need for a donor. While hailed as a game-changer, the therapy’s high cost of $2.2 million per patient and potential long-term effects raise concerns about accessibility and safety, prompting calls for ongoing monitoring and follow-up studies.
The World Health Organization estimates up to $431 billion in counterfeit drugs are sold worldwide on an annual basis. The United States has seen significant upticks in this activity over the past two years with nearly 20% increases in 2022 and 2023, according to CNBC. Several large pharmaceutical companies have filed lawsuits against entities accused of participating in these schemes, emphasizing the ongoing challenges in combating drug counterfeiting. Additionally, several investigations have been launched by the Department of Health and Human Services. Counterfeit medication has affected many pharmaceutical companies and touches various indications, focused primarily on medication with limited reimbursement. In some cases, medication vital for survival has been impacted by this activity and has put lives at risk.
The European Medicines Agency (EMA) has released a list of over 300 critical generic drugs that could potentially face shortages, aiming to prevent supply disruptions that may harm patients, Fierce Pharma reports. The list includes essential antibiotics, painkillers and vaccines for diseases like measles and rabies. European officials will use the list to define medicines requiring additional measures to strengthen supply; the EMA plans to update and extend the catalog next year as part of ongoing efforts to address drug shortages in the European Union. Europe has experienced major drug shortages throughout 2022 and 2023. The EMA hopes that this initiative will reduce such issues in 2024 and beyond.
For more insights in life sciences, check out RSM’s industry outlook.
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