This week we highlight the early 2024 surge in biotech initial public offerings, a potential TikTok campaign to boost vaccine uptake and proposals relating to extending the transition of European medtech regulations. We also examine the U.S. Food and Drug Administration’s warnings of potential cancer risks in CAR-T therapies. Additionally, we look at Martin Shkreli’s lifetime ban from the pharmaceutical industry.
Each week we highlight five things affecting the life sciences industry. Here’s the latest.
BioSpace reports a notable early surge in biotech IPOs in 2024, marking a significant rebound from the previous year’s downturn. Five companies, including Alto Neuroscience and CG Oncology, have already entered the market, with CG Oncology projecting substantial proceeds from its offering. This influx of public offerings is crucial for the industry, providing essential capital for technology and therapy development. Analysts had predicted this rebound, emphasizing the need for strong clinical data for successful public offerings.
Fierce Pharma reports on a unique approach proposed by a British politician to address the declining MMR vaccine uptake in England where measles cases are surging. Amid concerns over increasing measles cases and the lowest MMR vaccination rates in over a decade, the idea is to leverage TikTok for a social media campaign targeting parents under 40. This strategy aims to counter vaccine hesitancy, partly fueled by misinformation, and to improve vaccination rates, especially in areas like Birmingham, which has had the most cases.
The European Commission is advocating for an extended transition period for compliance with the in vitro diagnostic medical devices regulation (IDVR), focusing on ensuring the availability of essential health care products and patient care. This proposal, as reported by Med-Tech News, includes staggered deadlines until December 2027, 2028 and 2029 for high to low-risk in vitro diagnostics, along with a requirement for manufacturers to notify of potential supply interruptions. Additionally, it aims to enhance medical device sector transparency by expediting the launch of the European database on medical devices now pending adoption by the European Parliament and Council.
According to NBC News, the FDA has mandated a boxed warning, its most stringent safety label, for CAR-T therapy, a cancer treatment, because of potential cancer risks. This decision follows reports of rare blood cancers in patients who had undergone CAR-T therapy. Despite the warning, the FDA maintains that the benefits of CAR-T therapy, which uses a patient’s own immune cells to treat blood cancers like leukemia, outweigh the potential risks. The therapy has been highly effective in difficult cases, but the recent FDA action reflects growing concerns about long-term safety. The FDA’s move underscores the delicate balance between innovative cancer treatments and their potential long-term effects.
CNBC reports that a federal appeals court has upheld the lifetime ban on Martin Shkreli, the former CEO of Turing Pharmaceuticals, from working in the pharmaceutical industry. This decision also includes an order for Shkreli to pay up to $64.6 million in disgorged profits for anticompetitive actions related to the drug Daraprim. The ruling, affirming the district court’s injunction, is seen as a measure to protect the public from Shkreli’s past misconduct in the pharmaceutical industry, particularly his role in drastically raising the price of Daraprim, a life-saving drug. The court’s decision emphasizes the need for accountability in corporate actions that impact public health and consumer access to essential medications.
For more insights in life sciences, check out RSM’s industry outlook.