Equity investment in European biotechnology firms engaged in therapeutic discovery and development continued its downward slide during the third quarter. The total for the period, $1.106 billion, is down 39% on the second quarter of this year and down 41% on Q3 2021. The ongoing weakness of the public markets is the main driver of the trend. In Q3, listed firms raised little more than half of what they managed in Q1 of this year, while the IPO window remains firmly closed. At present, the sector is bumping along at investment levels last seen about five years ago.
The U.K. Medicines and Health Care Products Regulatory Agency (MHRA) announced recently that it is considering an increase in the fees it levies on industry for a variety of services and actions, such as premarket applications. One of these is a 10% indexation increase in all statutory fees, but there are also some proposed increases in cost recovery charges and an additional 22 new fees for cost recovery that would be new to applicants seeking access to the U.K. market.
In a development that is a potential boon for wearables and other sectors of the digital health industry, the U.K.’s NICE has petitioned the National Health Service (NHS) to expand its coverage of devices that monitor patients with Parkinson’s disease. That data would be used by NICE to inform a health technology assessment that might ultimately boost sales of these devices if the data suggest a strong benefit to patients and to the U.K. health care budget.
Fujifilm Healthcare Europe received the European CE mark for its next-generation therapeutic linear array ultrasound endoscope, the EG-740UT, designed for complex diagnostic and therapeutic endoscopic ultrasound procedures.
The U.K. could be downgraded as a place to research and launch new medicines because of economic shocks and a looming rebate of 30% or more on sales of branded products, according to industry sources.
Recognizing that academic sponsors and nonprofits are major contributors to the development of advanced therapy medical products (ATMPs) and diagnostic and delivery devices, the EMA is launching a pilot program to help them navigate the challenging regulatory requirements in the space.
To jumpstart the development of much-needed antibiotics, the European Federation of Pharmaceutical Industries and Associations (EFPIA) released a new report Sept. 28 demonstrating the economic benefit of granting additional exclusivity for another drug as a way of incentivizing antibiotic R&D.
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