It’s a time of economic crisis and political upheaval in the U.K. But, according to the country’s pharma trade body, there’s another looming problem of access to clinical trials in the country, which is becoming less and less attractive as a place to conduct life sciences research.
The U.K. is launching a £230 million (US$260 million) project to build a database linking the health records and genetic information of 5 million people, which will be open for discovery research and as a source of clinical trial recruits for academics and companies.
The U.K. is launching a coordinated national program of research into the unprecedented outbreak of monkeypox that has spread across Europe and North America – regions where the disease is not endemic – over the past six months. Taking a lead from the SARS-CoV-2 playbook, there will be work to sequence the viral genome and to study how it is evolving, linking this to changes in the transmission and pathology of the virus.
A vaccine for dengue fever, an advanced therapy for a complication after transplants, and a potential first-in-class drug for a form of psoriasis were among medicines recommended for approval by European regulators on Oct. 14.
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.
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.
In an effort to get drug regulators in the various EU member states on the same page, the EMA issued a Sept. 19 statement confirming that all biosimilars approved in the EU are interchangeable with other approved biosimilars referencing the same biologic, as well as the reference biologic itself.
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