After shelving it for the past decade, the EU Parliament this week adopted a directive forcing large publicly listed companies to break the glass ceilings that have allowed a men-only mentality to thrive in corporate boardrooms across much of Europe. The so-called Women on Boards Directive, formally adopted Nov. 22, will require EU-based public companies to have women in at least 40% of their nonexecutive director posts or 33% of all director posts by the end of June 2026. Companies with fewer than 250 employees will be exempt.
Shanghai Junshi Biosciences Co. Ltd. has submitted a new drug application (NDA) for its anti-PD-1 monoclonal antibody toripalimab to the European Medicines Agency, which marks the first NDA filing of toripalimab in Europe.
Britain’s National Institute for Health and Care Excellence (NICE), a key gatekeeper on the path to the U.K. market, is backing away from five COVID-19 treatments. No longer recommended in a draft guidance were Ronapreve (casirivimab + imdevimab) from Roche Holding AG, Xevudy (sotrovimab) from GSK plc, and Evusheld (tixagevimab + cilgavimab) from Astrazeneca plc. NICE also recommended discontinuing use of Lagevrio (molnupiravir) from Merck and Co. Inc. and Veklury (remdesivir) from Gilead Sciences Inc.
Europe is losing its innovative edge in biopharma, especially when it comes to advanced therapy medicinal products, including tissue, gene and cell therapies used to prevent, treat and cure rare conditions and some cancers.
Circuit dysfunction is clearly recognized as a driver of neuropsychiatric disease, and some neurodegenerative diseases such as Parkinson’s disease. And at the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) 2022 Congress, researchers made an argument that the same is true in multiple sclerosis (MS). Such a lens could explain the radiological-clinical paradox between the amount of structural damage and clinical severity.
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.