Facing a 26.5% rebate on 2023 sales of branded prescription drugs in the U.K., the Association of the British Pharmaceutical Industry (ABPI) is seeking talks with the government early in the new year to develop a new biopharma settlement for the future that will reflect the potential of the life sciences sector to drive improvements in the health and economy of the U.K.
Minervax Aps has closed a €72 million (US$76.6 million) financing round, enabling it to accelerate phase II development of its group B streptococcus (GBS) vaccine for the prevention of stillbirth and serious infections in newborns and complete the program next year.
The U.K. is taking the next step in applying genomics to health care with the launch of a £105 million (US$130 million) project that will sequence the whole genomes of 100,000 healthy newborn babies to detect rare genetic conditions.
The U.K. Bioindustry Association (BIA) is in an eleventh hour fight against changes to R&D tax breaks that it estimates will result in a £400 million to £800 million (US$480 million to $960 million) cut in payments to the sector. The changes will see cash credit claims reduced from 14.5% to 10%, cutting payments from 33 pence per £1 of spend to 18.6 pence per pound of spend from April 2023. Along with other tweaks, this is an effective 50% cut for biopharmas that do not pay any corporation tax because they are loss-making.
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 No longer recommended in a draft guidance were Ronapreve (casirivimab + imdevimab) from Roche Holding AG, Xevudy (sotrovimab) from GSK plc, and Evusheld (tixagevimab + cilgavimab) from Astrazeneca plc.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.