Cancer Research UK (CRUK) is worried that rising prices and its total dependence on public donations mean its funding model is becoming unsustainable. The charity is calling on the U.K. government to step in and plug a £1 billion (US$1.23 billion) shortfall it said will open up over the next decade, in order to maintain investment at 2019 levels in real terms.
The U.K. is mulling over whether to recognize U.S. FDA approvals of medical devices as part of moves to accelerate the implementation of its post-Brexit regulatory system.
Making it a done deal, the European Council adopted proposals April 12 to ensure the continued long-term supply of medicines from Great Britain to Northern Ireland and to address supply concerns in Cyprus, Ireland and Malta, which historically have been dependent on drugs from the U.K.
It was a busy week for the U.K.’s drugs regulator, the Medicines and Healthcare Products Regulatory Authority (MHRA), which fast tracked decisions on novel drugs for cancer and eczema and made a ruling on booster COVID-19 jabs from Astrazeneca plc and Pfizer Inc. But even as Prime Minister Boris Johnson tweeted his support over the approval of Amgen Inc.’s cancer drug Lumykras, there are questions over the future of the regulator as it faces a round of job cuts because of a lack of funding following Brexit.
LONDON – The U.K. Medicines and Healthcare products Agency (MHRA) has embarked on wide-ranging reforms that are designed to make the most of post-Brexit regulatory flexibility while capitalizing on the ‘spirit of the pandemic,’ which has seen it rise to the occasion in supporting rapid set up of large-scale randomized clinical trials and approvals of COVID-19 vaccines.
LONDON – It began life as a legal tidy-up of post-Brexit regulatory issues, but the Medicines and Medical Devices bill that emerged from its final reading last week is in a significantly different form. Most notably, the bill legislates for the creation of a national register of all implantable medical devices and the appointment of a patient safety commissioner to act a single port of call and advocate for patients when devices fail.
DUBLIN – Amid a bitter dispute between the European Commission (EC) and Astrazeneca plc over supplies of the latter’s SARS-CoV-2 vaccine, the EC’s drug regulator, the EMA, recommended approval of the product in question, COVID-19 Vaccine Astrazeneca (formerly AZD-1222).
LONDON – The 1,246 pages that make up the U.K./EU post-Brexit trade deal have “one paragraph we can build on,” said Steve Bates, chief executive of the Bioindustry Association (BIA), giving his initial reaction to the document published late on Dec. 24. That one paragraph refers to the setting up of a joint working group on medicinal products. It says the EU and the U.K. “shall endeavour to cooperate with a view to strengthening, developing and promoting adoption and implementation of internationally agreed scientific or technical guidelines.”
It might be difficult to view the past year through anything other than a COVID-shaped hole. But 2020 brought some remarkable and impactful news for the biopharma sector that had little to do with the novel coronavirus. In this end-of-year recap, BioWorld takes a look at some of achievements and trends affecting the industry that were completely unrelated to – or, in some cases, in spite of – the COVID-19 pandemic.
LONDON – The life sciences industry exhaled sharply and prepared to labor over the fine print in 1,246 pages of text after the EU and U.K. reported they had agreed a post-Brexit trade deal on Christmas Eve. The U.K. has said it will take a light touch, at least initially, with implementation of new border controls taking place in three stages up to July 30, 2021. The EU has not said what its approach will be.
