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BioWorld - Sunday, January 29, 2023
Home » Topics » Europe, BioWorld

Europe, BioWorld
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Clinical data illustration

Ligase embrace in BTK: Nurix depicts promising future with new approach

Dec. 31, 2021
By Randy Osborne
No Comments
Nurix Therapeutics Inc.’s Dec. 12 disclosure that the U.K. Medicines & Healthcare products Regulatory Agency granted to clearance for the company to kick off a phase I study with Bruton tyrosine kinase (BTK) inhibitor NX-5948 pumped more juice into the space, which has been consistently intriguing since the first drug in the class was approved about eight years ago by the FDA. The San Francisco-based firm will start an experiment in patients with relapsed and refractory B-cell malignancies at clinical sites in the U.K., with dosing of the first subject expected in the first half of 2022.
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U.K. flag on stethoscope

British Pakistani genomics study illustrates need for diversity

Dec. 28, 2021
By Nuala Moran
No Comments
It is acknowledged that the huge bias toward individuals of European ancestry means studies of the contribution of genetics to disease may not translate well to other ethnicities. That point is underlined in the first large-scale investigation of the population structure and demographic history of British Pakistanis, which shows an increased number and length of regions of homozygosity inherited from a common ancestor, and greatly elevated identity by descent, compared to the population at large.
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Astrazeneca starts work on Omicron vaccine as cases continue to rise

Dec. 22, 2021
By Richard Staines
No Comments
Astrazeneca plc has confirmed it is working with Oxford University to produce a vaccine against the Omicron variant of the SARS-CoV-2 virus. The Cambridge, U.K.-based pharma was one of the first to get a COVID-19 vaccine okayed by regulators, after acquiring rights to the shot from Vaccitech plc, a spin-out from Oxford University’s Jenner Institute specialist vaccine unit.
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EC takes steps to ensure Northern Ireland drug supply post-Brexit

Dec. 20, 2021
By Mari Serebrov
No Comments
Following extensive discussions with their British counterparts, the European Commission (EC) advanced proposals 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.
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New leader named to head NICE

Dec. 20, 2021
By Mari Serebrov
No Comments
The U.K.’s National Institute for Health and Care Excellence (NICE) will welcome a new chief executive in February. Samantha Roberts was named to succeed Gillian Leng, who is retiring after 20 years at the agency. With extensive experience in health care delivery and as a clinician, Roberts currently serves as managing director for health and care at NHS England.
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EU flags in front of the Berlaymont building

EU paves way for swifter MCM response in emergencies

Dec. 20, 2021
By Mari Serebrov
No Comments
The European Council reached an agreement Dec. 20 that will allow the European Health Emergency Preparedness and Response Authority to respond much more quickly to public health emergencies such as the COVID-19 pandemic by activating urgent and targeted medical countermeasures (MCMs) across the EU.
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EMA icons

EMA’s CHMP rejects Biogen’s application for European approval of Aduhelm in Alzheimer’s

Dec. 17, 2021
By Cormac Sheridan
No Comments
DUBLIN – The EMA has rejected Biogen Inc.’s application for European Union approval of Aduhelm (aducanumab), its controversial Alzheimer’s disease drug. Its human medicines committee (CHMP) issued a negative opinion on Biogen’s dossier during its December meeting this week, stating that the data from the key studies submitted in support of the application “were conflicting and did not show overall that Aduhelm was effective at treating adults with early stage Alzheimer’s disease.”
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AI silhouette
A look back as we head into 2022

Top Trends of 2021: Will Australian ruling on artificial intelligence as inventor be a trigger for others to follow suit?

Dec. 14, 2021
By Tamra Sami
No Comments
PERTH, Australia – Australia attracted international attention in July when a Federal Court ruled that artificial intelligence can be named as the inventor of a patent. In Thaler v. Commissioner of Patents, Federal Court Justice Jonathan Beach ruled that under Australian patent law, inventors don’t necessarily have to be human. The decision challenges the assumption that only human beings can be inventors. Beach did rule, however, that an AI system cannot apply for a patent or receive a patent.
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A look back as we head into 2022

Top Trends of 2021: UK-Europe regulatory breakup puts both in recovery mode for year ahead

Dec. 13, 2021
By Nuala Moran
No Comments
LONDON – The confluence of Brexit and pandemic has hit regulators in Europe hard this year, with the workload of assessing COVID-19 vaccines and antivirals made all the more onerous by the loss of expertise suffered by both the EMA and the U.K. Medicines and Healthcare products Agency (MHRA) as their close relationship was severed.
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Health professional recording info from patient

Smacked by COVID-19: Recruitment to UK’s cancer trials plummets 60%

Dec. 9, 2021
By Nuala Moran
No Comments
LONDON – New figures underline the devastating effect the pandemic is having on cancer clinical research, with recruitment to U.K. studies falling by 60%. A total of 27,734 patients were recruited in 2020/21, compared to an average of 67,057 in the three years previously. Over those three years, recruitment had been on the rise, going from 61,810 in 2017/18 to 71,709 in 2019/20, according to figures compiled by the Institute of Cancer Research in London.
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