Simulations do not replace human judgment: they inform it, making transparent what would otherwise remain a “black box.” EU law does not require them today; but a proportionate embrace, in the right legislative vehicle, with clear methodological standards, and without crushing noncommercial research, could make trials safer, faster, cheaper, and more reliable, without sacrificing rigor.
European Union regulators ordered Illumina to divest Grail. Illumina is appealing antitrust findings in Europe and the U.S., but the DNA sequencing giant revealed that divesting all or part of Grail is an option even if it wins both legal challenges.
Healthcare decision-makers, especially at pharmaceutical companies, must prioritize patient input. Data collected from social media listening is a significant step in the right direction.
In the EU, there is a widespread distrust of American tech companies, according to a recent conference presentation by an international healthcare lawyer. Because of this, the EU has established a number of new laws protecting its citizens' data privacy and creating frameworks for the secure exchange of information — laws that American health tech companies will have to comply with if they do business in the EU.
Aimed at science, engineering and technology specialists, the changes would create a fast-track visa system that would make it easier for them to enter and stay in the country.
The biotech company said it would price Zynteglo for beta-thalassemia at about $1.8 million for the European market. Data for the therapy in that disease and also sickle cell disease are being presented at EHA.
A report, by the UK Bioindustry Association, found that venture capital investment in UK biotech companies rose from $178 million in first quarter 2018 to $240 million in first quarter 2019.
In an interview, Kyan Health Co-Founder and Chief Commercial Officer Konstantin Struck discussed how Kyan gives mid-market and enterprise employers access to premium workforce mental healthcare, at a price point that is affordable.
Many supporters of the UK's withdrawal from the EU say "no deal, no problem," but drugmakers' actions suggest "no deal, big problem."
A number of scenarios could indeed diminish the UK's attractiveness, but it is likely to remain an important player, with a lot riding on the future regulatory regime.
The company expects reimbursement decisions by national-level authorities in 2019 and 2020. The UK's NICE recommended Cancer Drugs Fund coverage for another high-priced Novartis therapy, the CAR-T Kymriah, earlier this month.
Ian Hudson, CEO of the MHRA, will step down in September 2019. He cited the country's withdrawal from the European Union as a key factor.
BTK inhibitor has become an important treatment option for certain B-cell malignancies.
The Fitch Solutions report, released this week, notes that the number of clinical trials taking place in the UK has already fallen more than 25 percent.
With a positive CHMP decision, the European Commission is expected to rule in two months, but equity research analysts foresee significant headwinds for the gene therapy.
EU and U.S. agree to changes to rules on international data transfer, Google Ventures looks for AI in Europe, but end users don't seem quite ready for cognitive computing.
European Union law could shift to recognize extreme obesity as a disability, preventing employers from firing workers for the condition. The situation has come about based on a claim by Karsten Kaltoft, a Danish childminder who was dismissed by his local city council in 2010 after reportedly being unable to bend down to tie up […]