Biogen withdrew an application seeking approval in Europe for Alzheimer’s disease drug Aduhelm, a move that follows a negative opinion on the therapy issued by a European Medicines Commission committee last December. The company was unable to persuade European regulators to change their minds about the drug.
Unlearn.AI’s Series B round follows a positive European Medicines Agency draft opinion finding that the company’s artificial intelligence technology can be used in Phase 2 and Phase 3 clinical trials. The startup is now on the hunt for pharmaceutical partners that want to use this "digital twin" technology to speed up their clinical research.
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
A European Medicines Agency review concluded AstraZeneca’s Covid-19 vaccine may be linked to cases of blood clots. The regulator directed the company to conduct additional studies to learn more but stopped short of recommending other vaccines as alternatives.
In what was reported as an "unprecedented backlash," trade groups representing U.K. drugmakers - as well as four other industries - for the first time expressed concerns about a possible Brexit deal, having previously been more concerned about a possible no-deal Brexit.
Bayer said Monday that the European Medicines Agency had approved Vitrakvi for NTRK fusion-positive cancers. The drug won U.S. Food and Drug Administration accelerated approval in November.
The company said it would withdraw the application for Xyndari after a negative opinion from the EMA's Committee for Medicinal Products for Human Use, which had ruled against the drug in May. The FDA approved the drug under the brand name Endari in 2017.
At the Abarca Forward conference earlier this year, George Van Antwerp, managing director at Deloitte, discussed how social determinants of health and a personalized member experience can improve medication adherence and health outcomes.
An analyst wrote that bluebird bio would likely launch Zynteglo first in Germany, followed by other countries, but scaled back sales forecasts due to the therapy's high price tag of 1.575 million euros.
The rules are still more restrictive than the European Medicines Agency's, which allow national governments to determine interchangeability. The FDA would require additional testing to demonstrate products can be freely substituted like generic pharmaceuticals.
Nikkei Asian Review reported that the company would cover some or all the cost of the therapy, Alofisel, which won EMA approval last year, if it did not provide benefit. The UK's NICE has declined to recommend it, citing modest benefit in a clinical trial.
The EMA's Committee for Human Medicinal Products recommended a conditional approval for Zynteglo in beta-thalassemia. A third-party press release erroneously stated the agency had approved the product earlier this week.
We will highlight Build My Health's revenue practice management tools, which could help physician practices add up to $250,000 to their practices.
Two beta-thalassemia advocacy organizations - one British and one Italian - issued a press release Monday that claimed the EMA had approved the gene therapy under the brand name Zynteglo.
The Swiss drugmaker is concerned that a no-deal Brexit would disrupt delicate supply chains and urged the UK and EU to provide clarity in order to minimize disruptions.
The agreement would have allowed UK pharmaceutical regulations to remain under EMA authority after Brexit. Uncertainty around the planned withdrawal has caused worry in the life sciences sector.
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.
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.