The EMA will require all new clinical trial applications to be submitted via its clinical trials information system after Jan. 31, 2023, despite pharma companies and other users raising concerns about functionality and technical failures they are experiencing with the system.
For European biotechnology, 2022 was a year of contraction. Disclosed equity investments in European firms engaged in the discovery and development of therapeutics totaled $6.782 billion, down 55% on the previous year’s record-breaking tally of $15.193 billion. Last year’s tally is the worst performance since 2017 and is well below the totals achieved during the two years immediately preceding the onset of the COVID-19 pandemic, which triggered a boom in biotech investing.
A surgical team from the Curie-Montsouris Chest Center in Paris, has successfully performed thermal ablation of a metastatic lung lesion using microwaves via a computer tomography (CT)-guided endobronchial approach.
Bottneuro AG closed the first tranche of a bridge round, bringing its total capital raise in 2022 to $4.3 million. This is being used to develop its noninvasive, domestic therapy for treating early moderate-stage Alzheimer’s patients.
The U.K. Medicines and Healthcare products Agency (MHRA) reported a trio of research projects as part of a push to maintain its reputation as a leading regulator of drugs and medical devices now the U.K. is no longer part of EU regulatory systems, and to attract clinical trials - and the associated inward investment - despite no longer offering access to the EU single market.
Numares Health AG received $21.2 million from the European Investment Bank (EIB) in support to its automated and software based IVD platform for obtaining high-quality nuclear magnetic resonance metabolomics data from blood or urine biopsy samples.
Although the war is still raging in Ukraine, Russia is marching forward with asserting its regulatory framework on health care in the parts of Ukraine it’s claiming as the spoils of the war it started 11 months ago.
It was a year of turmoil in Europe as Russia’s invasion of Ukraine and the fall-out from the COVID-19 pandemic shaped the fortunes of the life sciences industry in 2022. After years of tension, Russia’s attempt to annex Ukraine on Feb. 24 caused outrage and disruption and was unanimously opposed on humanitarian grounds by the life sciences and pharma industry.
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.
Seekin Inc.’s cancer mutation detection kit Pancanseek for leukemia patients has received a CE-IVD mark, expanding the company’s reach in the testing space.