Thirteen months after Illumina Inc. and Grail Inc. merged, prior to regulatory approval, the deal has taken a turn for the worse. The prognosis looked better following an administrative law judge’s ruling Sept. 1 against the U.S. Federal Trade Commission’s lawsuit seeking to block the transaction, but the European Commission (EC) issued a decision Sept. 6 prohibiting the deal based on the likelihood that a merger would stifle innovation and limit choices in the early cancer detection liquid biopsy market.
Collagen is the most abundant protein in the human body, which would seem to make it an unlikely source for an immunotherapy target. But it is where researchers from Immatics Biotechnologies GmbH and the University of Pennsylvania have found a target that was expressed on stromal cells in a number of different solid tumors, but very rare in normal tissues.
Owkin Inc. has secured CE marking for two first-in-class artificial intelligence (AI)-based diagnostics, marking a move from research use only and towards the mainstream for AI in enabling faster and more efficient analysis of digital pathology slides.
International research project Multicentre Epilepsy Lesion Detection (MELD), led by University College London, has developed artificial intelligence software that can identify minute brain anomalies that lead to epilepsy seizures. These anomalies, known as focal cortical dysplasia, can often be treated with surgery but are difficult to visualize on an MRI.
Regulation of advanced therapies has come under scrutiny at a conference in London, as activity in the sector heats up amid Europe’s root and branch review of pharmaceutical legislation.
In the hope of preventing thousands of hospitalizations and deaths over the next few months, the U.S. CDC’s Advisory Committee on Immunization Practice (ACIP) voted 13-1 Sept. 1 to recommend the use of Moderna Inc.’s and Pfizer Inc.-Biontech SE’s updated vaccines that contain components of both the original SARS-CoV-2 virus and the omicron BA.4/5 subvariants as boosters.
Access to advanced therapies proved to be a major talking point at a conference in London, following the U.S. approval of Bluebird Bio Inc.’s Zynteglo (betibeglogene autotemcel) cell-based gene therapy for beta thalassemia and its $2.8 million price tag. Regulators in Europe backed Zynteglo in 2019 but Bluebird opted to withdraw the therapy in 2021 after deciding that the complex thicket of pricing bodies in Europe was too difficult to negotiate.
Medical science has been experimenting with smart devices for several years to determine whether these products can detect circulatory system diseases, and a study presented at the 2022 meeting of the European Society of Cardiology (ESC 2022) seems to strongly suggest that the answer is a resounding yes. The eBRAVE-AF study of more than 5,500 enrollees of middle age or older demonstrated the ability of a smartphone camera and a downloadable app to at beat conventional screening for atrial fibrillation (AF), a finding that could save lives and boost the prospects of device makers in the digital health space.
While it will need a “reasonable period of time” to do so, Turkey said Aug. 29 that it intends to establish a level playing field for foreign and domestic drug producers in accordance with the recommendations and rulings of World Trade Organization dispute arbitrators.
In pursuit of "an opportunity to accelerate the establishment of clinical development and commercial capabilities in the U.K.," Neurocrine Biosciences Inc. said it will buy Diurnal Group plc for about £48.3 million (US$56.5 million). Cardiff, U.K.-based Diurnal is a specialty pharma developing hormone therapies for rare and chronic endocrine conditions. The all-cash transaction represented a 144% premium of the Aug. 26 closing price of Diurnal shares (LSE:DNL). Shares closed 134.7% higher Aug. 30 at £26.40.
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