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.
A research team from Lille University Hospital in France has recently demonstrated that dual-energy computed tomography lung perfusion can provide valuable additional information for standard CT scans by visualizing perfusion changes in systemic sclerosis patients with normal or minimally infiltrated lung parenchyma. This clinical research team published their findings this summer in European Radiology.
German regulators have unveiled their initial report covering the prescription and deployment of reimbursable health apps. The survey was carried out by Hamburg-based health insurance fund Techniker Krankenkasse (TK) in conjunction with Bielefeld University in North Rhine-Westphalia and health care economics analysis research bureau Vandage GmbH, also based in Bielefeld.
In an effort to keep up with the advances being made in manufacturing technologies, the European Commission (EC) is updating its 2007 technical guidance on good manufacturing practices for sterile drugs.
The first randomized placebo-controlled trial assessing the effectiveness of the antiviral drug Tpoxx (tecovirimat) in treating monkeypox has begun in the U.K., with the first patients enrolled on Aug. 21.
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