Given the challenges of generating chemistry, manufacturing and control information on the compressed timelines used in the EMA’s Priority Medicines scheme and the U.S. FDA’s breakthrough therapy designation program, the two regulators published a joint question-and-answer document discussing quality and good manufacturing practice aspects of applications for both programs, which are aimed at speeding development of innovative products to address unmet medical needs.
A catastrophe was averted over the weekend of March 11-12, 2023, when the U.K. government and the Bank of England orchestrated the rescue of the U.K. arm of Silicon Valley Bank, after its U.S. parent was shut down by the receiver. While that saved dozens of small biotechs with large deposits at the bank, it signified the fragile economic environment during the year, compounded by wider geopolitical frictions, with a market described by Chris Hollowood, CEO of Syncona Investment Management, as “the worst in my career.”
With the use of artificial intelligence (AI) increasing in both biopharma R&D and the regulatory science used to evaluate new drug candidates in member states, the EMA and Heads of Medicines Agencies have laid out a five-year workplan to ensure that the European medicines regulatory network remains at the forefront in benefiting from AI in medicines regulation.
Carl Zeiss Meditec AG reported it plans to buy Dutch Ophthalmic Research Center BV (DORC) from investment firm Eurazeo SE for approximately €985 million (US$1.08 billion).
After years of battling to retain its hold on Grail Inc., Illumina Inc. finally announced that it will be unwinding the ill-fated acquisition of the multi-cancer early detection test maker. In addition to stiff opposition from activist investor Carl Icahn that cost Illumina’s previous CEO and board chair their positions, European and U.S. regulators have consistently opposed the deal.
Medtronic plc received CE mark for its Percept RC neurostimulator for deep brain stimulation, which the company hopes will transform brain modulation and empower patients in the E.U. with neurological indications. The device is designed to capture and record brain signals and provide clinicians with insights to enable them to adapt and personalize therapy for patients.
MLA Diagnostics BV secured a strategic seven-figure investment in its recent investment round to support external validation of the company’s melanoma prognosis test. Co-founders NLC Health Ventures and Brightlands Life Sciences Ventures participated in the round along with LIOF, the regional development organization for the Limburg province of the Netherlands.
Putting into jeopardy what was on track to be the first approved therapy in Europe for geographic atrophy (GA), an advanced form of age-related macular degeneration that causes blindness, Apellis Pharmaceuticals Inc. learned of a negative trend vote by the EMA’s Committee for Medicinal Products for Human Use (CHMP) on its MAA for intravitreal pegcetacoplan.
The European Union’s Artificial Intelligence Act (AI Act) is widely seen as a groundbreaking piece of legislative handiwork, but companies in the life sciences may see it as a groundbreaker with negative consequences. The latest edition of the AI Act continues to treat medical AI software as a high-risk product, which would make these products exceptionally expensive and burdensome to bring to market in the EU and convince some companies in the medical AI business to skip the European market altogether.
Biospectal SA has received a CE MDR class IIa medical device certification for its optical fingertip blood pressure monitoring app, Optibp. The device records fingertip blood flow optically and transforms the information into a pulse wave that it analyzes to estimate blood pressure.
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