As their term in office winds to a close, MEPs in the two main political groupings of the European Parliament still have huge differences of opinion over the proposed reform of the EU pharmaceutical regulation and how best to achieve the stated aims of improving patient access whilst encouraging innovation.
Over the past few years, the health care sector has been progressively leveraging artificial intelligence techniques for activities such as end-to-end drug discovery and development, diagnosing patients, improving communication and engagement between physician and participant, transcribing medical documents and remotely treating and monitoring patients.
Pharma companies facing the pricing pressures unleashed by the U.S. Inflation Reduction Act will find little respite in European markets in 2024, as governments erect higher market access hurdles around pricing and reimbursement in a bid to constrain drug budgets.
Following the decision of Australia’s Therapeutic Drugs Administration to allow prescribing of MDMA for post-traumatic stress disorder and psilocybin in treatment-resistant depression from July 2023, and with U.S. FDA approval of MDMA for treating PTSD expected in 2024, the EMA is under increasing pressure to set out a path to approval for psychedelics.
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.
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