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.
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.
After five years and 350,000 hours of DNA sequencing, the UK Biobank has opened up access Nov. 30 to the whole genome sequences of half a million people who volunteered to give samples 15 years ago.
The U.S. FDA put out a safety warning Nov. 28 that antiseizure drugs levetiracetam and clobazam can cause a rare but serious hypersensitivity drug reaction that may start as a rash but can progress to injure internal organs. In addition, U.K. health care providers are being told to get a plan in place now to implement the first phase of the Medicines and Healthcare products Regulatory Agency’s new regulatory measures to reduce the risks of valproate, a treatment for epilepsy and bipolar disorder.
Cancer Research UK (CRUK) is worried that rising prices and its total dependence on public donations mean its funding model is becoming unsustainable. The charity is calling on the U.K. government to step in and plug a £1 billion (US$1.23 billion) shortfall it said will open up over the next decade, in order to maintain investment at 2019 levels in real terms.
Bioxodes SA has set the stage for the phase IIa study of its novel anticoagulant in the treatment of intracerebral hemorrhage (ICH), after raising a €12 million (US$13 million) series A. Days before announcing the closure of the round, the first patient in the proof-of-concept study was treated, on Nov. 17, and eight of 10 sites across Belgium are geared up to take part in the trial. The aim is to develop the product, Ir-CPI, as the first injectable antithrombotic that is suitable for use within the first 72 hours of an ICH.
The long-running row over the U.K. voluntary scheme that controls the national drugs budget has been settled, in what the industry is describing as a “tough deal.” Under the scheme there is an annual cap on total sales of branded drugs to the National Health Service, with sales over the agreed limit reimbursed via a levy. In 2022, pharma companies paid back £2 billion (US$2.5 billion) in rebates on total sales of £14 billion. In the new five-year agreement, the allowed annual increase in sales will be 2% in 2024, the same as across the current scheme from 2019 – 2023, but it will then increase to 4% by 2027.
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