Citing “serious breaches” of its code of practice, the Association of the British Pharmaceutical Industry (ABPI) suspended the membership of Novo Nordisk A/S in the trade organization for two years. The suspension marks the eighth time in 40 years that the association has invoked such sanctions.
The U.K. Medicines and Healthcare products Agency (MHRA) is to stop carrying out its own appraisals of drugs that are being reviewed by the U.S. FDA, the EMA or Japan’s PDMA, and will instead set up “global recognition routes,” through which companies can apply to place products on the U.K. market that have passed regulatory scrutiny elsewhere.
Seamless Therapeutics GmbH raised $12.5 million in seed financing to take forward a novel gene editing technology based on reprogramming recombinase enzymes.
The U.K. arm of Silicon Valley Bank (SVB) is to be acquired by HSBC UK Bank plc for a symbolic £1, after senior ministers and the Bank of England worked all weekend on a rescue package. The acquisition is to complete immediately, averting what the U.K. government had acknowledged would be a crisis for the biotech and tech sector.
First the stick and now the carrots. The pharma industry in the U.K. on March 1 published its proposal for a new pricing scheme, under which it is offering to pay a fixed rebate of 6.88% across all eligible drug sales, an offer it said will deliver more than £1 billion (US$1.2 billion) per annum back to the National Health Service.
Plans by the U.K. government to claw back from pharma companies another 3.1% of the proportion of the drugs they sell to the National Health Service have been heavily criticized by the pharmaceutical industry as sending the “worst possible signal” to global investors. The Department of Health and Social Care announced in a consultation in December that it planned to increase the statutory scheme payment percentage from 24.4% to 27.5% starting April 1, 2023.
Looking to turn around the decline of clinical trials within its borders, the U.K. government appointed James O’Shaughnessy, a former health minister, board member of Health Data Research UK and a senior partner at Newmarket Strategy, to conduct an independent review of the country’s commercial clinical trial landscape.
The stage is set for a showdown between the pharma industry and national governments and public health experts over which policy the EU should grasp, as it bids to create a pan-European incentive scheme that will encourage innovation and get more antibiotics through to market. At issue is a proposal supported by the industry, under which companies getting approval for a new antibiotic would be given a voucher allowing them to extend market exclusivity of any different drug of their choice for one year.
The U.K.’s medicines and vaccines manufacturing environment needs a complete overhaul, with the worrying decline in exports and investment in the country addressed, if the UK is to beat global competition, the Medicines Manufacturing Industry Partnership believes.
It is a “landmark moment” in the long-awaited upgrade of the management of clinical research in Europe, but the industry has given a lukewarm welcome to a mandate to submit all clinical trial applications via the EMA’s clinical trials information system, as of Jan. 31.
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