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Regulatory Daily Summary

Regulatory Daily Summary: What Happened on October 23, 2026

MHRA approves Icotyde for plaque psoriasis from age 12

The briefing also covers a U.S. proposal that could affect some China-linked biotech activity, a DOJ fraud-tip reward pilot and guidance for Bundibugyo vaccine trials.

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Today in brief

The UK’s MHRA authorized Icotyde for eligible adults and adolescents with moderate to severe plaque psoriasis, supported by four Phase 3 trials.1 A proposed U.S. Treasury rule could restrict some deals involving Chinese biotech companies while allowing pharmaceutical licensing deals.23

The Justice Department’s three-year pilot offers initial rewards of $10,000 to $30,000 for tips leading to criminal charges, initially focusing on federal health care fraud.4 European and African regulators issued joint guidance on clinical development of vaccines against Bundibugyo virus disease.5

MHRA authorizes Icotyde for adults and adolescents with plaque psoriasis

The UK’s Medicines and Healthcare products Regulatory Agency authorized Icotyde for moderate to severe plaque psoriasis in patients aged 12 or older who weigh at least 40 kg and are candidates for systemic therapy.1 Icotyde contains icotrokinra hydrochloride, an oral drug that selectively blocks the IL-23 receptor.1

Four Phase 3 trials involving about 2,500 people supported the decision, including 72 adolescents aged 12 to under 18 who weighed at least 40 kg.1 At week 16, all four trials showed the drug was effective compared with placebo in the populations studied.1 The recommended dose is one 200 mg tablet daily, according to the patient information leaflet.1 The MHRA said it will continue monitoring the medicine’s safety.1

Treasury proposal could affect U.S.-China biotech collaborations

The U.S. Treasury Department released a proposed outbound investment rule on October 22 that could restrict some deals involving Chinese biotech companies.23 A Treasury official said the proposal does not address pharmaceutical licensing deals. The proposal would allow U.S. drugmakers to license molecules from Chinese companies.2

The proposal could discourage a broader range of collaborations between U.S. and Chinese companies, according to the reported assessment of its potential effects.2

Also worth knowing

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    The Justice Department’s three-year WHIP pilot, announced October 20, offers initial rewards of $10,000 to $30,000 for tips leading to criminal charges. It initially focuses on federal health care offenses, including fraud involving hospice, home health, day care and special services.4

  • Prilenia Therapeutics and Ferrer received EU authorization to start PRECISE-HD, a Phase 3 pridopidine trial in Huntington’s disease designed to enroll around 400 people, with the primary endpoint assessed at week 52.6

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