LONDON – The U.K. has set up the first randomized controlled trial of COVID-19 vaccines in pregnant women, to assess different dosing schedules. The aim is to find the balance between longer intervals that are known to spur a greater immune response, against shorter intervals that provide faster protection.
The U.K.’s Competition and Markets Authority (CMA) hit Advanz Pharma Corp. Ltd. and two private equity firms July 29 with fines totaling more than £100 million (US$139 million) for increasing the price of a thyroid drug by more than 6,000% since 2007.
LONDON – More than six years after the technical specification was agreed, the EMA clinical trial information system (CTIS) has cleared the final hurdle and can go live in January 2022, after notice of approval was published in the EU Official Journal on Saturday July 31. The approval, following an independent audit of the system, was the spur for the EMA to intensify the training program it is putting in place for trial sponsors and national regulators, to ensure CTIS’ successful implementation.
LONDON – T-knife Therapeutics GmbH closed a $110 million series B, as it advances plans for the phase I/II trial of its first fully human T-cell receptor (TCR) in the treatment of solid tumors, which is due to start later this year.
LONDON – Relaxing of control measures such as mask wearing and social distancing at a time when most of a population has been vaccinated against COVID-19 greatly increases the probability of the emergence of a vaccine-resistant strain, according to a new modeling study.
NHS England has announced a new £340 million (US$481 million) Innovative Medicines Fund, as the country grapples with the issue of bringing ultra-pricey specialist medicines to patients on the country’s taxpayer-funded health care system.
Sweden’s Calliditas Therapeutics AB has licensed its rare kidney disease therapy to Stada Arzneimittel AG in Europe to help it navigate the complexity of the region’s market, ahead of a potential European and U.S. approval in the coming months.
Responding to the growing number of state-sponsored cyber threats to health care and other key sectors and to the compromise of the Microsoft Exchange Server, which was disclosed in March, Canada, the EU, U.K., U.S. and other NATO allies issued statements July 19 laying out expectations and markers for how responsible nations behave in cyberspace and specifically calling out China’s “malicious cyber activity.”
DUBLIN – Panakès Partners SGR SpA has raised €150 million (US$177 million) in a first close of its second fund and is looking to secure a final tally of €180 million by year-end. That would represent more than twice the size of its first fund of €80 million and reflects its move into therapeutics investing.
French biotech Pep-Therapy SAS is taking its potentially first-in-class cancer cell penetrating peptide technology into the clinic, after raising €5.4 million (US$6.4 million) in an extended series A funding round. The series A fundraiser initially brought in €2.6 million, but the extension brought in a further €1.6 million in equity from Anaxago, i&i Prague and Badge as well as a €1 million loan from Bpifrance.
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