News

Emer Cooke, currently a director at the World Health Organization, has been nominated to become the new executive director of the European Medicines Agency, succeeding Guido Rasi whose term ends on 15 November. Ms Cooke is scheduled to address a committee of the European Parliament on 13 July, after which the appointment will be finalised.

The France-based microbiome company Enterome SA has closed a €46.3 million Series E financing round to advance the development of a microbiome derived product for cancer. The financing was supported by Takeda Pharmaceutical Company Ltd, which also has a collaboration with the company, and the investors Seventure Partners and Nestlé Health Science.

Kymab Ltd has beaten back a challenge by Regeneron Pharmaceuticals Inc to its transgenic mouse technology for creating antibodies following a decision by the Supreme Court of the United Kingdom. The decision is important for Kymab, the smaller of the two companies, which has a pipeline of preclinical and early clinical antibody therapeutics to treat cancer and immune diseases. Regeneron had challenged Kymab’s foundational technology.

The US Food and Drug Administration is to set up a trial website to provide retrospective data on how patients responded to oncology treatments during a clinical trial leading up to the approval of a new drug. The data is already used by the agency in the drug review process but to date, has not been made publically available.

Sanofi Pasteur, the vaccines arm of Sanofi SA, has reached an agreement with Translate Bio of the US to expand a two-year old collaboration in order to bring forward a candidate vaccine for COVID-19. The vaccine candidate uses messenger RNA (mRNA) technology and is expected to be ready for a first human trial in the fourth quarter of this year.

Regulatory authorities in the US and EU have taken further steps to align their practices in light of the coronavirus pandemic. Officials from the two regions already hold regular conversations about issues relating to the authorisation of new medicines. Now they are broadening their discussions to consult on pandemic issues such as the use of real world evidence to better understand the epidemiology of COVID-19.

Epidarex Capital, the Edinburgh, UK-based venture capital firm, has closed a new fund to support early-stage UK life science companies. The fund raised £102.1 million at the close, of which £50 million represents a commitment from Enterprise Capital Funds, a government-supported scheme to help the growth of young businesses.

Oxford Biomedica Plc has raised a gross £40 million in a private share placement to support its ongoing gene therapy business which includes the manufacture of lentiviral vector for the Novartis product Kymriah. Kymriah was the first chimeric antigen receptor (CAR) T cell therapy to be approved for cancer. Most recently, Oxford Biomedica secured a contract with AstraZeneca Plc to manufacture an adenoviral vector based vaccine for COVID-19.

ISA Pharmaceuticals BV of the Netherlands has expanded a collaboration with Regeneron Inc to include a new trial for the companies’ combination treatment for human papillomavirus type 16 (HPV16)-induced cancers. The trial will recruit patients with oropharyngeal cancer, a type of head and neck cancer that affects tissues of the throat.

The UK government has approved the use of a generic corticosteroid, dexamethasone, for the treatment of patients in hospital with COVID-19 that require oxygen, including those on ventilators. This follows the results of a clinical trial conducted by the University of Oxford which showed that the drug can reduce the risk of death of patients on ventilation by as much as 35% and those on oxygen by 20%.