The US Food and Drug Administration has approved a new treatment for seizures associated with Dravet syndrome, but with a warning that the drug is associated with valvular heart disease and pulmonary arterial hypertension. The drug, Fintepla (fenfluramine), is an amphetamine derivative.
Hong Kong-based Hutchison China MediTech Ltd (Chi-Med) has raised $100 million from a share placement with a global equity firm to support the development of its oncology business. The placement was with General Atlantic which has offices on four continents and a significant life science portfolio.
Netherlands-based BioGeneration Ventures has closed its fourth fund BGV IV at €105 million to continue its work building new companies in Europe around single assets or technology platforms. New investors included Industriens Pension of Denmark and KfW Capital of Germany, while Bristol-Myers Squibb Co, an investor in BioGeneration’s third fund, also participated in the new vehicle.
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. But in an opinion delivered on 24 June, the UK court declared that claims made by Regeneron were not valid.
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.
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.