The European Medicines Agency has started a rolling review of a prospective vaccine for Covid-19 being developed by Oxford University and AstraZeneca Plc on the basis of preliminary data showing that it triggered the production of antibodies and T cells that target the virus. The agency announced the review on 1 October.
A new fund for medical diagnostics has secured €50 million in capital from leading European institutions, including the European Investment Fund (EIP), an agency of the EU. The fund, Kurma Diagnostics 2, is being launched by Kurma Partners, a venture capital company based in Paris, France. It is expected to invest in about 15 companies specialising in molecular and digital diagnostic technologies.
Galecto Inc has raised $64 million in equity financing to prepare for a potential conditional approval of its lead product for the treatment of idiopathic pulmonary fibrosis in the EU and to further advance its clinical-stage products for liver fibrosis and myelofibrosis.
The US Food and Drug Administration has approved a new indication for Nucala (mepolizumab) for hypereosinophilic syndrome (HES), a group of rare blood disorders characterised by the overproduction of eosinophils, a type of white blood cell. It is the first approval for this patient group in nearly 14 years.
Prescription drugs sold in Canada at cheaper prices than in the US will be eligible for importation under a new rule adopted by the US Food and Drug Administration on 25 September. The rule implements an executive order issued by the White House in July.
A case study of a 45-year old woman with severe Covid-19 has shown that administration of APN01, an experimental biologic, enabled the generation of neutralising antibodies against SARS-CoV-2 and a rapid drop in virus load. The results of the study were reported online in The Lancet Respiratory Medicine on 24 September 2020.
APN01 is being developed by the Austrian company Apeiron Biologics AG and has been shown to be safe in Phase 1 studies of healthy volunteers. It is currently being investigated in Phase 2 trials in Austria, Germany, Denmark, the UK and Russia.
The gene and cell therapy industry has significant potential. But this will only be realised if manufacturers share information about their technologies, enabling the advanced therapies to be produced at scale and marketed at affordable prices.
ADC Therapeutics SA of Lausanne, Switzerland has priced an upsized US public offering of its common shares yielding gross proceeds of $204 million to support the commercialisation of an antibody-drug conjugate (ADC) for diffuse large B cell lymphoma. The offering of six million shares was priced at $34 per share and will close on 28 September. In addition, certain existing shareholders have granted the underwriters a 30-day option to purchase up to 900,000 additional common shares.
ADC Therapeutics is listed on the New York Stock Exchange.
Nordic Nanovector ASA has raised NOK 231 million ($25 million) in a private share placement to support Betalutin, an antibody radionuclide conjugate that is being developed for follicular lymphoma, a type of non-Hodgkin’s lymphoma.
Semorinemab, an antibody directed against the tau protein, has failed to have an impact on patients with early Alzheimer’s disease despite earlier promise, the developer AC Immune SA announced on 23 September. Semorinemab is being developed with Genentech, a member of the Roche Group.