Ofatumumab, a monoclonal antibody originally developed for cancer, is being recommended to treat relapsing forms of multiple sclerosis. The European Medicines Agency has given the drug a positive review based on data from two Phase 3 studies which showed that it is superior to teriflunomide (Aubagio), a marketed multiple sclerosis treatment.
A coronavirus vaccine developed by Oxford University and AstraZeneca Plc was approved by the European Commission on 29 January, only hours after the European Medicines Agency gave the product a positive opinion. The approval is the third for a Covid-19 vaccine in the EU. The other two are vaccines developed by Moderna Inc, approved on 6 January, and a vaccine developed by BioNTech SE and Pfizer Inc, approved on 21 December 2020. Authorisation of the AstraZeneca vaccine was based on data showing an efficacy rate of around 60%.
Johnson & Johnson Inc said that its single-shot vaccine against Covid-19 was 66% effective in preventing moderate to severe disease following a Phase 3 trial that included participants from the US, South Africa and countries in Latin America.
Novavax Inc has reported that its protein-based Covid-19 vaccine achieved an efficacy rate of 89.3% in a Phase 3 trial conducted in the UK, even as a new strain of the virus was circulating in that country. Meanwhile, a separate Phase 2b study of the same vaccine achieved a 60% efficacy rate in South Africa in a study population that was HIV-negative. For the overall trial population, including those with and without HIV, the efficacy rate was 49.4%.
The German vaccine producer CureVac NV has announced the pricing of a follow-on share issue on Nasdaq giving total gross proceeds of $450 million. This comes five months after the company, which is developing a messenger RNA (mRNA) vaccine for Covid-19, raised $245.3 million in an initial public offering. In the latest financing, CureVac issued five million common shares at a price of $90 per share.
Enthera Pharmaceuticals Srl has closed a Series A financing at €35 million, giving it the resources to bring its lead product for Type 1 diabetes and gastrointestinal diseases into the clinic and develop other assets. The Italian company is developing biologics that are designed to inhibit a protein interaction thought to be critical in the death of beta cells in the pancreas and stem cells in the gut.
Novartis improved its profitability in 2020 against a modest increase in sales and continuing pressure on prices and competition from generics. Sales for the year amounted to $48.7 billion, up by 3% from a year earlier. Operating income was $10.2 billion, up by 12% giving an operating margin of 20.9%. This compares favourably with a margin of 19.2% the previous year.
A spin-out of Harvard University in Cambridge, US, has raised seed funding of $5 million to develop a therapy for the delivery of healthy mitochondria into cells where these organelles are impaired. Cellvie Inc received the funding from an investment group led by Kizoo Technology Capital which supports start-up companies and early-stage portfolios. Founded in the US and headquartered near Zurich, Switzerland, Cellvie is developing cell-based medicines for treating mitochondria dysfunction.
An Israeli company which is developed new antimicrobial peptides has won €10.8 million in European Union funding to conduct early clinical studies of a product directed against infections caused by Gram-negative bacteria. Omnix Medical Ltd of Jerusalem has developed its technology by studying how insects use their innate immune systems to kill bacteria – an evolutionary mechanism that goes back millions of years.
An oncology drug developed by PharmaMar SA of Spain has shown potent antiviral activity against SARS-CoV-2 in both laboratory and animal experiments, suggesting promise as a candidate for treating Covid-19, according to an article in Science on 25 January 2021. The drug, plitidepsin (Aplidin) is an anticancer agent of marine origin.
It was approved for the treatment of multiple myeloma in Australia in December 2018 and holds orphan drug designations in both the US and the EU.