A partnership that brings together industry, pharmaceutical regulators and the US National Institutes of Health (NIH) is being created to speed up the development of therapies and vaccines for COVID-19. The planned alliance is the work of the NIH and its sister foundation, the Foundation for the NIH.
Roche has announced plans to launch a new serology test to detect protective antibodies in people who have been exposed to the SARS-CoV-2 virus. The test is expected to be available by early May in countries that recognise the CE registration mark. The company is also applying to the US Food and Drug Administration to get emergency use authorisation for the US market.
The US Food and Drug Administration has reported positive results from a clinical investigation of synthetic swaps that might be used at the front of the nose to test for the presence of the SARS-CoV-2 virus in the general population. The swabs have been tested by a collaboration that includes the FDA; the Bill & Melinda Gates Foundation, the insurer UnitedHealth Group; and the contract research organisation Quantigen LLC. The diagnostic is a polyester-based swab developed by US Cotton, which manufactures cotton swabs.
The German biotech BioNTech SE has joined forces with Pfizer Inc to co-develop a candidate vaccine against infection from the coronavirus SARS-CoV-2 which had affected 1.7 million people globally as of 12 April and resulted in 105,952 deaths.
A Phase 3 trial of the lung cancer drug Tagrisso (osimertinib) will be unblinded early on the recommendation of the data monitoring committee on evidence of overwhelming efficacy, the developer AstraZeneca Plc announced on 10 April. Tagrisso, a tyrosine kinase inhibitor targeting the epidermal growth factor receptor (EGFR), has already been approved for first and second-line use in patients with advanced non-small lung cancer. The Phase 3 trial, called ADAURA, was treating patients with early-stage disease. The primary endpoint of the trial is disease-free survival.
Evotec SE has set up a gene therapy research and development site in Austria, broadening its drug discovery capabilities to include advanced therapies as well as small molecules and biologics. The company announced the new site on 6 April, while simultaneously disclosing a contract with Takeda Pharmaceutical Co Ltd to generate gene therapies for the Japanese company’s four therapeutic areas: oncology, rare diseases, neuroscience and gastroenterology.
The Danish antibody pioneer Symphogen A/S is to be acquired by Laboratoires Servier, culminating more than two years of close partnership between the two companies focused on oncology. The value of the transaction was not disclosed however the sums already committed by Servier for access to Symphogen’s portfolio are considerable. Potential milestone payments under the companies’ existing partnership amount to DKK 9 billion (€1.2 billion).
Oncology developer iTeos Therapeutics Inc has raised $100 million in an oversubscribed fundraising led by RA Capital Management and Boxer Capital LLC bringing total monies generated under its B financing round up to $175 million. The funds will enable the company to progress two early clinical-stage compounds for treating solid tumours which target mechanisms of immunosuppression.
The US Food and Drug Administration has approved a new therapy for adults and adolescents with haemophilia who do not respond to blood clotting factor replacement treatments because of neutralising antibodies.The new therapy, Sevenfact, is a recombinant factor VIIa treatment whose active ingredient has been obtained from genetically engineered rabbits. Factor VIIa is a recognised bypassing agent for patients with inhibitors to treatments for haemophilia A and B.
The US Food and Drug Administration has asked for the immediate removal from the market of ranitidine medicines, some of which are sold under the trade name Zantac, owing to the presence of an impurity which may cause cancer. The FDA decision was announced on 1 April and follows an investigation that started in September 2019. The impurity is called N-Nitrosodimethylamine (NDMA) which is a known environmental contaminant found in water and foods. At low levels it is not considered dangerous.