The US Food and Drug Administration has placed clinical holds on six trials of the HIV medicine islatravir after some trial participants showed a decrease in total lymphocyte and CD4+ T cell counts – a sign of weakened immune systems. Developed by Merck & Co Inc, islatravir is being studied for both the treatment and prevention of HIV-1 infection. “With the FDA’s clinical hold, no new studies may be initiated,” the company announced on 13 December.
A new study by researchers from the University of Oxford has shown that the Omicron variant of the SARS-CoV-2 virus has the potential to increase infections among the population, including individuals who have already been vaccinated. However there is no evidence thus far that the variant can cause severe disease, hospitalisation or deaths in vaccinated populations.
Sanofi SA is to expand its vaccine capacity with the acquisition of a privately-owned Austrian company, Origimm Biotechnology GmbH, that has a candidate product for acne vulgaris, a common, chronic skin disease. Acne vulgaris is linked to the bacterium Cutibacterium acnes, a complex Gram positive bacteria. The therapeutic vaccine, which is based on recombinant proteins, entered clinical studies in the third quarter.
A French start-up company with assets in-licensed from Sanofi SA has raised €12 million in seed financing to discover potential drugs for heart failure. Corteria Pharmaceuticals SAS will use data from subpopulations of patients with cardiovascular disease to identify targets for new therapies.
A venture capital company backed by Swedish and Danish institutions has closed its first fund at €122.3 million. Designed to support promising life science companies in the Nordic region, Eir Ventures I AB has already invested in nine companies, two of which have completed initial public offerings (IPOs) on the US Nasdaq market.
The Roche Group has established a partnership with a drug discovery company in Salt Lake City, US to identify novel targets for new neurology drugs and for one indication in oncology. The partner, Recursion Pharmaceuticals Inc, has technology for searching large biological and chemical datasets for information on biological relationships, particularly in neuroscience.
The New England Journal of Medicine has published data from a Phase 3 trial of Dupixent (dupilumab), a widely prescribed anti-inflammatory drug which was recently approved by the US Food and Drug Administration for children with uncontrolled moderate-to-severe asthma. Data from the trial formed the basis of a US approval and have been included in a regulatory filing with the European Medicines Agency.
Merck & Co Inc paused enrolment on 6 December for two Phase 3 trials of its lead investigational treatment for HIV – a little more than two weeks after stopping dosing in a Phase 2 study of an HIV combination therapy. The measures were taken on the recommendation of the trials’ respective data monitoring committees. They affect MK-8507, a non-nucleoside reverse transcriptase inhibitor, and islatravir, a nucleoside reverse transcriptase translocation inhibitor. In both cases, the actions were taken in relation to total lymphocyte and CD4+ T cell counts in patients.
The Covid-19 vaccine produced by Pfizer Inc and BioNTech SE is able to neutralise the Omicron variant of the SARS-CoV-2 virus after three doses, preliminary laboratory studies have shown. Two doses of the vaccine appear to be less effective, but still offer protection against the most severe forms of the disease, the companies reported on 8 December.
More than 43% of the global population of 7.9 billion people have been fully vaccinated against Covid-19 with all regions of the world except Africa making progress in immunising their people, according to statistics released by the European Commission on 8 December. The World Health Organization has set an immunisation target of 70% to be achieved by September 2022 at the next meeting of the United Nations General Assembly.