With some positive early data for an antibody to block the COVID-19 virus, Sorrento Therapeutics Inc. is now looking to test a product in a few dozen intensive care patients by the end of July or early August and move into a much broader pool of patients by October.
LONDON – The World Health Organization (WHO) is stepping up its effort to try and ensure equitable access to any approved COVID-19 vaccines and therapies, putting in place a system for sharing all intellectual property, information and clinical trials data needed to enable generic manufacturing.
SUZHOU, China – With the outbreak tightly contained, business activities are starting to get back to normal in China. Opening in Suzhou on Thursday, the Enmore Bio Conference 2020 is one of the first industry galas to take place since the coronavirus hit the country. In the opening session, Chinese biotech insiders pointed to a bumpy road ahead for Chinese companies in the post-COVID-19 era.
Exact Sciences Corp., of Madison, Wis., detailed three studies of the Oncotype Dx Breast Recurrence Score test during the virtual 2020 American Society of Clinical Oncology Annual Meeting. According to the company, the findings highlight the value of the test for personalizing and improving neoadjuvant treatment decisions in women with hormone receptor positive, HER2-negative breast cancer.
LONDON – After eight years in development, Memed Diagnostics Ltd. has secured CE marking for its point-of-care blood test, which is able to distinguish between bacterial and viral infections in 15 minutes.
Swept up into a coronavirus whirlwind, the biopharma industry has ramped up development of therapeutics and vaccines and altered business plans to fight the SARS-CoV-2 virus in a way that nobody could have imagined only months ago. BioWorld began tracking these efforts in late February when there were 30 candidates in development and about 83,000 worldwide cases, according to the World Health Organization (WHO). So what are the numbers as of the end of May? There are currently 318 therapeutics and 115 vaccines in development for COVID-19. Tracked diagnostics featured in BioWorld MedTech have reached 275, including antibody, antigen and molecular-based tests, of which 117 have emergency use authorization (EUA) from the FDA.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Avita Medical, Citius, College Park Industries, Fibralign, Icometrix, Lumendi, Medx, Mölab, Mybio, Myndtec, Maness Veteran Medical, Nuprobe, Ourcrowd, Pathgroup, Protech Home Medical, Qualigen Therapeutics, Respira Technologies, Steeper Group, Surgery Exchange, Technopath Clinical Diagnostics, Terumo.
The Kaiser Family Foundation (KFF) reported that 48% of U.S. adults surveyed had postponed medical care due to the COVID-19 pandemic. In good news, more than two-thirds of those who delayed care expected to get the care they have delayed over the next three months.
The COVID-19 pandemic has demanded much of the FDA, and commissioner Stephen Hahn said on a June 1 conference call that “there have been hiccups along the way” as the enormity of the threat came into view. The agency’s use of emergency use authorizations (EUAs) has drawn criticism, but Hahn defended those EUAs and other regulatory flexibilities even has he declared that the FDA is not “walking away from” randomized, controlled clinical trials as the gold standard for premarket review.