LONDON – In the rush to test drugs against COVID-19, clinical trials in other indications are starting to be interrupted by the strains on health care systems and the fact that many potential patients are those most at risk from the effects of the novel coronavirus. Read More
With medical researchers across the globe adjusting to the far-reaching impacts of COVID-19, commercial and academic trialists are taking action to protect essential studies. Regulators, too, are now joining the effort in a more concerted way, with the FDA issuing new guidance for industry, investigators and institutional review boards on conducting clinical trials during the pandemic. Read More
As the world goes to war with COVID-19, the U.S. is ripping open the purse strings to fund mobilization against both the coronavirus and the economic devastation it’s causing. Read More
Geneva-based Obseva SA’s phase III Primrose 2 trial with gonadotropin-releasing hormone (GnRH) antagonist linzagolix in heavy menstrual bleeding (HMB) due to uterine fibroids (UFs) hit the primary endpoint in 94% of patients, and the company in the second quarter of 2020 will report six-month data from the Primrose 1 study, which is also a phase III experiment, in the same indication. Read More
DUBLIN – The middle of a pandemic may not be the optimal time to launch an oncology-focused company, but Klosterneuburg, Austria-based Oncoone Research & Development GmbH unveiled a €13 million (US$14.1 million) series A round Wednesday, March 18, and laid out plans to develop several different approaches to targeting an immunologically distinct form of a ubiquitous inflammatory cytokine, which is unique to cancer cells and which is associated with a poor prognosis. Read More
BEIJING – One day after the U.S. began the first human trial of an mRNA vaccine candidate for COVID-19 on March 16, China said Tuesday evening that it had approved the first clinical trial of a vaccine candidate developed by domestic researchers. Read More
Randomized trials of the broad-spectrum antiviral favipiravir, marketed as an anti-influenza treatment by Fujifilm Holdings Corp., have shown "obvious efficacy" against COVID-19, according to Zhang Xinmin, head of the China National Center for Biotechnology Development. Read More
The U.S. capacity for SARS-CoV-2 testing is limited by several items, including the swabs used to collect patient specimens, but the supply of reagents has been front and center recently. Despite those concerns, several private test makers said they are quickly ramping up production, including Thermo Fisher Scientific Inc., of Waltham, Mass., which said it has enough supplies of all types on hand to provide 2 million reactions per week, a volume that should increase to 5 million per week in April. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Addex, Enlivex, Graybug, Ideaya, Iveric, Sellas, Vivoryon. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alpine, Biohaven, Pharnext, Rhythm, Sage, Synairgen. Read More
The latest global regulatory news, changes and updates affecting biopharma, including: Astrazeneca, Boehringer Ingelheim, Janssen, Lilly, Merck. Read More
