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.
Google sister company Verily Life Sciences LLC has been under an unprecedented amount of scrutiny since it was promoted over the weekend by President Donald Trump as responsible for a nationwide information and testing program for the emerging novel coronavirus.
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.
The past week has seen a lot of movement in terms of tests to detect SARS-CoV-2, the virus that causes COVID-19. “It is notable that the diagnostics community is coming together in a way we have not seen in our 20 years covering this industry,” wrote William Blair analyst Brian Weinstein in a March 14 note. “Regulators, lab professionals, and manufacturers are all in a frenetic fury to try and get testing up and running, and we generally see a sense of ‘in it together’ playing out.”
Investigators at Stanford University Medical Center have treated the first patient in a pivotal phase III study of Abeona Therapeutics Inc.'s EB-101, an autologous cell therapy for recessive dystrophic epidermolysis bullosa (RDEB). The trial, delayed by an FDA clinical hold placed in September 2019, has now resumed, with the majority of its 15 expected participants pre-screened.
Jerusalem-based Brainsway Ltd. had good news to report with the presentation of positive data from a multicenter study evaluating its deep transcranial magnetic stimulation (dTMS) system as an aid in smoking cessation.
Beta-O2 Technologies Ltd. plans to enroll its first patients in clinical trials for its second-generation bio-artificial pancreas, ßAir, in the coming months. The small, implantable titanium device has separate components that hold pancreatic cells and a rechargeable oxygen tank. Beta-O2 is based in Rosh-Haayin, Israel.
Bridgebio Pharma Inc. subsidiary QED Therapeutics Inc., seeded in 2018 with $65 million and a license to Novartis AG's infigratinib, said the first patients have been dosed with the drug in two separate cancer trials.