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.
PERTH, Australia – Mesoblast Ltd. plans to evaluate remestemcel-L in patients with acute respiratory distress syndrome caused by coronavirus (COVID-19) in the U.S., Australia, China and Europe.
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.”
The number of biopharmas and nonprofits pitching in to find a treatment for COVID-19 continues to grow. In the past few weeks, that number has more than doubled and it shows no signing of slowing.
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.
Anti-drug antibodies noted in the phase Ib portion of the PREVAIL study in lupus drew queries for Oldwick, N.J.-based Provention Bio Inc. during a conference call related to earnings, but analysts seemed more interested in the company’s later-stage push in type 1 diabetes (T1D).
Novi, Mich.-based startup Delphinus Medical Technologies Inc. has been working for roughly a decade to introduce whole breast ultrasound tomography to improve breast cancer diagnosis and treatment.
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