Clinical updates, including trial initiations, enrollment status and data readouts and publications: Alkermes, Arch, Astex, Beyond Air, Cidara, Cyclo, Diffusion, Forma, KBP, Roche, Santhera.
According to an analysis conducted by BioWorld of the first quarter 2020 financial reports filed by the top 100 public biopharmaceutical companies ranked by market cap, and excluding big pharma companies, the amount that was invested in research and development (R&D) during the period increased by 13% compared to the same period last year.
Responding to COVID-19’s wakeup call as it exposes the risks of relying heavily on foreign biopharma supply chains, the U.S. Department of Health and Human Services (HHS) signed a four-year, $354 million agreement with a team of private industry partners, led by Phlow Corp., to expand U.S. manufacturing of essential medicines at risk of shortage during the pandemic and in future public health emergencies.
LONDON - EMA Director General Guido Rasi has hit out at the lack of coordination in COVID-19 clinical trials, questioning if the huge number of small studies that are running will support regulatory decision-making.
Representing the highest amount ever raised by a public biopharma company on a U.S. exchange, Moderna Inc. priced a $1.34 billion follow-on offering to help fund worldwide manufacturing and distribution of its mRNA-1273 vaccine for COVID-19.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Kempharm, Novartis, Organicell, Theralase, Tolero.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Agios, Amplyx, Arbutus, Biogen, Covis, Hepion, Lidds, Mezzion, MGB Biopharma.
Moderna Inc.’s chief medical officer, Tal Zaks, said that the results in hand “give us great confidence that we've got the right dose range for phase III” work slated to begin this summer with COVID-19 vaccine prospect mRNA-1273. A regulatory filing could come as early as 2021.