LONDON – The European Commission offered up to €80 million (US$89.4 million) of funding to Curevac AG, to scale up development and production of a vaccine against the coronavirus in Europe, following reports that the U.S. administration had made an offer for the German biotech, in order to get exclusive control of its COVID-19 vaccine candidate. Read More
The circuit breakers activated almost immediately when the markets opened this morning as the Dow plummeted, with investors moving into cash and away from equities. Clearly, they were not impressed with the Federal Reserve’s decision to slash its benchmark interest rate to nearly 0% to help combat the economic fallout from the coronavirus outbreak. Read More
“We look forward to the day where we can get back to normal,” U.S. President Donald Trump said Monday at a COVID-19 news conference in which reporters sat every-other-seat apart. In an unusually somber tone, the president said it now looks like it will be at least July or August before the outbreak “washes through.” Read More
Mainz, Germany-based Biontech SE has struck two deals in its Project Lightspeed, one for inside China and one for outside China, to develop and commercialize a COVID-19 messenger RNA (mRNA) prevention vaccine. The agreements caused the stock (NASDAQ:BNTX) to soar 29.3%, or $9.07, to close at $40 on Monday in the midst of a bear market. Read More
The U.S. effort to deploy diagnostics for the novel coronavirus has been plagued by missteps by the CDC and the FDA from the outset, leading to delays and missed opportunities. The Trump administration declared a national emergency March 13, but concerns remain about how quickly the array of available tests can be conducted and whether there are enough testing supplies to handle the anticipated demand. Read More
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.” Read More
Undetected cases were a major driver of the early spread of SARS-CoV-2 in Wuhan, China, despite being less infectious on a case-by-case basis, according to a modeling study published in the March 16, 2020, online issue of Science. Read More
A U.S. Court of Appeals affirmation of a lower court ruling requiring the FDA to grant Eagle Pharmaceuticals Inc.'s bendamustine infusion product, Bendeka, seven years of orphan drug exclusivity appears to resolve a key piece of uncertainty that had troubled Eagle and others in similar circumstances. Read More
Several companies are awaiting regulatory decisions from the FDA over the next several months. BioWorld will periodically feature a chart of Drugs on Deck that show upcoming PDUFA dates. The current month includes four products that are waiting in the wings to treat diverse indications such as multiple sclerosis, migraine and renal disease. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: AGTC, Aimmune, Aptevo, Arcutis, Biocryst, Can-Fite, Genetx, Moderna, Novo Nordisk, Regeneron, Sanofi. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Acelrx, Advanz, Akebia, Amarin, Armas, Brainstorm, Correvio, Homology, Kirin, Medivir, Nanoviricides, Pharmamar, Protalix, Spherix, Tango, Tetraphase, Therapeuticsmd, Twist, Xortx. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aurinia, Cytodyn, Kadmon, Lilly, Tracon, Zai Lab. Read More
