LONDON – The EMA has concluded that the rare cases of serious blood clots with low platelet counts seen after administration of Astrazeneca plc’s COVID-19 vaccine are caused by the vaccine, but said the benefits of its use continue to outweigh the risks. The possibility of cerebral venous sinus thrombosis and splanchnic vein thrombosis in the abdomen will now be listed as rare side effects and the EMA’s guidance to health care professionals will be updated.
With less uncertainty surrounding the pandemic, the biopharma industry appears on track to shift efforts back to its internal programs and possibly meet, if not exceed, the record-breaking deal level of 2020. Strong financial markets, however, may continue to hold M&As down.
Cambridge, Mass.-based Agios Therapeutics Inc.’s encouraging phase III data from a pair of trials with allosteric activator mitapivat in pyruvate kinase deficiency brought more attention to the space, where Rocket Pharmaceuticals Inc. – at a much earlier stage – is trying a gene therapy called RP-L301.
Shoreline Biosciences Inc., a San Diego-based company developing allogenic natural killer and macrophage cellular therapies for cancer and other diseases, has raised $43 million in a financing led by Boxer Capital.
The biopharmaceutical sector is showing no signs of slowing the pace of attracting capital. After coming off a record year, global private and public companies collectively raised $37 billion in the first quarter, indicating that it could be another bumper year for financings.
Fibrogen Inc. said senior management’s prep for an upcoming FDA advisory committee meeting included a surprise. The internal review unearthed a primary cardiovascular safety analysis of roxadustat for treating anemia of chronic kidney disease (CKD) that included post-hoc changes to the phase III study’s stratification factors.
LONDON – DNA damage response (DDR) specialist Artios Pharma Ltd. has signed a potential $1.3 billion deal to apply its technology to discover drugs that will work in combination with Novartis AG’s radioligand therapies.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Arcellx, Biogen, Bioinvent, Bluerock, ERC, Fibrogen, Eli Lilly, Incyte, Pfizer.
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