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. Read More
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. Read More
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. Read More
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. Read More
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. Read More
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. Read More
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. Read More
The latest global regulatory news, changes and updates affecting biopharma, including: EC provides emergency funding for COVID-19 research; Final judgment against former Retrophin attorney; FDA hits company for deviations from drug, device GMPs. Read More
New hires and promotions in the biopharma industry, including: Allena, Arch Oncology, Biotheryx, Exact, Inmagene, Innocan, Nkgen, Penrose, Tessera, T-knife. Read More
Biopharmas raising money in public or private financings, including: Achilles, ACM, Applied Molecular, CM Life Sciences, Delta 4, Homology, Humanigen, Icosavax, Innovatus Life Sciences, Ionis, Metagenomi, Panacea Acquisition, Xoma. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Aim, AVM, Bridge, Chinook, Daiichi Sankyo, Horizon, Recognify. Read More
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. Read More
