Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Genbody, Vieworks, Wision.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ascletis, Astrazeneca, Biocryst, Immunabs, Janssen, Jubilant, Panbela, Syros, Vaxcyte, Xortx.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Arcutis, Astria, Biogen, Noema, Novavax, PDS, Pfizer, Rain, Scynexis, Union, Xortx.
Bio-Rad Laboratories Inc. signed a $170 million deal to acquire all the outstanding shares of molecular diagnostics subsidiary Curiosity Diagnostics SpZoo from Scope Fluidics SA. The deal consists of approximately $100 million in cash and up to $70 million in future milestone payments. The pre-commercial platform company is the developer of a CE-marked 15-minute point-of-care (POC) rapid PCR system which tests for SARS-CoV-2 virus and methicillin-resistant or-sensitive Staphylococcus aureus bacteria (MRSA/MSSA).
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Biontech, Calidi, Cellectis, Pfizer, Takeda.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Alzecure, Avalo, Axcella, Bio-Thera, Caladrius, Eliem, Halozyme, Ocuterra, Orca, Satsuma, Structure, Tavanta.
As omicron subvariants of the SARS-CoV-2 virus take hold, global cases began to rise in the past month, just as the U.S. authorized its fourth COVID-19 vaccine and developers continue their work on a fall booster targeting BA.4 and BA.5. Worldwide deaths have remained lower than each of the last two pandemic years, signaling that the worst is over. It is clear, however, that as current treatments lose their effectiveness and the virus continues to evolve, efforts to contain the virus will be ongoing.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alx, Arcutis, Armata, Beam, Biosight, Celyad, Eccogene, Eledon, Gamida, Janssen, Krystal, Pharming, Scynexis, Veru, Zenas.