The FDA has its hands full with the impact of the mutations to the SARS-CoV-2 virus, but test developers can count on an ever-increasing base of data for those viruses thanks to a new contract taken by the CDC. The CDC indicated recently that its sequencing efforts and that of other organizations churned out nearly 14,000 sequences for the week of April 3, but Aegis Sciences Corp., of Nashville, Tenn., announced April 7 that it had undertaken an agreement to perform next-generation sequencing of samples from all 50 states and Puerto Rico, ensuring plenty of access to up-to-date information on those mutations.
Hologic Inc. is tucking in yet another diagnostics manufacturer, this time with the acquisition of Mobidiag Oy for approximately $795 million. The privately held Finnish-French company develops and markets polymerase chain reaction (PCR)-based tests for acute care testing such as gastrointestinal and respiratory infections, antimicrobial resistance management and health care-associated infections.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FCC says no need to revisit telehealth grants; NICE updates sphere usage for hepatocellular carcinoma; Health Canada: Docs, nurses not needed for workplace testing.
Challenges to ongoing efforts to provide effective aid for hospitalized patients with COVID-19 continued April 8, with two new trial failures reported. A phase III trial testing the Olumiant (baricitinib) vs. placebo, both on top of standard of care, missed its primary endpoint of progression to non-invasive ventilation, invasive mechanical ventilation or death, said drugmakers Eli Lilly and Co. and Incyte Corp. A phase II trial testing Beigene Ltd.'s Brukinsa (zanubrutinib) vs. placebo in patients hospitalized with respiratory symptoms of COVID-19 also fell short, missing its co-primary efficacy endpoints of respiratory failure-free survival or reduction in days on oxygen.
HONG KONG – Covig-19, an anti-SARS-CoV-2 hyperimmune immunoglobulin therapy that Takeda Pharmaceutical Co. Ltd. developed alongside the Covig-19 Plasma Alliance, has failed to meet its endpoints in a global phase III trial. The multicenter Inpatient Treatment with Anti-Coronavirus Immunoglobulin trial was sponsored and funded by the National Institute of Allergy and Infectious Diseases. It aimed to demonstrate the drug’s safety, tolerability and efficacy in hospitalized adults at the onset of COVID-19 progression, the companies said.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Beigene, Cansino, Cytodyn, Gilead, Immutep, Teva.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Bio-Thera, Biogen, Context, Cytoimmune, Dicerna, DS, Hemostemix, Hyundai, Immunoprecise, Integral Molecular, Medolife, Metriopharm, Moderna, Nuvothera, Oncology, Regen, Talem, Trisalus, Vir.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Algernon, Aurinia, Beigene, BMS, Connect, Eli Lilly, Galderma, Global Blood, GT, Immunitybio, Incyte, Laurent, Merck, Ocuphire, Portage, Secura.
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.
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