Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Empowered Diagnostics.
SD Biosensor Inc. and SJL Partners LLC plan to take Meridian Biosciences Inc. private in a $1.53 billion cash deal reached after four months of negotiation. Meridian shareholders will receive $34 per share, which represents a premium of 32% on the share price at market close on March 17, the day before SDB and SJL first presented an offer to buy the company. On July 7, the proposed price was a 16% premium based on the one-month average price per share of Meridian’s common stock.
Oxford University has opened the doors to its new Pandemic Sciences Institute, a £100 million (US$119.5 million) initiative to build on the research and experience of COVID-19, to counter future pandemic threats.
SARS-CoV-2 infection caused damage to brain blood vessels via a cascade of immune system reactions that was most likely initiated by antibody-dependent cytotoxicity, researchers from the National Institute of Neurological Disorders and Stroke reported in the July 5, 2022, online issue of Brain.
Curevac NV has filed a patent lawsuit against fellow German mRNA pioneer Biontech SE claiming that the latter firm’s COVID-19 vaccine, Comirnaty, infringes its intellectual property.
South Korea’s Ministry of Food and Drug Safety has granted marketing authorization to SK Bioscience Ltd.’s COVID-19 vaccine, Skycovione (GB-510), marking the country’s first homegrown COVID-19 vaccine to be approved. The company has already signed an advanced purchase agreement with the Korea Centers for Disease Control for 10 million doses of the vaccine.
Japan is establishing a centralized infectious disease crisis management agency that will be under direct control of the prime minister. One of the goals is to better clarify the chain of command and to bring together resources and COVID-19 task forces from the Cabinet Secretariat and the Ministry of Health, Labor and Welfare.
Japan is establishing a centralized infectious disease crisis management agency that will be under direct control of the prime minister. One of the goals is to better clarify the chain of command and to bring together resources and COVID-19 task forces from the Cabinet Secretariat and the Ministry of Health, Labor and Welfare.
The U.S. FDA’s guidance to COVID-19 vaccine manufacturers, announced June 30, that they should develop modified bivalent boosters that include an omicron BA.4/5 spike protein component marks the beginning of a new era in the pandemic in which manufacturers are no longer driving the development of the vaccines.
With vaccines now authorized for children as young as six months, omicron boosters in development for the fall, and the nation’s first protein subunit vaccine for COVID-19 pending authorization, the U.S. appears to be well on its way to exiting the turmoil caused by the deadly SARS-CoV-2 virus. Globally, there is reason for optimism as well.
