The annual med-tech conference hosted by the Advanced Medical Technology Association, always features an FDA town hall, but this year’s town hall labored under the overhang of the COVID-19 pandemic. Nonetheless, Jeff Shuren, director of the Center for Devices and Radiological Health (CDRH), repeatedly gave voice to frustration with the statutory authorities currently enjoyed by the center, stating on more than one occasion that the Medical Device Amendments of 1976 are more than 40 years old and are in need of updates to cope with modern medical technology.

CAJICA, Colombia –The government of Costa Rica issued guidelines recently that will allow the country’s social security system to source the country's hospitals with ventilators produced by the faculties of the universities of the Latin American country, during the COVID-19 outbreak.

Amid speculation that the White House had killed it, the FDA issued a promised guidance Oct. 6 on what it will take to get an emergency use authorization (EUA) for a COVID-19 vaccine.

HONG KONG – Cambridge, U.K.-based Astrazeneca plc has resumed phase I/II trials in Japan for AZD-1222, the experimental, adenovirus vector-based candidate coronavirus vaccine that it is co-developing with the University of Oxford.

Just as financings are hitting record levels, biopharma deals should finish out 2020 on top, based on solid partnerships signed in the first three quarters of the year. While mergers and acquisitions have slowed this year, particularly in the third quarter, several big-money M&As slated to close in the fourth quarter could move the needle, putting this year within the top three highest values.