PERTH, Australia – The majority of medical device and biopharma industry respondents agreed that Australia’s Therapeutic Goods Administration (TGA) responded effectively to COVID-19, but they want to see the agency improve its processes to act faster and with more clarity, according to the TGA’s annual stakeholder survey.
The 39th Annual J.P. Morgan Healthcare Conference was sans Celgene Corp.'s annual tradition of kicking off the conference with preliminary revenue and earnings from the previous year, but plenty of other companies stepped up and offered preliminary results of their own. Unfortunately, some companies continued to face headwinds selling drugs during the pandemic as patients avoided their doctors' offices.
CAJICA, Colombia – Brazil’s health care surveillance agency, Anvisa, granted the first two emergency approvals for COVID-19 vaccines on Sunday, Jan. 17, giving the green light to Sinovac Biotech Ltd.’s Coronavac and to Covishield, developed by Astrazeneca plc and the University of Oxford.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Astrazeneca, Bioinvent, C4, Dr. Reddy's, Genmab, Gracell, Immunitybio, Khondrion, Metacrine, Molecular Templates, Omeros, Pieris, Precision, Steba, Takeda, Tessa, Tracon, Transgene.
The U.S. FDA notice regarding device risk classification proposes to eliminate premarket notification requirements for several device types, a welcome development for industry. However, Amanda Johnston, senior attorney at Gardner Law PLLC, of Stillwater, Minn., told BioWorld that there is a question regarding the provenance of the document, as it fails to identify any FDA staff member. In addition, the notice omits several device types that are solid candidates for down-classification.