Despite an NIH move to pause enrollment in a trial testing Eli Lilly and Co.'s COVID-19 antibody candidate, LY-CoV555, after a participant's unexplained illness, at least three other studies of the candidate remain underway, the company said Oct. 14.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: ICER cost models going global; Canada prepares for ICH Q12; HHS partners on Lyme innovation; AMA adds codes for COVID-influenza testing; MedPAC concerned about post-pandemic telehealth; CMS: CLIA audits yield cease-and-desist letters.
The latest global regulatory news, changes and updates affecting biopharma, including: ICER cost models going global; Canada prepares for ICH Q12; HHS partners on Lyme innovation.
PERTH, Australia – Starpharma Holdings Ltd. completed a AU$45 million (US$32 million) placement to domestic and international investors that will see it advance its COVID-19 antiviral nasal spray. The treatment is based on the company’s antiviral dendrimer, SPL-7013.
Humanigen Inc. reported progress in COVID-19 treatment by deploying a drug candidate, lenzilumab, that was created to fight cytokine storms in CAR T patients. The drug is partnered for the latter with Gilead Sciences Inc., which rolled out pandemic news of its own related to the investigational broad-spectrum antiviral Veklury (remdesivir).
PERTH, Australia – Starpharma Holdings Ltd. completed a AU$45 million (US$32 million) placement to domestic and international investors that will see it advance its COVID-19 antiviral nasal spray. The treatment is based on the company’s antiviral dendrimer, SPL-7013, which inactivates viruses by blocking the interaction between viral surface proteins and the human cell receptor proteins.
The latest global regulatory news, changes and updates affecting biopharma, including: FDA stands by plasma EUA; Benzodiazepines to get added warnings; EMA posts draft guidance for registry-based studies; SEC finalizes whistleblower changes; Gilead to pay $97M; Plandai, CEO settle with SEC.
Gilead Sciences Inc.’s recent decision to acquire Immunomedics Inc. looks even smarter now in light of the full data in a phase III study of Trodelvy (sacituzumab govitecan-hziy) released at the European Society for Medical Oncology (ESMO) over the weekend.
Antibody-drug conjugates (ADCs) are making a comeback. After a relatively slow start with Adcetris (brentuximab vedotin, Seattle Genetics Inc.) and Kadcyla (ado-trastuzumab emtansine, Roche Holding AG) approved by the FDA in 2011 and 2013, respectively, the regulatory activity has swelled with four FDA approvals over the last nine months.
In the company’s largest acquisition and potentially the fifth biggest biotech M&A ever, Gilead Sciences Inc. will acquire Immunomedics Inc. for $21 billion in a move that substantially transforms Gilead’s oncology portfolio.
