Merck & Co. Inc. dropped a bombshell Jan. 25, announcing that it was terminating its two COVID-19 vaccine programs, V-590 and V-591, because neither demonstrated convincing levels of efficacy in phase I trials. As a relatively late entrant to the COVID-19 vaccine race, Merck, of Kenilworth, N.J., was never a leading contender in the effort to bring safe and efficacious vaccines to market. Even so, the failure of these programs is a significant setback, given the company’s scale and experience as a global vaccine manufacturer. Read More
LONDON – There is “a realistic possibility” that infection with the B 1.1.7 variant of SARS-CoV-2 is associated with a 30% to 40% increased risk of death compared to earlier variants of the virus, according to scientists on the U.K. government’s New and Emerging Respiratory Virus Threats Advisory Group. That conclusion is based on studies by three university groups, linking community PCR testing to mortality. Read More
PERTH, Australia – Australia’s Therapeutic Goods Administration (TGA) has granted provisional approval to Pfizer Australia Pty Ltd. for its COVID-19 vaccine, branded Comirnaty, making it the first COVID-19 vaccine to receive approval in Australia. Read More
Aurinia Pharmaceuticals Inc. got its first drug approval with the FDA’s nod to Lupkynis (voclosporin) for treating active lupus nephritis in adults. It’s the first FDA-approved oral therapy for the indication and the second approval in little more than a month for those patients, following the agency’s Dec. 17 approval of Glaxosmithkline plc’s Benlysta (belimumab), for treating active LN. Read More
Tscan Therapeutics Inc. CEO David Southwell told BioWorld that his firm’s series C financing of $100 million will allow two IND filings in liquid tumors this year and three – possibly more – in solid tumors starting next year. “We’ll be filing a lot of INDs in solid tumors,” he said. The Waltham, Mass.-based firm works with T-cell receptor-engineered T-cell therapies. Read More
The 2020 World Conference on Lung Cancer, which was scheduled to take place in Singapore last August, is set to kick off virtually later this week. The postponement gave companies time to generate additional data as they battle to treat patients with their targeted therapies. Read More
The Human Skin Cell Atlas, comprising transcriptomes of 528,253 single cells, shows that cellular processes involved in skin development in embryos are reactivated in inflammatory skin diseases. In addition to suggesting potential new drug targets for atopic dermatitis and psoriasis, the transcriptomes provide a new route to understanding other inflammatory diseases. Read More
A consequence of one of President Joe Biden’s first executive orders (EOs) is that some low-income patients may have to wait at least two more months to get the out-of-pocket relief they were promised for insulin and injectable epinephrine. Read More
The latest global regulatory news, changes and updates affecting biopharma, including: And now the state cases; Advamed urges administration to communicate on DPA; Looking for GCP volunteers. Read More
New hires and promotions in the biopharma industry, including: Atea, Awakn, Cidara, Cyclerion, Diversigen, Novavax, Noveome, Tmunity, Vericel. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Alector, Antios, Astrazeneca, Durect, Dynavax, Exelixis, Genentech, Macrogenics, Medigen, Synairgen, Zydus. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abeona, Albireo, Arrowhead, Astrazeneca, Aurinia, Beigene, EMD Serono, Eusa, Iterum, Junshi, Pfizer, Waymade. Read More
