Amid a world that has been brought to its knees by the COVID-19 pandemic, the biopharma industry has learned how to quickly adapt under these extreme circumstances. Not only has it rapidly brought to bear huge research efforts to uncover potential therapeutics and vaccines to counter the circulating coronavirus, but also it has learned how to conduct its business activities in a completely different way. For example, the pandemic hasn't stopped biopharmas from going public, with 15 companies graduating to the public arena in June alone. These financings have contributed to the $62 billion that has been generated in combined global public and private company financings in the first half of the year. Read More
DUBLIN – Even by any normal measure of European biotechnology investment, the first two quarters of 2020 were memorable. If it maintains the present momentum, Europe’s drug development sector is on course for a record-breaking year, having already raised $5.034 billion in publicly disclosed equity investments. That puts it well ahead of any other year – the sector edged to a new high in 2019 when it raised $7.739 billion over the full 12 months – but, of course, comparisons with any other year seem irrelevant. This year is like no other. The COVID-19 pandemic has changed everything. Read More
HONG KONG – SK Biopharmaceuticals Co Ltd.’s shares are still basking in the afterglow of a successful entrance on the Korea Exchange, which raised ?959.30 billion (US$799 million). Read More
Missing the primary endpoint along with key secondary endpoints in a phase III trial of Kevzara (sarilumab), an interleukin-6 (IL-6) receptor antibody, for treating COVID-19 patients who need mechanical ventilation caused Regeneron Pharmaceuticals Inc. and Sanofi SA to halt the study. Read More
A large epidemiological study published in the July 6, 2020, advance online issue of The Lancet found that most individuals who became infected with SARS-CoV-2 developed antibodies to the virus, confirming that infection usually results in at least a short-term immune response. Read More
Geneva-based Obseva SA’s top-line data from the pivotal phase III studies called Primrose 1 and 2 with GnRH antagonist Yselty (linzagolix) pleased the company, but Wall Street not so much. Read More
DUBLIN – Idorsia Ltd. plans to file an NDA before the year-end for its insomnia drug, daridorexant, following a read-out of top-line data from a second phase III study, which the company said closely tracked an earlier phase III study, although it failed to meet one of two primary endpoints with statistical significance. Read More
The failure of an experimental refractory chronic cough drug to yield statistically significant reductions in placebo-adjusted cough frequency sent shares of its developer, Bellus Health Inc. (NASDAQ:BLU), down 71.7% to $3.40 on July 7. Read More
LONDON – Mission Therapeutics Ltd. has sealed a discovery deal with Pfizer Inc. around its small-molecule protein degradation platform and raised $15 million as an extension to its series C, with Pfizer Ventures leading the round. Read More
Viiv Healthcare Ltd., late Thursday, won FDA approval for Rukobia (fostemsavir), a gp120-directed attachment inhibitor for the treatment of adults with multidrug-resistant HIV-1 infection failing their current antiretroviral regimen due to resistance, intolerance or safety considerations. The drug was reviewed under FDA's fast track and breakthrough therapy status programs. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: ADC, Adial, Ascendis, CSL Behring, Daiichi Sankyo, Esperare Foundation, Gilead, Medivir, Mesoblast, Mylan, Napo, Sinovac, Viiv. Read More
