HONG KONG – Japan has become the first country in the world to approve Veklury (remdesivir), Gilead Sciences Inc.’s experimental drug, to treat COVID-19. The fast approval was based on U.S. data and that country’s emergency use of the drug to tackle the pandemic, although it is unclear whether the drug is safe or effective for treating COVID-19.
In the rush to develop a COVID-19 vaccine, integral parts of the equation are being overlooked in the U.S., according to a whistleblower complaint filed this week by Rick Bright over his removal as director of the Biomedical Advanced Research and Development Authority (BARDA). Even if millions of doses of vaccine are ready to go by January, as the NIH’s Anthony Fauci a few weeks ago said could happen, there may not be enough needles and syringes to deliver those doses.
CEO Carsten Brunn said Selecta Biosciences Inc. has “not seen a material impact” from the COVID-19 pandemic and remains on track to report in the third quarter phase IIb data from a head-to-head trial comparing its refractory gout candidate, SEL-212, with Krystexxa (pegloticase), from Horizon Therapeutics plc, of Dublin.
LONDON – Computational biology specialist Precisionlife Ltd. has used UK Biobank data to find sepsis risk genes that are present specifically in patients who suffer severe COVID-19 infections and shown that 13 of those genes are known druggable targets.
DUBLIN – Bavarian Nordic A/S, Europe’s largest independent vaccine developer, is placing a bet on virus-like particle (VLP) technology as a potentially useful contribution to the desperate global effort to push back against SARS-CoV-2.
PERTH, Australia – Melbourne-headquartered CSL Behring Australia, a subsidiary of CSL Ltd., will begin developing an anti-SARS-CoV-2 plasma product to treat people with serious complications of COVID-19 in Australia.
PERTH, Australia – Roughly 40% of Australia’s biotech companies are seeking capital as they feel the pinch from international travel bans that seriously hamper capital raising, according to a recent Ausbiotech survey.
HONG KONG – Israeli biopharma Redhill Biopharma Ltd. is looking to extend access to its new investigational drug, opaganib (Yeliva, ABC-294640), following the drug’s initial success from a compassionate-use study treating six patients in Israel hospitalized with moderate to severe COVID-19 symptoms.
BEIJING – In one of the latest Sino-foreign collaborations formed to find a cure for the pandemic that has infected 3.5 million people worldwide, Shanghai-based Junshi Biosciences Co. Ltd. and Eli Lilly and Co. have disclosed an agreement to co-develop therapeutic antibodies for preventing and treating COVID-19. Under the terms, Junshi grants Lilly an exclusive license, outside of greater China, to conduct R&D, manufacture and distribute the SARS-CoV-2 JS-016 neutralizing antibodies developed by Junshi.
While many biopharma companies are holding the line on U.S. drug prices during the COVID-19 pandemic, a few are providing more fuel to fire up lawmakers over prescription drug prices. The latest flames were stoked by last month’s 220% increase in the price of Jaguar Health Inc.’s Mytesi (crofelemer), a botanical drug used to treat the gastrointestinal side effects of HIV antiretroviral treatments. Two days after the FDA denied an emergency use authorization (EUA) for the drug to be used to treat diarrhea in COVID-19 patients who were given antivirals, Jaguar raised the price of Mytesi from $688.52 per bottle to $2,206.52 per bottle.
