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.
Investors are beginning to show confidence in the financial markets, once again believing that the worst of the ravages caused by the COVID-19 pandemic are behind us and that the stringent restrictions on business activity and personal behavior currently in place will be slowly lifted. As a result, stocks in all sectors rallied in April from their March meltdowns. The Dow Jones Industrial Average recorded an 11.08% increase in the period, its largest one-month percentage gain since January 1987.
With Gilead Sciences Inc. donating its existing stock of finished and unfinished remdesivir to help address the global COVID-19 pandemic through clinical trials, emergency use authorization (EUA) and compassionate use programs, patient accessibility to the investigational drug will be limited by supply, not price.
LONDON – In a potent demonstration of how COVID-19 is transforming the U.K. clinical trial landscape, 47,000 patients have been recruited to studies investigating potential treatments for the infection in a little over two months.
The EMA's Committee for Medicinal Products for Human Use said Friday it has started a rolling review of Gilead Sciences Inc.'s antiviral, remdesivir, for the potential treatment of COVID-19. The move put into play one of multiple regulatory tools it has deployed "to speed up the assessment of a promising investigational medicine during a public health emergency."
How U.S. health care emerges from the COVID-19 pandemic is a million-dollar question, as patients, providers, payers and drug manufacturers are adapting to a new reality that’s advancing telehealth and changing how providers interact with patients.
Following revelations that a randomized, placebo-controlled study of the Gilead Sciences Inc.’s antiviral, remdesivir, reduced time to recovery for hospitalized patients with "advanced" COVID-19, along with additional data from an open-label phase III trial from its maker, the FDA is "working with Gilead to figure out a mechanism to make this easily available to people who need it," Anthony Fauci, director of the NIH’s National Institute for Allergy and Infectious Diseases (NIAID), said April 29.
Six of six critically ill COVID-19 patients survived after being treated as compassionate care cases with Capricor Therapeutics Inc.’s lead candidate, an off-the-shelf cardiac cell therapy. The success prompted the FDA to review the data and approve the company’s expanded access protocol for treating as many as 20 more COVID-19 patients.
A pair of good-news items from Chimerix Inc. pushed the Durham, N.C.-based company’s stock (NASDAQ:CMRX) to $2.15, closing up 64 cents, or 42%, higher as backers reacted to near-term NDA plans for smallpox countermeasure brincidofovir (BCV) and the start of a phase II/III trial with dociparstat sodium (DSTAT) in COVID-19 patients with acute lung injury (ALI).