The massive deal Jounce Therapeutics Inc. has cut with Gilead Sciences Inc., an agreement that could eventually add up to about $805 million, will strengthen Jounce’s ability to develop its pipeline and choose new partners, the company’s CEO and president told BioWorld.
As of Aug. 13, more than 90,000 patients hospitalized in the U.S. with COVID-19 already had been given access to convalescent plasma through a national expanded use protocol (EAP) sponsored by the Mayo Clinic. The FDA’s decision Sunday to grant emergency use authorization (EUA) for the potential therapy will further expand access to convalescent plasma for hospitalized patients throughout the country at a time when fully approved COVID-19 treatments are nonexistent and even EUAs are few and far between.
Avoiding the political overtones that seem to be more viral than COVID-19 these days, Anand Shah, deputy commissioner for medical and scientific affairs at the FDA, stressed that even though the agency is making decisions in real time in response to the urgency of the pandemic in the U.S., its decisions are being driven by scientific integrity, regulatory independence and the FDA’s historic commitment to ensuring the safety and efficacy of the products it regulates.
An FDA rejection of Galapagos NV's rheumatoid arthritis (RA) drug filgotinib, announced Aug. 18, was "disappointing and unexpected," CEO Onno van de Stolpe said, adding that "there is so much more" to his company's story and pipeline. Gilead Sciences Inc., the Belgian company's partner and a substantial backer of both the drug and the pipeline, said it would "evaluate the points raised" by the CRL, but continued to believe in the drug.
Tango Therapeutics Inc. CEO Barbara Weber told BioWorld that Gilead Sciences Inc.’s decision to greatly expand their 2018 deal in oncology – a pact then valued as high as $1.7 billion – was based on brisker than expected progress in the original, five-target effort.
According to an analysis conducted by BioWorld of the second-quarter 2020 financial reports filed by 120 public biopharmaceutical companies with market caps greater than $1 billion, and excluding big pharma companies, the amount that was invested in research and development during the period increased by 14% compared to the same six-month period last year.
Amid all the political positioning, finger-pointing, blame games and mountains of misinformation that have been as much a part of the COVID-19 pandemic as the coronavirus itself, there’s one point of agreement: The pandemic has been a painful experience that everyone needs to learn from so it’s not repeated in the future.
Amid all the political positioning, finger-pointing, blame games and mountains of misinformation that have been as much a part of the COVID-19 pandemic as the coronavirus itself, there’s one point of agreement: The pandemic has been a painful experience that everyone needs to learn from so it’s not repeated in the future.
Citing the limited supplies and the pricing of the COVID-19 therapy, nearly three dozen U.S. states and territories are clamoring for the federal government to march in on Gilead Sciences Inc.’s patents for remdesivir. And if the feds won’t, then states should be given that authority, according to a letter sent Tuesday to the Department of Health and Human Services, the NIH and the FDA.
The share prices of blue-chip biopharmaceutical companies continued on their lackluster trajectory, which started in June and collectively lost ground last month, with the BioWorld Biopharmaceutical index slipping about 1.3% as investors took a break in order to digest the deluge of COVID-19 vaccine data released during the period and the impact on the bottom lines that the pandemic has exerted among those companies that have reported their second-quarter results.
