DUBLIN—Can high-dose inhaled nitric oxide (NO) make a meaningful contribution to patients with COVID-19 infection? The FDA was sufficiently persuaded by the data presented by Bellerophon Therapeutics Inc., to grant it expanded access approval for its iNOPulse system for pulmonary delivery of NO. This means that the Warren, N.J.-based firm can start shipping its at-home system immediately. If it works – and there is as yet no clinical evidence to suggest that it does – it could help take some of the burden off the hospital system as the case load starts to climb.
Clinical testing and the new virtual reality in time of COVID-19
It took less than a week from the publication of Science 37’s whitepaper on March 12 encouraging virtual clinical trials to the FDA’s decision to endorse the idea, tailored to address the COVID-19 pandemic. It was a decision years in the making, one so swift that it surprised the whitepaper’s author, who said the FDA up to this point had been unwilling to even use the word “virtual” because its mere mention evoked a feeling that the process was not real. “It speeds up the trajectory we’re already on,” Science 37’s Jonathan Cotliar told BioWorld. “The basic tacit approval that the regulators are giving us is amazing. Even before the guidance and the whitepaper, we were inundated with sponsors who were desperately trying to help to keep studies on track.”
Policy advocates propose measures for clinical disruptions in China
BEIJING – China was the first country to face serious disruptions in clinical trials caused by COVID-19, and policy advocates in the country moved quickly to identify lessons for future outbreaks and address the concerns of a biotech industry in dismay. Clinical trials for oncology drugs have been hit hardest. Patients have found it difficult or impossible to visit hospitals for pre-screening or to see their physicians and get their medications regularly. “We see a lot of pharmaceutical companies trying to deliver drugs to the patients. While it is not a direct impact of the outbreak, it’s a side effect that cannot go unnoticed,” Song Ruilin, chairman of the China Pharmaceutical Innovation and Research Development Association, told BioWorld.
Despite disruptions, COVID-19 could have silver linings for biotech industry
BEIJING – The COVID-19 pandemic has temporarily impacted partnerships and investment opportunities, but it has also prompted other forms of collaboration within the biotech community and helped R&D-driven companies learn valuable lessons.
Deeming day dawns Monday for insulin, other small proteins
As if the FDA doesn’t have enough on its hands with COVID-19, Monday is deeming day.
That’s the day nearly 100 drugs approved via new drug applications (NDAs) are to be deemed biologics, courtesy of the 2010 Biologic Price Competition and Innovation Act. Ten years in the making, deeming day is more than transferring the small proteins from the FDA’s Orange Book of NDAs to its Purple Book listing of approved biologic license applications. The day is expected to open the door to interchangeability, a new level of biologic competition.
Design Therapeutics raises $45M to take on degenerative disorders
Design Therapeutics Inc., a San Diego startup developing new therapies for degenerative disorders caused by nucleotide repeat expansions, has raised $45 million in series A financing. SR One led the round, with participation from Cormorant Asset Management, Quan Capital and Westriver Group. The money will help advance the company’s lead program for Friedreich’s ataxia toward clinical development as well as development of discovery-stage programs for other degenerative diseases, including fragile X syndrome and myotonic dystrophy.
Nineteengale is born, a spinout of Neurotheryx and Cyclica
Neurotheryx Canada Ltd. and Cyclica Inc., both of Toronto, have launched a joint venture, Nineteengale Therapeutics, to find and develop novel cannabinoid-inspired drugs for bipolar disorder, anxiety and pain management. The new company is based on combining Neurotheryx’s phenotype-based drug discovery platform and Ligand Express, Cyclica’s proteome screen platform, to design molecules that reduce off-target effects while also detailing each molecule's activity by applying integrated systems biology and structural pharmacogenomics. The initial molecules generated by Ligand Design have shown promising in vitro and in vivo data, the company said.
Targeting glycosylated PD-1 induces potent antitumor immunity
Targeting glycosylated programmed cell death protein 1 (PD-1) immune checkpoint may be a promising new cancer immunotherapeutic strategy, according to a collaborative study led by Taiwanese researchers, which was reported online in the March 10, 2020, edition of Cancer Research.
Free access to BioWorld coronavirus articles
The articles from BioWorld’s ongoing coverage of the COVID-19 coronavirus outbreak are available at www.bioworld.com/coronavirus. Note that we have added three critical tables which are constantly updated:
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