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. Read More
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. Read More
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. Read More
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. Read More
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 (BPCIA). Read More
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. Read More
Nineteengale Therapeutics is a new joint venture that was launched to fill a large void. Cyclica Inc., along with its partner, Neurotheryx Canada Ltd., both of Toronto, created Nineteengale to find and develop cannabinoid-inspired drugs for bipolar disorder, anxiety and pain management. Read More
Targeting glycosylated 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. Read More
BioWorld looks at translational medicine, including: Heparan sulfate DAMPens acetaminophen toxicity; Study links GABA, mitochondria, social defects; Recruiting NK cells to the antitumor battle; Potassium channel blocker improves motor learning in fetal alcohol syndrome; A20s inflammation-fighting properties decoded; Brown fat activity without fat browning; Agonists selectively wake up melatonin receptor subtypes; Multistep method wrests causality from GWAS; BET on BD1 for cancer, BD2 for inflammation. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Adaptive Biotechnologies, Immune Therapeutics, Junshi, Lexicon, Olix, Polarisqb, Revive, Ridgeback, Sciclone, Sorrento, Sosei, Tarveda. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Agex, Bellerophon, Imstem, Oncology Ventures, Viiv. Read More
