Following a public backlash to Monday’s news that the FDA had granted Gilead Sciences Inc. an orphan drug designation for remdesivir, an antiviral in development to treat COVID-19, the Foster City, Calif., company is taking the unprecedented step of rescinding its request for the designation.
DUBLIN – Silence Therapeutics plc entered a wide-ranging siRNA-based drug discovery and development deal with Astrazeneca plc that has propelled it toward the front ranks of siRNA platform companies. It is banking an up-front payment of $60 million, another $20 million as an equity investment and up to $400 million in option fees and milestone payments per candidate drug, in an alliance that could entail up to five active programs within three years.
HONG KONG – Singapore-based Proteona Pte. Ltd. has formed a couple of significant partnerships recently, including a Germany-Singapore partnership to develop a drug screening and discovery platform using single cell multi-omics analysis for patient-derived micro-tumors, and an international alliance to develop antibodies against coronaviruses.
Business as usual only three months ago has transformed into health care industry overdrive as biopharma and med-tech companies scramble to test and scale-up treatments, vaccines and diagnostics to address COVID-19.
Hoth Therapeutics Inc., of New York, and Voltron Therapeutics Inc. have formed a joint venture, Halovax, to develop a vaccine for COVID-19 that can be advanced to clinical testing.
Three candidates for FDA approval remain on BioWorld’s Drugs on Deck list for March, all of which have PDUFA dates scheduled for this month, even though most of the agency’s attention as of late is on the COVID-19 pandemic.
Humanigen Inc., the Burlingame, Calif.-based developer of an anti-human-GM-CSF monoclonal antibody for preventing and treating cytokine storms, is urgently working to spin up a phase III trial of the candidate, lenzilumab, for COVID-19 patients whose immune systems have gone into overdrive.
Business as usual only three months ago has transformed into health care industry overdrive as biopharma and med-tech companies scramble to test and scale-up treatments, vaccines and diagnostics to address COVID-19.
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.
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).
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