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The FDA sent an email holding the planned Phase I trial for LB1901 after the first and only patient dosed was found to have low CD4+ T-cell counts in the peripheral blood.
With the Omicron surge waning, at least in the U.S., there is speculation that the COVID-19 pandemic may be in its end stages. Some experts, however, warn that this could be premature.
The FDA committee voted 8 yes and 14 no. The decision now goes back to the OND to decide the FDDR on Avenue Therapeutics’ IV Tramadol.
Star Therapeutics has exited stealth mode and announced a spin-off company, Electra Therapeutics.
Moderna announced plans to expand in Asia with the opening of four new subsidiaries in Malaysia, Taiwan, Singapore and Hong Kong.
HOOKIPA Pharma Inc.’s shares have soared after stating it amended and restated a collaboration and license agreement with Gilead Sciences to develop immunotherapies against HIV.
The NDA acceptance is based on positive results from the KRYSTAL-1 trial, which looked into the effect of using 600mg BID of adagrasib in patients.
Psychedelics therapies – serotonin 2 A receptor agonists – are trying to enter mainstream medicine for depression and as anti-inflammatory or neuroprotective treatments.
TenSixteen Bio recently came out of stealth mode with $40 million in funding to target somatic mosaicism – particularly clonal hematopoiesis of indeterminate potential (CHIP).
As the market seems to be taking a turn against biotech stock, more companies are opting for private funding instead of going public for the moment. And VC firms are happy to jump in.
Together, Intellia and ONK hope to develop, engineer and test new allogeneic CRISPR-edited NK cell therapies.
After a filibuster was broken Monday, the Senate confirmed Califf’s nomination in a 50-46 bipartisan vote.
Antibody research on cancer and neurological diseases is prioritized in series of biopharma research agreements.
While the “speed of science” to develop a successful coronavirus vaccine against the novel COVID-19 has been record-setting, scientists are telling us it’s not enough.
After announcing that the FDA was investigating a possible death associated with its lymphoma drug Ukoniq (umbralisib), things are seemingly looking up for TG Therapeutics.
Senseonics has finally received approval from the U.S. Food and Drug Administration for its Eversense E3 Continuous Glucose Monitoring System (CGM) System.
Kallyope focuses on the gut-brain axis, a bi-directional communication between the gastrointestinal tract and the brain.
Shares of ImmunoGen are climbing this morning after the company announced an antibody drug conjugate (ADCs) collaboration with Eli Lilly valued at up to $1.7 billion.
Terray Therapeutics has generated $60 million from a Series A financing round just shortly after getting $20 million in seed funding for the AI drug discovery.
Robert Califf’s nomination to resume his role as FDA Commissioner continues to advance in the Senate, despite some opposition from a key Democrat, Sen. Joe Manchin.