Phase I
Shares of Utah-based Lipocine, Inc. are down more than 41 percent in premarket trading after the company announced it received a second Complete Response Letter from the U.S. Food and Drug Administration (FDA) for its testosterone replacement therapy product.
Akili Interactive, headquartered in Boston, closed a $55 million Series C financing. Akili is a prescription digital medicine company. Its goal is to treat certain disorders via high-quality video games.
The uses of viruses as therapeutics is growing, largely because new gene therapy treatments require viruses.
Pharmaceutical execs who leave their positions with big pharmaceutical companies, unless opting to retire for good, often move to leadership positions at other big companies. There are other choices.
As we get closer to seeing the U.S. Food and Drug Administration green light the first gene therapy for hemophilia, analysts estimate that the cost of the probable one-time treatment could have a whopping price-tag of $1.5 million.
Shares of Sarepta Therapeutics slipped Thursday after the company announced a European Medicines Agency committee rejected Exondys 51 (eteplirsen), the company’s treatment for Duchenne Muscular dystrophy.
Bluebird has been chosen to receive the Cooley Anemia Foundation’s Humanitarian of the Year Award at its annual gala in June.
Shares of Achaogen are down more than 30 percent in premarket trading following the results of split support from a U.S. Food and Drug Administration panel for its lead antibiotic treatment, plazomicin, which is being developed for the treatment of adults with complicated urinary tract infections and bloodstream infections.
Regeneron and its longtime development partner Sanofi are keeping their proverbial fingers crossed that their profitable collaboration will yield yet another approved treatment this year.
At the World Medical Innovation Forum, panelists observed that AI can be used to scour old clinical trial data for new applications and possibly take over part of clinical trials in “virtual” models.
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