→ FDA commish Scott Gottlieb was spreading the love Monday morning, welcoming back FDA staff and looking to get the world’s fastest drug regulatory agency back up to full swing ASAP. Of course, it could all come crashing to a halt again February 15, unless lawmakers either outlaw government shutdowns or come to a compromise of sorts. In the meantime, the FDA is open for business.
I look forward to being outside Building 1 today to greet ALL my colleagues as we return to our posts TOGETHER. I know there will be additional challenges ahead as we catch up on missed work and deadlines. I’ll support you in all of these efforts as we forge ahead as ONE #FDA pic.twitter.com/0zJSmNXU9o
— Scott Gottlieb, M.D. (@SGottliebFDA) January 28, 2019
→ Not everything was shuttered at the FDA. The agency has approved Allogene’s IND for a clinical trial using their off-the-shelf CAR-T ALLO-501 for non-Hodgkin lymphoma. The drug will be infused into patients following fly/cy lymphodepletion and ALLO-647, their CD52 antibody.
→ The FDA has given Xenon’s $XENE XEN007 rare pediatric disease status to treat Alternating Hemiplegia of Childhood (AHC) — a rare, severe and debilitating neurological movement disorder that presents in infancy and has no approved treatments. The agency has also allowed the CNS drug developer to test its XEN1101 in humans for epilepsy and other neurological disorders.
→ Fibriotic disease drug developer Indalo Therapeutics has appointed Robert Jacks as its president and CEO, who comes from Symbiomix Therapeutics where he served as co-founder, president and CFO. The company is expected to take its lead drug, IDL-2965, into the clinic in early 2019.
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