Reversal of lymphopenia is not an acceptable endpoint for Anktiva FDA approval. $IBRX could file but if it did, the application would be rejected.
This week's Biotech Scorecard newsletter: -- What to expect from $GOSS Gossamer Bio’s late-stage lung disease study -- A better, safer Alzheimer’s treatment? ProMis $PMN takes its shot https://t.co/YaA8kvUR4Z
$INSM guides to 2026 Brinsupri sales of "at least $1B" in line with consensus. https://t.co/o7JhPKU3m1
The FDA’s Moderna $MRNA pirouette is one more sign of chaos at the agency https://t.co/zThJqhT2BS via @matthewherper
$MRNA says FDA will now review its flu vaccine. PDUFA date is Aug. 5. https://t.co/npZzeEa5nk
This is not a Saudi-USA Biotech Alliance, it’s a Saudi @DrPatrick $IBRX “you pay we pay” marketing campaign. Anktiva is stalled in the US because he can’t generate the clinical data to move the drug forward, so he goes to...
FDA rejects rare disease therapy from $IRON Disc Medicine, early recipient of commissioner’s voucher CNPV program falters out of the starting gate... https://t.co/w4ptB2ecRS via @LizzyLaw_ and me
It would be highly instructive to read the pembrolizumab paper highlighted by @DrPatrick. Of course, he doesn't expect anyone to do that. This is what it says IN THE FIRST PARAGRAPH: The FDA approved pembrolizumab on May 23, 2017, for...
This week's Biotech Scorecard newsletter: The old Vinay Prasad never left. He just changed jobs Submissions to the FDA are handled by teams of reviewers, of course. But when I look across all of these recent cases, I see a...
$CRVS Corvus pill shows promise in early-stage eczema trial 75% of participants treated with soquelitinib achieved EASI 75 after 8 weeks compared to 20% of placebo participants offered a placebo. https://t.co/XlOmX0GUZf
The $IBRX Quilt-3.092 CAR-NK study also requires patients to undergo lymphodepleting chemotherapy prior to cell therapy infusion. https://t.co/fPMR7Jhwht