Nantkwest / Immunitybio -> IBRX WKN: A2QQ2E ISIN: US45256X1037 Kürzel: IBRX Forum: Aktien User: captainpump97
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18:21:13 Uhr,
Lang & Schwarz
Kommentare 18.034
captainpump97,
03.12.2025 13:56 Uhr
0
Damit ist wohl klar was PSS in. Richtung Trump meint mit: „he is near doing something great“
captainpump97,
03.12.2025 14:20 Uhr
0
Two Republican lawmakers were invited to attend a Food and Drug Administration meeting about the potential expanded approval of a drug backed by billionaire Patrick Soon-Shiong, but the plan was scrapped due to internal opposition at the agency.
Wisconsin Senator Ron Johnson, one of the two lawmakers who were invited, said the meeting was about a drug made by ImmunityBio Inc., a company Soon-Shiong founded. FDA head Marty Makary was aware the lawmakers were invited to the meeting, according to documents reviewed by Bloomberg, though it’s unclear if he endorsed the move.
The invitation was unusual for the FDA, whose regulatory process is supposed to be dictated by science rather than politics. Lawmakers have generally not been allowed to attend drug approval meetings to prevent the appearance of political interference in the review process, though the practice is not banned outright. It was unclear who extended the invitation to the lawmakers.
captainpump97,
03.12.2025 14:20 Uhr
0
Johnson said he had planned to attend the review meeting that the company had scheduled, but that FDA officials underneath Makary “forcefully” objected to the senator’s attendance. Johnson plans to receive a readout of the meeting, and has suggested a follow-up meeting with him, Makary and Soon-Shiong.
Soon-Shiong has been publicly pressuring the FDA to expand approval of Anktiva, an immunotherapy developed by his company ImmunityBio. The drug is currently cleared only for a specific type of bladder cancer, but Soon-Shiong has launched a publicity blitz to secure broader approval – across social media posts, podcast interviews and direct appeals to President Donald Trump.
If the plan had gone forward, Johnson and Florida Representative Neal Dunn would have attended the drug review meeting on Dec. 3, according to the documents. ImmunityBio recently disclosed it had planned to meet with the FDA this month to discuss possible new approval routes for Anktiva.
captainpump97,
03.12.2025 14:21 Uhr
0
An FDA spokesperson said the agency is committed to keeping the drug review process free of outside influence.
“FDA’s long-standing process is to protect the independence and integrity of the scientific review process, a core tenet of the MAHA agenda,” an FDA spokesperson said, referring to the Make America Healthy Again movement.
Dunn’s office and ImmunityBio did not respond to requests for comment.
Political Pressure
Peter Lurie, a former FDA official who leads the Center for Science in the Public Interest, said the review process is supposed to be based on balancing a drug’s safety and effectiveness, and that lawmakers could skew the outcome.
“Their presence would create enormous pressure on FDA employees to approve a product,” Lurie said.
captainpump97,
03.12.2025 13:54 Uhr
0
https://www.bloomberg.com/news/articles/2025-12-03/lawmakers-invited-to-fda-meeting-for-patrick-soon-shiong-s-drug
JoSu123,
03.12.2025 12:03 Uhr
0
Der hat oftmals (zu) flinke Finger.
Manchmal kommt der mir vor wie ein Opa, dem man ab und zu am besten einfach Mal das Handy wegnehmen sollte.
DAKo,
03.12.2025 7:54 Uhr
0
Ich habe mir gerade die Therapiemöglichkeiten bei Weichteilsarkomen angesehen. Da gibt es bisher hauptsächlich Chemotherapie und Bestrahlung neben Ops.
Weiß jemand ob Thomas Gottschalk in Deutschland behandelt wird? In den USA wäre Bioshield bei den bisherigen Therapiemöglichkeiten sicher ein interessanter Ansatz.
captainpump97,
02.12.2025 17:55 Uhr
0
Jedes Mal wenn man ein bisschen Hoffnung auf Besserung schöpft, wird man angespritzt in den Boden gerammt - und jedes Mal lerne ich nicht daraus 😵💫😡
ElSeniore,
02.12.2025 15:16 Uhr
0
Servus. Ganz schön ruhig geworden..
Wäre schön, wenn es endlich mal wieder ordentlich positive Signale geben würde
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