Nantkwest / Immunitybio -> IBRX WKN: A2QQ2E ISIN: US45256X1037 Kürzel: IBRX Forum: Aktien User: captainpump97

Under the new Trump administration, the agency has faced criticism for appearing to merge drug reviews with political priorities. One of Makary’s signature initiatives is a program that allows the agency to speed up drug reviews if companies align with the administration’s priorities on domestic manufacturing, drug pricing or public health. In late November, Senator Bernie Sanders and House Representative Frank Pallone sent a letter to Makary, expressing concern that the program “will enable corruption by creating a new, lucrative gift for drugmakers and allies politically favored by President Trump.” Last year, ImmunityBio’s drug Anktiva was approved in the US to treat some patients with bladder cancer. It competes against treatments from other drugmakers, including Merck & Co. and Johnson & Johnson. ImmunityBio wants to expand Anktiva’s use to treat other forms of cancer, including lung cancer.

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.

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.

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.

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Damit ist wohl klar was PSS in. Richtung Trump meint mit: „he is near doing something great“

https://www.bloomberg.com/news/articles/2025-12-03/lawmakers-invited-to-fda-meeting-for-patrick-soon-shiong-s-drug

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.

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.

Warum schreibt PSS so eine Nachricht, wenn absolut nichts relevantes von Trump gesagt wurde?

Der Post klingt eher wie Kritik an Trump ob Reglementierung

...ungespitzt..

Und eigentlich heißt es unangespitzt...

Angespritzt, angespitzt.. Ich weiß was du meinst 😄🤣

Jedes Mal wenn man ein bisschen Hoffnung auf Besserung schöpft, wird man angespritzt in den Boden gerammt - und jedes Mal lerne ich nicht daraus 😵‍💫😡

Geht ja scheinbar erstmal wieder Richtung Süden😑