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Latest From Imunon, Inc.
Tech Transfer Roundup: Tiba And CEPI Strategize Together On ‘Disease X’
Immix collaborates with Israeli research institutions on BCMA-targeted CAR-T therapy. NeoImmuneTech/NIAID alliance could pave way for “animal rule” approval in acute radiation syndrome.
Novartis Settles US Exforge Case For $245m
Novartis has agreed to pay out $245m to purchasers and retailers to resolve a lawsuit accusing the originator of an unlawful deal with Par that delayed US competition to the Exforge antihypertensive.
With 37 Novel Approvals in 2022, US FDA CDER’s Five-Year Hot Streak Comes To An End; Gene Therapies Carry CBER To 8 Novel Approvals
US FDA’s novel agent count fell back to average as agency kept up high rate of complete response letters and refuse to file actions; CBER’s workload shifted to regenerative medicine.
Yo-Yo Approvals? Maybe Accelerated Approval Isn’t Fixed After All
Oncopeptides’ reversal on Pepaxto may or may not prove to be the right decision – but it underscores the inherent limits to US FDA’s efforts to police ‘dangling’ accelerated approvals.
- Gene Therapy, Cell Therapy
- Large Molecule
- Other Names / Subsidiaries
- Egen, Inc.
- Expression Genetics, Celsion Corporation
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