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Latest From Astex Pharmaceuticals, 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.
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.
BrainStorm Hoping For Advisory Committee After FDA Refuses To File BLA For Its ALS Cell Therapy
BrainStorm, which has a history of antagonizing FDA with direct appeals to patients for NurOwn, tells investors that public elements of an adcomm could be ‘persuasive,’ but first step will be formal meeting request to try to overcome the RTF. Firm sees Relyvrio as template for success.
Deal Watch: OrsoBio Reveals Its Metabolic Health Focus With Four Licensing Pacts
California biotech also notes prior licensing deal with Gilead for mitochondrial candidate. Twentyeight-Seven acquires RNA-splicing cancer candidate from Basilea.
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