Esteve Pharmaceuticals, S.A.
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Latest From Esteve Pharmaceuticals, S.A.
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.
VC funding slowed recently, but public company financings kept up a brisk pace with follow-on public offerings for Allakos and Alpine, private placements for Ventyx and Syros, and Albireo’s royalty deal. In restructuring updates, Biogen raised $592m in a real estate deal and Acerus is assessing options.
Keeping Track: US FDA Clears New Uses For Incyte’s Pemazyre, AbbVie’s Imbruvica; Minerva Seeks First Negative Symptoms Claim In Schizophrenia
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
The firm’s potential new therapy for the negative symptoms of schizophrenia is now in the hands of the US Food and Drug Administration – some have concerns over whether the supporting data will be enough.
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