FDA rejects hearing requests and withdraws NDAs for Searle's Pro-Banthine with Phenobarbital and DuPont's Valpin with Phenobarbital. In Sept. 14 Federal Register notice, FDA said firms submitted no new data, but rather "relied on legal arguments," principally that they need more time to conduct studies ant that FDA is required to act on the combos as a class
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Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.
Hyloris has secured licensing deals with Aguettant for its Maxigesic IV combination of paracetamol and ibuprofen in a further eight European markets through partner AFT Pharmaceuticals.
Execs On The Move: Activity In Board Rolls As AxoGen, Alafair, InfuSystem And Others Appoint New CEOs
Alongside a number of chief executive officer appointments, companies such as Endotronix, TruScreen, Glaukos, and others have appointed new board members. AxoGen and Acutus announced new chief financial officers.