Trevena provided an update on the activities to support resubmission
of the new drug application, or NDA, for oliceridine.
The company plans a resubmission
in the first quarter of 2020 with the requested stability data.
The FDA indicated that efficacy data from an additional clinical trial will be needed to support a resubmission
The US FDA has indicated that efficacy data from an additional clinical trial will be required to support a resubmission
. The company continues to enrol patients in its ongoing STRIDE three (STRIDE - Short Term Relief In Dry Eye) Phase three clinical trial, and expects this trial will serve as the basis of its response to the CRL.
The purpose of the type A meeting was to obtain the Agency's feedback and agreement on the Company's plan to address deficiencies cited in the April 2019 Complete Response Letter (CRL) in support of a resubmission
of the Gimoti NDA.
In Revenue Memorandum Circular (RMC) 48-2019 it issued on April 17, the BIR extended the deadline for the mandatory resubmission
of registration for POS machines, cash register machines (CRM), special purpose machines (SPMs), as well as sales machines or software with a PTU of taxpayers to the bureau's eAccReg.
Biopharmaceutical business EMD Serono Monday announced the successful resubmission
of a New Drug Application (NDA) for cladribine tablets as a potential treatment for patients with relapsing forms of multiple sclerosis (MS) with the US Food and Drug Administration (FDA) in response to the Complete Response Letter requesting an improved understanding of safety risks and the overall benefit-risk profile.
Consequently, Imran reported took the task of preparing the list himself and directed party lawyer Babar Awan to review legal process for resubmission
of the priority list.
No additional clinical trials have been scheduled, and resubmission
will take place as soon as the additional documentation is prepared.
The FDA had accepted Sanofi and Regeneron's resubmission
of the Biologies License Application for Kevzara in late April.
Further, the US Food and Drug Administration recently provided clear feedback related to the resubmission
of the new drug application for Scilex's lead product candidate, ZTlido (lidocaine patch 1.8%), a branded lidocaine patch formulation being developed for the treatment of postherpetic neuralgia, the chronic pain that sometimes develops with shingles.