Vifor Pharma (SIX Swiss Exchange:VIFNI) (SIN:CH0364749348) disclosed on Monday that it has agreed to acquire the priority review voucher (PRV) from US Food and Drug Administration (FDA).
The company stated that the PRV entitles the holder to obtain priority review for a New Drug Application or Biologics License Application thereby reducing the target review time and potentially leading to a faster approval.
This transaction is subject to customary closing conditions and clearance under the Hart-Scott Rodino (HSR) Antitrust Improvements Act.
Headquartered in Switzerland, the pharmaceuticals company is engaged in iron deficiency, nephrology and cardio-renal therapies. It said it strives to help patients around the world with severe and chronic diseases to lead better, healthier lives.
Nicox completes key data package for NCX 470 NDA submissions
Immusoft's ISP-002 granted US FDA Orphan Drug Designation in MPS II
Orphan Therapeutics Accelerator signs MoU with Fondazione Telethon
Bioretec wins FDA breakthrough status for biodegradable orthopaedic DrillPin
Amferia raises EUR3.5m to advance antimicrobial wound-care platform
Sobi s Aspaveli marketing authorisation receives positive European regulatory opinion
BioCryst wins FDA approval for oral HAE prophylaxis in young children
NanOlogy launches drug development program for diffuse intrinsic pontine glioma treatment