ProPharma’s team of dedicated experts is at the forefront of both existing and emerging industry trends. ProPharma’s team inspires tomorrow by leveraging rich data insights across our service lines and functional areas to develop innovative solutions that answer the most complex needs of both existing and prospective clients.
May 5, 2017
On Monday, May 1st, the FDA approved Imfinzi™ (durvalumab). Imfinzi is manufactured by AstraZeneca, and it is a PD-L1 inhibitor indicated for the treatment of patients with locally advanced or...
May 2, 2017
On Thursday, April 27th, the FDA announced the approval of Brineura™ (cerliponase alfa). Brineura, manufactured by BioMarin International Ltd., is an infusion indicated for the treatment of...
April 27, 2017
On Friday, April 21st, Reneflexis® (SB2, infliximab – abda) was approved by the FDA. Reneflexis is manufactured by Samsung Bioeipis, and is a biosimilar product to Janssen’s Remicade® (infliximab)....
April 6, 2017
On Tuesday, March 28th, the FDA announced the approval of Dupixent (dupilumab), an injection for the treatment of adults with moderate-to-severe atopic dermatitis. What is Atopic Dermatitis? Atopic...
February 7, 2017
In October 2015, the FDA published a guidance document which outlines its recommendations regarding “the nonclinical evaluation of previously approved drug substances when a new formulation or a new...
September 6, 2016
On Wednesday, August 30th, the FDA announced the approval of Sandoz’s Erelzi™ (etanercept-szzs). Erelzi is biosimilar to Amgen’s Enbrel® (etanercept) and is indicated for the treatment of multiple...
August 2, 2016
The Prescription Drug User Fee Amendments of 2012 (PDUFA V) allows FDA to collect user fees for the review of applications concerning human drug and biological products, the establishments where...
July 25, 2016
FDA Revises Review Timeline Due to Increasing Number of Orphan Drug Applications: In 1983 Congress passed the Orphan Drug Act, which created FDA’s Orphan Drug Designation (ODD) program. The goal of...
July 18, 2016
On Thursday, July 7th, the FDA issued two draft guidance documents regarding the compounding of drugs that are essentially copies of commercially available or approved drugs. In these documents,...