BioMarin Pharmaceutical

Fastest drug developers and their practices

Tuesday, August 1, 2017

Drug development is a long and costly process, and companies struggle with efforts to compress cycle times and reduce costs. A new CenterWatch analysis of new molecular entities (NMEs) approved by the FDA from 2014 through 2016 shows no signs of dramatic, industry-wide improvement. Sponsors interviewed by CenterWatch cited multiple factors that influence the speed of their development programs. In particular, the selection of investigative sites and vendors (including CROs), and the relationships forged with them, were an important focus of companies seeking to improve the speed and efficiency of clinical trials.

[Read More]

FDA approves Brineura for CLN2 disease

Wednesday, May 3, 2017

BioMarin Pharmaceutical announced that the FDA approved Brineura (cerliponase alfa) to slow the loss of ambulation in symptomatic pediatric patients 3 years of age and older with late infantile neuronal ceroid lipofuscinosis type 2 (CLN2), also known as tripeptidyl peptidase 1 (TPP1) deficiency. Brineura is the first treatment approved to treat children with CLN2 disease, a form of Batten disease.

[Read More]

BioMarin to acquire Prosensa for $680M

Tuesday, November 25, 2014

BioMarin Pharmaceutical, based in San Rafael, Calif., will acquire Prosensa for $17.75 per share, for a total up-front consideration of approximately $680 million. In addition, two approximately $80 million contingent milestones are payable for the approval of drisapersen in the U.S. no later than May 15, 2016, and Europe no later than Feb. 15, 2017, respectively.

[Read More]

BioMarin launches phase I BMN 673 trial

Tuesday, July 19, 2011

BioMarin Pharmaceutical reported the initiation of a phase I trial for BMN 673, a poly ADP-ribose polymerase (PARP) inhibitor, for the treatment of patients with advanced hematological malignancies.  A phase I/II trial for BMN 673 for the treatment of patients with solid tumors was initiated in January 2011 and is ongoing.

[Read More]