United States

FDA grants Biohaven’s trigriluzole Fast Track Designation

Wednesday, May 17, 2017

Biohaven Pharmaceutical announced that the FDA has granted the company Fast Track Designation for Biohaven’s product candidate trigriluzole (BHV-4157) for the potential treatment of Spinocerebellar Ataxia (SCA). Trigriluzole previously received Orphan Drug Designation from the FDA for the treatment of SCA in 2016. Biohaven is currently conducting a phase II/III clinical trial in patients with SCA, with topline results expected in 2018.

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Proteon receives FDA Breakthrough Therapy designation for vonapanitase

Wednesday, May 10, 2017

Proteon Therapeutics, a company developing novel, first-in-class therapeutics to address the medical needs of patients with kidney and vascular diseases, has announced that its investigational treatment, vonapanitase, has received Breakthrough Therapy designation from the FDA for increasing arteriovenous fistula secondary patency (i.e., survival of the fistula without abandonment) and use for hemodialysis in patients on or expected to initiate hemodialysis.

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PaxVax, in collaboration with the U.S. Army, initiates clinical trials of a modernized Adenovirus vaccine

Monday, May 8, 2017

PaxVax, a leading independent specialty vaccine company, announced today the initiation of a new clinical trial program, in collaboration with the U.S. Army Medical Material Development Activity and the Walter Reed Army Institute of Research to protect U.S. military personnel. This is the first initiative to modernize the Adenovirus Serotypes 4 and 7 (Ad 4/7) vaccine in more than 30 years. PaxVax is developing an updated and improved version of the vaccine. The vaccine, known as the Modernized Production Adenovirus Vaccine (MPAV) Prototype A, will ultimately be administered to U.S. service members during basic training. [Read More]

CluePoints opens U.S. office

Wednesday, May 3, 2017

CluePoints, a provider of Risk-Based Monitoring (RBM) and Data Quality Oversight solutions for clinical trials, will be expanding its operations in the U.S. with the opening of a new office in Wayne, Pennsylvania. The expansion marks a key milestone in CluePoints’ growth strategy that will see the company build its infrastructure to support its rapidly growing U.S. client base.

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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.

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