Clinical Intelligence

Anthera screens first patient in pivotal Sollpura study

Wednesday, May 17, 2017

Anthera Pharmaceuticals has commenced screening in the RESULT phase III clinical study of Sollpura for exocrine pancreatic insufficiency due to cystic fibrosis. Based on feedback from the FDA, this non-inferiority study will compare the efficacy of Sollpura, a biologically manufactured pancreatic enzyme replacement therapy (PERT), to Pancreaze, a porcine-extracted PERT, as assessed by CFA after four weeks of treatment. Topline data are expected at the end of 2017 or early 2018, depending on the speed of patient enrollment.

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AbbVie reported Imbruvica CLL/SLL data

Wednesday, May 17, 2017

AbbVie, a global biopharmaceutical company, announced results from an analysis of data pooled from three phase III studies evaluating Imbruvica (ibrutinib) use in patients with high-risk chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL): RESONATE, RESONATE-2 and HELIOS.

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Ocular Therapeutix reported dextenza phase III data

Thursday, May 11, 2017

Ocular Therapeutix, a biopharmaceutical company focused on the development, manufacturing and commercialization of innovative therapies for diseases and conditions of the eye, presented ocular pain data from a pooled analysis from three phase III clinical trials evaluating the efficacy and safety of dextenza (dexamethasone insert) 0.4mg for intracanalicular use, for the treatment of ocular pain and inflammation following cataract surgery.

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European Commission approves EUSA Pharma’s dinutuximab beta for neuroblastoma

Wednesday, May 10, 2017

EUSA Pharma (EUSA), a specialty pharmaceutical company with a focus on oncology and oncology supportive care, has announced that the European Commission has approved Dinutuximab beta for the treatment of patients with high-risk neuroblastoma. Dinutuximab beta is the only anti-GD2 monoclonal antibody approved in the European Union (EU). EUSA Pharma will begin commercializing Dinutuximab beta across the EU immediately.

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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]

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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