Clinical Intelligence

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.

[Read More]

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.

[Read More]

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.

[Read More]

Medeor receives FDA IND clearance for MDR-101 study

Wednesday, May 3, 2017

Medeor Therapeutics, a private, clinical-stage biotechnology company dedicated to the discovery, development and commercialization of personalized cellular immunotherapies, has received clearance from the FDA for an Investigational New Drug (IND) application for the company’s lead product candidate MDR-101. In addition, the FDA has agreed to a Special Protocol Assessment (SPA) for the design of a pivotal phase III clinical study of MDR-101 in.

[Read More]

Cambridge Epigenetix licenses DNA Methylation IP from Boston Children’s Hospital

Tuesday, May 2, 2017

Cambridge Epigenetix, a pioneer in the development and application of epigenetic technologies, has entered into an exclusive license agreement with Boston Children’s Hospital giving access to DNA profiling technologies, which may hold the key to improved diagnoses and treatment of many diseases, including cancer. The licensed intellectual property (IP) is based upon the early findings of Professor Anjana Rao; an expert in immunology and cancer epigenetics, formerly of Boston Children’s Hospital and now with the La Jolla Institute, and a member of the Cambridge Epigenetix Scientific Advisory Board (SAB). Professor Rao’s pioneering research group was the first to identify 5-hydroxymethylcytosine (5hmC) as an important biomarker for cancer diagnosis that cannot be measured by traditional epigenetic sequencing methodologies. She also determined that the ten-eleven translocation (TET) family of enzymes generate 5hmC from 5-methylcytosine (5mC) and are key regulators of cellular differentiation that are frequently mutated in cancer.

[Read More]