News

New pharmacovigilance activities seek to support the creation of guidelines for safe switching from innovator products to biosimilars.

A naturally occurring CRISPR (clustered regularly interspaced short palindromic repeats) system that specifically can be used to modify the RNA of an organism is the newest development in the technology’s evolution. A new study, published on June 2, 2016 in Science, identifies C2c2, a bacterial protein that can be used as a tool to cleave single-stranded RNA sequences at desired locations.

Production of kilogram-scale batches of synthetic molecules for early-stage development are now available to US customers.

The company opened a new sales office located in Seoul, South Korea.

The company opened its 62,000 square foot facility, called the BioProcess Innovation Center, in Triangle Park, NC.

FDA issues a warning letter to Megafine Pharma Limited for data integrity violations.

Samsung Bioepis and partner Biogen announced on May 30 that the European Commission approved Flixabi for the treatment of six inflammatory conditions.

Jazz will acquire Celator for approximately $1.5 billion.

BioPharm sat down with an intellectual property lawyer to examine how companies are protected when they engage in activities where sharing of trade secrets must occur.

The United States Geological Survey study detected one or more pharmaceuticals in 59 streams throughout the Southeast United States.

The agency cited Tai Heng Industry with CGMP deviations, including failure to ensure data integrity.

Sandoz is seeking approval for the same indications as Roche’s reference product MabThera.

In the largest-ever report of its kind, drugs entering clinical development in Phase I were found to have only a 1 in 10 chance of FDA approval.

Cell and Gene Therapy Catapult and the Australian CRC for Cell Therapy Manufacturing will collaborate on a project to test technology for T-cell stimulation and expansion.

FDA accepted for review Samsung Bioepis’ BLA for SB2, a biosimilar to Remicade (infliximab).

The companies have launched VEGF 165, their first joint product for cell culture applications.

Sanofi announced that it is making several changes to its executive committee, effective June 1, 2016.

A new study in Nature Communications explores how to remove the bulk of the soaps that are added to injectables to make hydrophobic drugs more soluble.

Genentech received accelerated approval for its immunotherapy atezolizumab for the treatment of bladder cancer.

Celgene will pay Agios $200 million to lead exploratory, research, drug discovery, and early development work for metabolic immuno-oncology.

The company’s method reduces the time required to crystallize antibodies from weeks to one day.

The company recalls products due to sterility concerns.

The agency detailed its 2015 achievements in an annual report.

The NIH and partners will launch a large-scale clinical trial in South Africa to evaluate the effectiveness of an HIV vaccine regimen

The awards were presented at the AAPS Biotechnology Conference and included awards for ligand binding, innovation in biotechnology, and graduate student symposiums.

The agency provides guidelines on generating histopathology data in nonclinical biomarker qualification studies.

Pfizer will acquire Anacor for $5.2 billion and expects the transaction to complete in the third-quarter of 2016.

Caribou announced the completion of a $30-million Series B financing round, which included the participation of new and current investors.