Randi Hernandez

Two recently published studies suggest that pre-exposure to the dengue virus (DENV) could predict a person’s reaction to the Zika virus (ZIKV) because of of the antigenic similarity between the viruses. One study was published on June 23, 2016 in Nature Immunology and the other on June 27, 2016 in Proceedings of the National Academy of Sciences of the United States of America (PNAS). Dengue and Zika are both mosquito-borne flaviviruses that are cross-reactive.

A research team associated with Dr. Carl June announces it has discovered a way to engineer a patient’s own immune cells to recognize cancer-specific glycoantigens on tumor cells.

The assay, co-developed by Grifols and Hologic, will be used to test blood donations in the United States.

In a lawsuit against Celltrion, Janssen alleges the GE subsidiary infringed one of Janssen’s patents covering the method of making the cell-culture media that HyClone later supplied to Celltrion.

The first-ever use of CRISPR in humans will be evaluated by the National Institutes of Health during a meeting from June 21–22, 2016.

A new indication for Emergent BioSolutions’ BioThrax will give the drug market exclusivity through November 2022.

Results of a Phase II clinical trial reveal that stem-cell transplantation treatment following complete immune system destruction increases the duration of long-term remission in patients with multiple sclerosis.

The vaccine alternative, manufactured with a GE FlexFactory system, could be associated with fewer adverse reactions than the live vaccine option

J&J’s Darzalex, in combination with two older drugs, was found to significantly extend progression-free survival in patients with relapsed refractory multiple myeloma.

Uncertainty about the demand for a biologic medication can be partly mollified with some well-planned capacity outsourcing, contends a new report by ORC International sponsored by Patheon.

An article in Nature Reviews Drug Delivery reports the clinical success rates of biologics, and these numbers differ from those recently highlighted in a similar BIO study.

New research presented at the American Society of Clinical Oncology meeting demonstrates that atezolizumab could be a promising first-line therapy for the treatment of bladder cancer in cisplatin-ineligible patients.

Results of the HERITAGE study were announced at the 2016 American Society of Clinical Oncology meeting.

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.

Scale-up of complex, innovative products requires commercialization models that are sustainable.

Barriers to the production of biopharmaceuticals in moss are explored.

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

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.

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.

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.

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

*Updated May 11, 2016Following JHL Biotech’s opening of a FlexFactory flexible manufacturing facility in Hsinchu, Taiwan in 2014, the company opened a second manufacturing location in Wuhan, China on May 10, 2016. According to the company, with the addition of the new Wuhan facility, JHL Biotech will now hold the largest volume of single-use cell-culture capacity in all of Asia.

The GPhA and its Biosimilars Council expressed concern about the new proposed value-based reimbursement rules for Part B medications.

Typical single-use bags and materials cannot withstand a large range of temperatures. Many of the items on the market are associated with extractables that can leach into bioprocessing fluids-an issue that has recently been a topic of conversation among groups that seek to standardize single-use systems, such as the BioPhorum Operations Group (BPOG) and the Bio-Process Systems Alliance (BPSA).

Traditional methods of measuring the effectiveness of vaccines against the flu are called into question by new findings from the NIH.

Linker technology and drug combinations play an important role in the efficacy of ADCs.

The National Institute of Health will conduct an internal review of the National Cancer Institute’s cell manufacturing facilities, which will affect multiple Kite projects.

Cornell researchers reveal that an existing FDA-approved drug can facilitate the delivery of other large molecules across the blood-brain barrier.

Inflectra is the second biosimilar to hit the market in the United States.