Randi Hernandez

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.

The company’s Aramus bags are made of an innovative material that is unlike that of the material currently used in commercial single-use bags.

Experts discuss some of the emerging trends in bioprocessing in 2016, including 4D bioprinting, 2D-NMR, and the CAR-T design space.

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.

Jack Lew, Obama’s secretary of the treasury, announced on April 4, 2016, that the US Department of the Treasury and the Internal Revenue Service (IRS) is issuing temporary and proposed regulations to limit the “benefits of and limit the number of corporate tax inversions.” The government bodies also plan to address earnings stripping in these inversions, so it will examine past inversion deals that have already been completed.

The BARDA-supported monoclonal antibody was approved both as a treatment after anthrax exposure and as an anthrax prophylactic.

The group argues that the so-called “incentives” for physicians to prescribe more costly medications are essentially non-existent following a handful of prior cuts to Medicare Part B reimbursement.

The five-year Medicare initiative seeks to change the way in which drugs are reimbursed under Medicare Part B.

The US Drug Enforcement Agency (DEA) has granted permission for the import of pharmaceutical-grade cannabidiol to Catalent Pharma Solutions for a feasibility study in conjunction with Kannalife Sciences, according to a company press release.

The pharma company revealed in a fourth quarter call that it will improve its cell-culture capabilities by focusing on the use of naïve, highly proliferative cells to manufacture its CAR-T drug candidate.

Company representatives said a bulk of the increase was due to strong sales of its bioprocessing products.

FDA fast-tracked the monoclonal antibody based on early clinical data from a Phase I trial.

FDA cracks down on makers of products extracted from Cannabis and says the products cannot be considered dietary supplements.

There are no clinically meaningful differences between Celltrion’s CT-P13 and Remicade, according to an FDA briefing released ahead of the formal panel meeting.

Researchers describe a new method to compare the higher-order structure of a reference biologic with its proposed biosimilar product candidates.

Although switching has occurred in European markets for some biosimilars, most biosimilar manufacturers will focus on securing new users, according to Merck.

The body’s over-editing of synaptic interactions is recognized as a probable cause of schizophrenia in a landmark study.

The partnership will focus on the identification and analysis of host-cell proteins in biologics.

BioPharm highlights the monoclonal antibodies that may gain United States regulatory approval in 2016.

The new arrangement draws from a consignment approach, in which Walgreens will sell-but not directly own-Valeant’s products.

While stakeholders generally welcome improvements to quality initiatives, they are concerned with how the new requirements will be implemented for more complicated supply-chain models.

The CEO of a US-based biosimilar manufacturer explains the legal and intellectual property issues of bringing a biosimilar to market in the United States.

The CEO of a US-based biosimilar manufacturer explains the legal and intellectual property issues of bringing a biosimilar to market in the United States.