Drug Delivery

FDA issues draft guidance on dissolution testing for immediate-release solid oral dosage forms.

Industry experts spoke to BioPharm International about the key considerations in the development of a drug-delivery device for a biologic drug, the importance of human factors engineering, the advantages of prefilled syringes, and the challenges in the manufacture of these devices.

The authors explore the use of statistical experimental design and multivariate analysis to develop a drug substance formulation matrix.

Gene and cell therapies represent the next-generation treatments for a wide range of diseases, but one challenge in the development of these therapeutics is the controlled delivery to the targeted site to maximize expression or engraftment while limiting systemic exposure.

Will AbbVie stave off biosimilar competitors by following Teva’s model for Copaxone?

The Catalent Applied Drug Delivery Institute and AAPS recognize four groups for emerging scientific talent and academic excellence.

Mylan issued a voluntary withdrawal of calcium chloride intravenous infusion 10% w/v 10mL prefilled syringe due to difficulties in administration.

Two companies have been fined a total of GBP550,000 for faulty insulin syringes, which contained no drug and caused the death of a diabetic patient.

The new facility expands the company’s commercial manufacturing capability at its Bend, Ore. site.

Novasep's new antibody drug conjugate facility at its site in Le Mans, France will be commissioned in 2016.

The agency clarifies its requirements for allowable excess volume and labeled vial fill size in injectables and biologics.

Experts attending the European Psychiatry Association Congress in Vienna say that Adasuve has made an impact in the treatment of agitation in patients suffering from schizophrenia or bipolar I disorder.

A vaccine patch may eliminate the need for traditional means of vaccine distribution, according to an article in NPR.

Dicerna Pharmaceuticals announces that FDA granted its primary hyperoxaluria type 1 (PH1) treatment Orphan Drug designation.

Ethylene vinyl acetate (EVA) drug-release technologies are explored.

Second-generation needle-free injection systems will make parenteral drug administration more convenient, efficient, and safe.

Drug spending rose last year at the highest rate since 2003, driven by specialty medicines, according to a report from pharmacy benefit manager Express Scripts.

The agency will employ a ring vaccination method similar to the one used to eradicate smallpox.

Sanofi launched a rapidly absorbed, short-acting inhalable insulin in the US to help control type 1 and type 2 diabetes.

Mylan announced a partnership with Theravance Biopharma to develop and commercialize TD-4208, a novel investigational COPD treatment.

The 2016 White House Budget proposes a change to the data exclusivity period for biologics and the authority to influence drug pricing.

As ADCs move through the drug-development process, different analytical methods are often required.

Under terms of the agreement, Zymeworks could earn up to $164 million per successful drug candidate.

Catalent Pharma Solutions and Sanofi-Aventis R&D have entered into a collaboration to develop Sanofi’s proprietary antibodies using Catalent’s SMARTag antibody drug conjugate (ADC) platform.

Ligand-binding assays are fundamental to characterizing biosimilars.