Formulation and Drug Delivery, Specialty Dosage Forms

Many antibody-drug conjugate therapies are in the pipeline; only a handful have been approved. What are the bottlenecks?

Inovio received a $71-million contract from the US Department of Defense to scale up manufacture of its Cellectra smart device to deliver its DNA vaccine.

Intertek has announced the expansion of its pharmaceutical services laboratory in Melbourn, near Cambridge, UK, through the acquisition of a new 20,000 sq. ft facility.

The EMA’s Committee for Medicinal Products for Human Use has recommended marketing authorization approval for AstraZeneca’s benralizumab, a monoclonal antibody for treating severe asthma.

The authors of the study believe it could have significant implications for the discovery of new dermatological products for major diseases such as psoriasis.

Through the support of the Japanese agency, Daiichi Sankyo intends to further develop its genetic vaccine platform focused around its new nucleic acid delivery technology.

There is a lot of interest in delivering biologics via non-invasive routes in attempt to improve patient compliance and convenience.

Lonza further expands its micronization services with the acquisition of Swiss contract manufacturer, Micro-Macinazione, following its previous $5.5-billion acquisition of dosage form provider, Capsugel.

Amgen discussed the drug-delivery approaches to two of its biologics in a recent second-quarter earnings call.

The wearable devices for the delivery of biologic products are now being manufactured and will be tested in clinical trials in the near future, according to the company.

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.

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?

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.

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

Industry experts discuss the benefits and challenges of self-administration of injectable therapies.

Formulation strategy is an important consideration when selecting and managing outsourced biopharmaceutical development programs.

The year 2007 witnessed the approval of fifteen biopharmaceuticals in the United States and European Union.

US Food and Drug Administration's Division of Biologic Oncology Products has approved two new biologics license application (BLA) supplements expanding the approval of Genentech's Herceptin (trastuzumab) for the treatment of breast cancer.

The transdermal delivery of biologics-as well as of conventional drugs-is growing in popularity because the technique offers numerous advantages.