Development

The European Union is strengthening its pioneering role in the regulation of biosimilars by further developing the basic rules for determining the levels of compatibility for this group of drugs. There are, however, some key issues that are not easy to resolve, as evident in a recent workshop on biosimilars organized by the European Medicines Agency (EMA).

The rising cost of drug development and the decreasing proportion of drug-naive population in the US and European markets are driving international pharmaceutical companies to consider emerging markets as a location to conduct their clinical trials. Asia stands out among the emerging markets given its double-digit growth rates.

FDA releases a strategic plan and issues a proposed notification rule to improve prevention and resolution of drug shortage problems.

A new report details FDA's role and responsibilities in personalized medicine.

BioPharm International speaks with industry experts about challenges faced in managing the cold chain.

USP is developing and revising distribution standards in response to changes in the global supply chain.

The authors discuss how to develop a cost-effective thermally protective packaging system.

GSK and the Gates Foundation will invest a combined $1.8 million in early stage research into vaccine thermostability.

The first part of CPhI's Annual Expert Industry Report examines ADCs, single-use technology, and regulatory failure.

The authors review the angiopoietin pathway as an alternative for safer and more efficacious anti-angiogenic therapeutics.

FDA publishes guidance on ANDA submissions.

EMA releases details of restructuring.

EMD Millipore receives recertification of GMP compliance for Biodevelopment Centre in Martillac, France.

FDA updates guidance to reflect advances in technology.

Establishing a well-defined training program is a crucial activity for any biopharmaceutical organization.

Novasep's Sius single-use tangential flow filtration skid offers a 100% single-use TFF solution.

EMD Millipore and PharmaCell have entered into a collaboration to develop optimized large-scale expansion and harvest of HepaRG cells using bioreactor technology.

The report highlights a need for greater third party certification to ensure GMP vigilance.

A new end-user survey of more than 220 physicians and 650 patients by Frost & Sullivan finds that regardless of disease area, physicians select drug delivery methods that drive consistent patient compliance and effective outcomes.

Almac's Clinical Services business unit has expanded its service offering for dispensing and bottling solid dosage products.

The facility, which includes state-of-the-art formulation, analytical and synthetic laboratories as well as a customer training center, will focus on bioavailability enhancement and oral dosage formulations.

Falsified Medicines Directive requires imported APIs to have written confirmation of GMP standards.

The $1-billion deal includes select parts of Merck?s manufacturing site in Oss, The Netherlands and Sioux City, Iowa as well as 11 finished products.

European governments are under pressure to take regulatory action, but solving the problem of medicine shortages is not as straightforward as it seems.

Increased manufacturer outsourcing requires clear policies and written agreements with CMOs.

The EMA's Committee for Medicinal Products for Human Use has recommended granting of marketing authorizations for the first two monoclonal antibody biosimilars.

A Q&A with SCHOTT Pharmaceutical Systems and West Pharmaceutical Services

Bills to regulate drug compounding and establish a national track and trace system face political and policy differences.

A science- and risk-based approach to verify and demonstrate that a process operating within predefined specified parameters consistently produces material that meets all its critical quality attributes.

Companies can use metrics as a tool to help drive positive change and quality process improvements.