Dosage Forms

The Human Microbiome Project has increased our understanding of the relationship between humans and microorganisms. The authors offer a new perspective on how this knowledge should be considered in setting standards for pharmaceutical quality control in microbiology.

A drug-product manufacturing classification system (MCS) for oral solid-dosage forms is proposed by an Academy of Pharmaceutical Sciences working group.

In this article, industry experts discuss critical analyses for demonstrating biosimilarity.

FDA approves a biosimilar and loses a commissioner in March.

Multivariate data analysis (MVDA) is being used to effectively handle complex datasets generated by process analytical technology (PAT) in biopharmaceutical process development and manufacturing.

Merck Serono announces that it will work with Intrexon to develop a cancer therapy using chimeric antigen receptor T-cells.

Rentschler Biotechnologie launches 2000-L single-use bioreactor and announces additional expansion.

Drug makers back alternative to FDA labeling update rule.

Biosimilar applicants will not be required to hand over their biosimilar applications and manufacturing dossiers to innovator companies, determines FDA.

FDA has approved another indication for Eylea, a treatment for diabetic retinopathy in patients with diabetic macular edema.

Emergent BioSolutions announced FDA approval of Anthrasil, an inhalable treatment that targets Anthrax toxins, as well as a contract with BARDA to develop NuThrax, an anthrax vaccine candidate.

The agency provides guidance on determining the need for environmental assessments for gene therapies, vectored vaccines, and viral and microbial products.

Clinical trial results suggest that monoclonal antibodies targeting the function of proinflammatory cytokine IL-17A in psoriasis may be significantly superior to other treatments.

Guidance provides labeling standards and an implementation guide for electronic submission of lot distribution reports.

A new machine is designed for inspection of prefilled syringes.

Member of parliament, Desmond Swayne, will officially open the 42,000-square-foot facility on March 20, 2015.

WuXi's new facility in Philadelphia will manufacture CAR T-cell therapies and other cancer immunotherapies.

Penn Pharma's equipment addition meets growing need for continuous dry granulation and for handling of highly potent drugs.

Innovative equipment, analytical techniques, software, and modeling systems are improving the tableting process.

Taste may be subjective, but it is crucial to patient compliance, particularly for pediatric treatments.

Analytical technologies must accurately identify and measure the critical material attributes of APIs and excipients.

PAT has aided formulation, both pre-and post-filing, by reducing costs and time frames.

Ionic liquid technologies offer a new way to improve bioavailability.

New cellulosic polymers have been shown to improve solubility in these key amorphous solid dispersion processes.

BIO and the Colorado BioScience Association urge Colorado Governor Hickenlooper to sign a bill that will help patients gain access to interchangeable biologic products following FDA approvals.

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.

Mallinckrodt Pharmaceuticals has bought Ikaria, a privately-held critical care company, for $2.3 billion.

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

In a landmark decision, FDA approved Zarxio, making it the first biosimilar product in the United States.

Baxter has bought SuppreMol, a German biopharmaceutical company that focuses on autoimmune treatments, for €200 million ($225 million USD).