Formulation and Drug Delivery

FDA releases long-awaited guidance documents regarding the assessment of biosimilarity.

Catalent’s Zydis technology will be used to develop thermo-stable and cold-chain independent vaccines.

The agency has recommended granting marketing authorization for Opdivo.

Originator product manufacturers will have to update and improve their processing platforms to stay competitive with the biosimilars coming to market.

A presentation by Jim Miller will offer a detailed review of the contract services landscape.

GSK notifies CDC and FDA that it is recalling the remaining doses of its 2014–2015 flu vaccine, Flulaval Quadrivalent Thimerosal-free Pre-Filled Syringes, due to decreased potency.

The acquisition expands Sartorius Stedim Biotech’s service portfolio.

The Ph. Eur. contemplates adding specifications for sub-visible particles in eye drops and eye lotions to its monograph.

The single-use clarification system eliminates centrigues; harvesting can be performed in one step; and process robustness and predictability are ensured.

The license approval marks another milestone in Aptar Pharma’s ongoing service development to provide large-scale production services to customers.

As the prevalence of falsified medicines continues to increase, Switzerland is taking measures to secure its supply chain such as the implementation of serialization.

Aptar Pharma has partnered with Shanghai Sine Promod Pharmaceutical to develop and launch its new budesonide dry powder inhaler (DPI), which features Aptar Pharma’s user-friendly and cost-effective Twister DPI.

GlaxoSmithKline announces global vaccines research and design facility to be based in Rockville, MD, USA.

NIH announced positive safety results from the vaccine, VSV-ZEBOV, and found that all patients in the study experienced a strong antibody response.

Emerging controlled-release technologies could lead to more effective therapies in the near future.

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.

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.

The White House confirmed that it would release a plan to tackle the growing problem of antibiotic-resistant superbugs.

Adroit Science AB will support Recipharm’s pharmaceutical development with solid-state characterization services.

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.