Manufacturing, Biologic Drugs

US Department of Health and Human Services announced a declaration to provide immunity to legal claims made in the US in relation to three investigational Ebola vaccines.

No evidence that Fluad vaccine caused deaths in Italy, says EMA.

Dalton Pharma Services announced it was awarded funding from ISTPCanada for its project to develop vaccines for respiratory syncytial virus and parainfluenza type 3.

Johnson& Johnson is collaborating with WHO and others on clinical testing, development, production, and distribution of an Ebola vaccine.

IDT Biologika completes large-scale biologics finishing facility in Dessau, Germany.

NIH seeks new therapeutic products to bolster the protective properties of vaccines.

CALIXAR and VirPath use new manufacturing techniques to create a vaccine for the pandemic flu, influenza A (H1N1), available in 2015.

Texas A&M dedicates national pandemic influenza vaccine manufacturing facility.

FDA gives NewLink Genetics approval to proceed to Phase 1 clinical studies of Ebola vaccine.

Pfizer announced an agreement to acquire Baxter International?s marketed vaccines for $635 million.

The regulatory filing marks the first step in the approval process toward making RTS,S available as an addition to existing tools currently recommended for malaria prevention.

Arecor and the Center for Process Innovation (CPI) Biologics are working on a project to enhance the compatibility of biologics with their containers.

A new report from GlobalData states that biosimilars will overtake the market share after 2019.

The effect of absorbed vapor-phase hydrogen peroxide on a lyophilized product Protein Z, was studied by spiking experiments with different amounts of hydrogen peroxide.

New formulations and expanded vaccine production are encouraged.

FDA develops an assay that could speed the release of pandemic influenza vaccines.

Pfizer intends to submit a biologics license application for its investigational Meningococcal B vaccine candidate, Bivalent rlp2086, to FDA by mid-2014.

FDA clarifies recommendations for injectable drug products packaged in vials and ampules.

HHS plan makes progress in ensuring availability of safe vaccines.

EMA releases an update on its flu vaccine guidance.

MedImmune has entered into a research collaboration with Immunocore to develop novel cancer therapies.

NMR analysis provides crucial structural information of synthesized glycans while LC-MS/MS is ideal for quantitation of free sugars in biological matrices.

Antibody fragments pose unique challenges in terms of recovery, purification, and formulation.

With SMEs gaining wider recognition as the powerhouse of research and innovation in Europe, regulatory agencies are urging companies to engage with regulators early in the drug-development process.

Pfizer appoints management changes to take effect in 2014.