Dosage Forms

A look at MVI's malaria work in developing countries.

Novartis' Matthew Stober discusses vaccine manufacturing, including egg- and cell-based systems.

President Obama and HHS eye innovation and countermeasures to protect public health.

The early part of the decade saw a decline in vaccine sales and manufacture, but finally the industry is bouncing back, with Europe particularly well placed to make an impact.

The authors describe the operational requirements and design of a process-ready PAT-based IBD system.

The author discusses new detection-system technologies that can improve performance and provides key criteria to consider when selecting or upgrading a system for pharmaceutical use.

The generic-drug company Actavis (Hafnarfjordur, Iceland) is considering acquiring a 51% stake in the biopharmaceutical company BioPartners Holdings (Barr, Switzerland) from Bioton, a Polish biotechnology company.

The author describes the types and sources of rouge and explains ways to prevent and mitigate this problem.

US Pharmacopeia apparatuses for testing the dissolution of transdermal drugs produce good, reproducible results. Yet some scientists believe that further modifications could improve the instruments? suitability for this application.

Director General of the European Generic Medicines Association (EGA), Greg Perry, has emphasised the need for EU biosimilar guidelines for monoclonal antibodies (mAbs), as well as a harmonised, global approach to biosimilars in general, at the agency's 8th International Symposium on Biosimilar Medicines.

Director General of the European Generic Medicines Association (EGA), Greg Perry, has emphasized the need for EU biosimilar guidelines for monoclonal antibodies (mAbs), as well as a harmonized, global approach to biosimilars in general, at the agency's 8th International Symposium on Biosimilar Medicines.

The European Medicines Agency (EMA) has launched a review of GlaxoSmithKline's pandemic influenza vaccine Pandemrix to investigate whether there is a link between vaccination and cases of narcolepsy, a rare sleep disorder.

The President's Council on Advisors on Science and Technology (PCAST), a group administered by the federal Office of Science and Technology Policy (OSTP), issued recommendations to improve the country's ability to accelerate vaccine production and delivery in the event of a pandemic flu outbreak.

A Strengths, Weaknesses, Opportunities and Threats analysis of the biosimilars market is given.

Both biosimilar and generic drugs have an abbreviated approval process; however, the clinical trial requirements differ enormously.

In light of the impressive size and predicted growth of the market, there has been a rising interest in the development of biosimilars.

The main advantage of outsourcing highly potent API (HPAPI) manufacture is that it eliminates the need to invest in expensive containment infrastructure, which can also be complex to engineer, install and maintain.

Many hurdles lie between a biosimilar and success on the market. In particular, there are three main questions that companies will be asking themselves.

Both biosimilar and generic drugs have an abbreviated approval process; however, the clinical trial requirements differ enormously.

Last year, the global market for biological products exceeded $125 billion, accounting for 17% of the total market for pharma/biopharma products.

US Department of Health and Human Services (HHS) Secretary Kathleen Sebelius released last week an examination of the federal government's system to produce medical countermeasures, or medications, vaccines, equipment, and supplies needed for a health emergency.

Two new reports describe the vaccine market's recent growth and predict future market expansions.

Recent figures published by the EMA relating to centralized procedure activities for human medicines appear to show a marked slow down in the number of generic product applications started and finalised this year to date.

Recent figures published by the EMA relating to centralized procedure activities for human medicines appear to show a marked slow down in the number of generic product applications started and finalized this year to date (9 and 12, respectively).

Making highly potent active pharmaceutical ingredients (HPAPIs) can be costly because the process often requires equipment specialized to achieve containment and extra attention to safety concerns. Pharmaceutical professionals may wonder whether disposable components, which have reduced the cost of some operations, might be appropriate in the manufacture of HPAPIs.

In a draft guidance published this week, the US Food and Drug Administration recommended that makers of transdermal and transmucosal drug-delivery systems use "an appropriate scientific approach" during product design, development, and manufacturing to minimize the amount of residual drug substance present at the end of the products' labeled use periods.

FDA Approves Flu Vaccines; Caraco Names COO; And More.

Green chemistry in pharmaceutical development often centers around approaches in the synthesis of the active ingredient, but green-chemistry techniques also can be applied to drug-product manufacturing, formulation development, and drug delivery.

The different pathways to regulatory approval of a biosimilar vary worldwide, ranging from no pathways at all in some developing countries, to the complex and precise mechanism that exists in Europe.

We speak to The European generic Medicines Association about the environment for biosimilars.