Formulation and Drug Delivery

As emerging markets become increasingly important for the pharmaceutical majors, companies are re-evaluating their outsourcing strategies. This article is part of the 2010 Outsourcing Resources special issue.

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.

The authors describe recent market trends and indicate the likely future direction of the pharmaceutical and biopharmaceutical industries. This article is part of the 2010 Outsourcing Resources special issue.

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

The EMA's Guideline on Similar Biological Medical Products provides overarching guidance, but since its introduction a range of more specific guidelines have also been developed.

As biopharmaceuticals will soon make up 50% of new drug approvals there has been a significant rise in interest in the field of biosimilars.

The biggest differences between the development of a biosimilar and a generic medicine lie primarily in the preclinical and clinical stages.

Why the primary defence against biosimilars is to develop better molecules that can be launched quickly.

The FDA has approved the first generic version of the blockbuster low molecular weight heparin Lovenox (enoxaparin sodium), much to originator sanofi-aventis's displeasure.

Merck and Sinopharm Sign Agreement; Agilent Appoints CFO; And More.

Teva and Sun Pharmaceuticals? motion to overturn a verdict issued against them in April 2010 for patent infringement has been denied by a US court, leaving the companies at the mercy of pharma giants Pfizer and Nycomed, who have said they will "vigorously" pursue damage claims.

Researchers claim that a dissolving microneedle patch may be able to offer improved vaccination against influenza compared with traditional needles, and also allow people without medical training to easily and safely administer the vaccine.

Pfizer Ends Second Tanezumab Clinical Program; Catalent VP Joins USP Panel; And More.

Teva's and Sun Pharmaceuticals' motion to overturn a verdict issued against them in April 2010 for patent infringement has been denied by a US court, leaving the companies at the mercy of pharma giants Pfizer and Nycomed, who have said they will "vigorously" pursue damage claims.

The pharmaceutical industry?s increasing interest in inhaled drugs has prompted several researchers to propose standard dissolution-testing methods for these products.

Xcelience and Penn Form Joint Venture; Almac Appoints QA Director; And More.

States can reduce their Medicaid programs' healthcare expenditures by changing laws to enable generic drugs to be substituted for branded medications more easily and quickly, according to a new study conducted by CVS Caremark, a large pharmacy healthcare provider.

Eli Lilly to Acquire Alnara Pharmaceuticals; Exelixis CEO Leaves for Biogen Idec; And More.

Nanotechnology is an important area of drug and biomedical research, and advancing nano-analysis is crucial for its further development.

To continue innovating, the biopharmaceutical sector needs support from all levels.

The functionality and performance of three types of commercial superdisintegrants were evaluated in the application of orally disintegrating tablets.

Is now the time for multiparticulates to shine as a controlled-release solution?

Technical Note: The authors investigated the variables important for calcium-alginate formation as well as dissolution.

Excipient manufacturers expand their products, services, manufacturing capacity, and technology positions.

After a spate of industrial disasters, the public seeks greater oversight of corporations-so does FDA.