Formulation and Drug Delivery

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.

Company and People Notes: Lonza Acquired Vivante; PPD Appoints VP of Quality Management; And More.

Pending legislation may give FTC the authority to regulate all Hatch-Waxman settlements.

Industry participation is crucial as USP embarks on far-reaching monograph modernization initiative. This is an online-exclusive article.

New data provide insight into pharma-industry professionals' daily lives.

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.

Changing demands in drug development lead to new service combinations and models.

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.

Bristol-Myers Squibb's fit-for-purpose mode for clinical-trial materials for early-stage development seeks to achieve a better way in resource allocation. This article is part of a special issue on API Development, Formulation, Synthesis and Manufacturing.

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.

One particularly crucial parameter for nasal sprays is the size of the droplets produced during actuation, which can potentially impact bioavailability.

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

Week of Aug. 23, 2010: Company and People Notes: Quark and Novartis Form Agreement; Hospira CEO Retires; And More.

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).

Eli Lilly Ends Semagacestat Program; Selecta Appoints CEO; And More.

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.

Penwest and Endo to Merge; Watson Makes Senior Appointments; And More.