Drug Development

Randi Hernandez was science editor at Pharmaceutical Technology from September 2014 to May 2017.

Articles

Intellectual property lawyers estimate biosimilar litigation will swell as early as 2018.

Biosimilars Will Bring Significant Litigation and Patent Challenges

Eric Langer has over 25 years experience in biotechnology and life sciences strategic marketing management, market research, and publishing. He has held senior management and marketing positions at biopharmaceutical supply companies. He has published and authored many books and reports on topics in Biotechnology, Large-scale BioManufacturing, and bioscience commercialization and communication. He teaches at Johns Hopkins University marketing management, biotech marketing, services marketing, and marketing in a regulated environment. In 1989 he co-founded BioPlan Associates, Inc. to provide market analysis, and strategy to biotech and healthcare organizations.

While the United States and Europe still dominate, CMOs and CROs based in emerging markets continue to capture market share.

Biomanufacturing Outsourcing Globalization Continues

Cynthia A. Challener is a contributing editor to Pharmaceutical Technology.

An integrated pilot plant tests heteronucleation and continuous crystallization.

Considering Continuous Crystallization

Stephen Wicks, PhD, is the scientific regulatory policy and intelligence officer of the European Directorate for the Quality of Medicines & HealthCare (EDQM) of the Council of Europe, Stephen.WICKS@edqm.eu. EDQM is a leading organization that protects public health and amongst other things is responsible for the European Pharmacopoeia.

The European Pharmacopoeia defines the format and content of monographs for biologicals to keep pace with recent approaches and meet the needs of its users.

Ensuring the Quality of Biologicals

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

FDA Releases Final Biosimilar Guidance

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

Catalent Awarded Vaccine Research Grant

The agency has recommended granting marketing authorization for Opdivo.

EMA Recommends Authorization of Melanoma Treatment

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

Biosimilars May Spur Improvements in Reference Product Manufacturing Processes

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

Reviewing the Contract Services Market

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.

Formulation and Drug Delivery