Drug Development

Agnes Shanley is senior editor of Pharmaceutical Technology.

Articles

Quality by design, in-vitro release testing, and modern analytical methods are improving understanding and control of these complex formulations.

Optimizing Semisolid Dosage Forms

Andrew Teasdale, PhD, is a Principle Scientist at AstraZeneca.

Laura Rutter is a SM manager, analytical services at GlaxoSmithKline

Courtney M. Callis is research scientist, Health/ Safety/Environmental, Lilly Research Laboratories

Bruce D. Naumann is executive director, Toxicology, Merck & Co.;

Gretchen Allison is a senior director in Global Quality Operations at Pfizer Inc.

Wendy Luo is an associate director, Drug Safety Evaluation, Bristol-Myers Squibb;

The results of an industry workgroup’s examination of EMA’s guide on shared facilities are presented.

EMA Guideline on Setting Health-Based Exposure Limits

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

The CEO of a US-based biosimilar manufacturer explains the legal and intellectual property issues of bringing a biosimilar to market in the United States.

Litigation and Manufacturing Hurdles Block US Biosimilars Market Success

Xcelodose provides automated processing of API directly into capsules at low doses. The expansion of Xcelodose reinforces Juniper’s early stage capsule filling capability.CDMO Juniper Pharma Services, a subsidiary of Juniper Pharmaceuticals, announced that it has expanded its Xcelodose powder micro-dosing system. This move reinforces the company’s early stage capsule filling capability.

Juniper Pharma Services Strengthens Capsule Capability with Xcelodose

While some industry trade groups are gunning for distinct, nonproprietary names for biosimilars (mostly providers, brand manufacturers, and patient advocacy groups), and others for common names (mostly biosimilar manufacturers, insurers, pharmacies, and the Federal Trade Commission [FTC]), some are requesting that no decisions be made at all at this stage in the game. Express Scripts, a large pharmacy benefit manager (PBM), submitted a comment to FDA asking that the regulatory agency hold off on naming decisions until it releases formal guidance on interchangeability first.

Express Scripts to FDA: Hold Off on Biosimilar Naming Decisions for Now

A study backed by the Centre of Regenerative Medicine found that laminins are crucial cell components that could help aid the commercial production of stem cell therapies.

Laminins Key to Production-Scale Stem Cell Development

Text from a merger prospectus reveals the termination fee for the proposed Pfizer-Allergan deal would change if any new tax regulations were passed prior to the closing of the transaction.

The $3.5-Billion Pharmaceutical Prenup

The University of Sheffield has appointed Cobra Biologics to advance novel fusion protein technology into Phase 1 clinical trials.

Cobra Biologics to Scale Production of Growth Hormone

BioOutsource releases informational video detailing issues associated with ADCC assays and how to effectively analyze them.

BioOutsource Releases Video Addressing Issues with using ADCC Assays

The UK’s National Biologics Manufacturing Centre will use Novasep’s BioSC Lab for protein purification.

Formulation and Drug Delivery