Formulation and Drug Delivery

How will the move to more specialized and personalized medicines impact drug delivery and dosage forms?

Antibody fragments pose unique challenges in terms of recovery, purification, and formulation.

Emerging markets are an engine for growth in the custom-manufacturing and pharma markets.

Roger Hayes of MPI Research discusses highly potent drug development.

With SMEs gaining wider recognition as the powerhouse of research and innovation in Europe, regulatory agencies are urging companies to engage with regulators early in the drug-development process.

ProBioGen signs agreement with Emergent BioSolutions for access to ProBioGen's avian AGE1.CR cell line.

Leidos Holdings awards Pfenex a subcontract in support of the development of an anthrax vaccine.

A collaborative pharmaceutical project to develop paediatric formulations using smart design and predictive science has received the go ahead after securing a ?660,000 grant from UK-based Technology Strategy Board.

CMC Biologics and OnoSynergy form an agreement from cell-line development.

Pfizer appoints management changes to take effect in 2014.

FDA and EMA launch initiative to share bioequivalence inspection information.

Biogen and Samsung Bioepis, a joint venture between Samsung Biologics and Biogen Idec, advance plans for anti-TNF biosimilar product candidates.

BioWa and Lonza have entered into a licensing agreement with MedImmune for cell line technology.

FDA details efforts to evaluate potential risks from use of nanomaterials in drug products and discuss analytical considerations, impact on stability, safety, and toxicology effects.

OGD is under pressure to improve review operations.

Teva Pharmaceutical Industries releases a financial outlook for 2014 based on two possible scenarios concerning its multiple-sclerosis drug Copaxone (glatiramer acetate).

Researchers at Massachusetts recently reported on the development of a drug-eluting contact lens designed to provide prolonged delivery of the glaucoma medication, latanoprost.

Alvotech plans investment in biosimilars portfolio and manufacturing facility.

Jill E. Sackman, D.V.M., PhD, senior consultant at Numerof & Associates, Inc. discusses the market forces impacting biopharmaceutical manufacturing

EMA revises its polices on fee reductions for orphan drugs for 2014.

The European Union is strengthening its pioneering role in the regulation of biosimilars by further developing the basic rules for determining the levels of compatibility for this group of drugs. There are, however, some key issues that are not easy to resolve, as evident in a recent workshop on biosimilars organized by the European Medicines Agency (EMA).

In this sponsored podcast, Adam Stuart, Senior Design Engineer at 3M Drug Delivery Systems, discusses the role of dose counters for metered dose inhalers and the technical challenges companies can face when adding this feature to their inhaler products.

European Medicines Agency announces the launch of the Accelerated development of vaccine benefit-risk collaboration in Europe (ADVANCE) project.

Unilife to begin commercial supply in 2014.

John J. Castellani, President and CEO of the Pharmaceutical Research and Manufacturers of America of the PhRMA Research & Hope awards and creating an ecosystem for promoting new vaccine development