Formulation and Drug Delivery

Celltrion Announces that Remicade Biosimilar Could Save Up to $380 Million USD

February 23, 2015

Celltrion announced that its Remicade biosimilar, Rensima, could save France, Italy, and the UK up to €336 million in costs to treat Crohn’s disease.

Revlimid Gains FDA Approval for NDMM Patients

February 20, 2015

Celgene announced that its drug, Revlimid, gained FDA approval for the treatment of newly diagnosed multiple myeloma.

Cell Medica Begins Commercial Manufacturing of Cell Therapies

February 19, 2015

The Berlin-Buch facility will begin manufacture of the company’s immune cell therapy.

Single-use Purification Media Improves Efficiency

February 18, 2015

The all-synthetic 3M Emphaze AEX Hybrid Purifier contains both an anion-exchange nonwoven media and a fine-particle, bioburden reduction membrane.

First Hospira Biosimilar mAb Approved in West Europe

February 17, 2015

Hospira’s Inflectra (infliximab), a biosimilar for Remicade, is approved by the European Commission.

New Financial Strategies Needed to Support Biomedical Innovation

February 17, 2015

The ongoing battle over drug reimbursement and pricing has raised questions about whether the pharmaceutical industry can continue to rely on high United States revenues to fund biopharmaceutical R&D.

CDER and Biotech Quality Assessment

February 11, 2015

The Center for Drug Evaluation and Research seeks a more flexible system for assessing biotech product quality.

Pfenex Announces Partnership with Hospira to Develop Lucentis Biosimilar

February 11, 2015

Pfenex announced that it entered into an agreement to partner with Hospira on the development and commercialization of PF582, a biosimilar candidate to Lucentis.

Amgen Announces Humira Biosimilar Clinical Studies Success

February 06, 2015

Amgen announced that it met primary and secondary endpoints in its biosimilar evaluation of adalimumab for the treatment of rheumatoid arthritis, when compared to Humira.

First Inhalable Insulin Comes to the US

February 04, 2015

Sanofi launched a rapidly absorbed, short-acting inhalable insulin in the US to help control type 1 and type 2 diabetes.