Formulation and Drug Delivery

Classifying Potent and Highly Potent Molecules

August 01, 2018

Determining how much containment is needed for API handling requires evaluation of multiple factors.

Designing Combination Products

August 01, 2018

API can be mixed with silicone and other polymers to create drug-delivery combination products.

CMO Roundup: Expansions for Biomanufacturing

August 01, 2018

CMOs have been active over the past year in expanding their biologics production and capabilities.

EMA Recommends Sixteen Medicines for Approval

July 27, 2018

The recommended drugs include two orphan medicines and three biosimilars.

Novartis Has Production Hiccup for Kymriah CAR-T Therapy

July 19, 2018

The company has run into a snag in producing Kymriah for the diffuse large B-cell lymphoma patient population, the second indication for which the therapy was recently approved by FDA.

FDA Reveals Biosimilar Plan; Gottlieb Blasts Delays

July 19, 2018

In launching FDA’s Biosimilar Action Plan, Gottlieb takes innovator companies to task for delaying competitive biosimilar products.

AbbVie Signs Patent License with Mylan for Humira Biosimilar

July 18, 2018

AbbVie will grant Mylan license to launch a biosimilar to AbbVie’s Humira.

Novartis, CELLforCURE Partner to Manufacture CAR-T Therapies

July 18, 2018

CELLforCURE will produce cancer CAR-T treatments for Novartis at a manufacturing facility in Les Ulis (Essonne), France.

Hydroxyapatite Chromotography Media Offers Enhanced Biomolecule Purification

July 18, 2018

The media, by Tosoh Bioscience, is composed of calcium and phosphate buffers and offers mixed-mode properties for biomolecule purification.

FDA Commissioner Gottlieb Releases Statement on Advancement of Gene Therapies

July 12, 2018

The agency is releasing six new draft guidances to provide a regulatory framework for handling gene therapies.