Formulation and Drug Delivery

FDA Releases ANDA Submission Guidance

January 03, 2018

The agency published draft guidance on good practices for submitting abbreviated new drug applications.

Tackling the Opioid Crisis with Abuse-Deterrent Formulations

January 02, 2018

Abuse-deterrent opioid formulations generally fall into two categories: the first is based on a physiochemical abuse-deterrent approach and the second combines the opioid with an antagonist.

Elucidating Parenteral Packaging Requirements for Future Drugs

January 02, 2018

The development of new packaging solutions that are fit for drugs of the future requires close collaboration between the pharmaceutical manufacturer and its packaging suppliers and machine vendors.

Determination of Dermal PDE for Pharmaceutical Products

January 02, 2018

The authors offer recommendations for permissible daily exposures and concentration limits of elemental impurities for dermal drug products.

FDA Approves Spark Therapeutics’ Gene Therapy for Inherited Vision Loss

December 20, 2017

FDA has approved a new gene therapy for treating patients born with a rare, inherited vision loss.

MilliporeSigma to Offer End-to-End MAb Manufacturing Using the iCON Platform

December 20, 2017

MilliporeSigma will collaborate with IPS and G-CON to offer end-to-end, turnkey, modular MAb manufacturing.

BioTek Adds “OnDemand” Mode to BioSpa Software

December 19, 2017

BioTek Instruments has released a second edition of its BioSpa software that now offers users a simplified but effective interface for kinetic imaging or detection workflows.

Sanofi and Alnylam Seek EMA Approval for RNAi Therapeutic

December 19, 2017

Sanofi Genzyme and its partner, Alnylam Pharmaceuticals, have filed a marketing authorization application with EMA for an investigational RNAi therapeutic for treating a genetic-based disease.

TxCell Completes CAR-Treg Manufacturing Process Development

December 19, 2017

The company has completed development of a first-generation production process for its chimeric antigen receptor regulatory T cell product portfolio and is selecting a CMO for clinical supply.

Federal Circuit Decides in Favor of Novartis in Biosimilars Patent Dispute with Amgen

December 18, 2017

The US Court of Appeals for the Federal Circuit has decided in favor of Novartis’ Sandoz in rendering the opinion that Amgen cannot use state laws to prohibit or delay the marketing of biosimilars.