Drug Development

Articles

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

FDA Approves Spark Therapeutics’ Gene Therapy for Inherited Vision Loss

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

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

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.

BioTek Adds “OnDemand” Mode to BioSpa Software

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.

Sanofi and Alnylam Seek EMA Approval for RNAi Therapeutic

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.

TxCell Completes CAR-Treg Manufacturing Process Development

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.

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

MJR PharmJet's MicroJet Reactor technology is a continuous process for producing nanoparticles with tightly controlled particle size and particle size distribution.  

Nanoparticle Reactor Technology Controls Particle Size and Distribution

FDA has approved a Pfizer biosimilar to J&J’s top-selling anti-inflammatory biologic, Remicade.

FDA Approves Pfizer Biosimilar to J&J’s Remicade

Abzena has entered into a Master Services Agreement with a US biotech company to provide process development and manufacturing services to progress a novel antibody-drug conjugate (ADC) to clinical trials.

Abzena Secures ADC Manufacturing Contract with US Biotech Firm

The approval for Admelog (insulin lispro injection) marks the first short-acting insulin approved as a “follow-on” product. 

APIs and Excipients