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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

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. 

FDA Approves Sanofi’s Follow-On Insulin

In partnership with Indian pharmaceutical firm, Torrent Pharmaceuticals, Novo Nordisk has expanded an insulin manufacturing facility at Torrent’s Indrad, Gujarat, India site.

Novo Nordisk Expands Insulin Manufacturing Facility in India

The companies will co-develop and co-commercialize the lead candidate generated from their earlier collaboration to treat genetic blood disorders.

Vertex and CRISPR Therapeutics Partner on Gene Therapy for Blood Disorders

The agency has approved Nucala (mepolizumab) to treat Eosinophilic Granulomatosis with Polyangiitis (EGPA) to GlaxoSmithKline. This indication is the first FDA-approved therapy specifically to treat EGPA.

Drug Substance Analysis