Drug Development

Articles

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 low viscosity of Colorcon’s Opadry QX, even at solid levels as high as 35%, reduces coating and preparation time compared to traditional hydroxypropyl methylcellulose-based coatings.

An Innovative Excipient System for Film Coating

The new 30,000-L, $150-million biologics manufacturing facility in Wuxi, China, quintuples the company’s existing manufacturing capability.

WuXi Biologics Starts Up Large-Scale, Single-Use Biomanufacturing Facility

Gilead Sciences will acquire Cell Design Labs to further cell-therapy research and development efforts.

Gilead Sciences and Kite to Acquire Cell Design Labs

Adeline Siew is editor for Pharmaceutical Technology Europe. She is also science editor for Pharmaceutical Technology.

The method developed by Cambrex uses standard plant equipment and requires only two synthetic steps and one recrystallization, minimizing waste and use of solvents.

A New Efficient Synthesis of Ospemifene

The contract research, development, and manufacturing organization has expanded API aseptic manufacturing capacity at its Valladolid, Spain, facility.

APIs and Excipients