Manufacturing, Biologic Drugs

FDA Approves Sanofi’s Follow-On Insulin

December 13, 2017

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

Novo Nordisk Expands Insulin Manufacturing Facility in India

December 13, 2017

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

Vertex and CRISPR Therapeutics Partner on Gene Therapy for Blood Disorders

December 13, 2017

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

EMA Approves mAb Production at Samsung BioLogics Facility

December 13, 2017

The European Medicines Agency has granted Samsung BioLogics approval to manufacture a monoclonal antibody at the company’s second facility in Songdo, Incheon, South Korea.

FDA Accepts Lilly’s Application for Migraine Biologic

December 11, 2017

FDA has accepted for review Eli Lilly and Company’s biologic drug candidate that is in development for treating migraine.

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

December 08, 2017

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

Stakeholders Comment on FDA Draft Guidance for Evaluating Biosimilarity

December 05, 2017

Biopharma majors are among the industry stakeholders who have commented and raised questions about FDA’s recently proposed draft guidance for analytical assessment of similarity in biosimilars.

Designing Sustainable Pharma Facilities

December 02, 2017

Optimizing water and HVAC systems can reduce resource use in all pharma facilities, and, for biopharma manufacturing, the supply chain of consumables should be evaluated.

Orchard Therapeutics Opens Gene Therapy Laboratory Facility

December 01, 2017

The company has opened a new California facility that, combined with its existing site in Foster City, CA, will quadruple its laboratory footprint for gene therapy products.

Lonza in Gene Therapy Licensing Agreements

December 01, 2017

PTSM: Pharmaceutical Technology Sourcing and Management

Lonza has entered into strategic license agreements for exclusive rights to a gene-therapy platform for developing treatments for hearing and balance disorders.