Formulation and Drug Delivery

WuXi Biologics Subsidiary in $3-Billion Vaccine Manufacturing Contract

February 18, 2020

WuXi Vaccines, WuXi Biologics’ joint venture with Shanghai Hile Bio-technology, has signed a 20-year vaccine manufacturing contract with a global vaccine leader for $3 billion.

Sanofi Partners with BARDA for Novel Coronavirus Vaccine Development

February 18, 2020

Sanofi will use a recombinant DNA platform that produces a genetic match to proteins found on the surface of COVID-19 to formulate the vaccine.

FDA Responds to Coronavirus Outbreak

February 17, 2020

The agency is taking steps to monitor the supply chain and assist in the development of treatments.

MilliporeSigma and ReForm Collaborate on Excipient Commercialization

February 13, 2020

The companies have entered into a global licensing and collaboration agreement to commercialize ReForm excipients used in biotherapeutic formulations.

Catalent Appoints New Vice-President of Operations

February 12, 2020

Jim Walter will take on the role of vice-president of operations for Catalent’s Oral and Specialty Delivery business.

Schott to Present New Syringe Format at Pharmapack 2020

February 06, 2020

The company will showcase the syriQ BioPure syringe in a 2.25-mL format for autoinjectors at Pharmapack in Paris, France from Feb. 5¬¬–6, 2020.

Coronavirus Offers Opportunities and Challenges for Biopharma R&D

February 06, 2020

The research community is moving quickly to launch clinical trials of potential countermeasures, while regulatory authorities aim to support product development through regulatory flexibility.

FDA and FTC Collaborate on Competitive Biologics Market

February 06, 2020

The two agencies are collaborating to support a robust biologics marketplace by taking steps to deter anti-competitive business practices.

Guidance on Biosimilar Licensure

February 06, 2020

FDA published draft guidance for applicants seeking licensure of a proposed biosimilar or proposed interchangeable biosimilar.

FDA Approves Seqirus’ Adjuvanted, Cell-Based Pandemic Influenza Vaccine

February 04, 2020

The vaccine is designed to provide active immunity against the influenza A (H5N1) strain and can be easily deployed in a pandemic event.