In this week’s news, US FDA moves to help pharma avoid shortages, Emergent beefs up drug portfolio with eye on US procurement contract and more.

US FDA moves to help pharma and CDMOs avoid shortages

The US FDA has published new draft guidance to help CDMOs and drug firms forge risk management plans aimed at combating potential shortages. 

The document describes a framework for stakeholders to consider when developing risk management plans that aligns with principles in the ICH guideline on Q9 Quality Risk Management.

The FDA identifies risk factors to consider as well as the steps needed to reduce disruption. It also points out that drug supply may vary among the different manufacturers in the supply chain for a given product. 

Emergent buys rights to smallpox antiviral

Emergent BioSolutions will acquire exclusive worldwide rights to Tembexa, the first US FDA approved antiviral for smallpox from Chimerix. 

The CDMO will pay $225 million upfront and up to a total of $100 million in milestone payments contingent on the potential exercise by the US government of procurement options following the base period. 

Upperton to invest in new UK manufacturing site

UK CDMO Upperton Pharma Solutions will invest around £15m to set up a 50,000 sq ft facility in Beeston, near Nottingham.

According to local newspaper the Business Desk, the new facility will increase Upperton’s manufacturing capacity by 10% and create 100 jobs over the next few years. 

The firm cited demand for its oral, nasal and pulmonary dosage form development and GMP manufacturing services as the prompt for the investment.

Also in the news

Pharmaron has agreed to buy an active pharmaceutical ingredients (API) manufacturing site in the US from Noramco.

Reuters reported that the WHO wants to play more of a role in global healthcare and is seeking more funding as well as powers to track and manage disease outbreaks.

ArchiMed has invested in Canada-based Corealis Pharma according to an article by LaingBuisson.

Endpoints looked at Fujifilm Irvine Scientific’s new Innovation and Collaboration Center in Suzhou, China. The site will focus offer cell culture media optimization, analysis and design services

The Hindustan Times covered a drug recall initiated by Sun Pharmaceuticals.

FiercePharma reported that WuXi Biologics has returned China rights to Vir’s COVID antibody, sotrovimab.

DCAT Value Chain Insights examined Novartis decision to sell its active pharmaceutical ingredient (API) manufacturing facility and assets in Grimsby, UK to Humber Industrials.

CDMO tends

Some developments of note in the contracting sector: 

Catalent will spend $175 million to expand its manufacturing facility for large scale oral dose forms in Winchester, Kentucky. 

Piramal Pharma Limited says a new active pharmaceutical ingredient (API) plant at the its site in Aurora, Ontario, has come online and completed its initial production runs.

Kodiak Sciences and Lonza have opened a new, custom-built, bioconjugation facility at the latter’s manufacturing complex in Visp.

AGC Biologics has said it will add viral vector suspension technology and capacity for the development and manufacturing of gene therapies at its commercial-grade campus in Longmont, Colorado.

Be Biopharma and National Resilience have teamed up to advance initial programs in Be Bio’s rare disease pipeline. 

The New Jersey Innovation Institute (NJII) has sold its CDMO BioCentriq to GC for $73 million. The contractor makes cell and gene therapies and specializes in viral vector production, cell and viral banking, and upstream and downstream processing.