Catalent

The 15th edition of the CMO industry analysis uses FDA NDA approvals as the primary performance indicator for contract manufacturing organizations.

The FDA declined to approve Regeneron's lymphoma therapy odronextamab for the second time, citing manufacturing issues at a third-party Catalent facility rather than safety or efficacy concerns.

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended approval for Pfizer and BioNTech's LP.8.1-adapted COMIRNATY vaccine targeting XFG and NB.1.8.1 variants.

Italian authorities appointed a special commissioner to expedite Novo Nordisk's promised 2 billion-euro ($2.34 billion) investment in a factory south of Rome that will produce weight loss and diabetes drugs.

Akadeum Life Sciences closed a $20 million+ financing round led by Michigan Capital Network to scale commercial operations and support customers entering clinical trials.

• Moderna's Innovation and Technology Centre in Harwell, Oxfordshire has received Good Manufacturing Practice certification, enabling commercial production of mRNA vaccines for pandemic preparedness. • The facility is part of a ten-year partnership between Moderna and the UK government, with plans to produce at least 250 million vaccine doses during future pandemics for the NHS. • The flexible manufacturing setup allows rapid switching between different vaccine types within weeks, with the first priority being a new COVID-19 vaccine for the NHS next winter.

Multiple CDMOs secured significant contract manufacturing opportunities as regulatory bodies approved new indications for established drugs, particularly in oncology and rare diseases.

• Novo Nordisk has committed $1.09 billion to expand its Montes Claros facility in Brazil, adding aseptic production processes, a warehouse, and a quality control laboratory to boost GLP-1 receptor agonist production. • The expansion, one of the largest pharmaceutical investments in Brazil's history, will create 600 permanent jobs and is expected to begin operations in 2028 to meet growing global demand for semaglutide products. • The facility will be designed with sustainability features including 100% solar power, water conservation strategies, and low-carbon construction materials, targeting LEED certification.

Small pharmaceutical companies are increasingly adopting adaptive clinical trials that allow protocol modifications based on interim data, offering flexibility to adjust doses or participant sample sizes during studies.

• MMJ International Holdings has achieved a milestone in developing MMJ-002, a novel cannabis-derived therapeutic combining THC and CBD for Huntington's Disease treatment. • The FDA's response to the company's IND application highlights key requirements including impurity identification, stability testing, and manufacturing transparency protocols. • Regulatory guidance emphasizes the need for botanical consistency, comprehensive clinical pharmacology studies, and detailed manufacturing process documentation for the cannabis-based drug.