Catalent

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. • AstraZeneca's portfolio saw substantial growth with expanded approvals for Imfinzi, Tagrisso, and Lynparza, strengthening partnerships with contract manufacturers including Lonza, Dottikon, and Samsung Biologics. • Contract manufacturers supporting treatments for autoimmune conditions showed strong performance, with Argenx's Vyvgart Hytrulo receiving expanded indications for myasthenia gravis and CIDP.

• 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.

• Catalent and Galapagos NV have formed a strategic collaboration to support decentralized manufacturing of GLPG5101, an investigational CAR-T therapy for relapsed/refractory non-Hodgkin lymphoma. • The partnership leverages Catalent's Princeton facility to deliver fresh CAR-T cells with a median vein-to-vein time of seven days, eliminating the need for cryopreservation and bridging therapy. • This innovative manufacturing approach aims to improve patient experience by bringing production closer to cancer treatment centers across New Jersey, New York, and surrounding areas.

• Novo Nordisk's Ozempic faces scrutiny as Danish regulators request an EMA review due to reports of a rare eye disease in patients using the GLP-1 medication. • Novo Holdings received regulatory clearances to finalize its $16.5 billion acquisition of CDMO Catalent, marking a significant investment in biopharmaceutical manufacturing. • The biopharmaceutical industry saw a year of strategic manufacturing investments, shifting M&A activity, challenging IPO landscape, and clinical trial outcomes.

• Analysts predict renewed investor enthusiasm for GLP-1 drugs in 2025 due to increased supply following Novo Nordisk's Catalent acquisition. • Novo Nordisk's REDEFINE-1 study results could lead to the launch of more potent weight-loss drugs, enhancing its competitive edge. • A study is due in the second half of the year that tests semaglutide versus Alzheimer's disease. • GLP-1 drug usage may negatively impact alcohol consumption, affecting companies like Molson Coors and Constellation Brands.

• The European Commission has granted approval for Novo Holdings' $16.5 billion acquisition of Catalent, marking a significant milestone in the pharmaceutical manufacturing landscape. • Following the acquisition, Novo Holdings will divest three of Catalent's manufacturing facilities to Novo Nordisk, located in Bloomington (US), Brussels (Belgium), and Anagni (Italy). • The transaction, which has already received shareholder approval, is expected to be completed by the end of 2024, pending additional regulatory clearances.