Navigating key news stories in pharma
Featured Stories
Overall, 2024 was a good year to be working in the CDMO industry, but will the outlook stay positive for 2025?
Forecasts predict a steady rise in continuing growth trends from 2024, with estimates indicating the global pharmaceutical CDMO market is set to grow from USD 184.90 bn in 2024 to USD 197.40 bn in 2025, and looking further ahead, predicted to reach USD 368.70 bn by 2034.
SCHOTT Pharma, the pharma drug containment solutions and delivery systems company, has unveiled a groundbreaking nest design for ready-to-use cartridges to improve operational efficiency and sustainability for pharmaceutical manufacturing. The new design optimizes the arrangement of cartridges, reducing the risk of breakage and contamination during high-speed automated filling, and enhancing productivity by streamlining the fill-and-finish process, resulting in faster handling and increased throughput.
French biotech, Samabriva, has unveiled a significant expansion with a new 1,400-square-meter biomanufacturing facility located in Liege, Belgium, to aid the transition from research and development to industrial-scale production. The state-of-the-art facility is equipped with proprietary bioreactors specifically designed for hairy root culture, enabling the production of natural molecules for pharmaceutical applications.
German CDMO Adragos Pharma has acquired Swiss manufacturer Baccinex, marking the addition of its sixth global manufacturing site and strengthening its position in sterile manufacturing. The facility, based in Courroux, Switzerland, specializes in fill-finish services for clinical trials and small-to-medium-scale commercial production. It will continue to operate under the leadership of founder and CEO Ursula Bausch.
Dealmaking
German CDMO Adragos Pharma has acquired Swiss manufacturer Baccinex, marking the addition of its sixth global manufacturing site and strengthening its position in sterile manufacturing. The facility, based in Courroux, Switzerland, specializes in fill-finish services for clinical trials and small-to-medium-scale commercial production. It will continue to operate under the leadership of founder and CEO Ursula Bausch.
South Korean pharma, Boryung Corp., has announced a partnership with Taiwanese CDMO Lotus Pharmaceutical, for services focused on cytotoxic drugs and will take on the role of manufacturing an anticancer injection for Lotus.
Munich-headquartered pharmaceutical CDMO, Adragos Pharma, has expanded its global footprint by acquiring Swiss aseptic fill-finish manufacturing company, Baccinex, as it targets expanding its capabilities in sterile production through the acquisition of its sixth worldwide manufacturing site.
GSK has entered a partnership with Vesalius Therapeutics to develop treatments for neurodegenerative diseases, including Parkinson's disease and another unspecified neurodegenerative condition. Utilizing its proprietary platform, Vesalius will lead the drug discovery efforts, while GSK will have development and commercialization rights to the preclinical small molecule targeting Parkinson's, along with options to advance other programs.
Future Biopharma
Pharmaceutical industry deals have hit a decade-low in 2024, with only 558 deals totalling USD 67.2 bn by late November - the lowest since 2016. The largest biotech purchase of 2024, Vertex's USD 4.9 bn acquisition of Alpine Immune Sciences, is dwarfed by Pfizer's USD 43 bn Seagen takeover in 2023.
The decline in major acquisitions can be attributed to several factors: pharma companies digesting previous large deals, high valuations of listed biotech's deterring potential buyers, a focus on smaller, "bolt-on" deals under USD 5 bn, and antitrust concerns and political uncertainty in an election year.
Aizon has raised $20 million in Series C financing, with NewVale Capital leading the round with support from current backers. This funding boost is set to advance their AI-based platform for pharmaceutical manufacturing and aid in deploying their latest electronic batch record (eBR) system.
Sponsored by Expert Insights and Orientation Marketing, a panel of senior executives from the development and manufacturing partners charged with scaling and supplying medicines to patients were optimistic about 2024, but reflected on some of the challenges the industry will face too.
Brought to you by Orientation Marketing, hear thought-provoking views from five experienced c-level executives from leading development, technology, manufacturing, and bioprocessing partners.
R&D
An AI proof-of-concept study from Dandelion Health has identified an additional 44 million lower-risk cardiovascular patients who could benefit from a GLP-1 treatment. Using inclusion criteria similar to the Novo Nordisk-sponsored trial that helped convince the FDA that Wegovy had heart benefits, Dandelion examined whether GLP-1 use might reduce the risk of major adverse cardiac events such as heart attack or stroke in overweight and obese patients in lower-risk patients that didn’t have severe pre-existing cardiovascular disease.
Pfizer’s experimental drug, ponsegromab, has shown promising results in a Phase 2 clinical trial aimed at treating cancer cachexia - a serious condition characterized by muscle and weight loss. Presented at the 2024 ESMO conference, the candidate achieved weight gains of up to 5.6% in patients suffering from cachexia due to lung, pancreatic, or colorectal cancer, surpassing the 5% threshold deemed clinically significant. Pfizer is planning to commence Phase 3 trials by 2025, and aims to provide the first FDA-approved treatment for this life-threatening condition, which currently relies on nutritional support and anti-inflammatory treatments.
The 2024 Lasker Award, given to the living person or persons considered to have made the greatest contribution to medical science, has been awarded to scientists Joel Habener, Jens Juul Holst, and Dr. Gojko Mojsov for their discovery of GLP-1 (glucagon-like peptide-1). Their groundbreaking work has paved the way for life-changing treatments for diabetes and obesity, revolutionizing the management of these conditions through drugs like Ozempic and Wegovy, resulting in a wave of new medications entering the market.
Amgen is advancing its next-generation obesity drug, MariTide, into a Phase 3 clinical program aimed at addressing obesity in conjunction with other weight-related conditions such as heart, liver, and kidney diseases. The injectable therapy, which activates the GLP-1 receptor while blocking the GIP receptor, demonstrated a 14.5% reduction in body weight during Phase 1 trials.
Expansion
French biotech, Samabriva, has unveiled a significant expansion with a new 1,400-square-meter biomanufacturing facility located in Liege, Belgium, to aid the transition from research and development to industrial-scale production. The state-of-the-art facility is equipped with proprietary bioreactors specifically designed for hairy root culture, enabling the production of natural molecules for pharmaceutical applications.
India-based CDMO, OneSource Specialty Pharma, is expanding its capacity to manufacture GLP-1 drug-device combinations, driven by growing global demand for diabetes and obesity treatments. The company, which specializes in drug-device combinations, including cartridge filling, assembly, and fill-finish, recently raised funding through equity issuance to fund this expansion.
Florida biotech, Dyadic International, has secured a USD 3 mn grant from the Gates Foundation to develop affordable monoclonal antibodies for RSV and malaria, using its C1 protein production platform to address the limited access to mAb treatments in low- and middle-income countries.
Roche Holdings, Inc. has agreed to acquire Poseida Therapeutics, Inc., a clinical-stage biopharmaceutical company specializing in allogeneic cell therapies and genetic medicines, integrating the company into Roche's Pharmaceuticals Division, and enhancing their capabilities in allogeneic cell therapy.
The acquisition brings Poseida's innovative pipeline which includes a proprietary non-viral technology platform, which enables the development of allogeneic, T stem cell memory (T SCM)-rich CAR-T therapies, which include hematologic malignancies, solid tumors, and autoimmune diseases.
Strategy
Biomanufacturing CDMO, National Resilience, has announced plans to lay off approximately 105 employees at its Alachua, Florida facility as part of a strategic pivot away from government business toward commercial development and manufacturing. The restructuring coincides with a leadership change, as CEO Rahul Singhvi steps down and is replaced by William Marth. However, the company will continue to expand elsewhere, including a USD 225 mn investment in Cincinnati and creating 440 new jobs at its West Chester, Ohio facility.
Massachusetts biotech Agenus is undergoing its second reorganization in 16 months, pivoting to include CDMO services at its 25,000-square-foot Berkeley clinical facility and 83,000-square-foot Emeryville commercial plant for third-party biologics manufacturing.
Californian-based, SK pharmteco, has announced a brand unification initiative, bringing together several respected organizations under its umbrella to create a global CDMO. SK biotek, SK biotek Ireland, Center for Breakthrough Medicines, Yposkesi, AMPAC Fine Chemicals, and AMPAC Analytical, will now combine to operate as SK pharmteco, providing a comprehensive range of services from early-stage development to commercial manufacturing and analytical testing.
Swiss manufacturing company, Lonza, has announced a strategic shift to focus on its CDMO business. The company will restructure its existing CDMO business into three new units - integrated biologics, advanced synthesis, and specialized modalities - as it focuses on its ambition to achieve and maintain leadership across therapeutic modalities.
Regulatory
The European Commission has granted unconditional approval for Novo Holdings A/S to acquire Catalent, Inc., with the acquisition expected to close by the end of 2024. Catalent's CEO Alessandro Maselli has welcomed the approval, while Novo Holdings' Senior Partner Jonathan Levy affirmed their commitment to supporting Catalent's future growth. The transaction remains subject to final regulatory clearances and closing conditions.
The BIOSECURE Act - intended to address national security concerns by restricting U.S. government contracts with certain Chinese biotechnology companies - has been omitted from the 2025 National Defense Authorization Act (NDAA), providing a temporary reprieve to targeted Chinese firms like WuXi AppTec, WuXi Biologics, and BGI Group.
The possible appointment of Robert F. Kennedy Jr. to a cabinet position has ignited fierce controversy in the U.S.; raising questions that could reshape the pharmaceutical industry and challenge the direction of federal scientific agencies.
With a well-publicized history of being a vaccine sceptic, Kennedy’s track record suggests a blend of reformist zeal and controversial positions that could redefine the role of agencies he is likely to oversee – the FDA, NIH and CDC.
Earlier this year, the FTC requested additional information regarding Novo Holdings’ proposed acquisition of Catalent, but now, the EU antitrust regulators have announced they are probing the deal for anti-competitiveness impacts surrounding injectables, pre-filled syringes, orally dissolved pills and soft gels.
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