
Featured Stories
Terumo’s Ultimaster™ Stents Gain MDR Approval for High-Bleeding Risk Patients
Medical technology company, Terumo, has announced that it has received Medical Device Regulation (MDR) approval for an expanded indication of its Ultimaster Nagomi™ and Ultimaster™ Tansei™ stent systems.
How CDMOs Are Driving the Adoption of Continuous Biomanufacturing
Biopharma companies are increasingly dependent on CDMOs to streamline production, enhance efficiency, and accelerate drug development. As therapies become more complex and regulatory demands grow, the ability to outsource manufacturing to a trusted partner has never been more essential.
Catalent Appoints Three Industry Leaders to Board
Catalent has appointed Susan Mahony (formerly of Eli Lilly), Marie-France Tschudin (ex-Novartis executive), and Tim Walbert (CEO of Horizon Therapeutics) to its Board of Directors as the company looks to strengthen its position as an independent CDMO under Novo Holdings' ownership.
J&J Sues Samsung Bioepis Over Biosimilar Breach
Johnson & Johnson (J&J) has filed a lawsuit against Samsung Bioepis, alleging a breach of their 2023 agreement concerning the launch of Pyzchiva, a biosimilar to J&J's Stelara. The dispute centers on Samsung's attempt to sublicense Pyzchiva to a private-label distributor, a move J&J contends violates their settlement terms.
Eli Lilly to Invest in U.S. Manufacturing Expansion
Eli Lilly is committing USD 27 bn to build four new manufacturing plants in the United States, to increase domestic production of active pharmaceutical ingredients and injectable therapies.
Merck Faces Keytruda Price Cuts Under IRA by 2028
Merck expects its leading cancer drug, Keytruda, to be included in government price negotiations under the IRA starting in 2026 as its U.S. patent expires at the end of 2028. In 2024, Keytruda accounted for 46% of Merck’s total sales, and Merck’s CEO has expressed that price-setting via Medicare could limit the development of new therapies.
Eikon Therapeutics Secures USD 350 Million in Series D Funding to Advance Clinical Programs
Advanced drug discovery and development biotech, Eikon Therapeutics, has announced the initial closing of a USD 350 mn Series D funding round, bringing Eikon's total private funding since its 2019 founding to over USD 1.1 bn.
Vertex Terminates Liver Disease Gene Editing Collaboration with Verve Therapeutics
Vertex Pharmaceuticals has ended its 2022 research collaboration with Verve Therapeutics, set up to develop an in vivo gene editing program for a specific liver disease. The decision, attributed to Vertex's shifting research priorities, allows Verve to regain full rights to the program.
Summit Therapeutics Partners with Pfizer to Evaluate Ivonescimab in Combination with ADCs
Summit Therapeutics has announced a clinical trial collaboration with Pfizer to assess a novel investigational PD-1/VEGF bispecific antibody, ivonescimab, in combination with Pfizer's antibody-drug conjugates across various solid tumor settings.
Tiziana Life Sciences Partners with Renaissance Lakewood to Advance Intranasal Foralumab
Immunomodulation therapy company, Tiziana Life Sciences, has entered into a product development services agreement with Renaissance Lakewood LLC, a leading CDMO focused on nasal drug delivery, to optimize the formulation and scale-up production of Tiziana's intranasal lead candidate, foralumab, which is under development for treating neurodegenerative and inflammatory diseases or conditions.
Magnet Biomedicine & Eli Lilly Partner to Develop Molecular Glue Medicines
Molecular glue company, Magnet Biomedicine has entered into a collaboration and license agreement with Eli Lilly to discover, develop, and commercialize molecular glue therapeutics, with a focus on oncology applications.
Granules India Buys its Way Into Peptide Market
Indian pharmaceutical manufacturing company, Granules India, has acquired Swiss CDMO Senn Chemicals AG for USD 22.3 mn to expand into the peptide therapeutics market. Senn Chemicals, which specializes in liquid- and solid-phase peptide synthesis, will strengthen Granules’ position in high-growth areas like GLP-1 receptor agonists used for diabetes and obesity treatments.
Novartis’ Rare Kidney Disease Candidate Gains Positive EU Committee Opinion
Novartis' Fabhalta® (iptacopan), an oral drug targeting the alternative complement pathway, has received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for treating a rare kidney disease in adults, C3 glomerulopathy (C3G).
Thermo Fisher Acquires Solventum's Purification & Filtration Business in Cash Transaction
Thermo Fisher Scientific has agreed to acquire Solventum's purification & filtration business for USD 4.1 bn in cash. The purification & filtration unit - which generated around USD 1 bn in revenue in 2024 - specializes in purification filters and membranes used in biopharma, medical technology, microelectronics, food and beverage production, and water filtration.
Enzene Secures EU GMP Certification to Expand Global Biologics Capabilities
End-to-end CDMO, Enzene, has announced EU GMP certification for its two facilities in Pune, India, to provide commercial-scale microbial and mammalian drug substance supply, and drug product fill/finish and packaging.
Bionova Expands with New Fremont Process Development Facility
CDMO, Bionova Scientific, has opened a 55,000 sq. ft. process development and pilot plant in Fremont, Calif., to enhance early-stage biologics development and support future manufacturing growth and to strengthen the company’s presence in the Bay Area, which generate USD 142 bn annually.
Can CDMOs Redefine Sustainability in Pharmaceutical Manufacturing?
Pharmaceutical manufacturing is the backbone of global healthcare, yet its environmental footprint is a growing concern. The sector is responsible for significant greenhouse gas emissions, excessive water consumption, and large-scale hazardous waste production.
hVIVO Secures USD 2.5 MN Contract for hMPV Study
hVIVO plc., a CRO specializing in human challenge trials, announced it has signed a USD 2.5 mn contract to advance a new biopharmaceutical client’s research in human metapneumovirus (hMPV). Should the current phase of research be deemed a success, and subject to regulatory approval, the final phase of the study is expected to commence in the second half of 2025.
Rovi Issues Profit Warning Amid Declining CDMO Activity
Rovi, the Spanish specialized pharmaceutical company, has announced that its 2024 EBITDA is expected to be 10% to 15% below market consensus, due to reduced activity in its CDMO segment during the fourth quarter.
Lifecore Biomedical Expands to Target GLP-1 Injectables and Big Pharma
Over the past 18 months, Minnesota-based CDMO Lifecore Biomedical has moved from being a food business to a pure-play sterile injectable fill-finish CDMO. To support its transition, the company announced the installation of a high-speed, GMP-ready five-head isolator filler to double its production capacity and target USD 130 mn revenue for its 2025 fiscal year.