
Navigating key news stories in pharma
Featured Stories
CDMO partnerships are great when they are successful, but what happens when they falter? The complexity of modern outsourcing partnerships means that failure is often costly, with consequences that can ripple across timelines, budgets, and reputations.
Drug delivery companies — SHL Medical and Kindeva Drug Delivery — have formed a partnership to enhance SHL Medical’s Molly® autoinjector platform aimed at pharmaceutical and biotechnology companies.
CDMO, Suven Pharmaceuticals, aims to reach USD 1 bn in revenue by 2030, by investing in new facilities to increase production capacity and strengthen its capabilities in drug development and manufacturing to support global pharmaceutical clients.
Advanced therapy medicinal products specialist CDMO, Porton Advanced, and clinical-stage biotech, Eureka Therapeutics, have entered a strategic collaboration to accelerate the development and commercialization of T-cell therapies for cancer treatment.
Dealmaking
Drug delivery companies — SHL Medical and Kindeva Drug Delivery — have formed a partnership to enhance SHL Medical’s Molly® autoinjector platform aimed at pharmaceutical and biotechnology companies.
Advanced therapy medicinal products specialist CDMO, Porton Advanced, and clinical-stage biotech, Eureka Therapeutics, have entered a strategic collaboration to accelerate the development and commercialization of T-cell therapies for cancer treatment.
Curium, a global leader in nuclear medicine, has announced the acquisition of radiopharmaceutical company, Monrol, as the company aims to improve its position in the global nuclear medicine market,.
Novo Nordisk has entered into an exclusive global licensing agreement with Lexicon Pharmaceuticals for Lexicon’s promising drug candidate, LX9851, which targets gastrointestinal disorders.
Future Biopharma
India’s pharmaceutical industry has long been synonymous with cost-effective pharmaceutical manufacturing - particularly when it comes to generic drugs. In recent years, India has been making a significant shift from low-cost generic drug production into CDMO services.
The global biologics market is expected to reach USD 720 bn by 2030 - fueled by the increasing demand for biologics, biosimilars, and advanced therapies - and is undoubtedly an area of keen interest for CDMOs specializing in biologics.
The CDMO industry saw significant growth in 2024, as biotech and pharmaceutical companies continued the trend toward outsourcing R&D activities. This surge was evident in the global CDMO market value, which ended the year with a valuation of USD 185 billion.
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.
R&D
BioDuro, the global contract research, development and manufacturing (CRDMO) company, has opened a new state-of-the-art laboratory in Shanghai, China for the synthesis of high-potency APIs for the pharmaceutical industry.
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).
French biotech, SeaBeLife's, has announced promising preclinical trial results for its drug candidate, SBL03, an ophthalmic gel aimed at treating geographic atrophy (GA), a severe form of age-related macular degeneration (dry AMD). The gel - a dual inhibitor of regulated necrotic cell death - demonstrated significant protection of retinal structure and function after repeated topical applications.
Pharmaceutical packaging company, SCHOTT Pharma, has introduced its SCHOTT TOPPAC® infuse polymer syringe system; a new cap design for prefillable polymer syringes featuring tamper evidence at the individual syringe level.
Expansion
Biologics CDMO, Wheeler Bio, has successfully raised USD 35 mn in an oversubscribed Series A-1 funding round. The funds will help the company strengthen its biologics’ manufacturing capabilities, such as planning the development of a large-scale facility.
Canadian CDMO, Delpharm, has secured a USD 42 mn investment from the Canadian Government to enhance the production capacity of its injectables manufacturing facility in Montreal, Canada.
Spanish CDMO, Esteve Química, is investing USD 100 mn to expand its U.S. manufacturing capabilities, focusing on increasing production capacity for high potency APIs (HPAPIs) amid increasing market demands for their use.
Innovation, science, and pharmaceutical services partner, Bend Bioscience, is expanding its Gainesville, Georgia facility with the addition of a commercial-scale spray dryer and a Gerteis drug granulation system.
Strategy
CDMO, Suven Pharmaceuticals, aims to reach USD 1 bn in revenue by 2030, by investing in new facilities to increase production capacity and strengthen its capabilities in drug development and manufacturing to support global pharmaceutical clients.
CDMO partnerships are great when they are successful, but what happens when they falter? The complexity of modern outsourcing partnerships means that failure is often costly, with consequences that can ripple across timelines, budgets, and reputations.
Indian CDMO, Shilpa Medicare, has launched a 'hybrid' CDMO model at DCAT 2025. Focusing on oncology, the company will begin to offer both traditional CDMO services and ready-to-license novel formulations, allowing clients to leverage Shilpa's expertise without development risks or delays.
Florida-based CDMO, GBI Biomanufacturing (GBI), has announced the appointment of Sven Lee to its board of directors. Mr. Lee brings decades of global experience in the biologics CDMO sector, having held executive and board positions at companies such as Abzena, Catalent, and Biocina, with expertise encompassing strategic growth, marketing, commercialization, licensing, and innovation in drug development.
Regulatory
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.
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.
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.
The U.S. government has awarded Moderna USD 590 mn to advance its mRNA-based avian influenza vaccine, mRNA-1018, into late-stage clinical trials amid rising human H5N1 infections. The funding also supports clinical studies for up to five additional pandemic influenza subtypes.
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