
Featured Stories
MilliporeSigma Invests $76 mn to Triple ADC Production Capacity
MilliporeSigma, the life sciences division of Merck KGaA in the U.S. and Canada, is investing $76 mn to expand its ADC production facility in St. Louis, which will triple the site's current capacity, improve process and analytical development labs, and include new manufacturing spaces, labs, and cold storage, creating 170 new jobs in the process.
The announcement follows a similar investment in 2022, where the company invested $65 mn at its Verona, Wisconsin facility, as it looks to expand production capabilities to meet the ever-growing demand for its services.
Rentschler Biopharma to Build State-of-the-Art Buffer Media Station in Laupheim
Leading CDMO for biopharmaceuticals, Rentschler Biopharma SE, has announced plans to commence construction of a new buffer media station at its headquarters in Laupheim, Germany, from next year.
The facility, spanning 3,400 square meters and expected to be operational by 2028, will enhance production efficiency and modernize the site to meet evolving client and patient needs. The four-story building will house advanced equipment, including media and buffer tanks, ensuring high standards of hygiene, safety, and automation, whilst also supporting Rentschler's sustainability goals and improving employee ergonomics.
UK's Labour Party Unveils £520 Million Innovative Manufacturing Fund in Life Science-Heavy Budget
The UK government has pledged up to £520 mn through the Life Sciences Innovative Manufacturing Fund (LSIMF) to drive economic growth and enhance the National Health Service (NHS). The fund will support capital investments across the life sciences sector - providing grants for the manufacture of human medicines, including active pharmaceutical ingredients (APIs) and finished products, medical diagnostics for disease identification and monitoring, and MedTech products related to human health.
The initiative aims to strengthen the UK’s position in life sciences while simultaneously ensuring the NHS is equipped for future healthcare needs, as well as to support innovation and expand manufacturing capabilities across the UK.
Bora Pharmaceuticals Expands Rare Disease Reach with Pyros Pharmaceuticals Acquisition
Bora Pharmaceuticals has announced its acquisition of U.S.-based Pyros Pharmaceuticals.
Founded in 2017, Pyros recently launched VIGAFYDE™ (vigabatrin), the first and only ready-to-use oral solution for infantile spasms, a rare and severe form of epilepsy in young children. Approved by the FDA in June 2024, VIGAFYDE simplifies dosing and provides much-needed treatment for pediatric patients.
Bora's CEO, Bobby Sheng, highlighted the synergies between Pyros' innovative research and Upsher-Smith’s expertise in pediatric CNS conditions, foreseeing enhanced patient outcomes through this powerful alliance. Pyros co-founder and CEO, Michael Smith, expressed excitement about the partnership, emphasizing the shared mission of improving care for rare disease patients. The acquisition follows Bora’s recent purchases of Upsher-Smith Laboratories and TWi Pharmaceuticals, reinforcing its rapid global growth in the CDMO and commercial prescription sectors.
Jim Petrilla Joins Vernal Biosciences as CEO
Vernal Biosciences has appointed Jim Petrilla as CEO and Board Member, as the company focuses on strategic growth as an mRNA and lipid nanoparticle (LNP) manufacturing leader.
With over 25 years in biopharma and clinical research, Petrilla brings a wealth of operational excellence expertise in leadership roles at major biopharma firms such as Bristol-Myers Squibb and Becton Dickinson, where he spearheaded transformative projects, achieved substantial revenue growth, and led a global NDA filing.
Petrilla succeeds founder Christian Cobaugh, Ph.D., who will now focus on his role as Chief Scientific Officer within the company.
CDMO Samsung Biologics Bags $1.2B Contract, Boosting 2024 Value to Over $3.3B
Samsung has locked down a $1.2 bn contract with an unnamed Asia-based pharmaceutical company that’s expected to run through December 2037.
The manufacturing project, which will be carried out at Samsung’s biomanufacturing site in the Songdo area of Incheon, South Korea, brings the company’s total new contract value for the year to more than $3.3 bn.
In addition, the company is on track to complete its fifth production plant in Korea by the end of 2024 - a dedicated ADC facility in Incheon - which will add 180 kL to its existing 784 kL capacity and expected to go online in April 2025.
Laurus Labs Expands Product Portfolio & Boosts CDMO Capabilities
Dr Satyanarayana Chava, CEO of pharmaceutical company Laurus Labs', is predicting robust growth for his company in the latter half of 2024/25, primarily driven by CDMO and active API segments.
Already this year, the company has reported a 40% increase in CDMO revenue, attributing the growth to substantial investments in CDMO capabilities with planned deliveries set to boost revenues further in Q3 and Q4. However, Chava was clear to point out that the 16% dip in API revenue in Q2 - due to planned facility modifications - is back on track and aligned with upcoming contractual needs as it looks to expand its expertise in oncology and other specialized therapeutic areas.
Activist Investors Eyeing Big Pharma: What It Means for the Industry
Last month, hedge fund Starboard Value acquired a $1 bn stake in Pfizer, at the same time, sharply criticizing the company's management for recent underperformance and strategic missteps. According to Starboard, Pfizer has seen at least $20 bn in value evaporate since 2019.
This move is a textbook example of activist investing. Investors - individuals or institutions - buy a significant stake in a company to influence its management and strategy with the aim of boosting the company’s value and, ultimately, profit from their investment.
But why target Pfizer? And why now?
Afton Scientific to Invest $200 Million on Facility Expansion
U.S.-based CDMO, Afton Scientific, is planning a $200 mn expansion of its sterile injection manufacturing facility in Charlottesville, Virginia, that will significantly increase the company’s production capacity for sterile injectables, whilst adding 200 new jobs. As part of the expansion, the company will be able to offer “newer manufacturing technologies,” although a projected completion date is yet to be determined.
Matica Secures Multiple Viral Vector CDMO Contracts
Korean cell therapy and biotech company, Matica Biotechnology, a subsidiary of CHA Biotech, has secured multiple CDMO contracts, including deals with Puerto Rico-based CytoImmune Therapeutics and Houston-based Mongoose Bio, to produce retrovirus and lentivirus vectors for cancer therapies, and develop natural killer (NK) and T-cell receptor therapies, respectively.
Matica Bio became the first Korean company to establish a customized CDMO facility in Texas in 2022, specializing in CGT commercialization, with the company having developed a proprietary cell line to enhance viral vector production efficiency.
Zealand Pharma Faces Second FDA Rejection Due to CDMO Inspection Issues
Danish biotech, Zealand Pharma, has faced its second FDA rejection for its hypoglycemia drug - dasiglucagon - which is tied to manufacturing issues uncovered during a CDMO inspection. Despite the setback, Zealand said it remains committed to resolving the issues and pursuing approval for the drug, which is designed to treat severe low blood sugar in diabetic patients.
SpectronRx Announces Collaboration for European Radiotherapy Isotope Manufacturing Facility
Radiopharmaceutical CDMO, SpectronRx, and Belgian Nuclear Research Centre, have announced advanced plans to establish a European radiopharmaceutical CDMO (rCDMO) facility, on the Belgian Nuclear Research Center premises in Mol, Belgium.
The collaboration will see both companies working together to meet the rising demand for radioisotopes, particularly Actinium-225, which plays a crucial role in targeted radiotherapies for cancer treatment. The facility will offer end-to-end solutions, from isotope production to radiopharmaceutical development and manufacturing, and strengthen Europe's position in the radiotherapy market.
AGC Pauses CGT Operations
CDMO, AGC Biologics, has announced job cuts for 95 employees and the decision to idle most of its operations at its CGT plant in Longmont, Colorado, as the company announces restructuring plans. The company cited shifts in the biopharmaceutical landscape. The CDMO will continue its ongoing investments and operations at other sites around the world.
Celltrion to Establish Wholly-Owned CDMO Subsidiary by End of 2024
Korean biopharma, Celltrion, has announced plans to establish a wholly owned CDMO subsidiary by the end of 2024, leveraging its expertise in antibody development to compete with existing CDMOs by emphasizing its expertise in high productivity and cost efficiency. Facility expansion and commercial activities are set for 2025.
OmniaBio Opens New Facility in Canada to Advance Cell and Gene Therapy Manufacturing
Canadian CDMO, OmniaBio, has opened a new commercial manufacturing facility in Hamilton, Ontario, making it Canada's largest dedicated cell and gene therapy site. The commercially-ready facility will utilize AI and automation to deliver comprehensive services from process, analytical and associated AI development, through to commercial manufacturing for their global clients.
The company said the facility will be crucial in helping biotech's to deliver life-saving treatments, with its first client being MEDIPOST’s stem cell therapy, CARTISTEM®, used for treating knee cartilage defects.
Evonik Announces 260 More Layoffs as Part of Multi-Year Restructuring
Evonik has announced layoffs of around 260 employees - in addition to previously announced job cuts - as the company continues its ongoing multi-year reorganization to streamline operations and reduce costs in its specialty chemicals business to improve profitability and focus on higher-margin growth areas.
Sanofi and Orano Partner to Develop Next-Generation Radioligand Cancer Therapies
Pharma multinational, Sanofi, and pioneers in targeted alpha therapies in oncology, Orano Med, have entered a partnership to develop next-generation radioligand therapies (RLTs) using lead-212 alpha-emitting isotopes, which follows a recent announcement between Orano Med, RadioMedia and Sanofi to advance RLTs in rare cancers, focusing on one late-stage project, AlphaMedix™.
Targeted alpha therapy relies on combining the ability of biological vectors to target cancer cells with the short-range and highly energetic cell-killing capabilities of alpha-emitting radioisotopes. The vector directs the radioisotope to the target cancer cells expressing the specific marker. This unique mechanism of action aims to damage or destroy target cancer cells, while limiting impact on nearby healthy cells.
Catalent Expands ASD Capabilities in Boston
Catalent has completed a series of upgrades to its large-scale spray drying unit (GEA PSD-4) at its Boston, Massachusetts, facility. By adding capacity and multi-solvent capabilities, Catalent can now provide enhanced spray-drying services at the site for amorphous solid dispersion (ASD) formulations across late-stage to commercialization projects.
Lorenzo Carletti, president of clinical development and supply at Catalent, noted the importance of ASDs in overcoming the aqueous solubility issues that plague the oral development pipeline, suggesting that between 75-80% of molecules in pre-clinical and clinical development are affected, and require bioavailability enhancing technologies. He added that by adding to the company’s spray drying capabilities, “Catalent becomes the CDMO with the widest commercial-scale bioavailability enhancing technologies.”
LaNova Medicines Secures $42 Million in Funding to Accelerate Oncology Innovations
Chinese clinical-stage biotech company, LaNova Medicines, has raised $42 mn in a Series C1 funding round as it pursues innovations focusing on tumor microenvironment and developing innovative drugs for tumor specificity targeted ADCs and immunoregulatory large molecules.
The company plans to use the funding to speed up clinical progress of its products at clinical phase - including LM-302 and LM-108 - and develop an antibody platform, next-generation ADC technology platform, and dual-antibody technology platform.
Following promising preclinical results, the company has initiated its first-in-human clinical trial for LM-299, an anti-PD-1/VEGF BsAb targeting advanced solid tumors.
TuHURA Biosciences Completes Merger with Kintara Therapeutics
TuHURA Biosciences, a phase 3 immuno-oncology firm, has merged with Kintara Therapeutics, a developer of novel cancer therapies. The newly combined entity - continuing to trade as TuHURA Biosciences - will focus on advancing innovative cancer therapies, including their immune response agonist IFx-2.0 and tumor microenvironment modulators as the company seeks to overcome resistance to current immunotherapies.