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.

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.

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?

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.

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.

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.

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.

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.

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.

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 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.

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 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.”

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, 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.

BioDuro-Sundia, the U.S. headquartered contract research, development and manufacturing organization (CRDMO), has opened a new kilo laboratory at its R&D campus, located in the Free-Trade Zone of Shanghai, China. Kilo labs provide pilot-scale production and enable scale-up synthesis for drug substance. The company said the investment will further enhance its ability to accelerate more drug candidates from discovery through to preclinical and clinical phases to meet the growing demands of its global partners.

The opening follows closely behind that of a new compound management center at the same site, which enabled the site to store and handle clients’ compounds at the drug discovery phase.

Several U.S. consumer groups and labor unions have asked the FTC to block Novo Holdings planned $16.5 bn acquisition of Catalent, amidst concerns that the potential deal could stifle competition in the market for GLP-1 receptor agonist drugs.

The groups argue that the acquisition would further solidify Novo Nordisk's leading position - dominated by Ozempic and Wegovy – and that this could potentially lead to higher prices and reduced access to these critical medications. They also contend that the deal could give Novo Nordisk control over Catalent's production facilities, and thus limit its rivals' ability to manufacture competing drugs. The move comes amid growing scrutiny from lawmakers - including the U.S. Senator Elizabeth Warren - who has also raised concerns about the merger’s potential to reduce competition. Senator Warren has asked the FTC to closely investigate the deal.

As the 2024 U.S. election between Donald Trump and Kamala Harris approaches, the biopharma industry is keenly watching how each candidate's policies could shape the future of the sector.

Although the Inflation Reduction Act (IRA) has already set the stage for significant changes in drug regulations, neither candidate is expected to completely overhaul the current regulatory framework due to the IRA and a divided Congress, but their differing approaches could lead to important shifts in the industry.

The 2024 Nobel Prize in Physiology or Medicine has been awarded to Victor Ambros and Gary Ruvkun for their groundbreaking discovery of microRNA (miRNA) - a class of small RNA molecules that play a crucial role in gene regulation. Their research revealed a new mechanism that controls gene expression, which is essential for cellular function and development, which has significantly expanded the understanding of gene regulation and its impact on diseases like cancer and diabetes.

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.