German CDMO, Rentschler Biopharma, has opened a new production line in response to the surging demand for its CDMO services. The company is looking to increase its capacity to support the growing biopharmaceutical market, particularly in producing complex biologics, as the company seeks reliable partners for scaling up production.

Japanese biotech, Ajinomoto, plans to lay off 71 employees at its California facility as part of a strategic move to streamline its CDMO business. This decision follows the company’s recent $620mn investment in Forge Biologics, as it looks to enhance its capabilities in the biologics manufacturing sector through the optimization of operations and focus resources on key growth areas.

Personal genomics and biotechnology company, 23andMe, has announced it is shutting down its internal drug discovery group, and shifting its focus to the popular GLP-1 drugs. The decision will result in the loss of 30 jobs, as the company seeks an entry point in personalized weight loss treatment, amid struggles with declining revenue and a recent failed bid to take the company private.

Merck has announced its acquisition of CN201, an investigational B-cell depletion therapy from Curon Biopharmaceutical to target B-cell-mediated autoimmune diseases. As part of the deal, Merck will pay $700mn upfront for the rights to the treatment, which could rise by another $600mn based on successful development and regulatory approval targets.

The U.S. FDA has approved the first-ever nasal spray designed to treat severe allergic reactions, including anaphylaxis. ARS Pharmaceuticals received the approval for their product - Neffy - the first epinephrine nasal spray that provides a needle-free alternative to traditional epinephrine injections, making it easier and quicker for patients to manage severe allergic reactions.

Halda Therapeutics has secured $126mn to further develop and advance its innovative therapies targeting solid tumors. The therapies are designed to "hold and kill" tumor cells, whereby a heterobifunctional molecule is designed to target two proteins - a cancer-specific protein and a protein with an essential function - which can kill a cancer cell without damaging non-cancerous tissue.

Whilst we’re just past the halfway mark of 2024, mid-year analysis of the top selling drugs for the top 10 pharma companies provides some interesting insights into the demands of the market so far this year. Analysis from PharmaVoice shows that the leading drugs have generated over $55bn in revenue so far - just over 20% of the combined total revenue generated ($243.3bn) by the companies featured.

Shapiro Administration Invests Nearly $3 Million to Bring Adare Pharma Solutions’ Headquarters to Pennsylvania, Creating 115 New, Well-Paying Jobs in Philadelphia. The life sciences company is investing at least $16.8 million to relocate its headquarters to PA from New Jersey and upgrade its two current Philadelphia facilities, building on Pennsylvania’s reputation as a life sciences leader.

BeiGene CEO, John Oyler, has announced the opening of a new 42-acre innovation center in Hopewell, New Jersey, which is the culmination of a three-year project costing $800mn, as it expands the Company’s integrated manufacturing and research and development footprint in the U.S. The new facility will expand its biologics manufacturing and R&D capabilities - providing a production capacity of two million vials per year - as the company looks to explore new biologics partnerships and accelerate product launches, such as the PD-1 inhibitor Tevimbra.

The FDA has opened a public docket seeking input on their new guidance for biosimilar product development, with the agency having invited stakeholders to provide feedback on scientific and regulatory considerations for biosimilar and interchangeable biologics. The initiative aims to refine and enhance the development process for these emerging products and encourages the scientific public to submit comments and suggestions to help shape future policies and regulatory frameworks.

Viking Therapeutics is the latest company to demonstrate positive results with its weight loss drugs after announcing its candidate, VK2735, will enter Phase 3 trials following results demonstrating a 15% reduction in body weight following 13 weeks of dosing during its Phase 2 study. Separately, the company is set to advance an oral tablet formulation of VK2735, with initial results demonstrating a mean weight loss of 5.3% following 28 days of dosing.

Roche is fast-tracking the development of its newly acquired obesity treatments from Carmot Therapeutics as it looks for an entry point within the already competitive obesity market. Key assets including CT-388 and CT-996 have both been highlighted as promising candidates with mechanisms targeting GLP-1 and GIP receptors, with data already demonstrating significant promise in weight loss results.

Triastek - the global leader in 3D printing pharmaceuticals - and BioNTech have announced a research collaboration and platform technology licensing agreement to develop 3D-printed oral RNA therapeutics. This collaboration will leverage Triastek's advanced 3D printing technology to optimize the delivery of RNA drugs via innovative oral tablet designs, ensuring they reach specific parts of the gastrointestinal tract. Triastek will receive a $10mn upfront payment, which could exceed $1.2bn based on milestone payments and royalties.

The BIOSECURE Act's momentum may significantly raise drug development costs as U.S. companies reduce reliance on Chinese CDMOs like WuXi AppTec. The Act will restrict federal funding for biotech equipment and services from certain Chinese firms, pushing U.S. pharma companies to explore more expensive alternatives outside of the region, which could result in more complicated supply chains and increased expenses, particularly for small-to-mid-sized biotech's.

Alcami has expanded its pharmaceutical storage facility in Garner, North Carolina, as it looks to expand its offering for a wide range of cold, stability, and custom storage options. The new 65,000 ft² facility supports temperature-sensitive products like vaccines and biopharma therapies, with conditions ranging from controlled ambient to cryogenic storage.

End-to-end CDMO, Samsung Biologics, has reported a record-setting quarter, with a 37% increase in sales, driven primarily by its biosimilars unit, Samsung Bioepis. The company achieved significant year-over-year growth, including a 107% rise in biosimilars sales, largely due to successful products like Hadlima, a Humira biosimilars, increasing profits by 71%.

Agilent Technologies has recently announced an agreement to acquire leading, specialized CDMO, BIOVECTRA, for $925mn as the company looks to expand on its existing CDMO specialization in oligonucleotides and CRISPR. Utilizing BIOVECTRA’s specialization in biologics, highly potent active pharmaceutical ingredients, and other molecules for targeted therapeutics, Agilent will eventually be able to expand its capabilities in biologics, HPAPIs, and gene editing technologies.

GLP-1 drugs - Ozempic, Wegovy, Mounjaro and others - first attracted attention for their ability to manage and aid weight loss in diabetes patients. With such profound results, the drugs soon found Hollywood notoriety, before becoming popular with everyday users looking to fast track their weight loss efforts. Unsurprisingly, expenditure of semaglutide - the active ingredient in these medications - reached $38.6bn in 2023.

Pharmaceutical manufacturing is under a heavy spotlight. Policymakers are focused on the relationships between pharma companies and their manufacturing partners, and high-demand medications are stretching the limits of production. Join Endpoints for sessions focused on the latest trends and pressure points, and hear how leading experts are reacting to a fast-changing landscape.

Eurofins CDMO Alphora Inc. - has expanded its API capacity with a new manufacturing facility in Mississauga, Canada, as the company looks to better serve their growing client base and address increasing demand for life-saving therapies from Phase 1 to commercialization. The 15,000 sq.-ft. facility enhances the company’s existing capabilities with additional GMP processing and warehousing space that will support API batches up to 125 and handling of Safebridge Class 3 compounds.