Feliza Mirasol

The collaboration will combine fully automated and digitalized technologies to reduce CGT manufacturing timelines to 2.5 days.

Cytiva will combine its CGT manufacturing technologies with Cellular Origins' robotic manufacturing platform.

Production is set to take place at Samsung Biologics’ Songdo, South Korea, site, and the agreement will run through December 2030, subject to change.

Pharmapack identifies biologic approvals, drug delivery advancements, GLP-1 generics, and the return of funding flow as drivers for a record year in 2025.

Lonza will work with Iconovo to develop spray-dried formulations for an intranasally delivered biologic using a reformulated biologic drug candidate for obesity.

Through this global alliance, PackGene, Weill Cornell Medicine, and GC4K, an Australian non-profit, intend to deliver a custom-tailored gene therapy solution to treat hereditary spastic paraplegia type 56, a particularly rare neurological disease.

Posdinemab is the second tau-directed investigational therapy by J&J that has received fast track designation from FDA this year for Alzheimer’s disease.

Using splicing technology, the new company aims to innovate safer and more effective RNA therapies for severe genetic diseases.

With the new $94 million (€90 million) funding, the company will develop its pipeline of oral macrocycle drugs, nCycles, against validated biologic targets.

With this approval, HYQVIA [Immune Globulin Infusion 10% (human) with Recombinant Human Hyaluronidase] becomes the first and only facilitated subcutaneous immunoglobulin available in Japan to treat these disorders.

Under the agreement, the companies will advance development of IBI3009, Innovent’s ADC candidate, which has received IND approvals in the US, China, and Australia.

The comment period for the Federal Register Notice, “Evaluating the Immunogenicity Risk of Host Cell Proteins in Follow-on Recombinant Peptide Products: Establishment of a Public Docket: Request for Information and Comments”, has been reopened by FDA until March 3, 2025.

In a discussion on bispecific antibody development, Atul Mohindra, head of Biologics R&D at Lonza, points out the challenges and successes of these molecules as well as the field’s future direction from a CDMO perspective.

FDA's approval of Hikma Pharmaceuticals’ liraglutide injection makes this product the first generic version of Victoza, a GLP-1 receptor agonist.

The launch of Roche's cobas mass spectrometry solution will bring fully automated mass spec analysis to the clinical lab.

Results from a Phase IIb study missed the primary endpoint by failing to achieve statistical significance.

Cytiva's Nicolas Pivet, vice-president and general manager, Technology Solutions, emphasizes how automation benefits process development, particularly in the analytical space.

The companies will use Orexo’s powder-based drug delivery technology to develop mucosal vaccines in an inhaled formulation.

Scinai Bioservices Inc. has been established in Delaware as the company's new US-based subsidiary, which will serve biotech companies in early stage drug development.

AbbVie's latest acquisition target is Nimble Therapeutics, which will give AbbVie a lead asset, an oral peptide for treating psoriasis.

In the second part of a video interview, Colin McKinlay, PhD, senior director, Chemistry and Delivery Technologies, at Nutcracker Therapeutics, discusses trends and the future direction of mRNA–LNP development.

Colin McKinlay, the senior director of Chemistry and Delivery Technologies at Nutcracker Therapeutics, discusses current challenges in mRNA and LNP manufacturing as well as innovations that meet these challenges.

The partners will aim to establish a platform that enables rapid development of DPI products.

With these agreements, the respective parties will work to advance therapeutic candidates for treating fibrotic diseases, osteoarthritis, and Alzheimer’s disease.

With this investment, BioMarin will add a new laboratory to its Shanbally, Co. Cork, Ireland, manufacturing facility.

The European Commission has approved Novo Holdings' acquisition of Catalent, which includes the related sale of three manufacturing sites to Novo Nordisk, which is also acquiring the Czech Republic manufacturing site of Novavax for $200 million.

Novartis will in-license PTC's PTC518 program, which has the potential become the first oral disease-modifying therapy for Huntington's disease.

LNPs have gained solid ground as a drug delivery system for mRNA due to their success in the vaccines arena.

Lilly is investing $3 billion to expand its recently acquired manufacturing facility in Wisconsin, while Amgen is investing $1 billion to expand its facility in North Carolina.

Through the agreement, Cambrex will provide accelerated access to clinical development capabilities to Lilly’s biotech collaborators.