Feliza Mirasol

Under a global alliance with the Australian non-profit GC4K and Weill Cornell Medicine, PackGene aims to deliver a custom-tailored gene therapy solution for hereditary spastic paraplegia type 56, an exceptionally rare neurological disease.

This latest fast track designation marks the second such designation by FDA for J&J’s tau-directed investigational therapies for treating Alzheimer’s disease.

The new company will harness splicing technology to innovate safer and more effective RNA therapies for severe genetic diseases.

The $94 million (€90 million) Series A funding will be used to support the development of the company’s pipeline of nCycles, oral macrocycle drugs that will be focused on validated biologic targets.

The approval makes HYQVIA [Immune Globulin Infusion 10% (human) with Recombinant Human Hyaluronidase] the first and only facilitated subcutaneous immunoglobulin to be approved in Japan to treat these disorders.

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

FDA is reopening 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”, until March 3, 2025.

Atul Mohindra, head of Biologics R&D at Lonza, discusses the challenges and successes of bispecific antibodies as well as the field’s future direction from a CDMO perspective.

Advancements in bioprocessing and analytics are crucial to the future development of bispecific antibodies and beyond.

The approval of Hikma Pharmaceuticals’ liraglutide injection marks the first generic version of Victoza, a GLP-1 receptor agonist.

With the launch of its cobas mass spectrometry solution, Roche brings fully automated mass spec analysis to the clinical lab.

The results garnered from the Phase IIb study failed to achieve statistical significance in the primary endpoint.

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

Using Orexo’s powder-based drug delivery technology, the companies will develop mucosal vaccines in an inhaled formulation.

The company has formed Scinai Bioservices Inc., new US-based subsidiary operating out of Delaware that will serve biotech companies in early stage drug development.

In the latest of a series of acquisitions this year, AbbVie will acquire Nimble Therapeutics, which includes that company’s lead asset, an oral peptide for treating psoriasis.

In part two of a video interview, Colin McKinlay, PhD, senior director, Chemistry and Delivery Technologies, at Nutcracker Therapeutics, talks on current trends and the direction that mRNA–LNP development may take going forward.

With the DKK 8.5 billion (US$1.2 billion) investment, Novo Nordisk will build a new modular and flexible production facility in Odense, Denmark, to produce multiple products for rare diseases.

In a discussion on mRNA and LNP development, Colin McKinlay, the senior director of Chemistry and Delivery Technologies at Nutcracker Therapeutics, points out current challenges and innovations that meet these challenges.

The companies will develop a platform that can enable rapid development of DPI products.

Under the deals, the parties will advance therapeutics for fibrotic diseases, osteoarthritis, and Alzheimer’s disease.

The company will add a new laboratory facility at its Shanbally, Co. Cork, Ireland, manufacturing site.

The European Commission’s approval of the Catalent acquisition by Novo Holdings includes the related acquisition of three manufacturing sites by Novo Nordisk, which is also acquiring the Czech Republic manufacturing site of Novavax for $200 million.

Under the deal, Novartis will in-license PTC518, an mRNA splice modulator for the huntingtin gene, which has the potential to be the first oral disease-modifying therapy for Huntington's disease.

Lilly will expand its recently acquired manufacturing facility in Wisconsin with a $3 billion investment, and Amgen will expand its North Carolina facility with a $1 billion investment.

Cambrex will provide Lilly’s biotech collaborators with accelerated access to clinical development capabilities.

EXO Biologics and its subsidiary, ExoXpert, have received GMP certification of a European exosomes manufacturing facility and have successfully loaded mRNA and DNA payloads into GMP-grade exosomes for drug delivery.

Lonza’s new tailored offering leverages the company’s bi-layer capsule manufacturing technology.

The company will now include GMP cell-based potency assays at its Cambridge, UK, and San Diego, Calif., sites expanding its early and late phase analytical capabilities.

The investment will allow Sanofi to strengthen antibody bioproduction at its Lyon Gerland site in France.