Development

Webinar Date/Time: Thu, Feb 13, 2025 11:00 AM EST

Webinar Date/Time: Wednesday, February 12th at 11:00 AM EST

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.

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

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

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

This article looks at how the MAPPs assay works, how it integrates with other immunogenicity assays, and just how it can be flipped to help in vaccine design.

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.

AbbVie has completed its $1.4 billion acquisition of Aliada Therapeutics, giving it access to Aliada’s disease-modifying therapy for Alzheimer’s disease.

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.

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.

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.

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

A statistical procedure based on a quality range is proposed for demonstrating comparability between pre-change and post-change process slopes in an accelerated or stressed stability study.

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.

Jason Bock, co-founder and CEO of CTMC, discusses the industry impact and manufacture of patient-centered medicines.

The agency will review the company’s supplemental new drug application for vutrisiran, a treatment for ATTR amyloidosis with cardiomyopathy.

Webinar Date/Time: Tue, Dec 3, 2024 Session 1: 9:00 am EST | 1:00pm GMT | 2:00pm CST Session 2: 2:00 pm EST| 1:00pm CST| 11am PST

Webinar Date/Time: Thursday, December 5th, 2024 at 11:00 AM EST

Under the collaboration, the companies will create and test circVec DNA–LNP formulations with an eye toward potential therapeutic applications.

Webinar Date/Time: Thu, Dec 12, 2024 11:00 AM EST

Eisai Europe and Biogen have received a positive opinion for the monoclonal antibody therapy to be used as a treatment of adult patients with early Alzheimer’s disease.

Webinar Date/Time: Wed, Dec 4, 2024 11:00 AM EST

Avantor has launched its new, expanded Innovation Center in Bridgewater, NJ, with integrated workflows under one roof and purpose-built collaboration spaces.

Avantor executives discuss the future of the biopharmaceutical industry and the impact that a wave of next-generation biotherapeutics will bring.

With the launch of the Institute for Cell Therapy Discovery and Innovation, the MD Anderson Cancer Center will bring together expertise in developing cell therapies for cancer, autoimmune diseases, and infections.