Biologic Drugs in Development

Through the collaboration, Merck will use Mestag’s proprietary RAFT platform to investigate the pathogenic role that fibroblasts play in inflammatory diseases.

Under a deal worth potentially up to $1.3 billion, Merck, known as MSD outside of the United States and Canada, will acquire CN201, a next-generation bispecific antibody, from Curon Biopharmaceutical.

Genentech will leverage Sangamo’s proprietary capsid delivery platform and epigenetic regulation capabilities to develop genomic medicines to address certain neurodegenerative diseases.

Biopharmaceutical production faces the challenge of ensuring the quality of raw materials due to a lack of specific guidelines. By implementing effective risk assessment strategies and working with reliable, selected solution providers, biopharmaceutical manufacturers can minimize these challenges and improve product quality.

The new biotech company will use the Series A financing to advance the development of enhanced biologics to treat solid tumors and inflammatory and immunology diseases.

BeiGene has invested $800 million into a new biologics manufacturing facility in Hopewell, NJ, which also houses its clinical R&D capabilities.

GSK’s submission is supported by Phase III trials showing significant progression-free survival benefit and positive overall survival trends using Blenrep combinations compared to standard care.

The acquisition adds a Phase III therapeutic peptide candidate to AstraZeneca’s late-stage pipeline for rare diseases.

The acquisition adds NM26, a Phase II-ready bispecific antibody for treating atopic dermatitis, to Johnson & Johnson’s immune-mediated and inflammatory disease portfolio.

The companies have restructured their existing collaboration into a licensing agreement that invests in mRNA development.

The Celsius Therapeutics acquisition will add CEL383, a potential first-in-class anti-TREM1 antibody for IBD, to AbbVie’s portfolio.

With the Proteologix acquisition, Johnson & Johnson gains two bispecific antibody early phase assets for immune-mediated diseases.

FDA’s priority review status was granted based on positive results from a Phase III study evaluating Sarclisa in combination with VRd in treating transplant-ineligible newly diagnosed multiple myeloma.

Under an agreement, Johnson & Johnson will acquire Numab Therapeutics’ wholly owned subsidiary to gain global rights to NM26, a bispecific antibody targeting atopic dermatitis.

Under this partnership, AGC Biologics and BioConnection will provide development and manufacturing capabilities for biopharmaceutical drug substance and drug product.

Biogen’s acquisition of HI-Bio includes lead investigational mAb, felzartamab, under development for treating a range of immune-mediated diseases.

In a $1.8 billion transaction, Genmab will gain three clinical-stage next-generation ADC candidates with its acquisition of ProfoundBio.

Innovation in this space depends on strategizing for GMP compliance and market access.

J&J’s nipocalimab is in development for reducing the risk of FNAIT in alloimmunized pregnant adults, a rare disease that may risk the life of the fetus or newborn.

AstraZeneca notes that Ultomiris is the first and only long-acting C5 complement inhibitor that offers NMOSD patients the potential to live without relapsing.

ProBioGen and Mapp Biopharmaceutical will use the former’s GlymaxX technology to develop a cell line for an afucosylated antibody that targets Marburg virus infection

EMA has validated two MAAs submitted by AstraZeneca and Daiichi Sankyo for datopotamab deruxtecan in two types of cancer.

Johnson & Johnson’s $2 billion acquisition of Ambrx boosts its pipeline of next-generation ADCs for cancer treatment.

Under a global license and collaboration agreement, AbbVie and OSE Immunotherapeutics will aim to develop OSE-230, a mAb for treating chronic inflammation.

Despite a growing number of biosimilar approvals, market uptake remains a challenge.

Nona Biosciences and Boostimmune will collaborate to develop ADCs against novel targets using Nona’s proprietary platform technology.

Under the new partnership, Samsung Biologics will develop and manufacture an antibody for a LegoChem Biosciences ADC candidate.

In the ATMP space, CGTs are hitting their stride with unprecedented approvals in the past year alone.

The milestone approval of a gene-edited therapeutic paves the way for gene-editing technologies.

The final guidance provides specific recommendations for CMC, pharmacology, toxicology, and clinical study design for CAR-T cell products.