Biologics APIs

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.

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

CHMP has granted Eisai Europe and Biogen a positive opinion for the use of their monoclonal antibody therapy in treating early Alzheimer’s disease.

The new Institute for Cell Therapy Discovery and Innovation will utilize expertise to develop cell therapies for cancer, autoimmune diseases, and infections.

In the collaboration, the new company, Oblenio Bio, has been granted an exclusive option to license LBL-051, a tri-specific T-cell engager antibody, from Leads Biolabs.

The collaboration aims to advance clinical development of a Phase I drug candidate, MRT-6160, and to explore other therapeutic opportunities across multiple indications.

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

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

Genentech will have access to Sangamo’s capsid delivery platform and epigenetic regulation capabilities to develop genomic medicines for 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.

Platform processes and effective risk assessments help overcome time and cost challenges.

With the Series A funding, the new biotech company will advance the development of enhanced biologics for treating solid tumors and inflammatory and immunology diseases.

BeiGene has opened its new $800 million Hopewell, NJ-based biologics manufacturing facility, which also houses the company's clinical R&D capabilities.

GSK's MAA is supported by an interim analyis of Phase III trials, which demonstrated significant progression-free survival benefit and positive overall survival trends from Blenrep combination therapies.

With this acquisition, AstraZeneca gets a Phase III therapeutic peptide candidate that adds to the company's rare disease pipeline.

Johnson & Johnson gains NM26, a Phase II-ready bispecific antibody in development for atopic dermatitis, boosting its immune-mediated and inflammatory disease portfolio.

Weighing development costs/resources and performance benefits is essential.

Roche voluntarily recalled Susvimo’s ocular implant, insertion tool, and initial fill kit when test results did not satisfy company standards.

Other indications for which the Sanofi treatment has been approved include atopic dermatitis, asthma, and chronic rhinosinusitis.

This acquisition will give AbbVie acces to Celsius Therapeutics' lead drug candidate, CEL383, a potential first-in-class anti-TREM1 antibody for treating IBD.

Johnson & Johnson gets two bispecific antibodies in early phase development for immune-mediated diseases through its Proteologix acquisition.

FDA granted priority review to Sanofi's sBLA for Sarclisa in combination with VRd in treating transplant-ineligible patients who are newly diagnosed with multiple myeloma.

Johnson & Johnson will gain NM26, a bispecific antibody targeting atopic dermatitis, via the acquisition of a wholly owned subsidiary of Numab Therapeutics.

The partnership aims to provide end-to-end development and manufacturing for biopharmaceutical drug substance and drug product.

With the acquisition, Biogen gains felzartamab, HI-Bio's lead investigational mAb candidate being developed for the treatment of a range of immune-mediated diseases.

The company is presenting preclinical data at the American Society of Gene & Cell Therapy annual meeting that supports the potential of the company’s CAP-002 gene therapy for correcting neurological phenotypes associated with genetic epilepsy due to syntaxin-binding protein 1 (STXBP1) mutations.

Genmab's acquisition of ProfoundBio will boost its clinical and preclinical pipeline of ADCs for targeted cancer treatment.

FDA granted fast track designation to nipocalimab, which J&J is developing for helping alloimmunized pregnant adults treat FNAIT, a rare disease that poses risk to the fetus or newborn.

FDA has approved AstraZeneca's Ultomiris, marking the first and only long-acting C5 complement inhibitor for patients with NMOSD.

Mapp Biopharmaceutical will use ProBioGen’s GlymaxX technology for the development of an afucosylated antibody against Marburg virus infection