Development

The biopharma industry is seeking ways to apply cell and gene therapies to mass patient populations.

The authors have reviewed applications of novel technologies in the major stages of biosimilars development: process development, pharmacology, toxicology, and clinical trials, with an emphasis on recent regulatory requirements.

With this acquisition, AbbVie gains Cerevel’s clinical-stage assets that complement AbbVie's emerging neuroscience pipeline as well as branded products for treating psychiatric disorders, migraine, and Parkinson's disease.

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.

Giroctocogene fitelparvovec is designed to allow patients to produce FVIII on their own for a time after a single infusion, an alternative to routine IV injections.

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 of EyeBio adds a late-phase antibody drug candidate for diabetic macular edema and neovascular age-related macular degeneration to Merck’s pipeline.

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

Through a multi-year collaboration, Pfizer and Evotec aim to conduct early discovery research for therapeutics against metabolic and infectious diseases.

Kisunla (donanemab-azbt) reduced amyloid plaques in Phase III study participants by 84% after 18 months.

A strategic partnership between LenioBio and Labscoop is aimed at making scalable cell-free protein synthesis technology more accessible across North America.

The company is referring to its search for innovative approaches as crowdsourcing and will award at least one cash prize.

Webinar Date/Time: Wed, Jul 24, 2024 12:00 PM EDT

The typical cycle of ceasing and then reinitiating fremanezumab treatments may actually result in increased monthly migraine days, the study said.

The seven chosen sponsors will help accelerate development of novel drugs and biologics for rare diseases.

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

Results of a Phase III trial showed that Tagrisso with the addition of chemotherapy reduced the risk of disease progression or death associated with EGFR-mutated non-small cell lung cancer by 44%.

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

Imfinzi (durvalumab) combined with chemotherapy decreased the risk of disease progression or death by 58% in a 700-patient trial.

The collaboration and licensing agreement will focus on the discovery and development of RNA exon editing therapeutics.

At BIO 2024 in San Diego, John Dunlop, PhD, chief scientific officer at Aliada Therapeutics, sat down for an interview with BioPharm International to discuss the firm’s MODEL platform and its potential impact on therapeutic delivery for brain-related conditions.

Syngene has launched a new protein production platform that offers faster production with lower risk.

Swiss CDMO CordenPharma and Spain-based Certest will collaborate on the development of ionizable lipids for LNP formulations.

Using a multi-pronged strategy to find optimum, tailored formulations is best.

Chemify founder and CEO, Lee Cronin gives insight into the combination of digital chemistry, robotics, and AI in the drug discovery process.

Enzene's new division will provide end-to-end integrated discovery services.

Webinar Date/Time: Wed, Jun 19, 2024 11:00 AM EDT

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.