Development

Opaganib was given orphan drug designation for the treatment of neuroblastoma in children, which is rare, but the most common infancy malignancy.

The collaboration builds on Novartis’ acquisition of Chinook Therapeutics just over a year ago.

The approvals and authorizations come amid a late summer surge in the virus that is tracking a bit earlier than the early fall wave in the US in 2023.

The combination of Opdivo plus Yervoy is already established as a second-line treatment for patients with advanced hepatocellular carcinoma.

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.

Approximately 15% of all lung cancers diagnosed in the US are of the small-cell variety, and of those, 70% are considered extensive-stage.

Breyanzi demonstrated an overall high response rate in adults with relapsed or refractory follicular lymphoma in a Phase II study.

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

National Institutes of Health’s National Institute of Allergy and Infectious Diseases collaborated with the University of Sciences, Techniques and Technologies of Bamako, Mali to conduct the trials.

The 94.3% efficacy of the Octapharma product was just a shade ahead of the 94.2% measured in a comparative product, Kcentra.

The virus, which is contagious and a common cause of respiratory illness, hospitalizes up to 160,000 people and is responsible for as many as 13,000 deaths in the United States every year.

BioPharm International® spoke with Zara Bukhari, a PhD scholar at the University of the Pacific, Stockton, CA, and co-author of the peer-review research paper, Biosimilars Drug Development: Advances in Technologies from Molecule Design to Clinical Trials, published in the July/August 2024 issue, about process development for biosimilars.

AAV and lentivirus both have pros and cons in their use for specific gene therapy applications.

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.

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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.