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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.

Imfinzi may be used alone, or with chemotherapy in tandem with the other approved treatment, Lynparza.

Yorvipath is a prodrug of parathyroid hormone (PTH) (1-34), designed to be administered once daily to provide continuous exposure to released PTH.

AstraZeneca and Daiichi Sankyo first entered into an agreement to develop Enhertu in March 2019, and the antibody-drug conjugate has since been approved for various groups in more than 65 countries.

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.

Under the license agreement, Andelyin Biosciences will expand its AAV Curator Platform by including MyoAAV plasmids developed by Broad Institute of MIT and Harvard.

The program, for which visits will be scheduled through September 2025, does not replace or supplement a regulatory inspection.

Enamine’s library of 5400 TPD-related linkers, and 13,000 more linker molecules, is now being integrated into Cresset’s Spark tool for library searching.

With a $15 million fund-raising goal, US Specialty Formulations plans to invest in expanding its biopharma facility in Allentown, Pa.

BioIVT has launched new cleanroom manufacturing space using Germfree’s technology that boosts its cell and gene therapies development capabilities.

Synovial sarcoma is a rare form of cancer impacting about 1000 adults in the United States each year, most of them men in their 30s or younger.

Freudenberg Medical now offers custom single-use assemblies to expand its offerings in silicone extrusion and molding for biopharma applications.

Will Sanofi’s plan to recruit the younger generation through its participation in the upcoming 2024 Olympic and Paralympic Games, being held in Paris, pay off?

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.

STADA and Alvotech have launched Uzpruvo, the first approved biosimilar to Stelara (ustekinumab), in the European market, marking the second biosimilar brought to market by this partnership.

The HemoTemp II Blood Bag Temperature Indicator, which is an FDA-approved medical device, and the HemoTemp II Activator both were given the “Standards-Compliant” seal.

An additional 11 medicines were recommended for extension of therapeutic indications, while one negative opinion was issued.

Scorpius Holdings expects to launch its first CGMP campaign for mammalian-based biomanufacturing in the 2024 third quarter.

The questions come as FDA is revisiting best practices for advancing the development of new biosimilar products under the terms of its updated Biosimilars Action Plan.

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.

Under the expanded agreement, Univercells and University of Pennsylvania will evaluate certain bioreactors for scalable gene therapy production.

Combination products may be reviewed in a single application or in separate applications for each constituent part, and in rare cases, FDA may decide which type of application process is appropriate.

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.

While the document does not address treatment or prevention of the long-term complications of ulcerative colitis or Crohn’s disease in children, it aims to help sponsors developing drugs for pediatric patients currently affected.