Development

New guidance from FDA, including standards for interchangeability, is expected to speed development of biosimilars, but experts warn against oversimplifying risk to reduce costs.

Under a collaboration potentially worth more than $1.5 billion, the companies aim to develop the antisense therapy to treat patients with certain cardiovascular and metabolic diseases.

The agency has approved Gilead Sciences’ Descovy (emtricitabine 200 mg and tenofovir alafenamide 25 mg) for reducing the risk of HIV-1 infection.

The new joint venture, named Oerth Bio, will use Arvinas’ Protac technology to develop innovative new agricultural products. As part of its collaboration with Arvinas, Bayer is also using this technology to develop human therapeutics.

Leveraging automation and a step-by-step approach are keys to success.

BioPharm International spoke with Marybeth Reynoso, senior director, early development strategic operations at PPD about the direction the industry is taking regarding the outsourcing of early development operations to contract research organizations (CROs).

Learning to think with the end in mind will help clients and their selected CRO to design and conduct the right studies.

Under a new co-development license agreement, Boehringer Ingelheim and Inflammasome Therapeutics aim to develop novel therapies for retinal diseases.

The companies have advanced their collaboration to the next stage and will continue to develop a plant-based biosimilar candidate to Roche’s Rituxan.

The Phase III clinical studies for the drug candidate, elenbecestat, were discontinued based on a recommendation by a data safety monitoring board.

The acquisition gives PPF a 19.2% stake in Autolus and provides a pipeline of cell therapy product candidates.

The acquisition will enhance Lundbeck’s brain disease therapy portfolio as well as its antibody process and development capabilities.

The companies will develop and commercialize a Phase III cell therapy candidate for treating chronic low back pain in a deal worth potentially $1 billion.

Passage Bio has licensed a sixth gene therapy development program under its partnership with the University of Pennsylvania for the clinical development of a potential treatment for a nerve disorder.

Bayer will use ProBioGen’s GlymaxX technology to maximize the potency of its antibody drug candidate in development for oncological indications.

The new antibody, Citryll’s CIT-013, could offer new treatment options for various human diseases including lupus, vasculitis, pulmonary fibrosis, and organ damage due to sepsis.

FDA announced it is developing a series of guidance documents to promote methodological patient-focused drug development.

A new report by GlobalData projects 2.9% growth by 2028 for the hemophilia A and B market across the eight major world markets.

In a Phase III trial for advanced small-cell lung cancer, the investigational antibody drug conjugate, Rova-T (rovalpituzumab tesirine), did not demonstrate a survival benefit for patients taking it.

The company has received breakthrough therapy designation for its prophylactic respiratory syncytial virus vaccine candidate for treating adults aged 60 years or older.

Vertex will use the acquisition to develop cell-based treatments for type 1 diabetes.

The new facility, located in Ness Ziona, Israel, will support clinical phage manufacturing and can be expanded in the future to support commercial-scale manufacturing.

In an effort to secure a continuous, sustainable supply of an important vaccine ingredient, Agenus is turning to a plant cell-based cell culture method for production.

Particulates or aggregates are a notable challenge for injectables, but there are several methods available to help with identification during formulation and development.

Stability testing for biologics is more complex than for small-molecule drugs, so companies should be aware of the potentially serious issues that can be costly and jeopardize drug development.

The editors welcome technical article contributions from biopharma industry experts.

Innovation in manufacturing technologies must occur to ensure the availability of gene and cell therapies.

The evolution of cell-culture technology is driving the need for improvements in modeling solutions.

Medical researchers from the Centenary Institute and the University of Sydney in Australia have managed to successfully develop and test a new vaccine targeting tuberculosis.

GSK will handle the development, regulatory, commercialization activities, and costs of the drug, while Ionis will obtain license fees and milestone payments of up to $262 million, including a $25 million license fee.