Development

AbCellera and Rallybio are teaming up to discover, develop, and commercialize novel antibody-based therapeutics for rare diseases.

Emmes’ new facility is designed to support clients conducting cell and gene therapy research worldwide.

Particle engineering can be a resourceful tool to advance drug candidates by offering drug delivery innovation.

Deeper biological understanding and technology innovations have improved the fate of ADC development.

Through the integration of human expertise, artificial intelligence, and automation robotics, bio/pharma companies can more efficiently target drug discovery efforts with bigger payoff.

Generate Biomedicines published a preprint describing technology that can generate novel proteins towards desired functional or other properties.

The guidance discusses statistical approaches for BE comparisons and focuses on how to use these approaches both generally and in specific situations.

Results from Eisai and Biogen’s Alzheimer's treatment, lecanemab, indicated significantly slowed cognitive decline in patients relative to placebo.

Science news can be just so weird, or weirdly useful, that everything else recedes as we ponder whether it is true and what consequences it might bring.

Biotech startup, Cradle, has raised $5.4 million in seed funding with an AI-enabled design platform that allows for the synthetic building of cell factories to produce proteins.

A novel mathematical approach for fitting concentration-response curves is proposed that offers a more accurate estimation of potency data.

Companies need to consider and address formulation challenges to employ a successful reformulation strategy.

The Start-Up Market at CPHI Barcelona brings together 27 start-ups, innovators, and small enterprises from across the pharma landscape.

New medications show exciting outcomes for weight loss.

Increasing molecular diversity is creating a need for the reinvention of process development and control strategies.

Pharma companies set goals and adopt more sustainable alternatives.

Learning from early market failures, the biopharma industry has worked to improve the fate of antibody drug conjugates.

FDA has accepted Ashland’s Viatel bioresorbable mPEG-PDLLA pharmaceutical excipient into the FDA Novel Excipient Review Pilot Program.

Roquette has launched excipients PEARLITOL CR-H and PEARLITOL 200 GT.

AstraZeneca’s Imjudo (tremelimumab) was approved by FDA in combination with Imfinzi (durvalumab) for treating unresectable liver cancer.

Using a minimum valuable product and process approach would make it is possible to discipline and structure the development of biopharmaceuticals in the fastest way possible.

There are many benefits of employing a reformulation strategy, but companies must also overcome a variety of challenges too.

A simplified downstream process can save time and costs but requires enabling technologies.

FDA is highlighting how the Patient-Focused Drug Development program has encouraged active involvement of many patient groups in bringing their perspectives into the process of developing, testing, and approving new medicines.

A combination of eye imaging techniques and adaptive optics has revealed key details of choroideremia.