Development

Under the expanded agreement, the companies are targeting amyloid removal strategies to address unmet needs in rare diseases.

siRNA-based cell reprogramming shows potential to improve metabolic health with durable effects, signaling a notable development for future therapeutic strategies.

Engineered exosomes could reshape therapeutic development by redefining delivery, manufacturing models, and regulatory standards.

FDA outlines reduced primate testing for monoclonal antibodies, signaling a shift toward modern evaluation tools that may influence drug development practices.

The new collaboration will aim to streamline formulation-to-manufacturing workflows and de-risk development.

FDA’s internal findings raise new concerns over pediatric vaccine safety and signal potential regulatory shifts affecting future COVID-19 vaccine development.

How is the biopharma industry solving manufacturing and scale-up bottlenecks for cell and gene therapies? Read on to find out.

The transformative impact of complex biopharmaceuticals hinges on integrating advanced delivery systems, often accelerated by AI modeling, with robust manufacturing practices and regulatory alignment to ensure stability, safety, and effective patient access.

Samsung Life Science Fund’s investment in Phrontline Biopharma highlights growing industry momentum behind dual-payload ADCs.

Progress in vaccine development is closely tied to advancements in biopharmaceutical technologies, regulatory landscapes, and quality assurance methodologies.

Regulators and manufacturers face new uncertainty as shifting CDC vaccine language raises concerns for evidence-based oversight and biopharma compliance.

Sapient said the workflow will allow for direct measurement of more than 10,000 protein groups in a single, 5-µm slide.

RxCelerate and Constructive Bio will combine programmable biology with integrated discovery tools to speed engineered biologics for hard-to-treat diseases.

Webinar Date/Time: Tue, Dec 9, 2025 11:00 AM EST

The new strategic collaboration seeks to develop up to four first-in-class myeloid cell engagers offering broad and safe treatment for blood and solid cancers.

Webinar Date/Time: Thu, Dec 11, 2025 11:00 AM EST

Biogen reports CHMP support for an enhanced nusinersen regimen, signaling potential shifts in SMA treatment strategies and global regulatory decisions.

Experts at AAPS PharmSci 360 discuss industry-wide transformation from AI implementation and the ripple effect on workforce development.

Government and academic leaders say that to prevent catastrophic loss of expertise and investment, coordinated policy and significant investment in workforce talent are urgently needed in the UK.

Help shape industry insights. Take our survey on the biopharma impacts of the FDA Commissioner’s National Priority Vouchers program.

Webinar Date/Time: Tue, Dec 9, 2025 2:00 PM EST

FDA’s newly introduced review route enables faster clearance of custom genetic and cell treatments, reshaping rare-disease development and manufacturing strategies.

The company demonstrates advances in glioma hydrogel, high-concentration biologics, and nanoencorafenib licensing, impacting drug delivery strategies.

At AAPS PharmSci 360, Kelly Donovan says tailored analytical strategies are necessary for reducing development delay risks.

Webinar Date/Time: Thu, Nov 20, 2025 12:30 PM EST