Remove 2020 Remove Drug Development Remove Pharmaceutical Companies
article thumbnail

Digital transformation can accelerate drug development and discovery process

Express Pharma

Ever-increasing drug discovery and development timelines are a multiscale issue causing delays in patient access to medicines and increasing costs for pharmaceutical companies.

article thumbnail

Understanding the Regulatory Environment in Japan for Generic Drug Development

Drug Patent Watch

The regulatory environment in Japan for generic drug development is complex and has undergone significant changes in recent years. New Drug Application (NDA) : Needed for marketing approval of new drugs. Abbreviated New Drug Application (ANDA) : Required for marketing approval of generic drugs.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

Trending Sources

article thumbnail

STAT+: Ionis blazed trails in genetic medicine. On the cusp of a major approval, can it also be a commercial success?

STAT

This isn’t just a drug approval, but a major strategic shift. For more than 30 years, Ionis developed all of its medicines in partnership with large pharmaceutical companies. This time, it is standing alone.

article thumbnail

Drug development and working with specialised Rare Disease networks

pharmaphorum

However, despite the work still left to be done, there are now a growing number of treatments in the pipeline and 2020 proved to be a remarkable year for orphan drug approvals, with the US FDA approving more orphan designated treatments than non-orphan drugs. The potential to leverage genomic data.

article thumbnail

Bristol Myers Squibb aims to improve disability diversity in clinical trials

European Pharmaceutical Review

The DDiCT project will be co-led by Bristol Myers Squibb (BMS)’s Disability Advancement Workplace Network (DAWN) and the Global Drug Development Team. The goal is to “ensure all patient groups are reflective of the real-world population and aligned with the epidemiology of the disease studies,” a statement said.

article thumbnail

Clinical success begins early for small molecule drugs

European Pharmaceutical Review

1 Within these programmes, the ability to identify and solve challenges in the early stages with agility and flexibility is critical to successful early clinical trials that will help advance drugs from late stage through product launch. Addressing bioavailability challenges for small molecule drugs.

article thumbnail

The rising importance of containment in small molecule drug development

Pharmaceutical Technology

HPAPIs may now represent more than 30% of the drug development pipeline. Within that figure, GlobalData estimates that around 60% of pipeline HPAPIs are developed to target oncology. Many companies are now prioritising investments in containment systems, GlobalData research shows.