article thumbnail

Understanding the Regulatory Environment in Japan for Generic Drug Development

Drug Patent Watch

Pharmaceutical Regulations in Japan 2020. Freyr Solutions. 11 Must-know FAQs about the Drug Approval Process in Japan. Retrieved from [link] Japan Pharmaceutical Manufacturers Association. Retrieved from [link] Pharmaceuticals and Medical Devices Agency. Regulatory System on Generic Drugs in Japan. Retrieved from [link] Raflzadeh-Kabe, J.

article thumbnail

Broad Institute and Bayer extend their cardiovascular alliance

Broad Institute

First launched in 2015 and renewed in 2020, the program began as a recognition that while a majority of cardiovascular disease can be associated with lifestyle factors such as tobacco consumption, diet, and level of physical activity, genomics can influence an individual’s predisposition to cardiovascular disease, age of onset, and severity.

Disease 93
Insiders

Sign Up for our Newsletter

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

article thumbnail

New tRNA tech aims to rewrite rare disease treatment

Drug Target Review

My transition to biotech and rare diseases was deeply personal – my son was diagnosed with Duchenne muscular dystrophy in 2020. “My My transition to biotech and rare diseases was deeply personal – my son was diagnosed with Duchenne muscular dystrophy in 2020,” Michelle explains.

Disease 80
article thumbnail

Organoids: the versatile platform for discovery and regeneration

Drug Target Review

MedComm (2020). Single Lgr5 stem cells build crypt-villus structures in vitro without a mesenchymal niche. 2009;459(7244):262-5. Yang S, Hu H, Kung H, Zou R, Dai Y, Hu Y, et al. Organoids: The current status and biomedical applications. 2023;4(3):e274. Lin YT, Seo J, Gao F, Feldman HM, Wen HL, Penney J, et al.

Treatment 106
article thumbnail

The rising impact of biomarkers in early clinical development

Drug Target Review

BEST (Biomarkers, EndpointS, and other Tools) Resource [Internet]. Silver Spring (MD): Food and Drug Administration (US); 2016-. Co-published by National Institutes of Health (US), Bethesda (MD). Bagyinszky E, et al. Transcriptomics in Alzheimers Disease: Aspects and Challenges. International Journal of Molecular Sciences. 21(10):3517.

article thumbnail

New cell therapy model accelerates cancer treatment development

Drug Target Review

Around 2020, Bock assumed the challenge of creating a new division at MD Anderson focused on advancing cell therapies by bridging the gap between research labs and the clinic. He described the initiative as vital for ensuring that therapies move efficiently from the lab bench to the bedside.

article thumbnail

With Verona deal, Merck wagers on strength of lung drug’s patents

BioPharma Drive: Drug Pricing

The main patent for Ohtuvayre, the COPD drug at the heart of Verona’s $10 billion sale, expired in 2020. For Merck to make good on the deal, other secondary patents will need to hold up.

Drugs 184