pharmaphorum

NOVEMBER 2, 2022

With the merger now completed, Norstella becomes a $5 billion group with 1,500 employees across the five business brands with the overarching objective of guiding life sciences companies through the drug development process so patients can get access to therapies more quickly. Photo by Edge2Edge Media on Unsplash.

Drug Development 101

Drug Development Communication 101

Syner-G

MAY 4, 2022

In May of 2014 and February of 2019 , the FDA released final Guidance for Industry outlining the Agency’s policies and procedures regarding expedited development and review programs for new drugs and biologics intended to treat serious or life-threatening conditions. Category: Regulatory Affairs , Drug Development Consulting.

Documentation 52

Documentation Drug Development Communication 52

pharmaphorum

SEPTEMBER 9, 2021

Public health agencies and pharma pivoted in countless ways, from decentralising clinical trials and accelerating research and development, to enabling remote care and remote working with rapid digitisation. And we transformed so quickly because the key players communicated and collaborated.

Communication 52

Communication Pharmaceutical Companies Pharmaceutical Companies Hospitals 52

Putting Patients First Blog

FEBRUARY 6, 2024

Nature Communications, 11(6265). The price of progress: funding and financing Alzheimer’s disease drug development. Translational Medicine Communications, 4(18). [link] 2 Aiyegbusi, O., Macpherson, K., Washington, J., Newsome, P., and Calvert, M. link] 3 Cummings, J., and Kumar, P. link] 5 Seyhan, A.

Communication 40

Communication Documentation Drug Development 40

Pharmaceutical Technology

NOVEMBER 30, 2022

Over the past few years, there has been a boom in anti-obesity drug development, with major companies achieving substantial sales in the field. According to GlobalData, as of November 28, there were 316 generic and novel drugs marketed to treat obesity. Anti-obesity therapeutic landscape.

Insurance Coverage and Processing 105

Insurance Coverage and Processing Diabetes Labelling Communication 105

Pharmaceutical Technology

NOVEMBER 30, 2022

Over the past few years, there has been a boom in anti-obesity drug development, with major companies achieving substantial sales in the field. According to GlobalData, as of November 28, there were 316 generic and novel drugs marketed to treat obesity. Anti-obesity therapeutic landscape.

Insurance Coverage and Processing 98

Insurance Coverage and Processing Diabetes Labelling Communication 98

FDA Law Blog: Biosimilars

JANUARY 12, 2025

Since that time, it was formalized in FDA regulations (21 CFR 314 Subpart H) in 1992, codified in the Food, Drug, & Cosmetic Act by FDAMA (21 USC 356(c)) in 1997, revised by FDASIA in 2012, and described in guidance, most importantly, in the 2014 Expedited Programs for Serious Conditions Drugs and Biologics (2014 Guidance).

Drug Development 64

Drug Development Communication Labelling 64