European Pharmaceutical Review

JULY 21, 2023

A recent report from the US Food and Drug Administration (FDA) shows that while the number of new drug shortages has fallen significantly from a high of 250 in 2011 to 49 in 2022, there was an increase in new drug shortages year-on-year.

Pharmaceutical 95

Pharmaceutical Food and Drug Administration Transportation Manufacturing 95

European Pharmaceutical Review

MARCH 8, 2023

After moving to London in 2011, Ekaterina worked in global health and medical philanthropy, focusing on improving outcomes in maternal and child health. At COMPASS, I currently oversee the development of innovative therapies which includes drug development, and innovations more broadly to support drug delivery, such as digital innovation.

Leads 52

Leads Pharma Food and Drug Administration Medicine 52

Clarivate

MAY 24, 2022

Recent policy and regulatory moves have begun to sketch out a framework for rare disease drug approvals in the country, but obstacles to approvals and patient access remain. The list, designed to serve as a reference point for prioritized drug review and evaluation policies, included 121 rare diseases. [8]. 10] [11] [12].

Patients 52

Patients Food and Drug Administration Marketing Pharma 52

European Pharmaceutical Review

SEPTEMBER 22, 2022

Rare disease drug development poses unique challenges that can be overcome by using real-world evidence (RWE). Another benefit is that fewer patients are required in clinical trials using HCs, thereby reducing time to trial completion and speeding drug approval. Patel et al.

Food and Drug Administration 113

Food and Drug Administration Patients Distribution FDA 113

European Pharmaceutical Review

JULY 13, 2023

Protein engineering comes with several challenges, including maintaining stability and immunogenicity of the novel protein and creating an inherently active drug. The molecule is a stable fusion protein that is administered as an active drug and does not degrade into native IL-2 inside the body. 2011; 117(11): 2993–3001.

Engineering 88

Engineering Food and Drug Administration Safety Patients 88

European Pharmaceutical Review

SEPTEMBER 22, 2023

Limitations of monoclonal antibody therapies Regulatory approvals from the US Food and Drug Administration (FDA) for aducanumab and lecanemab – and likely very soon for donanemab also – opened a route for different therapeutic modalities and other relevant disease targets, such as tau.

Food and Drug Administration 78

Food and Drug Administration Safety Patients Leads 78

pharmaphorum

SEPTEMBER 13, 2022

Just over a decade after it was developed by biochemist Nicholas Lyndon, Imatinib received US Food and Drug Administration (FDA) approval in 2001. This research paved the way for the first successful treatment of a patient with acute lymphoblastic leukaemia in 2011. 2002 – Emergence of CAR-T therapy.

Food and Drug Administration 92

Food and Drug Administration Patients Engineering Physicians 92

World of DTC Marketing

APRIL 7, 2022

Launch prices of new cancer drugs in the U.S. Food and Drug Administration (FDA). billion estimated cumulative spending on the new oral targeted cancer drugs by the end of 2018. billion estimated cumulative spending on the new oral targeted cancer drugs by the end of 2018. Health spending totaled $74.1

Healthcare 215

Healthcare Healthcare Food and Drug Administration Government 215

Pharmaceutical Technology

MAY 18, 2023

Other processes include direct-to-patient (DtP) shipments of drugs and other supplies to a patient’s home, as well as in-home care with mobile nurses. Lockdown measures, which hindered traditional trials, brought to the fore how DCTs could enable the recruitment of patients anywhere without the need to visit a clinical trial site.

Recruitment 52

Recruitment Food and Drug Administration Patients Media 52