FDA Law Blog: Drug Discovery

FEBRUARY 2, 2023

Since 1962, the FD&C Act has authorized FDA to require that sponsors of clinical trials submit data from “preclinical tests (including tests on animals)” in order to demonstrate that their drug is safe enough to advance to testing in humans. For more on FDORA’s other provisions, see HPM’s complete summary here ). 42 U.S.C. § 42 U.S.C. §

Animal Testing 64

Animal Testing Biosimilars Cell Based Assays FDA 64

DrugBank

OCTOBER 4, 2024

This involves assessing the strength and breadth of patents, evaluating the potential for future patent challenges, and analyzing the value derived from licensing agreements and royalty streams. The high costs associated with bringing a new drug to market, estimated to be over $2.6

Pharmaceuticals 69

Pharmaceuticals Pharmaceutical Companies Marketing Therapies 69

Drug Discovery World

MARCH 29, 2023

According to the Wellcome Trust 5 , it can take between 10 and 15 years and over $1billion to develop a new antibiotic, so systems such as this aim to provide incentive to drug developers. One of the main objectives was to mutually recognise the respective GMP inspection systems and reduce the number of foreign inspections 8.

Clinical Trials 130

Clinical Trials Biosimilars Pharma Companies Production 130

The Pharma Data

JANUARY 24, 2021

Toripalimab was included in the 2019 and 2020 Guidelines of Chinese Society of Clinical Oncology (CSCO) for the Diagnosis and Treatment of Melanoma. The results of the study were published in the Journal of Clinical Oncology in August 2019. and a disease control rate (DCR) of 86.2%

FDA 52

FDA Clinical Trials Trials Treatment 52

Agency IQ

AUGUST 2, 2024

The following PDUFA dates were obtained from publicly available sources. and the E.C.

FDA 40

FDA Science Regulations Biosimilars 40

Agency IQ

JUNE 2, 2023

6/27/2023 Notification FDORA, Section 3201 Within 180 days of the passage of FDORA, all biologics and biosimilars sponsors must submit a written notice to the FDA of all actively marketed products (i.e., The following PDUFA dates were obtained from publicly available sources. not discontinued) and are available for sale.

FDA 40

FDA Science Regulations Production 40

The Pharma Data

OCTOBER 29, 2020

Biogen licensed aducanumab from Neurimmune under a collaborative development and license agreement. have collaborated on the development and commercialization of aducanumab globally. Since October 2017 Biogen and Eisai Co., AD is suspected to represent around 60-70% of dementia cases.

Marketing 40

Marketing Disease Clinical Trials Treatment 40