Drug Discovery World

OCTOBER 4, 2022

Development of the drug was funded by $2.2 The approval is the result of a long advocacy campaign to convince the FDA to approve the treatment prior to completion of an ongoing Phase III trial. . “We Then in July 2016, the Association provided the Northeast ALS Consortium (NEALS) with a $1.46

FDA Approval 130

FDA Approval FDA Treatment Clinical Trials 130

Advarra

AUGUST 16, 2022

Orphan drugs have historically faced a number of barriers, such as limited research and development (R&D) investment due to an expected lack of profitability as well as challenges in clinical trial design and recruitment. Before 1983, only 38 orphan drugs had received U.S. Food and Drug Administration (FDA) approval.

Disease 52

Disease Clinical Trials FDA Approval FDA 52

The Pharma Data

JANUARY 31, 2021

Adjuvanted S-Trimer COVID-19 vaccine candidates demonstrated favorable safety and tolerability profiles and strong neutralizing immune responses in a phase 1 trial. Clover plans to initiate a global phase 2/3 trial in the first half of 2021 with an interim analysis for vaccine efficacy potentially in the middle of 2021.

Clinical Trials 52

Clinical Trials Vaccine Trials Virus 52

NIH Director's Blog: Drug Development

JUNE 14, 2016

Several years ago, the Food and Drug Administration (FDA) recommended that drug developers take special care to show that potential drugs to treat diabetes don’t adversely affect the cardiovascular system [1]. 2016 Jun 1;8(341):341ra76. [3] 2016 March 4. [5] December 2008. [2] Sci Transl Med.

Drugs 52

Drugs Disease Drug Development Clinical Trials 52

The Pharma Data

FEBRUARY 13, 2022

The sBLA is supported by data from the pivotal Phase 3 trial evaluating the efficacy and safety of Dupixent added to standard-of-care topical corticosteroids (TCS) in children aged 6 months to 5 years with uncontrolled moderate-to-severe atopic dermatitis.

FDA 40

FDA Disease Treatment FDA Approval 40

The Pharma Data

DECEMBER 3, 2020

The Phase 1 trial was a randomized, observer-blind, placebo-controlled study to assess the safety, reactogenicity and immunogenicity of the adjuvanted COVID-19 S-Trimer vaccine candidates formulated with different antigen levels. The Phase 1 clinical trial was funded by the Coalition for Epidemic Preparedness Innovations (CEPI).

Vaccine 52

Vaccine Immune Response Virus RNA 52

NIH Director's Blog: Drug Development

JULY 20, 2017

Helping to fuel this optimism are preliminary results released this week from early-stage clinical trials of three next-generation, triple combination therapies that modulate the function of CFTR. Credit: Zhang & Chen, 2016, Cell 167, 1586–1597. About 30,000 Americans have CF.

Clinical Trials 52

Clinical Trials Small Molecule Disease Therapies 52