Tags : FDA

Insights+: The US FDA New Drug Approvals in October 2020

The US FDA has approved 4 NDAs and 1 BLA in Oct 2020, leading to treatments for patients and advances in the health care industry. The Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) have approved 90 novel products so far in 2020, including 5 in Oct 2020. […]Read More

Biomarin Reports the US FDA’s Acceptance of Vosoritide’s NDA to

Shots: The acceptance marks the first marketing application accepted for achondroplasia in the US with an anticipated PDUFA date as of Aug 20, 2021. The US FDA is not planning to hold an advisory committee meeting to discuss the application Additionally, the company is expecting to complete enrollment in a P-II study assessing vosoritide in […]Read More

Eli Lilly Seeks the US FDA’s EUA for its COVID-19

Shots: Eli Lilly reports additional data on its SARS-CoV-2 neutralizing Ab programs including interim data on combination therapy in diagnosed patients with mild-to-mod. COVID-19 and plans to make therapies available to patients The new analysis P-II BLAZE-1 study assessing LY-CoV555 (2800mg) + LY-CoV016 (2800mg) vs PBO demonstrated reduced viral load@11days. meeting its 1EPs, reduction in […]Read More

AbbVie’s Elezanumab (ABT-555) Receives the US FDA’s Orphan Drug and

Shots:   The US FDA has granted ODD and FT destination to Elezanumab, which is an investigational treatment for patients following spinal cord injury The company is collaborating with Shirley Ryan AbilityLab and MC10 to evaluate elezanumab in a pilot study in 20 spinal cord injury patients. The pilot study will inform the ongoing P-II study […]Read More

BMS and bluebird bio Report the US FDA’s Acceptance of

Shots: The US FDA has accepted the PR of BLA for idecabtagene vicleucel to treat adult patients with MM prior treated with at least three therapies including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 Ab. The anticipated PDUFA date is Mar 27, 2021 The BLA is based on a P-II KarMMa study assessing […]Read More

UCB Reports the FDA’s and EMA’s Acceptance of BLA and

Shots: The marketing application submissions are based on three P-III studies- BE VIVID, BE READY, BE SURE assessing the safety and efficacy of bimekizumab in adult patients with mod. to sev. chronic PsO All 3 P-III studies met their 1EPs, demonstrating that bimekizumab achieved superior skin clearance @16wks. vs PBO and Humira (adalimumab) as measured […]Read More

PharmaShots Weekly Snapshot (Sept 14 -18, 2020)

1. AstraZeneca Reports Updated Results of Imfinzi in P-III Studies for NSCLC and ES-SCLC Published: Sept 18, 2020 | Tags:  AstraZeneca, Reports, Updated Results, Imfinzi, P-III, Studies, NSCLC, ES-SCLC 2. Roche Reports Results of Actemra in P-III EMPACTA Study in Patients with COVID-19 Associated Pneumonia Published: Sept 18, 2020 | Tags:  Roche, Actemra, EMPACTA study, […]Read More