Tags : FDA

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

Roche’s CINtec PLUS Cytology Test Receives the US FDA’s Approval

Shots: The approval is based on IMPACT trial, which enrolled ~ 35,000 women to clinically validate CINtec PLUS Cytology as a triage test in various screening scenarios. Publication of the full study findings is pending The approval gives laboratories access to the complete Roche Cervical Cancer Portfolio in the US, including the cobas HPV Test, […]Read More

The US FDA Rejects Mallinckrodt’s Terlipressin Due to Doubts in

Shots: The US FDA has issued CRL to Terlipressin’s NDA for the treatment of hepatorenal syndrome type 1 (HRS-1) and requires more information to support a positive risk-benefit profile for the therapy in HRS-1 patients The company is confident with its P-III CONFIRM study assessing the safety and efficacy of terlipressin in patients with HRS-1 […]Read More

Janssen Reports sBLA Submission to the US FDA for Darzalex

Shots: The sBLA submission is based on P-III ANDROMEDA study assessing Darzalex Faspro (SC) + bortezomib, cyclophosphamide, and dexamethasone (D-VCd) vs VCd as monothx. in 388 patients with newly diagnosed (AL) amyloidosis The study resulted in meeting its 1EPs overall hematologic complete response rate. The sBLA is being reviewed under the FDA’s RTOR program and […]Read More

Roche’s cobas BKV Test Receives the US FDA’s 510 (k)

Shots: The test provides standardized results to assess the risk of complications caused by the BK virus in transplant patients and identify effective treatment options It has received FDA’s BDD for improved treatment/diagnosis of life-threatening diseases for transplant patients. The approval allows Roche to offer HCPs a transplant testing portfolio that includes Cytomegalovirus, Epstein-Barr virus, […]Read More

Project ALS’ Prosetin Receives the US FDA’s Orphan Drug Designation

Shots: The US FDA has granted ODD to Prosetin for the treatment of ALS. ODD provides incentives for the development of drugs, biologics, and devices for diseases affecting 200,000 or fewer Americans By obtaining ODD, Prosetin is now eligible for benefits including up to 7yrs. of marketing exclusivity if it receives regulatory approval, exemption from […]Read More