Tags : Janssen

Weekly Snapshot

PharmaShots Weekly Snapshots (July 12 – 16, 2021)

Eli Lilly Signs an Agreement with Banner Alzheimer’s Institute to Evaluate Donanemab in P-III TRAILBLAZER-ALZ 3 Trial for Alzheimer’s Disease Published: July 16, 2021 | Tags: Eli Lilly, Banner Alzheimer’s Institute, Donanemab, P-III, TRAILBLAZER-ALZ 3 Trial, Alzheimer Disease AcelRx Signs a License Agreement with Aguettant to Commercialize Dzuveo in EU and for Two Pre-Filled Syringe […]Read More

Weekly Snapshot

PharmaShots Weekly Snapshots (July 05 – 09, 2021)

Lysogene Receives the US FDA’s Fast Track Designation for LYS-GM101 Gene Therapy to Treat GM1 Gangliosidosis Published: July 9, 2021 | Tags: Lysogene, US, FDA, Fast Track Designation, LYS-GM101 Gene Therapy, GM1 Gangliosidosis Jazz’s Vyxeos (daunorubicin and cytarabine liposome) for Injection Receives Health Canada Approval for the Treatment of High-risk Acute Myeloid Leukemia Published: July […]Read More

Insights+

PharmaShots’ Key Highlights of Second Quarter 2021

The second quarter of 2021 witnesses major acquisitions, approvals, and clinical data. There are major alliances in this quarter which include Merck signed ~$1.2B supply agreement with US Government for Molnupiravir to treat COVID-19 The big acquisition took place during the quarter including Microsoft acquired Nuance for ~$19.7B, MorphoSys acquired Constellation for ~$1.7B Our team […]Read More

Weekly Snapshot

PharmaShots Weekly Snapshots (June 21 – 25, 2021)

Regeneron and Sanofi’s Libtayo (cemiplimab) Receive the EC’s Approval as 1L Treatment for Advanced Basal Cell Carcinoma Published: June 25, 2021 | Tags: Regeneron, Sanofi, Libtayo, cemiplimab, EC, Approval, Advanced Basal Cell Carcinoma Regeneron and Sanofi’s Libtayo (cemiplimab) Receive the EC’s Approval as 1L Treatment for Advanced NSCLC Published: June 25, 2021 | Tags: Regeneron, […]Read More

Regulatory

Janssen Reports Submission of NDA to the US FDA for

Shots: The application is based on two studies i.e P-III EINSTEIN-Jr & UNIVERSE. The P-III EINSTEIN-Jr study evaluates Xarelto in 500 children in a ratio (2:1) aged birth to 17yrs. with previously diagnosed VTE, following 5 days of initial parenteral anticoagulation treatment The P-III UNIVERSE study evaluates Xarelto in children aged 2-8yrs. with congenital heart […]Read More