Month: <span>December 2019</span>

BMS’ Revlimid + Rituximab Receives EC’s Approval to Treat Adults

Shots: The approval is based on P-III AUGUMENT study involves assessing of Revlimid + Rituximab (R2) vs rituximab +PBO in patients with previously treated follicular lymphoma (FL) or marginal zone lymphoma (MZL) The study resulted improvement in 1EP mPFS (39.4 mos. vs 13.8 mos.) with median follow up 29.2 months. Additionally, the safety and efficacy […]Read More

Roche Signs a License Agreement with Sarepta for its Gene

Shots: Sarepta to receive $1.15B up front including $750M in cash $400M in Sarepta stock, priced at $158.59/share of common stock, up to $1.7B regulatory and sales milestones plus royalties on sales. Sarepta will be responsible for SRP-9001’s clinical development and manufacturing with global clinical cost equally shared Roche to get exclusive rights to commercialize […]Read More

PharmaShots Weekly Snapshot (December 16-20, 2019)

1. Merck’s Ervebo Vaccine Receives the US FDA’s Approval for Prevention of Ebola Virus   Published: Dec 20, 2019 | Tags: Sage Therapeutics, Reports, Results, SAGE-217, P-III, MOUNTAIN Study, Major Depressive Disorders 2. Novo Nordisk Signs a Five-Year Agreement with UVA Center for Diabetes Technology for Type 2 Diabetes Published: Dec 20, 2019 | Tags: Sage Therapeutics, […]Read More

PharmaShots Wishes you a Merry Chritmas and a Happy New

Shots: May all the sweet magic of Christmas conspire to gladden your heart and fill every desire We would like to Thank You all for your sincerest appreciation and concern as well as your trust you have shown to us Wishing you a season of joy and looking forward to continued success in 2020 and […]Read More

Merck’s Ervebo Vaccine Receives the US FDA’s Approval for Prevention

Shots: The approval is based on the study conducted in Guinea during the 2014-2016 outbreak in individuals 18 years of age and older evaluated 3,537 contacts with laboratory-confirmed EVD who received either “immediate” or 21-day “delayed” vaccination with Ervebo The study showed that Ervebo was 100% effective in preventing Ebola cases with symptom onset >10 […]Read More

Novo Nordisk Signs a Five-Year Agreement with UVA Center for

Shots: UVA in collaboration with Novo Nordisk to co-develop virtual patient modeling for T2D patients. The collaboration will utilize UVA’s work and insights on patient simulation and data-driven models within diabetes and will initially have 15 employees with an expectation of increment The focus of the collaboration is developing ‘virtual innovation lab’ for gaining deep […]Read More

Smith Medical Recalls Medfusion 4000 Syringe Pump Due to its

Shots: Smith Medical has recalled its Medfusion 4000 syringe pump with firmware version 1.7.0 due to malfunctioning alarms and potential interruption of therapy. The FDA has labeled it as Class I recall The 627 devices have recalled having model numbers are 4000-0107-01 and 4000-0106-01, manufactured on Jun 25, 2019, and distributed b/w Sept 27, 2019, […]Read More

Samsung Bioepis Initiates P-III Trial for Ontruzant in China

 Shots: The P-III study involves assessing of SB3 vs Herceptin in 208 Chinese breast cancer patients and plans to evaluate its safety and efficacy Samsung plans to conduct the trial in collaboration with AffaMed Therapeutics, a Chinese venture established by C-Bridge Capital Ontruzant is a (biosimilar, trastuzumab) and is targeted to treat patients with early […]Read More