Tags : Report

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

AstraZeneca and MSD Report Five Year Data of Lynparza in

Shots: The P-III SOLO-1 study involves assessing of Lynparza (300mg, bid) as a maintenance monothx. vs PBO in 391 patients in a ratio (2:1) with newly diagnosed BRCAm advanced ovarian cancer following 1L Pt.-based CT for ~2yrs. or until disease progression Five-year follow-up data demonstrated a 67% reduction in risk of disease progression or death, […]Read More

Takeda and Ovid Report Results of Soticlestat (TAK-935/OV935) in P-II

Shots: The P-II ELEKTRA study involves assessing of soticlestat vs PBO in pediatric patients, aged 2-17 yrs., with highly refractory epileptic seizures associated with DS (convulsive seizures) or LGS (drop seizures) Results: meeting its 1EPs i.e. reduction in DS & LGS (27.8% vs 3.1% & 29.8% vs 0.0%) during the 12-wks. maintenance period & 20-wks. […]Read More

Fitbit Reports Results of its COVID-19 Study for Early Detection

Shots: In May’2020, Fitbit has launched its COVID-19 study to build an algorithm that detects COVID-19 before symptoms starts. The study has enrolled 1000+ positive patients across the US and Canada is now delivering its first, preliminary results 90 days later The study demonstrated that its devices could detect ~50% of COVID-19 cases one day […]Read More

Lilly and Innovent Report the Global Expansion of their Alliance

Shots: Innovent to receive $200M up front, $825M as development and commercial milestones along with royalties on net sales of the therapy. Both the companies will retain the right to study Tyvyt in combination with other therapies as part of their own clinical programs Lilly will get an exclusive license for the therapy for geographies […]Read More

Roche Report Mixed Results of Etrolizumab in P-III Studies for

Shots: In the HIBISCUS I induction study, in patients without prior anti-TNF treatment, etrolizumab met its 1EPs while in HIBISCUS II study in the same kind of people, it did not meet its 1EPs. In the HICKORY study, in patients with prior anti-TNF treatment, therapy met its 1EPs at induction but not at maintenance In […]Read More

Regeneron with its Partner NIAID Report the Initiation of P-III

Shots: The P-III trial involves assessing REGN-COV2 with an expected enrollment of 2000 patients at 100 sites which will be evaluated to prevent infection among uninfected people who have had close exposure to a COVID-19 patient REGN-COV2 is also being evaluated in P-II/III portion of two P-I/II/III trials testing the cocktail’s ability to treat hospitalized […]Read More