Tags : US

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

True Digital Surgery and Aescula Launch Aesculap Aeos Robotic Digital

Shots: The robotic digital microscope enables surgeons to execute precision movements in neurosurgery, spine, and ear, nose, and throat operations, through a multi-axis robotic arm. The platform also offer potential improvements to safety and efficiency during surgeries as the heads-up display can be viewed while wearing PPE, which overcome the spread of COVID-19 The platform […]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

Fitbit to Launch ECG App in the US and EU

Shots: Fitbit’s ECG app has received the US FDA’s 510 (k) clearance and EC’s CE marking to assess heart rhythm for atrial fibrillation (AFib). The ECG app will be available in Oct’2020 to the users on the Fitbit Sense smartwatch The company has launched a multi-site clinical trial across the US, to detect AFib from […]Read More

Merck Signs Up to $4.5B Oncology Deal with Seattle Genetics

Shots: Seattle Genetics to receive $600M up front, $1B as equity investment, 5M shares of Seattle Genetics common stock at a price of $200/ share, ~$2.6B as milestones including $850M development milestones and $1.75B as commercial milestones. The companies will equally share costs and profits on the global development of ladiratuzumab vedotin and other LIV-1-targeting […]Read More