Month: April 2019

MedTech

Abbott Reports Results of High Sensitive Troponin-I Blood Test for

Shots: The Atherosclerosis Risk in Communities (ARIC) study results involves assessing of high-sensitive troponin-I blood test in 8,121 candidates with no known cardiovascular disease aged 54-73yrs. for 15yrs. The ARIC study results identified the risk of cardiac events by measuring the elevated troponin-I levels, 85% had detectable troponin, adults with high troponin-I level are twice, […]Read More

Pharma

AstraZeneca Collaborates with BenevolentAI to Develop Therapies for Chronic Kidney

Shots: AstraZeneca & BenevolentAI enter into an agreement to discover & develop therapies for chronic kidney disease (CKD) and idiopathic pulmonary fibrosis (IPF) utilizing artificial intelligence (AI) and machine learning AstraZeneca will combine its genomics, chemistry and clinical data with Benevolent AI’s target identification platform and biomedical knowledge graph (network of genes, proteins, diseases and […]Read More

Regulatory

ViiV Healthcare Files NDA for Cabotegravir + Edurant (rilpivirine) to

Shots: The submission is based on P-III ATLAS (Antiretroviral Therapy as Long-Acting Suppression) and FLAIR (First Long-Acting Injectable Regimen) studies results assessing Cabotegravir + Edurant (rilpivirine) (injected monthly) vs SOC (three-drug regimen) in 1,100+ patients infected with HIV + viral suppression across 16 countries for 48wks. The P-III ATLAS & FLAIR studies resulted in maintaining […]Read More

Biosimilars Biotech

Sandoz Signs an Agreement with EirGenix to Commercialize Proposed Trastuzumab

Shots: EirGenix to receive upfront, milestones with profit sharing on sales and will be responsible for the development & manufacturing of proposed biosimilar trastuzumab. Sandoz to get WW rights to commercialize the proposed biosimilar trastuzumab (Ex- China & Taiwan) The agreement is the third biosimilar collaboration for Sandoz in 18 months, which will further focus […]Read More

Regulatory

Novo Nordisk’s Esperoct (turoctocog alfa pegol, N8-GP) Receives CHMP’s Positive

Shots: The positive opinion is based on largest pre-registration clinical programme assessing Esperoct (FD, IV, q4days) in 270 patients previously treated with severe hemophilia A and more than 5 years of clinical exposure   The study resulted in effective routine prophylaxis in people with severe hemophilia A, efficacious in treatment and control of bleeding episodes […]Read More

Regulatory

Acutus Medical’s AcQMap Contact Mapping Software Receives CE Mark Approval

Shots: The AcQMap contact mapping is a software offering physicians with multiple options to inform individualized therapy, to reconstruct atrial anatomy utilizing ultrasound and mapping electrical patterns with non-contact, charge density technology creating 3D real-time images Acutus’ Robust Second-Generation Platform has received FDA’ approval used for patients with electrophysiology procedures to reconstruct the chamber with […]Read More

Pharma

Sanofi and Lexicon’s Zynquista (sotagliflozin) Receive EU’s MAA to Treat

Shots: The authorization is based on inTandem study consisting of three P-III trials assessing sotagliflozin (200/400 mg) vs insulin as monothx in 3000 adults with inadequately controlled T1D The study resulted reduction in average blood sugar (HbA1c), body weight, systolic blood pressure, improvement of time in target blood sugar range, patient-reported outcomes within 24 weeks […]Read More