Month: <span>September 2019</span>

Simcere Signs an Exclusive License Agreement with JW Pharmaceutical for

Shots: JWP to receive up front, commercial milestones & royalties on sales in China.  Simcere to get the license for clinical research, registration, and commercialization of URC-102 in China (including Hongkong & Macao) The collaboration will combine JWP’s expertise in new molecular entity drug discovery & development with Simcere expertise in clinical development and commercialization […]Read More

Ieso Launches Eight Billion Minds Digital Initiative Addressing Unmet Mental

Shots: Ieso Digital Health has launched Eight Billion Minds, a digital therapeutics program focusing on addressing the global and regional shortages of mental health practitioners Eight Billion Minds is built on the analysis of high volume, real-world clinical data from Ieso’s IECBT platform, ThinkWell technology-enabled 1:1 care platform with an aim to make mental health […]Read More

Medtronic Reports Results of Resolute Onyx DES in Onyx ONE

Shots: The Onyx ONE global study involves assessing of Resolute Onyx DES vs Biosensor International’s BioFreedom DCS in ~2000 high bleeding risk patients with one month of dual antiplatelet therapy (DAPT) The Onyx ONE global study results: met its 1EPs of cardiac death, MI & ST @1yr. showing non-inferiority to comparator stent; acute performance with […]Read More

Janssen’s Darzalex (daratumumab) Combination Therapy Receives FDA’s Approval for Frontline

Shots: The approval is based on P-III CASSIOPEIA (MMY3006) study involve assessing of Darzalex + bortezomib, thalidomide and dexamethasone (VTd) vs VTd in 1,085 newly diagnosed patients with previously untreated symptomatic MM who are eligible for high dose CT and stem cell transplant The P-III CASSIOPEIA study is sponsored by IFM in collaboration with HOVON […]Read More

AbbVie’s Mavyret (glecaprevir/pibrentasvir) Receives FDA’s Approval for its Expanded Indication

Shots: The US FDA has granted approval to Mavyret for shortening the treatment duration from 12 to 8wks. in treatment-naïve, compensated cirrhotic, chronic hepatitis C (HCV) patients across all genotypes (GT1-6) The label expansion is based on P-IIIb EXPEDITION-8 study assessing Mavyret in treatment naïve, GT1-6 chronic HCV patients with compensated cirrhosis for 8wks., resulted […]Read More

Medtronic to Initiate Clinical Study Evaluating Infuse Bone Graft in

Shots: Medtronic has initiated site recruitment for the Transforaminal Lumbar Interbody Fusion (TLIF) clinical study to enroll up to 50 sites with over 1,000 patients. The expanded indication to use Infuse posterior spine procedures provide patients a powerful option in a spine surgeon’s armamentarium Additionally, in 2017, Medtronic got approval to evaluate Infuse Bone Graft […]Read More

AstraZeneca and Innate Pharma to Advance Monalizumab in a P-III

Shots: AstraZeneca will evaluate the combination of Monalizumab with Cetuximab for patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) with the anticipated onset of the study in 2020 In Apr’2015, AstraZeneca and Innate collaborated to co-develop & co-commercialize Monalizumab for $1.275B out of which Innate has received $350M and […]Read More

Thermo Fisher to Expand its Clinical Trials Capabilities and Collaborates

Shots: Thermo Fisher expands its clinical trials supply and distribution services network in China with the investment of $4.4M in its Suzhou facility to support the growth of clinical studies and to provide biotech companies with the resources to develop and commercialize new therapies in China Additionally, Thermo Fisher collaborates with Frontier to expedite the […]Read More