July, 2020 | PharmaShots

Insights+ Exclusive: COVID-19 Healthcare News Monthly Updates – July 2020

July 31, 2020July 31, 2020Shiwani Sharma

Our planet is facing a major pandemic outbreak due to COVID-19 and health agencies are taking every measure to stop it. The COVID-19 [Read More...]

Oxford Biomedica Joins Consortium to Develop ChAdOx1 nCov-19 for COVID-19

Oxford Biomedica Signs Three Year Clinical Supply Agreement with Axovant to Manufacture and Supply AXO-Lenti-PD for Parkinson’s Disease

July 31, 2020July 31, 2020Tuba Khan

Shots: Oxford Biomedica will manufacture GMP batches for Axovant to support the ongoing and future clinical development of AXO-Lenti-PD (formerly OXB-102) to treat [Read More...]

Johnson & Johnson Initiates P-I/IIa Study of its Ad26.COV2.S in the US and Belgium

Johnson & Johnson Initiates P-I/IIa Study of its Ad26.COV2.S Against COVID-19 in the US and Belgium

July 31, 2020July 31, 2020Tuba Khan

Shots: J&J’s Ad26 vector-based vaccine demonstrated robust immune response in the pre-clinical study by neutralizing Abs, preventing infection and provide complete/ near-complete protection [Read More...]

Roche Receives the US FDA’s Approval for VENTANA HER2 Dual ISH Test as CDx to Identify Breast Cancer

July 31, 2020July 31, 2020Tuba Khan

Shots: The US FDA has approved the new VENTANA HER2 Dual ISH DNA Probe Cocktail assay to detect HER2 biomarker in BC and [Read More...]

Takeda’s Pevonedistat Receives the US FDA’s Breakthrough Therapy Designation to Treat Patients with Higher-Risk Myelodysplastic Syndrome

July 31, 2020July 31, 2020Tuba Khan

Shots: The BT designation is based on the final analysis of the Pevonedistat-2001 P-II study assessing pevonedistat + azacitidine vs azacitidine as monothx. [Read More...]

Roche’s Tecentriq + Cotellic and Zelboraf Receives the US FDA’s Approval for Patients with Advanced Melanoma

July 31, 2020July 31, 2020Tuba Khan

Shots: The approval is based on P-III IMspire150 study assessing Tecentriq (atezolizumab) + Cotellic (cobimetinib) + Zelboraf (vemurafenib) vs PBO + Cotellic + [Read More...]

Sangamo Highlights its Genomic Medicine Pipeline at R&D Day 2019

Sangamo Signs a Worldwide License Agreement with Novartis to Develop Genomic Therapies for Three Neurodevelopmental Targets

July 30, 2020July 30, 2020Shiwani Sharma

Shots: Sangamo to receive $75M upfront within 30 days, $720M milestone payments including up to $420M in development milestones and up to $300M [Read More...]

Eli Lilly Reports Results of Jardiance (empagliflozin) in P-III EMPEROR Trial for Heart Failure Patients with Reduced Ejection Fraction with and without Diabetes

July 30, 2020July 30, 2020Shiwani Sharma

Shots: The P-III EMPEROR Trial involves assessing of Jardiance (10 mg) vs PBO in two studies EMPEROR-Reduced [NCT03057977, N=3,730] & EMPEROR-Preserved [NCT03057951, N=5,990] [Read More...]

AstraZeneca Reports the US FDA Acceptance of sBLA and Granted Priority Review for Imfinzi (durvalumab) to Treat Patients with Extensive-Stage Small Cell Lung Cancer

AstraZeneca’s Tagrisso (osimertinib) Receives the US FDA’s BT Designation for the Adjuvant Treatment of Patients with Stage IB-IIIA EGFR-Mutated Lung Cancer

July 30, 2020July 30, 2020Shiwani Sharma

Shots: The BT designation is based on P-III ADAURA trial which involves assessing Tagrisso (80 mg) vs PBO in 682 patients with Stage [Read More...]

Henlius and Accord Receive CHMP’s Positive Opinion for its HLX02 (biosimilar, trastuzumab)

Henlius and Accord’s Zercepac (trastuzumab, biosimilar) Receive the EMA Approval for HER2-Positive Breast Cancer and Gastric Cancer

July 30, 2020July 30, 2020Shiwani Sharma

Shots: The approval is based on comparative quality studies, clinical studies including preclinical data and resulted in bio-similarity, comparable efficacy and safety of [Read More...]