Our planet is facing a major pandemic outbreak due to COVID-19 and health agencies are taking every measure to stop it The outbreak of the respiratory disease was first detected in Wuhan City, Hubei Province, China in Dec 2019 PharmaShots is keeping a track of all of the important updates in the Life-sciences sector, where […]Read More
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 mod. to sev. PD based on Oxford’s LentiVector platform Axovant is conducting a P-II SUNRISE-PD trial with AXO-Lenti-PD while the dosing of all patients in the second cohort is completed with 6mos. […]Read More
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 in the lungs from the virus in NHPs Based on the preclinical studies, the company has commenced the P-I/IIa study of Ad26.COV2.S, in healthy volunteers in the US and Belgium with expected […]Read More
Shots: The US FDA has approved the new VENTANA HER2 Dual ISH DNA Probe Cocktail assay to detect HER2 biomarker in BC and as a CDx for Herceptin (trastuzumab) therapy. The assay was launched as a CE IVD in Apr’2019 The assay is designed to be completed within the same day, enabling clinicians to get […]Read More
Shots: The BT designation is based on the final analysis of the Pevonedistat-2001 P-II study assessing pevonedistat + azacitidine vs azacitidine as monothx. in patients with rare leukemias, including HR-MDS The 1EPs of the study include OS, EFS, CR and transfusion independence, and AE profile. The designation addresses the needs of people living with HR-MDS, […]Read More
Shots: The approval is based on P-III IMspire150 study assessing Tecentriq (atezolizumab) + Cotellic (cobimetinib) + Zelboraf (vemurafenib) vs PBO + Cotellic + Zelboraf in patients with BRAF V600 mutation-positive advanced melanoma Results: mPFS (15.1 vs 10.6mos.); the safety profile of the Tecentriq combination was consistent with the known safety profiles of the individual medicines. […]Read More
Shots: Sangamo to receive $75M upfront within 30 days, $720M milestone payments including up to $420M in development milestones and up to $300M in commercial milestones plus royalties on sales of the product. Additionally, Sangamo to take care of certain research and manufacturing activities funded by Novartis Novartis to get exclusive license rights of ZFP-TFs […]Read More
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] in patients with HFrEF & HFpEF respectively The EMPEROR-Reduced study meets its 1EPs in reducing the risk for the composite of cardiovascular death or hospitalization due to heart failure while the overall […]Read More
Shots: The BT designation is based on P-III ADAURA trial which involves assessing Tagrisso (80 mg) vs PBO in 682 patients with Stage IB, II, IIIA EGFRm NSCLC following complete tumor resection and adjuvant chemotherapy as indicated across 20 centers and 200+ countries including the US, EU, South America, Asia, and the Middle East The […]Read More
Shots: The approval is based on comparative quality studies, clinical studies including preclinical data and resulted in bio-similarity, comparable efficacy and safety of Zercepac (HLX02) vs Herceptin Zercepac is developed under NMPA and EMA biosimilar guidelines and has been evaluated with the reference trastuzumab including comparative quality studies, preclinical studies, a P-I clinical study and […]Read More
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