Shots: The US FDA has put a partial clinical hold on Aprea’s clinical program that evaluates eprenetapopt + acalabrutinib or with venetoclax and rituximab in patients with lymphoid malignancies. The FDA’s decision is related to the safety & efficacy data from the P-III MDS study The patient enrollment will be pause until the clinical hold […]Read More
Shots: The company launches Sensor Cloud for managing sensor and digital health technology data during the clinical trial. Sensor Cloud integrates with Medidata Rave Clinical Cloud and supports continuous patient data collection from both Medidata and third-party medical-grade sensors The launch of Sensor Cloud strengthens Medidata’s unique data ingestion, analytics & insights capabilities, providing differentiated […]Read More
Shots: Sanofi will sponsor the clinical trials while MSD will provide KEYTRUDA. Additionally, Sanofi is separately evaluating the activity of THOR-707 in combination with other anti-PD-1 antibodies, including Libtayo (cemiplimab-rwlc) and with anti-EGFR and anti-CD38 antibodies for various types of cancer tumors In preclinical studies, THOR-707 demonstrated the ability to induce the expansion of CD8+T-cells […]Read More
With the race to develop an effective vaccine becoming intense, how has the coronavirus pandemic changed the pharmaceutical industry, and what can we expect in the long- and short-term? Let’s see…. The year 2020, and the new decade as a whole, has definitely got off to the worst possible start – and we have a […]Read More
Shots: Zydus’ ZyCoV-D has completed the preclinical studies and has received DCGI approval to initiate P-I/II human clinical trials in India. In its preclinical study, the vaccine demonstrated that it is capable to neutralize the wild type virus in the virus neutralization assay In its toxicology studies, the vaccine is found to be safe, well-tolerated […]Read More
Shots: Bharat Biotech has received DCGI approval to conduct P-I & II clinical studies assessing Covaxin, developed in collaboration with ICMR and NIV. The company anticipate initiating the clinical studies in July’2020 The DCGI’s approval is based on preclinical data demonstrating safety and immune response. The SARS-CoV-2 strain was isolated in NIV & transferred to […]Read More
2020 is a year that nobody ever thought could turn their lives upside down. The beginning of this year witnessed the worldwide onset of Coronavirus disease or COVID-19 that has till now infected millions of people around the globe killing tens of thousands. In March 2020, WHO declared it to be a pandemic. There has […]Read More
The Webinar on “Strategies to Conduct Clinical Trials effectively in Covid-19 era” organized by CliniMed LifeSciences Pvt. Ltd., Kolkata in association with Indian Society for Clinical Research (ISCR) and Peerless Hospital, Kolkata as knowledge partners and PharmaShots as a media partner, was held at 3 pm on June 6, 2020. Around 500 plus participants attended […]Read More
Claimed LifeSciences Pvt. Ltd., Kolkata is gladly organizing a Webinar on “Strategies to Conduct Clinical Trials effectively in Covid-19 era” in association with Indian Society for Clinical Research (ISCR) and Peerless Hospital, Kolkata as knowledge partners. The objective of this insightful webinar is to promote discussion among all stakeholders of clinical trials in the country […]Read More
Shots: The companies plan to file IND submission and initiate human clinical studies to evaluate neutralizing mAbs against COVID-19 in the US and China in Q2’2020 The article is being published in Nature, reports the identification and characterization of two mAb’s CA1 and CB6 from the COVID-19 recovered patients CA1 and CB6 mAb’s have demonstrated […]Read More
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