Tags : First

Chugai Reports NDA Submission of Risdiplam to the MHLW as

Shots: The NDA submission is based on FIREFISH study assessing Risdiplam in infants with symptomatic SMA Type 1 & SUNFISH study in children and young adults with SMA Type 2 or 3 FIRESISH study results: improvement in survival and motor milestones in infants. SUNFISH study results: improvement in motor function in people aged 2-25 with […]Read More

ReiThera Reports First Patient Dosing with its COVID-19 Vaccine Candidate

Shots: The first healthy volunteer has been dosed in a P-I study of GRAd-COV2 against COVID-19 which is conducted by the Lazzaro Spallanzani National Institute for Infectious Diseases under the sponsorship of ReiThera The P-I study will evaluate the safety & immunogenicity of GRAd-COV2 in 90 healthy volunteers divided equally into two age cohorts: 18-55yrs. […]Read More

Henlius’ HLX02 Receives the NMPA’s Approval as the First Trastuzumab

Shots: On Aug 14, 2020, HLX02 (biosimilar, trastuzumab) received NMPA’s approval to treat HER2+ early BC, HER2+ m-BC and HER2+ m-gastric cancer. Additionally, On 27th July, HLX02 has received EC’s approval under the brand name Zercepac Henlius followed the NMPA and EMA’s biosimilar guidelines and has taken multiple head-to-head comparisons b/w HLX02 and the reference, […]Read More

The US FDA Approves Guardant360 CDx as the First Liquid

Shots: The FDA has approved Guardant360 CDx as a liquid biopsy companion diagnostic that uses NGS to identify EGFR mutations in patients with metastatic NSCLC The assay utilizes two technologies- i) liquid biopsy that uses a blood sample to provide HCPs with genetic information about the patient’s tumor and ii) NGS that uses large-panel genetic […]Read More

Kite’s Tecartus (brexucabtagene autoleucel) Receives the US FDA’s Approval as

Shots: The accelerated approval follows FDA’s PR and BT designation and is based on ZUMA-2 study assessing Tecartus (formerly KTE-X19) in 74 patients with r/r MCL prior treated with  anthracycline/ bendamustine-containing CT, an anti-CD20 Ab therapy and a BTK inhibitor (ibrutinib or acalabrutinib) Results: 87% patients responded to Tecartus (single infusion), including 62 % patients […]Read More

Quest Diagnostic Receives the US FDA’s First EUA for Sample

Shots: The US FDA has authorized Quest SARS-CoV-2 rRT-PCR test for use with pooled samples containing up to 4 individual swab specimens collected under observation. The Quest test is the first COVID-19 diagnostic test to be authorized for use with pooled samples Quest Diagnostic expects to deploy the technique at its laboratories in Chantilly, VA […]Read More

Bharat Biotech to Initiate Clinical Trials Evaluating Covaxin (India’s First

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

Theravance Reports First Patient Dosing in a P-II Study of

Shots: The first patient has been dosed in a P-II study of TD-0903. The P-II study consists of two parts: the first part will assess the safety, tolerability, and clinical response to treatment in sequential ascending dose cohorts of hospitalized COVID-19 patients, with each patient demonstrating hypoxia being dosed for 7 days The second part […]Read More