Trial

Horizon Reports First Patient Enrollment in P-IIb Trial of HZN-825 for the Treatment of Diffuse Cutaneous Systemic Sclerosis

Shots: The company has enrolled the 1st patient in a P-IIb trial to evaluate HZN-825 (300mg, qd/bid) in a ratio (1:1:1) in 300 patients with dcSSc for 52wks. The study is based on the results of a P-IIa trial The 1EPs of the study is the change in FVC% after 52wks. of treatment & 2EPs …

Horizon Reports First Patient Enrollment in P-IIb Trial of HZN-825 for the Treatment of Diffuse Cutaneous Systemic Sclerosis Read More »

Roche Entered into a Clinical Trial Supply Agreement with Galecto to Evaluate GB1211 + Tecentriq (atezolizumab) in P-IIa Trial for 1L Treatment of NSCLC

Shots: The companies collaborated to evaluate the safety, tumor shrinkage, clinical activity & immune biomarkers of Galecto’s GB1211 (galectin-3 inhibitor) + Roche’s Tecentriq (PD-L1 checkpoint inhibitor) in P-IIa trial in a ratio (1:1) in 70 patients with NSCLC. The P-IIa study is expected to start in 2022 & results are expected in mid-2023 Galecto will …

Roche Entered into a Clinical Trial Supply Agreement with Galecto to Evaluate GB1211 + Tecentriq (atezolizumab) in P-IIa Trial for 1L Treatment of NSCLC Read More »

Regeneron and Sanofi Report Results of Dupixent (dupilumab) in P-III Trial for the Treatment of Eosinophilic Esophagitis

Shots: The second P-III trial evaluates the efficacy and safety of Dupixent (300mg weekly) vs PBO in 240 patients aged ≥12yrs. with EoE for 24wks. The trial met its co-primary EPs i.e., reduction in disease symptoms from baseline (64% vs 41%); patients experienced a (23.78 vs 13.86 points) improvement on 0-84 DSQ scale & achieved …

Regeneron and Sanofi Report Results of Dupixent (dupilumab) in P-III Trial for the Treatment of Eosinophilic Esophagitis Read More »

Pfizer and BioNTech Report Results of COVID-19 Vaccine Booster in P-III Trial for the Treatment of COVID-19

Shots: The P-III trial evaluates a booster dose of COVID-19 vaccine (30µg) in a ratio (1:1) in 10000+ individuals aged ≥16yrs. with COVID-19 who previously received the primary two-dose series of vaccine The results showed vaccine efficacy of 95.6% compared to a non-boosted group, median time b/w second & booster dose was ~11mos., symptomatic COVID-19 …

Pfizer and BioNTech Report Results of COVID-19 Vaccine Booster in P-III Trial for the Treatment of COVID-19 Read More »

Regeneron Publishes the Results of REGEN-COV (casirivimab and imdevimab) in P-III Trial for COVID-19 in NEJM

Shots: The P-III trial evaluates the efficacy and safety of REGEN-COV (casirivimab and imdevimab, 1200/2400mg) vs PBO in a non-hospitalized patient with COVID-19 The trial met its 1EPs & 2EPs i.e., 70% reduction in the risk of hospitalization or death in high-risk non-hospitalized patients & the safety profile was consistent with a previously reported data …

Regeneron Publishes the Results of REGEN-COV (casirivimab and imdevimab) in P-III Trial for COVID-19 in NEJM Read More »

Gilead Reports Results of Veklury (remdesivir) in P-III Trial for the Treatment of COVID-19

Shots: The P-III trial evaluates the efficacy & safety of a 3-day course of Veklury (IV) vs PBO in a ratio (1:1) in 562 non-hospitalized patients ≥aged 12yrs. with COVID-19 who are at high risk for disease progression. The results will be presented at IDWeek 2021 The results showed an 87% & 81% reduction in …

Gilead Reports Results of Veklury (remdesivir) in P-III Trial for the Treatment of COVID-19 Read More »

Cardiff Oncology Reports Results of Onvansertib in P-Ib/II Trial for the Treatment of KRAS-Mutated Metastatic Colorectal Cancer

Shots: The P-Ib/II trial evaluates the safety and preliminary efficacy of onvansertib + Folfiri and Avastin in 2L treatment of patients with KRAS-mutated mCRC As of July 2, 2021, 42% patients achieved a partial response at RP2D (15 mg/m2 dose); confirmed PR (37%); ORR (5-13%); mPFS has not yet reached. Additionally, 38% patients achieved an …

Cardiff Oncology Reports Results of Onvansertib in P-Ib/II Trial for the Treatment of KRAS-Mutated Metastatic Colorectal Cancer Read More »

Roche Enters into a Clinical Collaboration with Treos Bio for PolyPEPI1018 + atezolizumab in P-I/II Trial to Treat Late Stage Microsatellite Stable Metastatic Colorectal Cancer

Shots: The companies collaborated to evaluate Treos’ PolyPEPI1018 (Polypeptide cancer immunotherapy) + Roche’s atezolizumab (PD-L1-inhibitor) in P-I/II trial in patients with late-stage MSS mCRC which is expected to initiate in Q4’21 Treos has completed a P- I/II OBERTO 101 study for PolyPEPI1018 as 1L maintenance setting in patients with MSS mCRC that demonstrates the therapy …

Roche Enters into a Clinical Collaboration with Treos Bio for PolyPEPI1018 + atezolizumab in P-I/II Trial to Treat Late Stage Microsatellite Stable Metastatic Colorectal Cancer Read More »

Sorrento’s Resiniferatoxin Receives the US FDA’s Clearance to Initiate P-II Trial for the Treatment of Knee Pain in Patients with Osteoarthritis

Shots: The P-II trial will assess the efficacy & safety of RTX across several dose groups vs PBO in patients with a mod. to sev. OAK pain. The study follows the P-Ib trial results of RTX The P-Ib data demonstrated the significant efficacy supporting RTX for long term refractory OA pain, pain relief observed in …

Sorrento’s Resiniferatoxin Receives the US FDA’s Clearance to Initiate P-II Trial for the Treatment of Knee Pain in Patients with Osteoarthritis Read More »

Hutchmed Initiates P-I Trial of HMPL 295 for the Treatment of Advanced Solid Tumors in China

Shots: The company has initiated a P-I open-label study to evaluate the safety, tolerability, PK & preliminary efficacy of HMPL-295 & to determine MTD and RP2D in patients with advanced malignant solid tumors. The 1st patient has been dosed on 02 Jul, 2021 Following the initial dose-escalation stage, 10 to 15 patients will enroll at …

Hutchmed Initiates P-I Trial of HMPL 295 for the Treatment of Advanced Solid Tumors in China Read More »

Cardiff Oncology Reports First Patient Dosing in P-II Trial for Onvansertib + Irinotecan and 5-FU as a 2L Treatment for Metastatic Pancreatic Ductal Adenocarcinoma

Shots: The first patient has been dosed in a P-II study evaluating the safety & preliminary efficacy of onvansertib + Irinotecan and 5-FU in ~40 patients as a 2L treatment for metastatic PDAC who have failed 1L gemcitabine-based therapy across 6 sites in the US The 1EPs of the study is ORR and 2EPs include …

Cardiff Oncology Reports First Patient Dosing in P-II Trial for Onvansertib + Irinotecan and 5-FU as a 2L Treatment for Metastatic Pancreatic Ductal Adenocarcinoma Read More »

Regeneron and Sanofi Present Positive Results of Libtayo (cemiplimab) from P-III Trial for Cervical Cancer at ESMO2021

Shots: The P-III trial involves assessing libtayo (300mg, IV, q3w) as monothx. vs CT in patients with recurrent or metastatic cervical cancer that has progressed on platinum-based CT. The companies expect the regulatory submission in 2021 The results demonstrated a 31% reduction in the risk of death in the total population, improvement in OS, PFS, …

Regeneron and Sanofi Present Positive Results of Libtayo (cemiplimab) from P-III Trial for Cervical Cancer at ESMO2021 Read More »

Innovent Reports First Patient Dosing in P-II Trial of IBI302 for Neovascular Age-Related Macular Degeneration

Shots: The first patient has been dosed in the P-II trial assessing IBI302 in patients with active subfoveal or parafoveal choroidal neovascularization secondary to nAMD. The primary objective is to evaluate the efficacy and safety of IBI302 The two P- I studies of IBI302 (single/multiple-dose escalation) showed improvement in visual acuity with a reduction in …

Innovent Reports First Patient Dosing in P-II Trial of IBI302 for Neovascular Age-Related Macular Degeneration Read More »

Alphamab and Pfizer Initiate P-II Trial Evaluating KN046 + Inlyta (axitinib) as a 1L Treatment of Non-Small Cell Lung Cancer

Shots: The P-II trial will evaluate the efficacy, safety, and tolerability of KN046 + Pfizer’s Inlyta (axitinib) as a 1L treatment of NSCLC. The 1EPs of the study are ORR The P-II trial of KN046 for advanced NSCLC has demonstrated superior tolerability, safety, as well as PFS and OS. Following the results, the companies have …

Alphamab and Pfizer Initiate P-II Trial Evaluating KN046 + Inlyta (axitinib) as a 1L Treatment of Non-Small Cell Lung Cancer Read More »

BeiGene Reports Results of Brukinsa (zanubrutinib) in P-III Head-to-Head APSEN Trial for R/R Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Shots: The P-III head-to-head APSEN trial involves assessing Brukinsa (160 mg, PO, bid) vs ibrutinib (420 mg, PO, qd) in 652 patients with r/r CLL or SLL, until disease progression or unacceptable toxicity The interim analysis of the trial met its 1EP & pre-specified 2EPs i.e superior ORR & lower risk of atrial fibrillation or …

BeiGene Reports Results of Brukinsa (zanubrutinib) in P-III Head-to-Head APSEN Trial for R/R Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Read More »

Organicell Reports the Expansion of its Trial for Zofin to Treat COVID-19 Patients in India

Shots: The company reported the positive results of the initial trial for Zofin in the first 10 COVID-19 patients treated with Zofin in India. The trial is being conducted with CWI India and showed all patients have recovered from their symptoms and were discharged from the hospital Based on the positive results, the trial will …

Organicell Reports the Expansion of its Trial for Zofin to Treat COVID-19 Patients in India Read More »

COVID-19 Treatment Trial Reaches Out to Communities of Color

An ongoing problem in clinical trials over the years has been a failure to procure diverse enough representation among the participants. For a long time, this was due to bias and oversight on the part of the research community, and the consequence was a lack of full understanding in how medications and treatments affected women …

COVID-19 Treatment Trial Reaches Out to Communities of Color Read More »

Pfizer and BioNTech Initiate COVID-19 Vaccine Trial in Children Under 12

Shots: The companies have started testing BNT162b2 in children aged 6-11yrs. with initial results anticipated in H2’21. The companies are planning to expand the vaccination to that age range by early 2022 The companies plan to initiate the safety of BNT162b2 (10/20/30µg) vs PBO in P-I/II trial in 144-participant Pfizer and BioNTech later plan to …

Pfizer and BioNTech Initiate COVID-19 Vaccine Trial in Children Under 12 Read More »

Regeneron and Sanofi Report Results of Libtayo (cemiplimab) in P-III Trial for Cervical Cancer

Shots: The P-III trial involves assessing Libtayo (300mg, IV, q3w) as monothx. vs CT in patients with recurrent or metastatic cervical cancer that has progressed on platinum-based CT. The trial enrolled patients regardless of their PD-L1 status The results demonstrated a 31% reduction in the risk of death in the total population, improvement in OS, …

Regeneron and Sanofi Report Results of Libtayo (cemiplimab) in P-III Trial for Cervical Cancer Read More »

Sanofi and Translate Bio Initiate P-I/II Study of MRT5500 Against COVID-19

Shots: The companies reported the initiation of P-I/II trial to evaluate the safety, tolerability, and immunogenicity of MRT5500 (1 or 2doses given 21 days apart) vs PBO in ~415 healthy adults aged ≥18yrs. with its expected interim results in Q3’21 The study will evaluate three different dose levels of MRT5500 (15/45/135µg). The preclinical data of …

Sanofi and Translate Bio Initiate P-I/II Study of MRT5500 Against COVID-19 Read More »

Gilead Present Results of Lenacapavir in P-II/III CAPELLA Trial for the Treatment of HIV at CROI

Shots: The P-II/III CAPELLA trial involves assessing lenacapavir (SC, every 6mos.) vs PBO in 36 participants in a ratio (2:1) with multi-drug resistant HIV-1 infection The study demonstrated virologic suppression @26wks., viral load reduction from baseline of ≥ 0.5 log10 copies/mL for 14days functional monothx. period (88% vs 17), low (150 mg/kg) and high dose …

Gilead Present Results of Lenacapavir in P-II/III CAPELLA Trial for the Treatment of HIV at CROI Read More »

Alteogen Reports Completion of P-I Study of ALT-L9 (biosimilar, aflibercept) in Korea

Shots: The company has completed a P-I trial that assessed ALT-L9 vs Eylea in 28 patients in a ratio (1:1) with neovascular (wet) AMD. The trial was conducted at 4 major hospitals in Korea The safety & efficacy of ALT-L9 were similar to Eylea and the results showed similar improvement effects in BCVA and CST. …

Alteogen Reports Completion of P-I Study of ALT-L9 (biosimilar, aflibercept) in Korea Read More »

Lee’s Pharma to Initiate P-III Trial of Socazolimab as 1L Treatment of Extensive-stage Small-Cell Lung Cancer

Shots: The NMPA has approved Lee pharma to initiate P-III clinical trials to evaluate Socazolimab + CT as a 1L treatment of ES-SCLC. The study is expected to initiate patient recruitment in Q2’21 The clearance is based on the results from P- Ib trial in which Socazolimab + carboplatin and etoposide demonstrated a promising efficacy …

Lee’s Pharma to Initiate P-III Trial of Socazolimab as 1L Treatment of Extensive-stage Small-Cell Lung Cancer Read More »

Lilly Reports Results of Tirzepatide in P-lll SURPASS-2 Trial for Type-2 Diabetes

Shots: The P-III SURPASS-2 trial involves assessing Tirzepatide (5/10/15mg) vs Semaglutide (1mg) in 1,879 patients in a ratio (1:1:1:1) with T2D inadequately controlled with ≥1500 mg/day metformin alone for 40wks. Results: A1C reduction: (-2.09% /-2.37%/-2.46% vs- 1.86%); Weight reduction: (-7.8/-10.3/-12.4kg vs -6.2 kg); patients achieving A1C <7% (5.5%/88.9%/ 92.2% vs 81.1%); patients achieving A1C <5.7% …

Lilly Reports Results of Tirzepatide in P-lll SURPASS-2 Trial for Type-2 Diabetes Read More »

AstraZeneca and Amgen Report Results of Tezepelumab in P-III NAVIGATOR Trial for Severe Asthma

Shots: The P-III NAVIGATOR study involves assessing Tezepelumab + SOC vs PBO + SOC in 1061 adults (18–80yrs.) & adolescents (12–17yrs.) with severe, uncontrolled asthma, who were receiving treatment with medium/high dose ICS + at least 1 additional controller medication with/ out OCS The trial met its 1EPs i.e. 56% reduction in AAER @52wks. in …

AstraZeneca and Amgen Report Results of Tezepelumab in P-III NAVIGATOR Trial for Severe Asthma Read More »

Regeneron Reports IDMC Clearance of Efficacy for REGEN-COV (Casirivimab + Imdevimab) in P-III COVID-19 Outpatient Outcomes Trial

Shots: Regeneron reported changes to the P-III study assessing REGEN-COV in non-hospitalized patients with COVID-19, following recommendations from the IDMC The IDMC found clear clinical efficacy in reducing the rate of hospitalization and death with both doses (1,200 & 2,400 mg) of REGEN-COV vs PBO. The company will immediately stop enrolling patients in the PBO …

Regeneron Reports IDMC Clearance of Efficacy for REGEN-COV (Casirivimab + Imdevimab) in P-III COVID-19 Outpatient Outcomes Trial Read More »

Takeda Report Results of TAK-620 (maribavir) in P-III SOLCTICE Trial for the Treatment of Post-Transplant Patients with Cytomegalovirus Infection

Shots: The P-III TAK-620-303 (SOLSTICE) trial involves assessing TAK-620 (400mg) vs conventional antiviral therapies (IAT) in HCT and SOT recipients in a ratio (2:1) with R/R CMV infection refractory with/ out resistance, to one or a combination of the conventional antiviral therapies The 1EPs study shows confirmed CMV viremia clearance @ 8wk; (55% vs 26.1% …

Takeda Report Results of TAK-620 (maribavir) in P-III SOLCTICE Trial for the Treatment of Post-Transplant Patients with Cytomegalovirus Infection Read More »

Covaxx Initiates P-II Trial of UB-612 Against COVID-19 in Taiwan

Shots: The Taiwan Ministry of Health and Welfare granted conditional approval to initiate P-II trial of UB-612 in 3,850 subjects including adolescents, adults, and seniors across 11 medical centers and hospitals in Taiwan Additionally, Covaxx collaborated with UNMC to conduct clinical trials in the US, and with Dasa S.A. to conduct P-II/III study and distribute …

Covaxx Initiates P-II Trial of UB-612 Against COVID-19 in Taiwan Read More »

Clover and Dynavax Plan to Initiate P-II/III Trial for Adjuvanted COVID-19 Vaccine Candidate

Shots: Clover plans to initiate a global P-II/III efficacy trial with the S-Trimer COVID-19 vaccine candidate adjuvanted with CpG 1018 plus alum in the H1’2021 with an interim analysis for vaccine efficacy potentially in the middle of 2021 Additionally, Clover discontinued their partnership with GSK to evaluate the S-Trimer vaccine candidate with GSK’s pandemic adjuvant …

Clover and Dynavax Plan to Initiate P-II/III Trial for Adjuvanted COVID-19 Vaccine Candidate Read More »

Johnson & Johnson Report Results from P-III ENSEMBLE Trial for COVID-19 Vaccine

Shots: The P-III ENSEMBLE trial to evaluate the efficacy and safety of Janssen’s COVID-19 vaccine candidate in protecting mod-to-severe COVID-19 in 43,783 participants accruing 468 symptomatic cases with assessment of efficacy as of day 14 and as of day 28 as co-primary endpoints Results: The level of protection against mod-to-severe COVID-19 infection was 72% in …

Johnson & Johnson Report Results from P-III ENSEMBLE Trial for COVID-19 Vaccine Read More »

Zydus Cadila Seeks Approval to Commence P-III Clinical Study of ZyCoV-D

Shots: The company reported that the COVID-19 vaccine is safe, well-tolerated & immunogenic in the P-I/II study & plans to initiate P-III clinical trial in ~30000 volunteers upon receiving necessary approvals The P-II study of ZyCoV-D had been conducted in ~1000 healthy adult volunteers as part of the adaptive P-I/II dose-escalation study The trial has …

Zydus Cadila Seeks Approval to Commence P-III Clinical Study of ZyCoV-D Read More »

Regeneron’s Antibody Cocktail Demonstrate Promising Results in Hospitalized Patients on Low-Flow Oxygen

Shots: The company reported encouraging initial data from an ongoing P-I/II/III trial of its casirivimab + imdevimab (8,000/2,400mg) in hospitalized COVID-19 patients requiring low-flow oxygen. The results passed the futility analysis as seronegative patients treated with the Ab cocktail had a lower risk of death or receiving mechanical ventilation In seronegative patients, the cocktail reduced …

Regeneron’s Antibody Cocktail Demonstrate Promising Results in Hospitalized Patients on Low-Flow Oxygen Read More »

AstraZeneca’s Tezepelumab Fails to Meet its Primary Endpoint in P-III SOURCE Study for Asthma

Shots: The P-III SOURCE study involves assessing Tezepelumab (210mg, q4w) vs PBO in 150 adult patients as add-on therapy with patients maintained on their currently prescribed ICS + LABA, with/ out other asthma controller therapy for 48wks. The trial did not meet its 1EPs i.e., reduction in the daily OCS dose, without loss of asthma …

AstraZeneca’s Tezepelumab Fails to Meet its Primary Endpoint in P-III SOURCE Study for Asthma Read More »

reMYND Commences P-l Study of RES19-T for Alzheimer’s Disease

Shots: The P-l trial will evaluate the safety, tolerability, and PK of ReS19-T for the treatment of AD. In preclinical studies, ReS19-T has shown to robustly restore synaptic plasticity with an acute response and improve inflammation and AD pathology over a longer treatment duration reMYND has a broad pipeline of novel programs in development, with …

reMYND Commences P-l Study of RES19-T for Alzheimer’s Disease Read More »

Member of COVID R&D Alliance Report the First Patient Enrollment in COMMUNITY Study

Shots: Amgen, UCB, and Takeda reported that the first patient has been enrolled in the COMMUNITY trial. The study will test whether Amgen’s Otezla, Takeda’s lanadelumab, and UCB’s zilucoplan can reduce the severity of COVID-19 in hospitalized patients by moderating the immune system’s response to the disease The focus of the trial is to identify …

Member of COVID R&D Alliance Report the First Patient Enrollment in COMMUNITY Study Read More »

AstraZeneca’s AZD1222 Meets its Primary Endpoint in Preventing COVID-19

Shots: Interim analysis results of COV002 & COV003 study of AZD1222 in the UK & Brazil showed the vaccine is effective in preventing COVID-19 and no hospitalizations/ severe cases of the disease were reported One dosing regimen showed an efficacy of 90% when AZD1222 was given as a half dose, followed by a full dose …

AstraZeneca’s AZD1222 Meets its Primary Endpoint in Preventing COVID-19 Read More »

AstraZeneca and Amgen Report Results of Tezepelumab in P-III NAVIGATOR for Asthma

Shots: The P-III NAVIGATOR study involves assessing Tezepelumab + SOC vs pbo + SOC in adults (18–80yrs.) & adolescents (12–17yrs.) with severe, uncontrolled asthma, who were receiving treatment with medium/high dose ICS + at least 1 additional controller medication with or without OCS Trial met its 1EPs i.e. reduction in AAER @52wks. in the overall …

AstraZeneca and Amgen Report Results of Tezepelumab in P-III NAVIGATOR for Asthma Read More »

Celltrion Reports Results of CT-P59 in P-I Study for COVID-19

Shots: The P-I clinical trial involves assessing CT-P59 (20/40/80 mg/kg) vs PBO in 18 patients with mild symptoms of SARS-COV-2 infection who were randomized into 3 cohorts Results: patients demonstrated a 44% reduction in mean clinical recovery time, while no patients required hospitalization or antiviral therapy Celltrion has submitted the IND application for the clinical …

Celltrion Reports Results of CT-P59 in P-I Study for COVID-19 Read More »

UnitedHealth must reprocess thousands of illegally denied mental health claims, judge orders

In a trial last year, a federal judge found that a UnitedHealth subsidiary had illegally denied mental health and substance use disorder claims. The same judge has now ordered the payer to reprocess all the claims and reform its guidelines.

Boehringer Ingelheim Initiates P-II Study of BI 764198 for Patients with Severe Respiratory Illness from COVID-19

Shots: The P-II trial will assess BI 764198 (qd for ~4wks.) in patients hospitalized for COVID-19 with expected enrollment initiation in Oct’2020. The 1EPs will be the percentage of patients who are alive and free of mechanical ventilation at day 29 of treatment while other EPs include clinical improvement, oxygen saturation & ICU admission The …

Boehringer Ingelheim Initiates P-II Study of BI 764198 for Patients with Severe Respiratory Illness from COVID-19 Read More »

AstraZeneca’s Forxiga (dapagliflozin) Receive NMPA’s Approval for Label Update to Include Data of P-III DECLARE-TIMI 58 Study

Shots: The updated label includes P-III DECLARE-TIMI 58 study that assesses the effect of Forxiga vs PBO on CV outcomes in 17000+ patients with T2D at risk of CV events also assessed key renal 2EPs, across 882 sites in 33 countries The study demonstrated that Forxiga achieved a significant reduction in the composite EP of …

AstraZeneca’s Forxiga (dapagliflozin) Receive NMPA’s Approval for Label Update to Include Data of P-III DECLARE-TIMI 58 Study Read More »

Daiichi Sankyo Initiates P-I Study of DS-1055 for Relapsed/Refractory Advanced or Metastatic Solid Tumors

Shots: The P-I dose-escalation study will assess the safety, tolerability, and preliminary efficacy of DS-1055 in adult patients with r/r advanced or metastatic head and neck, gastric and esophageal cancers, and other tumor types The focus of the study is to determine the maximum tolerated dose and recommended dose of DS-1055 for further study and …

Daiichi Sankyo Initiates P-I Study of DS-1055 for Relapsed/Refractory Advanced or Metastatic Solid Tumors Read More »

Eli Lilly Pauses Enrollment in ACTIV-3 Clinical Trial Due to Safety Concerns

Shots:  The independent DSMB recommended pausing the enrollment of the ACTIV-3 clinical trial. The trial is evaluating Lilly’s bamlanivimab (LY-CoV555, 7000mg) + remdesivir as a treatment for COVID-19 in hospitalized patients, and is sponsored by the NIAID Lilly trusts the judgment & supports independent DSMB decisions to exercise caution in ensuring the safety of the …

Eli Lilly Pauses Enrollment in ACTIV-3 Clinical Trial Due to Safety Concerns Read More »

Sorrento to Initiate P-II Study of STI-5656 (abivertinib maleate) for COVID-19 in Brazil

Shots: The P-II study will evaluate STI-5656 in ~400 patients hospitalized due to COVID-19 having mild, moderate, and severe symptoms. The P-II clinical trials of abivertinib now cleared to proceed in both Brazil and the US The dose to be tested is the same as in the US P-II trial but the trial protocol in …

Sorrento to Initiate P-II Study of STI-5656 (abivertinib maleate) for COVID-19 in Brazil Read More »

BMS Report Results of Opdivo (nivolumab) + CT in P-III CheckMate-816 Trial for Resectable Non-Small Cell Lung Cancer

Shots: The P-III CheckMate-816 study involves assessing of Opdivo (360mg) + CT (q3w for 3 doses) vs CT (q3w for 3 doses), followed by surgery as a neoadjuvant treatment in 358 patients with resectable NSCLC The study met its 1EPs of improved pathologic complete response. The positive results marks the first time an immune checkpoint …

BMS Report Results of Opdivo (nivolumab) + CT in P-III CheckMate-816 Trial for Resectable Non-Small Cell Lung Cancer Read More »

Clover Reports First Patient Dosing in P-III Trial with SCB-808 (biosimilar, etanercept) in China

Shots: The P-III study involves assessing of SCB-808 (SC) vs Enbrel (SC) in patients with ankylosing spondylitis (radiographic axial spondyloarthritis) to evaluate its safety, efficacy and PK The company utilizes its Trimer-Tag technology platform to develop novel therapies targeting trimerization-dependent pathways and is also leveraging its cGMP biomanufacturing capabilities to develop biosimilars SCB-808 is mAb …

Clover Reports First Patient Dosing in P-III Trial with SCB-808 (biosimilar, etanercept) in China Read More »

Clover Reports Dosing of SCB-808 (biosimilar, etanercept) in P-III Trial in China

Shots: The P-III study involves assessing of SCB-808 vs Enbrel in patients with AS (axSpA) via SC administration SCB-808 is being developed in the prefilled syringe formulation which is ready for injection and can be self-administered by the patients, thus overwhelming the current Enbrel biosimilar which are available in lyophilized powder formulation in China Clover …

Clover Reports Dosing of SCB-808 (biosimilar, etanercept) in P-III Trial in China Read More »