Clinical Trials

Genentech Presents Results of Two-Year Data for Evrysdi (risdiplam) in Infants with Type 1 SMA at AAN2021

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Shots: The 2-year data from Part 2 of P-II/III FIREFISH study involves assessing Evrysdi in 41 infants aged 1-7mos. with symptomatic Type 1 SMA Results: improvement in maintained motor function b/w 12-24mos., babies were able to sit without support for at least 5sec. after 24mos.… Read More »Genentech Presents Results of Two-Year Data for Evrysdi (risdiplam) in Infants with Type 1 SMA at AAN2021

Innovent and Lilly Present Results of Tyvyt (sintilimab) in P-III ORIENT-3 Trial as 2L Treatment for Advanced or Metastatic Squamous NSCLC at AACR 2021

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Shots: The P-III ORIENT-3 trial involves assessing the efficacy and safety of Tyvyt (sintilimab) vs docetaxel (q3w) in 290 patients in a ratio (1:1) as a 2L treatment for advanced or m-sqNSCLC The trial met its 1EP i.e improvement in OS, mOS (11.79 vs 8.25… Read More »Innovent and Lilly Present Results of Tyvyt (sintilimab) in P-III ORIENT-3 Trial as 2L Treatment for Advanced or Metastatic Squamous NSCLC at AACR 2021

BMS Presents Results of Opdivo (nivolumab) + CT in P-III CheckMate-816 Trial for Resectable NSCLC at AACR2021

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Shots: The P-III CheckMate-816 study involves assessing Opdivo (360mg) + CT (q3w for 3 doses) vs CT, followed by surgery as a neoadjuvant treatment in 358 patients with resectable stage Ib to IIIa NSCLC The study met its 1EPs, i.e. improvement in pCR (24% vs… Read More »BMS Presents Results of Opdivo (nivolumab) + CT in P-III CheckMate-816 Trial for Resectable NSCLC at AACR2021

Bayer Reports Results of Aliqopa (copanlisib) + Rituximab in P-III CHRONOS-3 Study for Relapsed Indolent Non-Hodgkin’s Lymphoma

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Shots: The P-III CHRONOS-3 study involves assessing Aliqopa (IV) + rituximab vs PBO + rituximab in 458 patients with relapsed iNHL in extending PFS who have received at least one or more lines of prior rituximab-containing treatment Results: @median follow-up of 19.2mos., mPFS (21.5 vs… Read More »Bayer Reports Results of Aliqopa (copanlisib) + Rituximab in P-III CHRONOS-3 Study for Relapsed Indolent Non-Hodgkin’s Lymphoma

Daiichi Sankyo Initiates P-II Trial of Pexidartinib for Tenosynovial Giant Cell Tumor in Japan

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Shots: The first patient has been dosed in a P-II two-part OLE study that assesses the safety, efficacy, and PK of Pexidartinib {800mg/day (400mg, bid on an empty stomach)} in ~18 patients with symptomatic TGCT associated with severe morbidity or functional limitation and not amenable… Read More »Daiichi Sankyo Initiates P-II Trial of Pexidartinib for Tenosynovial Giant Cell Tumor in Japan

AstraZeneca’s Farxiga (dapagliflozin) Fails to Meet its Primary Endpoint in P-III DARE-19 Trial for COVID 19

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Shots: The P-III DARE-19 trial involves assessing the efficacy and safety of Farxiga vs PBO in addition to SoC therapy in 1,250 hospitalized patients with COVID-19 who are at high risk of developing serious complications The trial fails to meet its 1EP of prevention measures… Read More »AstraZeneca’s Farxiga (dapagliflozin) Fails to Meet its Primary Endpoint in P-III DARE-19 Trial for COVID 19

Roche Report Results of Ab Cocktail (Casirivimab + Imdevimab) in P-III REGN-COV 2069 Trial for Symptomatic COVID 19 Infection

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Shots: The P-III REGN-COV 2069 trial involves assessing the efficacy and safety of Ab cocktail (casirivimab (1200 mg, SC) + imdevimab (1200 mg, SC) vs PBO in 1,505 people to prevent symptomatic infection in household contacts of individuals infected with COVID-19 The trial met its… Read More »Roche Report Results of Ab Cocktail (Casirivimab + Imdevimab) in P-III REGN-COV 2069 Trial for Symptomatic COVID 19 Infection

How eConsent empowers more participant engagement in clinical trials

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Creating the simplest process for informed consent benefits the potential participant by allowing them the time and resources to understand fully what they are consenting to. Through eConsent processes, research also opens the door to a more diverse population to engage in trials.

Merck Report Results of Keytruda (pembrolizumab) in P-III KEYNOTE-564 Trial as Adjuvant Treatment for Renal Cell Carcinoma

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Shots: The P-III KEYNOTE-564 trial involves assessing Keytruda (200 mg, IV, on day1 of each 3wks. cycle for up to 17 cycles) as adjuvant therapy vs PBO in 950 patients with RCC, following nephrectomy and resection of metastatic lesions The study showed improvement in 1EPs… Read More »Merck Report Results of Keytruda (pembrolizumab) in P-III KEYNOTE-564 Trial as Adjuvant Treatment for Renal Cell Carcinoma

Lilly and Incyte Report Results of Baricitinib in P-III COV-BARRIER Study for Hospitalized Patients with COVID-19

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Shots: The P-III COV-BARRIER study evaluating Baricitinib (4 mg, qd) + SoC (corticosteroids, antimalarials, antivirals, azithromycin) vs PBO + SoC in 1525 patients hospitalized with COVID-19. The patients treated with baricitinib in addition to SoC includes 79% receiving corticosteroids and 19% receiving remdesivir, with some… Read More »Lilly and Incyte Report Results of Baricitinib in P-III COV-BARRIER Study for Hospitalized Patients with COVID-19

Daiichi Sankyo Reports First patient Dosing in P- I/II Trial of DS-1594 to Treat Acute Myeloid Leukemia and Acute Lymphoblastic Leukemia

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Shots: MD Anderson will sponsor and lead P-I/II study to assess DS-1594 as monothx. and in combination regimens for patients with r/r AML and ALL The 1EPs of the P-I part of the study is to determine the maximum tolerated dose and RP2D of DS-1594… Read More »Daiichi Sankyo Reports First patient Dosing in P- I/II Trial of DS-1594 to Treat Acute Myeloid Leukemia and Acute Lymphoblastic Leukemia

Cardinal Health and Deep Lens Collaborate for AI-based Oncology Clinical Trial Matching

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What You Should Know: – Today, Deep Lens and Cardinal Health announced a strategic collaboration that will integrate Deep Lens’ AI-based clinical trial matching solution, VIPER, into community-based oncology practices throughout the Cardinal network. VIPER will be a part of Cardinal Health’s new Navista advanced… Read More »Cardinal Health and Deep Lens Collaborate for AI-based Oncology Clinical Trial Matching

Horizon Presents Results of Uplizna (inebilizumab-cdon) in N-MOmentum Trial for NMOSD at AAN 2021

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Shots: The company reported the data from the N-MOmentum trial involves assessing Uplizna in patients with NMOSD The results from the N-MOmentum trial demonstrated a reduction in pain, long-term safety, and efficacy outcomes. Additional results from the new survey demonstrated NMOSD patient attitudes towards diagnosis… Read More »Horizon Presents Results of Uplizna (inebilizumab-cdon) in N-MOmentum Trial for NMOSD at AAN 2021

uniQure Reports Completion of Enrollment in First Cohort of P- I/II Trial for AMT-130 to Treat Huntington’s Disease

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Shots: The company has completed the enrollment in the first cohort of P- I/II trial involves assessing AMT-130 in 10 patients, out of which six patients received treatment with AMT-130 and four patients received imitation surgery for early manifest HD The company plans to initiate… Read More »uniQure Reports Completion of Enrollment in First Cohort of P- I/II Trial for AMT-130 to Treat Huntington’s Disease

Acceleron Presents Results of Sotatercept in P-II PULSAR Trial for the Treatment of Pulmonary Arterial Hypertension, Published in NEJM

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Shots: The P-II PULSAR trial involves assessing Sotatercept (0.3 mg/kg or 0.3 mg/kg, SC, q3w) vs PBO in 106 patients in a ratio (3:3:4) with PAH. The results were published in NEJM The results of the P-II PULSAR study that demonstrated sotatercept has the potential… Read More »Acceleron Presents Results of Sotatercept in P-II PULSAR Trial for the Treatment of Pulmonary Arterial Hypertension, Published in NEJM

Revance Presents Results of DaxibotulinumtoxinA for Injection in P-III ASPEN-1 Trial for the Treatment of Cervical Dystonia at AAN2021

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Shots: The P-III ASPEN-1 trial evaluating the efficacy and safety of DaxibotulinumtoxinA (either 125 unit or 250 unit dose) for injection vs PBO in adults with cervical dystonia, patients followed for a maximum of 36 wks in post-treatment The results showed median duration effect of… Read More »Revance Presents Results of DaxibotulinumtoxinA for Injection in P-III ASPEN-1 Trial for the Treatment of Cervical Dystonia at AAN2021

Janssen and SpringWorks Reports Dosing of First Patient in P-Ib trial for Nirogacestat + Teclistamab to Treat Relapsed or Refractory Multiple Myeloma

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Shots: The first patient has been dosed in P-Ib trial evaluating SpringWorks’ Nirogacestat (GSI) + Janssen’s Teclistamab (Ab targeting BCMA and CD3) in patients with r/r MM. Janssen assumes all costs of study & other expenses related to the supply of nirogacestat In preclinical models,… Read More »Janssen and SpringWorks Reports Dosing of First Patient in P-Ib trial for Nirogacestat + Teclistamab to Treat Relapsed or Refractory Multiple Myeloma

Alnylam Report Results of Lumasiran in P-III ILLUMINATE-A Study for Primary Hyperoxaluria Type 1, Published in NEJM

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Shots: The P-III ILLUMINATE-A Study involves assessing Lumasiran vs PBO in 39 patients with age 6 or older in a ratio (2:1) for PH1 The study met its 1EPs demonstrated a 53.5% reduction in urinary oxalate excretion from baseline to 6 mos. i.e. change in… Read More »Alnylam Report Results of Lumasiran in P-III ILLUMINATE-A Study for Primary Hyperoxaluria Type 1, Published in NEJM

Janssen Taps Komodo Health to Optimize Site Selection and Patient Recruitment for Clinical Trials

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What You Should Know: – Komodo Health today announced a new client engagement with Janssen solidifying its role as the leading life sciences patient data analytics platform. Janssen Research & Development, LLC (Janssen) will be using Komodo’s real-world data and AI software to accelerate clinical development. Janssen plans… Read More »Janssen Taps Komodo Health to Optimize Site Selection and Patient Recruitment for Clinical Trials

Eli Lilly along with VIR and GSK Report Results of Bamlanivimab + VIR-7831 in P-II BLAZE-4 Study for Low-Risk Adults with COVID

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Shots: The P-II BLAZE-4 study involves assessing bamlanivimab as monothx. and bamlanivimab (700mg) + VIR-7831 (500mg) vs PBO in 1000 participants with symptomatic low-risk COVID-19 in the outpatient setting across the US and Puerto Rico Results: The dual regimen met its 1EPs i.e. 70% relative… Read More »Eli Lilly along with VIR and GSK Report Results of Bamlanivimab + VIR-7831 in P-II BLAZE-4 Study for Low-Risk Adults with COVID

Tetra Bio-Pharma Initiates Additional Studies of ARDS-003 in Neuroinflammation and Antiviral Diseases

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Shots: Tetra and Targeted Pharmaceuticals collaborated with George Mason University NCBID to examine the potential benefits of ARDS-003 in neuroinflammation and other antiviral applications The collaboration with Targeted provides expertise into the areas of drug development to expand the potential Return on Investment of ARDS-003… Read More »Tetra Bio-Pharma Initiates Additional Studies of ARDS-003 in Neuroinflammation and Antiviral Diseases

BMS Report Results of Relatlimab + Opdivo (nivolumab) in P-II/III RELATIVITY-047 Study in Patients with Previously Untreated Metastatic or Unresectable Melanoma

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Shots: The P-II/III RELATIVITY-047 (CA224-047) study involves assessing the FD combination of relatlimab (160 mg) + Opdivo (480mg) vs Opdivo (480mg, IV, q4w) alone in 714 patients in a ratio (1:1) with previously untreated metastatic or unresectable melanoma The study met its 1EPs of the… Read More »BMS Report Results of Relatlimab + Opdivo (nivolumab) in P-II/III RELATIVITY-047 Study in Patients with Previously Untreated Metastatic or Unresectable Melanoma

AstraZeneca updates Covid-19 vaccine data, now showing 76% efficacy

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AstraZeneca’s latest efficacy data for its Covid-19 vaccine are down slightly from the 79% it previously reported. The most recent data will form the basis of an application for emergency use authorization, which the company still expects to file with the FDA in coming weeks.

Pfizer and Myovant Report Results of Relugolix Combination Therapy in P-III LIBERTY Withdrawal Study in Women with Uterine Fibroids

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Shots: The P-III LIBERTY withdrawal study involves assessing Relugolix combination therapy [relugolix (40 mg) + estradiol (1.0mg) & norethindrone acetate (0.5mg)] vs PBO in women with uterine fibroids for 24wks. The study met its 1EPs i.e. achieving the sustained responder rate @76wks. (menstrual blood loss… Read More »Pfizer and Myovant Report Results of Relugolix Combination Therapy in P-III LIBERTY Withdrawal Study in Women with Uterine Fibroids

ProQR Reports Results of QR-421 in P-I/II Stellar Trial for Usher Syndrome

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Shots: The P-I/II Stellar trial involve assessing QR-421a in 20 patients with usher syndrome and non-syndromic retinitis pigmentosa (nsRP) due to USH2A exon 13 mutations for 24mos. Results: QR-421 demonstrated benefit on multiple measures of vision, including best-corrected visual activity (BCVA), static perimetry, and retinal… Read More »ProQR Reports Results of QR-421 in P-I/II Stellar Trial for Usher Syndrome

AstraZeneca Reports Results of AZD1222 in Primary Analysis of P-III Trial for the Prevention of COVID-19

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Shots: The P-III D8110C00001 study involves assessing AZD1222 vs PBO in 32,449 participants in a ratio (2:1) aged ≥18yrs. across 88 trial centers in the US, Peru and Chile to prevent COVID-19. his primary efficacy analysis included the accrual of 190 symptomatic cases of COVID-19… Read More »AstraZeneca Reports Results of AZD1222 in Primary Analysis of P-III Trial for the Prevention of COVID-19

Novo Nordisk Presents Results of Semaglutide in P-IIIa STEP 4 Trial to Treat Obesity at ENDO 2021

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Shots: The P-IIIa STEP 4 trial involves assessing the safety and efficacy of Semaglutide (2.4 mg, SC, qw) vs PBO in adults with obesity for 68wks. The participants who reached the maintenance dose of semaglutide, during a 20wks. run-in period were randomized to either continue… Read More »Novo Nordisk Presents Results of Semaglutide in P-IIIa STEP 4 Trial to Treat Obesity at ENDO 2021

AstraZeneca’s Covid-19 vaccine data may have ‘outdated information,’ NIH cautions

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Federal health authorities say safety observers are concerned AstraZeneca did not release complete information about the efficacy of its Covid-18 vaccine. The company responded by saying its data were from a pre-specified analysis and it will provide the most up to date efficacy data within… Read More »AstraZeneca’s Covid-19 vaccine data may have ‘outdated information,’ NIH cautions

Regeneron Reports Results of REGEN-COV Antibody Cocktail in P-III Trial to Prevent COVID-19

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Shots: The P-III trial involves assessing REGEN-COV (casirivimab & imdevimab, 1200/2400mg, IV) vs PBO in non-hospitalized patients with COVID-19 The trial met its 1EPs i.e. showed a reduction in the risk of hospitalization and death with both doses by 70% /71% respectively and met its… Read More »Regeneron Reports Results of REGEN-COV Antibody Cocktail in P-III Trial to Prevent COVID-19

Roche Pauses Dosing of Tominersen in P-III GENERATION HD1 for Manifest Huntington’s Disease

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Shots: Roche discontinue the dosing in the P-III GENERATION HD1 study that assesses Tominersen (120 mg, every 2mos./120 mg every 4mos., IT) in 791 participants with manifest HD from 18 countries globally The discontinuation is based on the IDMC recommendation on potential benefit/risk profile for… Read More »Roche Pauses Dosing of Tominersen in P-III GENERATION HD1 for Manifest Huntington’s Disease

Roche Reports Results of Tecentriq in P-III IMpower010 Study for Patients with Early Lung Cancer

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Shots: The P-III IMpower010 study involves assessing Tecentriq vs BSC, in 1,005 participants in a ratio (1:1) with stage IB-IIIA NSCLC, following surgical resection and up to 4 cycles of adjuvant CT The study met its 1EPs showed improvement in DFS in PD-L1+ stage II-IIIA… Read More »Roche Reports Results of Tecentriq in P-III IMpower010 Study for Patients with Early Lung Cancer

BioMarin Report Results of Vosoritide in P-III OLE Study for the Treatment of Children with Achondroplasia at ENDO 2021

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Shots: The ongoing P-III OLE study involves assessing Vosoritide (15 mcg/kg) vs PBO in 119 children with achondroplasia. The CHMP opinion is expected in Europe in June 2021 The results demonstrated increased AGV, baseline mean AGV of 4.28 cm/year, sustained restoration of a major portion… Read More »BioMarin Report Results of Vosoritide in P-III OLE Study for the Treatment of Children with Achondroplasia at ENDO 2021

Sarepta Therapeutics Report Results of SRP-9003 for the Treatment of Limb-Girdle Muscular Dystrophy Type 2E

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Shots: The ongoing study involves assessing SRP-9003 (IV, with a one-time infusion) in children aged 4-15yrs. with LGMD2E. The study has cohort 1 (low dose-dose cohort, 1.85×1013 vg/kg) and cohort 2 (high-dose cohort, 7.41×1013 vg/kg), post-treatment biopsies were taken @60days The cohort 1 @24mos. showed… Read More »Sarepta Therapeutics Report Results of SRP-9003 for the Treatment of Limb-Girdle Muscular Dystrophy Type 2E

Sarepta Therapeutics Report Results of SRP-9003 for the Treatment of Limb-Girdle Muscular Dystrophy Type 2E

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Shots: The ongoing study involves assessing SRP-9003 (IV, with a one-time infusion) in children aged 4-15yrs. with LGMD2E. The study has cohort 1 (low dose-dose cohort, 1.85×1013 vg/kg) and cohort 2 (high-dose cohort, 7.41×1013 vg/kg), post-treatment biopsies were taken @60days The cohort 1 @24mos. showed… Read More »Sarepta Therapeutics Report Results of SRP-9003 for the Treatment of Limb-Girdle Muscular Dystrophy Type 2E

Gilead Expands its Collaboration with Novo Nordisk to Evaluate Triple Combination Regimen for Compensated Cirrhosis (F4) due to NASH

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Shots: The companies plan to initiate a P-IIb study assessing NovoNordisk’s semaglutide and FD combination of Gilead’s cilofexor + firsocostat vs PBO in ~440 patients with compensated cirrhosis (F4) due to NASH The trial will evaluate the therapeutic effect on liver fibrosis improvement and NASH… Read More »Gilead Expands its Collaboration with Novo Nordisk to Evaluate Triple Combination Regimen for Compensated Cirrhosis (F4) due to NASH

Gilead Expands its Collaboration with Novo Nordisk to Evaluate Triple Combination Regimen for Compensated Cirrhosis (F4) due to NASH

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Shots: The companies plan to initiate a P-IIb study assessing NovoNordisk’s semaglutide and FD combination of Gilead’s cilofexor + firsocostat vs PBO in ~440 patients with compensated cirrhosis (F4) due to NASH The trial will evaluate the therapeutic effect on liver fibrosis improvement and NASH… Read More »Gilead Expands its Collaboration with Novo Nordisk to Evaluate Triple Combination Regimen for Compensated Cirrhosis (F4) due to NASH

How do you get all the data quality benefits of eCOA in less time and at lower cost?

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Upcoming oncology trial? Which oncology eCOA Package offers the best ability to capture reliable endpoint evidence to increase speed, reduce cost, and ensure consistency across sites and geographies in less time? Find out. Consider these data points: 334 studies 158,000+ patients 67 countries 44,000+ sites… Read More »How do you get all the data quality benefits of eCOA in less time and at lower cost?

Novartis and Molecular Partners Report Inclusion of Ensovibep (MP0420) in NIH-Sponsored ACTIV-3 Trial for the Treatment of COVID 19

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Shots: The P-III ACTIV-3 trial plan to evaluate the safety & efficacy of Ensovibep (MP0420) vs PBO in 300 patients hospitalized with mild to moderate COVID-19. The first patient dosing is anticipated in Q2’21 If the ensovibep treatment has a positive benefit/risk profile, the trial… Read More »Novartis and Molecular Partners Report Inclusion of Ensovibep (MP0420) in NIH-Sponsored ACTIV-3 Trial for the Treatment of COVID 19

BMS Collaborates with Aveo to Evaluate Opdivo (nivolumab) + Fotivda (tivozanib) in P-III Study for Relapsed Renal Cell Carcinoma

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Shots: The P-III TiNivo-2 study involves assessing Fotivda (1.34 mg/qd for 21days followed by 7days off treatment) + Opdivo (480 mg, q4w) in ~326 patients in a ratio (1:1) with advanced r/r metastatic RCC following prior immunotherapy exposure The study plans to enroll patients across… Read More »BMS Collaborates with Aveo to Evaluate Opdivo (nivolumab) + Fotivda (tivozanib) in P-III Study for Relapsed Renal Cell Carcinoma

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

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

Eli Lilly Report Result of Donanemab in P-II TRAILBLAZER-ALZ Study for Alzheimer’s Disease

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Shots: The P-II TRAILBLAZER-ALZ study involves assessing donanemab vs PBO in 272 patients with early symptomatic AD who were selected based on cognitive assessments in conjunction with amyloid plaque imaging and tau staging by PET imaging The study met its 1EPs, showed a slowing of… Read More »Eli Lilly Report Result of Donanemab in P-II TRAILBLAZER-ALZ Study for Alzheimer’s Disease

Roche’s Actemra/RoActemra (tocilizumab) + Veklury Fail to Meet its Primary Endpoints in P-III REMDACTA Study for Patients with Severe COVID-19 Pneumonia

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Shots: The P-III REMDACTA study involves assessing Actemra/RoActemra (tocilizumab) + Veklury (remdesivir) vs PBO + Veklury in hospitalized patients with severe COVID-19 pneumonia receiving SOC The study did not meet its 1EPs i.e. improvement in time to hospital discharge up to day28 and failed to… Read More »Roche’s Actemra/RoActemra (tocilizumab) + Veklury Fail to Meet its Primary Endpoints in P-III REMDACTA Study for Patients with Severe COVID-19 Pneumonia

Elli Lilly Reports Results of Bamlanivimab (LY-CoV555) and Etesevimab (LY-CoV016) in P-III BLAZE-1 Study for the Prevention of COVID-19

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Shots: The P-III BLAZE-1 study involves assessing Bamlanivimab (700 mg) + Etesevimab (1400 mg) vs PBO in 769 COVID-19 patients aged ≥12yrs. who are at high risk for progressing to severe COVID-19 and/or hospitalization The results demonstrated an 87% reduction in hospitalizations and death with… Read More »Elli Lilly Reports Results of Bamlanivimab (LY-CoV555) and Etesevimab (LY-CoV016) in P-III BLAZE-1 Study for the Prevention of COVID-19

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

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

ViiV Healthcare Presents Results of GSK3640254 (GSK’254) in P-IIa study for the Treatment of HIV at CROI

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Shots: The P-IIa POC study involves assessing GSK3640254 (GSK’254, qd) in 34 treatment-naïve adults with HIV. The study is divided into 2 parts- in part 1, patients received GSK’254 (10/200mg) vs PBO for 10days and in part 2, patients got GSK’254 (40/80140 mg) vs PBO… Read More »ViiV Healthcare Presents Results of GSK3640254 (GSK’254) in P-IIa study for the Treatment of HIV at CROI

Gilead Presents Four-Year Data of Biktarvy for HIV-1 in Treatment-Naïve Adults at CROI 2021

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Shots: The two OLE P-III 1489 and 1490 studies assessing Biktarvy (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg) vs dolutegravir-containing triple for the treatment of HIV-1 in treatment naïve adults The study demonstrated the sustained efficacy & safety profile with no treatment-emergent resistance @144wks,… Read More »Gilead Presents Four-Year Data of Biktarvy for HIV-1 in Treatment-Naïve Adults at CROI 2021

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

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

ViiV Healthcare Present Results of Long- Acting Cabotegravir and Rilpivirine in P-IIIb ATLAS-2M Study for HIV at CROI 2021

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Shots: The P- IIIb ATLAS-2M study involves assessing long-acting cabotegravir and rilpivirine regimen for the treatment of HIV The ATLAS-2M 96wks. data reinforce the 1EPs @48wks. demonstrated the efficacy of every 2mos. dosing (q8w) was non-inferior to monthly dosing (q4w) dosing with (2.1% & 1.1%)… Read More »ViiV Healthcare Present Results of Long- Acting Cabotegravir and Rilpivirine in P-IIIb ATLAS-2M Study for HIV at CROI 2021

BioIntelliSense Partners with Leukemia & Lymphoma Society for Continuous Monitoring in Clinical Trials

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What You Should Know: –BioIntelliSense announced it has entered into a strategic partnership with The Leukemia & Lymphoma Society (LLS) to incorporate the BioSticker™ platform in clinical trials of hematological cancer patients. – The LLS clinical trials will include use of the BioSticker medical device… Read More »BioIntelliSense Partners with Leukemia & Lymphoma Society for Continuous Monitoring in Clinical Trials

Eli Lilly and Incyte Report Results of Olumiant (baricitinib) in P-III BRAVE-AA2 Study for Severe Alopecia Areata

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Shots: The P-III BRAVE-AA2 study involves assessing Baricitinib (2mg & 4mg, qd) vs PBO in 546 adults with a SALT score ≥ 50 (i.e., who had ≥50% scalp hair loss) and a current episode of severe AA lasting at least 6mos. but no >8yrs. The… Read More »Eli Lilly and Incyte Report Results of Olumiant (baricitinib) in P-III BRAVE-AA2 Study for Severe Alopecia Areata

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

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

Vir and GSK Provide Update on ACTIV-3 Trial of VIR-7831 in Hospitalized Adults with COVID-19

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Shots: The DSMB has recommended that the VIR-7831 arm of the trial be closed to enrollment while the data mature. The recommendation was based on pre-planned safety & efficacy data review of the first 300 patients hospitalized with COVID-19 enrolled in ACTIV-3 The companies will… Read More »Vir and GSK Provide Update on ACTIV-3 Trial of VIR-7831 in Hospitalized Adults with COVID-19

Roche Collaborates with Tempest to Evaluate TPST-1120 in a Combination Study as 1L Treatment for Hepatocellular Carcinoma

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Shots: The companies collaborated to evaluate TPST-1120 + Tecentriq (atezolizumab) and Avastin (bevacizumab) in P-Ib/II study in ~60 patients with advanced HCC prior not treated with HCC Tempest will retain the global rights to develop & commercialize TPST-1120 while Roche will manage the study operations… Read More »Roche Collaborates with Tempest to Evaluate TPST-1120 in a Combination Study as 1L Treatment for Hepatocellular Carcinoma

Amgen Reports Results of Blincyto (blinatumomab) in P-III Study for Relapsed Acute Lymphoblastic Leukemia in Pediatric Patients

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Shots: The P-III 20120215 study involves assessing of Blincyto vs SoC consolidation CT before alloHSCT in pediatric patients with high-risk first relapsed B-cell ALL. The findings were published in JAMA Results: @median follow-up 22.4mos., patients that are alive and event-free (69% vs 43%); patients achieved… Read More »Amgen Reports Results of Blincyto (blinatumomab) in P-III Study for Relapsed Acute Lymphoblastic Leukemia in Pediatric Patients

How clinical trial software can be used to optimize clinical trials

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Clinical trial software facilitates clinical trials from conception to finish. For example protocol management, CRF design, metadata management, and the collection, analysis, and submission of compliant clinical study data to regulatory authorities. The aim is to get quality clinical products to the market faster. Traditionally… Read More »How clinical trial software can be used to optimize clinical trials

Veru to Advance VERU-111 in P-III Study for COVID-19 Patients at High Risk for Acute Respiratory Distress Syndrome

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Shots: The US FDA agreed to advance VERU-111 into a P-III study which will evaluate VERU-111 vs PBO in ~400 hospitalized patients in a ratio (2:1) with COVID-19 and are at high risk for ARDS. The study is anticipated to begin in Apr’2021 with clinical… Read More »Veru to Advance VERU-111 in P-III Study for COVID-19 Patients at High Risk for Acute Respiratory Distress Syndrome

Virtual Clinical Trials: The Present And Future Of Pharmaceutical Research

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The lack of patient centricity in traditional clinical trials is known to inhibit trial sponsors to retain enough patients, which is critical to successfully complete safety and efficacy evaluations of novel therapeutic interventions on predetermined completion dates. In addition, the lack of participant compliance in… Read More »Virtual Clinical Trials: The Present And Future Of Pharmaceutical Research

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

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

GSK Report Results of Otilimab in P-II OSCAR Study to Treat Hospitalized Patients with COVID-19

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Shots: The P-IIa POC OSCAR study involves assessing the efficacy and safety of otilimab (90mg, IV) + SOC vs PBO + SOC in 806 hospitalized adults with aged 18-79yrs. with severe COVID-19 related pulmonary disease The study showed a 5.3% overall treatment difference in all… Read More »GSK Report Results of Otilimab in P-II OSCAR Study to Treat Hospitalized Patients with COVID-19

Takeda Reports First Patients Dosing in P-I/II Study of Novavax’s COVID-19 Vaccine Candidate in Japan

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Shots: Takeda is providing rapid & sustained access to COVID-19 vaccines in Japan through partnerships with Novavax and Moderna. Earlier, Takeda has completed enrollment in the P-I/II study of TAK-919 in Japan The studies are designed to include 200 healthy Japanese adults followed by 12mos.… Read More »Takeda Reports First Patients Dosing in P-I/II Study of Novavax’s COVID-19 Vaccine Candidate in Japan

MatriSys Report Results of MSB-0221 in P-I study for the Topical Treatment of Atopic Dermatitis

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Shots: The P-I trial involves assessing MSB-0221 (ShA9) or vehicle applied topically on forearm skin in 54 adults with staphylococcus aureus-positive AD for 1week The expression of mRNA for psmα was inhibited from S. aureus isolated from all participants while the correlation was observed within… Read More »MatriSys Report Results of MSB-0221 in P-I study for the Topical Treatment of Atopic Dermatitis

BMS Expands its Collaboration with Compugen to Evaluate the Combination of COM701 + Opdivo

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Shots: Under the amended agreement, BMS will supply its Opdivo (nivolumab) for Compugen’s P-Ib cohort expansion study to evaluate COM701 in combination with Opdivo in selected cancer indications. The study is expected to be initiated in Q2’21 The P-Ib study will examine fixed doses of… Read More »BMS Expands its Collaboration with Compugen to Evaluate the Combination of COM701 + Opdivo

AbbVie Report Results of Rinvoq (upadacitinib) in Second P-III Induction Study for Ulcerative Colitis

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Shots: The P-III U-ACCOMPLISH induction study involves assessing upadacitinib (45 mg, qd) vs PBO in patients with mod. to sev. UC The study met its 1EPs @8wks. i.e, patients achieved clinical remission (per Adapted Mayo Score) (31% vs 4%); met its 2EPs i.e clinical response… Read More »AbbVie Report Results of Rinvoq (upadacitinib) in Second P-III Induction Study for Ulcerative Colitis

Sanofi and GSK Initiate P-II Study of their Adjuvanted Recombinant Protein-Based COVID-19 Vaccine

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Shots: The companies reported the initiation of a P-II dose-finding study assessing the safety, reactogenicity, and immunogenicity of two injections given 21 days apart in 720 adults aged ≥18yrs. The P-II study assesses the potential for refined antigen formulation to achieve an optimal immune response,… Read More »Sanofi and GSK Initiate P-II Study of their Adjuvanted Recombinant Protein-Based COVID-19 Vaccine

Astellas Reports Results of Fezolinetant in Two P-III Studies for the Nonhormonal Treatment of VMS in Postmenopausal Women

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Shots: The P-III studies SKYLIGHT 1 & 2 involves assessing fezolinetant (30 & 45mg, qd) vs PBO in women with mod. to sev. vasomotor symptoms (VMS) for the first 12wks. followed by 40wks. active treatment extension periods Both the trials met all four co-1EPs demonstrating… Read More »Astellas Reports Results of Fezolinetant in Two P-III Studies for the Nonhormonal Treatment of VMS in Postmenopausal Women

Dermavant Report Results of Tapinarof Cream in P-III PSOARING 3 Study with Durable and Remittive Benefits for Plaque Psoriasis

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Shots: The P-III PSOARING 3 is an OLE study assessing Tapinarof (1%) in patients with plaque psoriasis for ~40wks. and a 4wks. safety follow-up period The interim analyses showed 57.3% of study participants who entered the study with a PGA of ≥ 2 achieved a… Read More »Dermavant Report Results of Tapinarof Cream in P-III PSOARING 3 Study with Durable and Remittive Benefits for Plaque Psoriasis

Myovant and Pfizer Publish the Results of Relugolix Combination Regimen in P-III LIBERTY Studies in NEJM

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Shots: The P-III LIBERTY 1 & 2 studies involve assessing of relugolix (40mg) + estradiol (1.0mg) & norethindrone acetate (0.5mg) vs PBO in women with uterine fibroids The results showed response rates in menstrual blood loss (73.4% & 71.2%) vs (18.9% & 14.7%) @24wks; 84.3%… Read More »Myovant and Pfizer Publish the Results of Relugolix Combination Regimen in P-III LIBERTY Studies in NEJM

Lilly Reports Results of Tirzepatide in P-lll SURPASS-3 and 5 Trials for Type-2 Diabetes

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Shots: The P-lll SURPASS-3 study involves assessing Tirzepatide (5/10/15 mg) vs titrated insulin degludec in 1444 participants in a ratio (1:1:1:1) with T2D treated with metformin with or without an SGLT-2 inhibitor for 52wks. The P-lll SURPASS-5 study involves assessing Tirzepatide (5/10/15 mg) vs PBO… Read More »Lilly Reports Results of Tirzepatide in P-lll SURPASS-3 and 5 Trials for Type-2 Diabetes

Exelixis Report Results of Cabometyx (cabozantinib) in P-II PAPMET Study for Patients with Metastatic Papillary Renal Cell Carcinoma

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Shots: The P-II SWOG S1500/PAPMET trial involves assessing cabometyx (60 mg, qd with dose reductions to 40 & 20mg ), crizotinib, and savolitinib vs sunitinib in a ratio (1:1:1:1) for patients with advanced or metastatic PRCC The results demonstrated significant improvement in PFS. The trial… Read More »Exelixis Report Results of Cabometyx (cabozantinib) in P-II PAPMET Study for Patients with Metastatic Papillary Renal Cell Carcinoma

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

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

Roche Reports Results of Faricimab in Four P-III Studies for Diabetic Macular Edema and Age-Related Macular Degeneration

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Shots: The P-III YOSEMITE & RHINE studies involve assessing faricimab (6mg at personalized dosing intervals of up to 4mos. and at fixed 2mos. intervals) vs aflibercept (2mg, fixed 2mos. intervals) in 1891 patients with DME The P-III TENAYA & LUCERNE studies assessing faricimab (6mg administered… Read More »Roche Reports Results of Faricimab in Four P-III Studies for Diabetic Macular Edema and Age-Related Macular Degeneration

Galapagos and Gilead Discontinue the P-III Trials of Ziritaxestat (GLPG1690) for Idiopathic Pulmonary Fibrosis

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Shots: The P-III program consists of two trials (ISABELA 1 & 2) assessing ziritaxesta (200/ 600mg, qd) + SOC vs PBO + SOC in ~1500 patients with IPF. The 1EPs of the study decline in forced vital capacity until 52wks. The termination of the study… Read More »Galapagos and Gilead Discontinue the P-III Trials of Ziritaxestat (GLPG1690) for Idiopathic Pulmonary Fibrosis

BMS Report Results of Opdivo (nivolumab) + Cabometyx (cabozantinib) in P-III CheckMate -9ER Trial for 1L Treatment of Advanced Renal Cell Carcinoma

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Shots: The P-III CheckMate -9ER trial involves assessing Opdivo + Cabometyx vs sunitinib in 651 patients with previously untreated advanced or metastatic RCC Results: @median follow-up of two years (23.5 mos.); median PFS (17.0 vs 8.3mos.), ORR (54.8% vs. 28.4%); Disease control rate (88.2% vs.… Read More »BMS Report Results of Opdivo (nivolumab) + Cabometyx (cabozantinib) in P-III CheckMate -9ER Trial for 1L Treatment of Advanced Renal Cell Carcinoma

Medidata launches cloud platform to gather clinical trial data from sensors

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Medidata has launched Sensor Cloud, a platform to manage a range of sensor and digital health technology data during clinical trials. The New York-based company, which is a wholly-owned subsidiary of French software firm Dassault Systemes, said the Sensor Cloud integrates Medidata’s existing clinical cloud… Read More »Medidata launches cloud platform to gather clinical trial data from sensors

Medidata Launches Sensor Cloud to Connect Device and Wearables in Clinical Trials

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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… Read More »Medidata Launches Sensor Cloud to Connect Device and Wearables in Clinical Trials

Celltrion’s Regdanvimab (CT-P59) Receives Korean MFDS Conditional Marketing Authorization for COVID-19

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Shots: The CMA is based on P-II/III study assessing CT-P59 vs PBO in patients with COVID-19. The CMA allows the emergency use of CT-P59 in patients aged ≥ 60yrs. with medical condition & mild symptoms of COVID-19, and adult with mod. symptoms of COVID-19 The… Read More »Celltrion’s Regdanvimab (CT-P59) Receives Korean MFDS Conditional Marketing Authorization for COVID-19

Daiichi Sankyo Initiates P-II Study of Patritumab Deruxtecan in Patients with EGFR-Mutated NSCLC

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Shots: The P-II HERTHENA-Lung01 study involves assessing patritumab deruxtecan in 420 patients in a ratio (1:1) with EGFR-mutated m/ LA NSCLC prior treated with TKI and Pt-based CT. The first patient has been dosed in P-II study The 1EPs of P-II study include ORR and… Read More »Daiichi Sankyo Initiates P-II Study of Patritumab Deruxtecan in Patients with EGFR-Mutated NSCLC

BMS’ Deucravacitinib Demonstrate Superiority Over Otezla (apremilast) in P-III POETYK PSO-2 Study for Plaque Psoriasis

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Shots: The P-III POETYK PSO-2 study involves assessing deucravacitinib (6mg, qd) vs PBO & Otezla (30mg, bid) in 1,020 patients with moderate to severe plaque psoriasis The trial met its co-1EPs & 2EPs demonstrating deucravacitinib was superior to Otezla (apremilast) in the patients reaching a… Read More »BMS’ Deucravacitinib Demonstrate Superiority Over Otezla (apremilast) in P-III POETYK PSO-2 Study for Plaque Psoriasis

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

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

Merck’s Report Results of Keytruda (pembrolizumab) in Combination With Ipilimumab vs Keytruda Monotherapy in P-III KEYNOTE-598 for Metastatic Non-Small Cell Lung Cancer Patients

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Shots: The P- III trial involves assessing of Keytruda in combination with ipilimumab vs Keytruda monothx in 568 patients in a ratio (1:1) as 1L treatment for metastatic NSCLC patients without EGFR or ALK genomic tumor aberrations and whose tumors express PD-L1 Results: @ median… Read More »Merck’s Report Results of Keytruda (pembrolizumab) in Combination With Ipilimumab vs Keytruda Monotherapy in P-III KEYNOTE-598 for Metastatic Non-Small Cell Lung Cancer Patients

Janssen Reports Results of Amivantamab in P-I CHRYSALIS Study for Metastatic or Unresectable NSCLC and EGFR Exon 20 Insertion Mutations

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Shots: The P-I CHRYSALIS study involves assessing of amivantamab (RP2D of 1050 mg [1400 mg for a patient weight of ≥80 kg]) as a monothx. and in combination with lazertinib in 460 patients with metastatic or unresectable NSCLC and EGFR exon 20 insertion mutations whose… Read More »Janssen Reports Results of Amivantamab in P-I CHRYSALIS Study for Metastatic or Unresectable NSCLC and EGFR Exon 20 Insertion Mutations

BioInvent Report Results of BI-1206 + Rituximab in P- I/IIa Study for Relapsed or Refractory B-cell Non-Hodgkin’s Lymphoma

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Shots: The P- I/IIa study assess BI-1206 + rituximab in patients with indolent r/r B-cell NHL. The study consists of 2 parts: P- l with dose escalation cohorts using a 3+3 dose-escalation and selection of the recommended RP2D and P-IIa which is an expansion cohort… Read More »BioInvent Report Results of BI-1206 + Rituximab in P- I/IIa Study for Relapsed or Refractory B-cell Non-Hodgkin’s Lymphoma

Regeneron’s REGEN-COV Antibody Cocktail Confirms its Effectiveness Against UK and South Africa SARS-CoV-2 Variants

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Shots: REGEN-COV neutralizes the SARS-CoV-2 B.1.1.7 variants, identified in the UK & SA. The data was included in a bioRxiv paper and submitted for peer-reviewed publication on the changing resistance of SARS-CoV-2 variants to Ab neutralization REGEN-COV retained its neutralizing capability against the B.1.1.7 variant.… Read More »Regeneron’s REGEN-COV Antibody Cocktail Confirms its Effectiveness Against UK and South Africa SARS-CoV-2 Variants

Pfizer’s Xeljanz (tofacitinib) Fails to Meet its Co-Primary Endpoint in ORAL Surveillance Safety Study

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Shots: The post marketing Oral Surveillance involves assessing the safety of tofacitinib at two doses (5 mg, bid and 10mg, bid) vs TNFi in 4362 patients in subjects with RA aged ≥ 50yrs. and had at least one additional CV risk factor The primary analyses… Read More »Pfizer’s Xeljanz (tofacitinib) Fails to Meet its Co-Primary Endpoint in ORAL Surveillance Safety Study

Eli Lilly Collaborates with GSK and VIR to Evaluate Bamlanivimab (LY-CoV555) with VIR-7831 (GSK4182136) for COVID-19

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Shots: Lilly has expanded its ongoing BLAZE-4 trial to assess the administration of bamlanivimab (700mg) with VIR-7831 (500mg) for symptomatic COVID-19 in the outpatient setting. These are two neutralizing Abs that bind to different epitopes of the SARS-CoV-2 spike protein The companies reported the first… Read More »Eli Lilly Collaborates with GSK and VIR to Evaluate Bamlanivimab (LY-CoV555) with VIR-7831 (GSK4182136) for COVID-19

Startup banks on immune-system memory to tackle cancer

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Loki Therapeutics is advancing research that leverages the immune system’s ability to recall childhood vaccinations and direct it against cancer. The company’s lead therapy candidate could enter phase 1 clinical trials this year.

Regeneron Reports Results of REGEN-COV Antibody Cocktail Used as Passive Vaccine to Prevent COVID-19

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Shots: The ongoing P-III trial involves assessing REGEN-COV (casirivimab & imdevimab) in 2000+ participants used as a passive vaccine to prevent COVID-19. An exploratory analysis, conducted on the first ~400 individuals, randomized to receive passive vaccination with REGEN-COV (1200mg, SC) vs PBO Reduction in overall… Read More »Regeneron Reports Results of REGEN-COV Antibody Cocktail Used as Passive Vaccine to Prevent COVID-19

Shionogi Concludes a License Agreement with BioAge for BGE-175 to Control the Aggravation of COVID-19

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Shots: Shionogi to receive an up front, milestones as well as royalties on sales of the therapy. BioAge to get exclusive US and EU rights to develop and commercialize BGE-17 for COVID-19 Additionally, BioAge gets an exclusive right to negotiate a license for additional indications… Read More »Shionogi Concludes a License Agreement with BioAge for BGE-175 to Control the Aggravation of COVID-19

Eli Lilly and AbCellera Report Results of Bamlanivimab (LY-CoV555) and Etesevimab (LY-CoV16) in P-II/III BLAZE-1 Study for Preventing COVID-19

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Shots: The P-II/III BLAZE-1 trial involves assessing of Bamlanivimab + Etesevimab (2800 mg) vs PBO in 1035 patients recently diagnosed with COVID-19 in the ambulatory setting The results demonstrated an 70% reduction in risk of COVID-19 related hospitalizations and deaths in high-risk patients and improvements… Read More »Eli Lilly and AbCellera Report Results of Bamlanivimab (LY-CoV555) and Etesevimab (LY-CoV16) in P-II/III BLAZE-1 Study for Preventing COVID-19

India’s Covid-19 Vaccine Drive Begins

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One of the world’s largest inoculation programs is set to begin on Saturday, but experts have questioned the data behind one of the country’s two vaccines — and patients don’t get to pick their shot.

India’s Covid-19 Vaccine Drive Begins

  • by

One of the world’s largest inoculation programs is set to begin on Saturday, but experts have questioned the data behind one of the country’s two vaccines — and patients don’t get to pick their shot.

Eli Lilly Reports Results of Bamlanivimab (LY-CoV555) in P-III BLAZE-2 Study for Preventing COVID-19 at Nursing Homes

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Shots: The P-III BLAZE-2 COVID-19 prevention trial involves assessing bamlanivimab (4,200mg) vs PBO in residents and staff at skilled nursing and assisted living facilities. The 965 &132 COVID-19 negative & positive participants were included in the analysis of 1EPS & 2EPs for assessing prevention &… Read More »Eli Lilly Reports Results of Bamlanivimab (LY-CoV555) in P-III BLAZE-2 Study for Preventing COVID-19 at Nursing Homes

Merck KGaA and GSK’s Bintrafusp Alfa Fails to Meet its Co-Primary Endpoints in Lung Cancer Study

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Shots: Merck KgaA provides an update on its P-III INTR@PID Lung 037 study and the extensive INTR@PID clinical trial program assessing bintrafusp alfa for patients with BTC and cervical cancer Based on the IDMC’s recommendation, Merck will discontinue the INTR@PID Lung 037 study as it… Read More »Merck KGaA and GSK’s Bintrafusp Alfa Fails to Meet its Co-Primary Endpoints in Lung Cancer Study

Biohaven’s Troriluzole Fails to Meet its Co-Primary Endpoints in P-II/III Study for Alzheimer’s Disease

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Shots: The P-II/III study involves assessing of Troriluzole (qd, PO) vs PBO in 350 patients with mild to mod. AD for up to 48wks. The study missed its co-primary endpoints i.e. ADAS-cog & CDR-SB. The therapy also failed to beat PBO on the 2EPs of… Read More »Biohaven’s Troriluzole Fails to Meet its Co-Primary Endpoints in P-II/III Study for Alzheimer’s Disease

Nanobiotix Presents Results of NBTXR3 (PEP503) in P-Ib/II Study for Rectal Cancer at ASCO-GI 2021

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Shots: The complete dose-finding part of P-Ib/II study assessed the safety, feasibility, and RP2D of NBTXR3 (intratumoral inj.) in 20 patients with LA (T3 to T4) or unresectable rectal cancer The study showed ORR after CCRT in >70% patients, 90% patients underwent total mesorectal excision… Read More »Nanobiotix Presents Results of NBTXR3 (PEP503) in P-Ib/II Study for Rectal Cancer at ASCO-GI 2021

Cardiff Oncology Report Results of Onvansertib in P- Ib/II Study for KRAS-Mutated Metastatic Colorectal Cancer

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Shots: The P-Ib/II study involves assessing of Onvansertib + Folfiri and bevacizumab in 44 patients with 2L treatment of KRAS-mutated mCRC. The company also provided an additional data update from its mCRC clinical program and initial findings from its EAP Out of the 12 P-1b… Read More »Cardiff Oncology Report Results of Onvansertib in P- Ib/II Study for KRAS-Mutated Metastatic Colorectal Cancer

GSK Presents Results of Dostarlimab in P-I GARNET Study for dMMR Solid Cancers at ASCO GI

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Shots: The ongoing P-I GARNET study involves assessing dostarlimab as monothx. in patients with advanced solid tumors. Cohort F of the GARNET trial enrolled patients with dMMR non-endometrial solid cancers in which patients received dostarlimab (500mg, q3w) for four doses and dostarlimab (1000mg, q6w) thereafter… Read More »GSK Presents Results of Dostarlimab in P-I GARNET Study for dMMR Solid Cancers at ASCO GI

India’s Covid-19 Vaccine Drive Begins

  • by

One of the world’s largest inoculation programs is set to begin on Saturday, but experts have questioned the data behind one of the country’s two vaccines — and patients don’t get to pick their shot.

India’s Covid-19 Vaccine Drive Begins

  • by

One of the world’s largest inoculation programs is set to begin on Saturday, but experts have questioned the data behind one of the country’s two vaccines — and patients don’t get to pick their shot.

India’s Covid-19 Vaccine Drive Begins

  • by

One of the world’s largest inoculation programs is set to begin on Saturday, but experts have questioned the data behind one of the country’s two vaccines — and patients don’t get to pick their shot.

India’s Covid-19 Vaccine Drive Begins

  • by

One of the world’s largest inoculation programs is set to begin on Saturday, but experts have questioned the data behind one of the country’s two vaccines — and patients don’t get to pick their shot.