Clinical Trials

To avoid crisis, pharma must address costs

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Scrutiny of drug prices will continue whether Trump or Biden wins. But pharma can take steps to address critics and cut costs before they reach a crisis point, according to a panel of industry experts.

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

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

Lilly Reports Results of Bamlanivimab (LY-CoV555) in P-II BLAZE-1 Study in New England Journal of Medicine

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Shots: The P-II BLAZE-1 study assesses bamlanivimab (700, 2800 & 7000 mg) vs PBO in the outpatient setting in patients with mild or moderate symptoms of COVID-19 as well as a positive SARS-CoV-2 test based on a sample collected no more than 3 days prior… Read More »Lilly Reports Results of Bamlanivimab (LY-CoV555) in P-II BLAZE-1 Study in New England Journal of Medicine

Regeneron Reports Results of REGN-COV2 in P-ll/lll Study in Patients with COVID-19 in Outpatient Setting

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Shots: The P-ll/lll trial involves assessing of REGN-COV2 (8gm/2.4gm) + SOC vs PBO + SOC in 524 patients with mild-to-moderate COVID-19 in an outpatient setting The study met its 1EPs & 2EPs demonstrating a reduction in viral load and patient medical visits. Moreover, Regeneron is… Read More »Regeneron Reports Results of REGN-COV2 in P-ll/lll Study in Patients with COVID-19 in Outpatient Setting

Dermavant Presents Results of Tapinarof in Pivotal P-III PSOARING Program at the 29th EADV Virtual Congress

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Shots: The pivotal P-III clinical program for tapinarof in adult with PsO consists of PSOARING 1 (NCT03956355) and PSOARING 2 (NCT03983980) PSOARING 3 (NCT04053387), an ongoing long-term safety study. Positive results of P-III studies were reported in Aug’2020 Tapinarof previously met the 1EP in separate… Read More »Dermavant Presents Results of Tapinarof in Pivotal P-III PSOARING Program at the 29th EADV Virtual Congress

Medidata Acquires Digital Biomarker Business of MC10 / Clinical Trials & Wearable Sensors

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What You Should Know: – Clinical trials technology company Medidata has acquired the digital biomarker business of MC10. – MC10’s offerings will bring novel clinical analytics and biosensor capabilities to Medidata’s existing technology solutions, enhancing Medidata’s capabilities to integrate data from wearable sensors – including… Read More »Medidata Acquires Digital Biomarker Business of MC10 / Clinical Trials & Wearable Sensors

Novartis Presents Results of Iptacopan (LNP023) in P-ll Study for C3 Glomerulopathy at ASN Annual Meeting 2020

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Shots: The P-II study involves assessing the efficacy, safety and PK of Iptacopan (LNP023) in patients with C3G (Cohort A) and patients who have undergone a kidney transplant and have C3G recurrence (Cohort B), interim results presented at ASN 2020 Result: @12wks., reduction in proteinuria… Read More »Novartis Presents Results of Iptacopan (LNP023) in P-ll Study for C3 Glomerulopathy at ASN Annual Meeting 2020

Sanofi and Regeneron Report Results of Dupixent (dupilumab) in Part A of P-lll Study for Eosinophilic Esophagitis (EoE)

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Shots: Part A of P-lll study involves assessing of Dupixent (qw, 300mg) vs PBO in 81 patients aged≥ 12 yrs. with EoE. The study resulted in meeting its co-primary and all key 2EPs, presented at the virtual ACG 2020 and UEG Week 2020 Results: Patients… Read More »Sanofi and Regeneron Report Results of Dupixent (dupilumab) in Part A of P-lll Study for Eosinophilic Esophagitis (EoE)

Samsung Bioepis Reports Results of Renflexis (biosimilar, infliximab) from Two Studies in IBD Patients

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Shots: The company reported results from two real-world studies of Renflexis (infliximab-abda) in patients with IBD registered in the US Veteran Affairs Healthcare System database. Data were presented at ACG 2020 One study assesses the safety of switching from reference infliximab or infliximab-dyyb to Renflexis… Read More »Samsung Bioepis Reports Results of Renflexis (biosimilar, infliximab) from Two Studies in IBD Patients

Evidera launches OffTheShelf ™ for historic patient data

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Learn more about the detailed patient points and associated physician data available from OffTheShelf. View our infographic. http://bit.ly/evidera-offtheshelf Highlights about OffTheShelf™: Understanding the market trends, market behavior, and competition when developing oncology therapies is critical to optimize market access and product uptake OffTheShelf™ provides access… Read More »Evidera launches OffTheShelf ™ for historic patient data

AstraZeneca Presents Results of Farxiga (dapagliflozin) in P-lll DAPA-CKD Study for Chronic Kidney Disease at ASN Kidney Week 2020

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Shots: The P-lll DAPA-CKD study involves the assessing of Farxiga (qd, 10 mg) + SOC vs PBO in 4304 patients with CKD stages 2-4 and elevated urinary albumin excretion, with/ out T2D Results of subgroup analysis : RRR & ARR (5.8% & 37%) for patients… Read More »AstraZeneca Presents Results of Farxiga (dapagliflozin) in P-lll DAPA-CKD Study for Chronic Kidney Disease at ASN Kidney Week 2020

Boehringer Ingelheim and Eli Lilly Report Results of Jardiance in Adults with HFrEF Regardless of Chronic Kidney Disease Status

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Shots: The companies present the findings from a new exploratory sub-analysis of the P-III EMPEROR-Reduced study demonstrating that Jardiance (empagliflozin) reduced the risk of adverse CV by 25% and kidney events by 50% in adults with HFrEF with/out diabetes regardless of CKD status at ASN… Read More »Boehringer Ingelheim and Eli Lilly Report Results of Jardiance in Adults with HFrEF Regardless of Chronic Kidney Disease Status

Akebia Presents Results of Vadadustat in P-lll INNO2VATE Program for Anemia Due to CKD at ASN Kidney Week

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Shots: The global program includes two P-III studies assessing vadadustat (PO) vs darbepoetin alfa (inj.) in a ratio (1:1) in incident dialysis patients (Correction/Conversion) and prevalent dialysis patients (Conversion), in ~3,923 adult patients on dialysis with anemia due to CKD The presentation expands on previously… Read More »Akebia Presents Results of Vadadustat in P-lll INNO2VATE Program for Anemia Due to CKD at ASN Kidney Week

Sanifit Presents Results of SNF472 for the Treatment of Vascular Calcification at ASN Kidney Week 2020

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Shots: The additional insight from the P-IIb CaLIPSO study showed that SNF472 slowed the progression of CAC across key subgroups of patients on hemodialysis participating in the study. The presentation highlights the PK/PD and exposure-response analyses Sanifit also presents the design of its ongoing P-III… Read More »Sanifit Presents Results of SNF472 for the Treatment of Vascular Calcification at ASN Kidney Week 2020

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

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

Dicerna Presents New Interim Data of PHYOX 3 OLE Study Evaluating Nedosiran for Primary Hyperoxaluria at ASN Week 2020

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Shots: The PHYOX 3 OLE study involves assessing of nedosiran in participants aged ≥6yrs. with PH1 or PH2 who have participated in any previous PHYOX clinical development program trial as well as their siblings aged 6-18yrs. with PH All participants regardless of PH subtype, achieved… Read More »Dicerna Presents New Interim Data of PHYOX 3 OLE Study Evaluating Nedosiran for Primary Hyperoxaluria at ASN Week 2020

ViiV Healthcare Present Results of Long-Acting Cabotegravir and Rilpivirine at IDWeeK 2020

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Shots: The company reported the positive findings of a pooled analysis of six ongoing clinical studies which includes P-IIb/IIIb LATTE-2, ATLAS, ATLAS-2M, FLAIR, POLAR, and CUSTOMIZE studies evaluating long-acting cabotegravir and rilpivirine regimen in 1,744 patients with HIV-1 infection across 16 countries The positive findings… Read More »ViiV Healthcare Present Results of Long-Acting Cabotegravir and Rilpivirine at IDWeeK 2020

FDA Grants AppliedVR Breakthrough Designation for Virtual Reality Chronic Pain Treatment

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What You Should Know: – FDA awards AppliedVR Breakthrough Device designation for treating treatment-resistant fibromyalgia and chronic intractable lower back pain – AppliedVR’s EaseVRx program helps patients learn self-management skills grounded in evidence-based cognitive-behavioral therapy (CBT) principles and other behavioral methods. AppliedVR, a pioneer advancing… Read More »FDA Grants AppliedVR Breakthrough Designation for Virtual Reality Chronic Pain Treatment

Jazz Reports Results of Xywav (calcium, magnesium, potassium, and sodium oxybates) in P-III Study for Cataplexy or EDS in Patients with Narcolepsy

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Shots: The P-III study involves assessing Xywav vs PBO in patients aged ≥ 7yrs. with cataplexy or EDS with narcolepsy Results: study met its 1EPs & 2EPs i.e. differences in median change in a weekly number of cataplexy attacks and ESS scores. Results were published… Read More »Jazz Reports Results of Xywav (calcium, magnesium, potassium, and sodium oxybates) in P-III Study for Cataplexy or EDS in Patients with Narcolepsy

Roche and Prothena to Advance Prasinezumab in P-IIb Study for Patients with Early Parkinson’s Disease

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Shots: The companies will advance the prasinezumab into a P-IIb study in patients with early Parkinson’s disease based on positive signals of efficacy consistent with disease modification in the PASADENA study The study is designed to further assess the efficacy of prasinezumab by expanding upon… Read More »Roche and Prothena to Advance Prasinezumab in P-IIb Study for Patients with Early Parkinson’s Disease

Galapagos & Servier’s GLPG1972/S201086 Fails to Meet its Primary Endpoint in P-II ROCCELLA Study for Knee Osteoarthritis

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Shots: The P-II ROCCELLA is a dose-ranging trial involves assessing GLPG1972/S201086 (PO, qd) in three different doses vs PBO in 932 patients with knee OA for 52wks. across 12 countries including EU, Asia, North and South America. Galapagos is responsible for ROCCELLA in the US,… Read More »Galapagos & Servier’s GLPG1972/S201086 Fails to Meet its Primary Endpoint in P-II ROCCELLA Study for Knee Osteoarthritis

Sanofi and Translate Bio to Advance MRT5500 into Clinical Study Against COVID-19

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Shots: The companies reported the preclinical results of MRT5500 demonstrating the potential of the vaccine in neutralizing the Abs against SARS-CoV-2. The two doses of MRT5500 induced neutralizing antibody levels significantly higher than those observed in COVID-19 patients The preclinical data support the advancement of… Read More »Sanofi and Translate Bio to Advance MRT5500 into Clinical Study Against COVID-19

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

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

Bayer Report 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 of Aliqopa + rituximab vs PBO + rituximab in 458 patients with relapsed indolent NHL who have received at least one or more lines of prior rituximab-containing treatment The P-II study met its 1EP of prolonged PFS, safety… Read More »Bayer Report Results of Aliqopa (copanlisib) + Rituximab in P-III CHRONOS-3 Study for Relapsed Indolent Non-Hodgkin’s Lymphoma

Lilly and Incyte’s Olumiant (baricitinib) Reports Additional Data Demonstrating Reduction in COVID-19 Recovery Time

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Shots: The companies shared the additional efficacy and safety data of the ACTT-2 study demonstrating baricitinib + remdesivir reduced time to recovery and improved clinical outcomes for patients with COVID-19 infection compared with remdesivir as monothx The biggest benefits were observed in patients requiring supplemental… Read More »Lilly and Incyte’s Olumiant (baricitinib) Reports Additional Data Demonstrating Reduction in COVID-19 Recovery Time

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

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

PhaseBio Reports First Patients Dosing in its P-III REVERSE-IT Study of Bentracimab in Canada

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Shots: The company has reported the expansion of its P-III REVERSE-IT study for bentracimab in Canada where the first patients from major health centers globally have been enrolled (approx. 200 patients) and dosed Bentracimab demonstrated sustained reversal of the antiplatelet activity of Brilinta (ticagrelor). In… Read More »PhaseBio Reports First Patients Dosing in its P-III REVERSE-IT Study of Bentracimab in Canada

Amgen Report Results of Sotorasib in P-II CodeBreaK 100 Study for Advanced Non-Small Cell Lung Cancer

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Shots: The P-ll CodeBreaK 100 study involves assessing of Sotorasib (proposed INN for AMG 510, 960mg) in 126 patients with KRAS G12C-mutant advanced NSCLC, whose cancer had progressed despite prior treatment with CT and/or immunotherapy Result: ORR is consistent with previously reported P-I study while… Read More »Amgen Report Results of Sotorasib in P-II CodeBreaK 100 Study for Advanced Non-Small Cell Lung Cancer

Novartis Reports Results of Beovu (brolucizumab) in Two New Post-Hoc Analyses of P-III HAWK and HARRIER Studies for Wet AMD

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Shots: The P-III HAWK (6/3mg) & HARRIER (6mg) study assessing Beovu [q12w/q8w with the majority on q12w following the loading phase) vs aflibercept (2mg) in 1,800 patients with wet AMD across 400 centers Results: first analysis ewer patients had early persistent fluid (12.5% vs 20.4%),… Read More »Novartis Reports Results of Beovu (brolucizumab) in Two New Post-Hoc Analyses of P-III HAWK and HARRIER Studies for Wet AMD

PRISYM ID appoints Software Delivery Manager to oversee clinical labeling team

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PRISYM ID appoints Software Delivery Manager to oversee team developing new clinical labeling solutions     Wokingham, United Kingdom — 30 September 2020 — PRISYM ID, a leading provider of regulated content and label management solutions, has announced the appointment of Amresh Bangalore as Software Delivery Manager. In his new role, Amresh will be responsible for overseeing and coordinating the people, resources and processes… Read More »PRISYM ID appoints Software Delivery Manager to oversee clinical labeling team

Amgen Report Five Year Data of Aimovig (erenumab-aooe) in Open-Label Treatment Period of P-II Study for Episodic Migraine

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Shots:   The OLE P-II study involves assessing of Aimovig monthly (70mg) vs PBO in 383 eligible adult patients with an episodic migraine for 12wks. 250 patients increasing their dosage to 140mg monthly after a protocol amendment to assess the long-term safety of the higher dose… Read More »Amgen Report Five Year Data of Aimovig (erenumab-aooe) in Open-Label Treatment Period of P-II Study for Episodic Migraine

J&J Vaccine Data

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We have more data on the J&J/Janssen coronavirus vaccine, which those keeping score at home will remember is an adenovirus vector candidate. It uses an obscure member of that virus family (Ad26) that very few people have ever been exposed to, as opposed to the… Read More »J&J Vaccine Data

Sobi & Selecta Report Results of SEL-212 in P-II COMPARE Study for Chronic Refractory Gout

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Shots:  The P-II COMPARE study assessing SEL-212 (once monthly) vs pegloticase (twice monthly) in 170 patients with chronic refractory gout SEL-212 showed a numerically higher response rate on 1EP during 3 & 6 mos., but didn’t meet 1EP of superiority, higher response rate during 3… Read More »Sobi & Selecta Report Results of SEL-212 in P-II COMPARE Study for Chronic Refractory Gout

Alnylam Reports Results of Lumasiran in P-III ILLUMINATE-B Study for Primary Hyperoxaluria Type 1 in Children Under the Age of Six

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Shots: The P-III ILLUMINATE-B study involves assessing Lumasiran in 18 patients with PH1 under the age of 6 (3-72mos.), with an eGFR >45 mL/min/1.73 m2 or normal serum creatinine if less than 12mos. old at 9 study sites in 5 countries across the globe The study demonstrated… Read More »Alnylam Reports Results of Lumasiran in P-III ILLUMINATE-B Study for Primary Hyperoxaluria Type 1 in Children Under the Age of Six

The Vaccine Protocols

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We now have the official clinical trial designs for the three biggest and most advanced coronavirus vaccine trials: Moderna, Pfizer/BioNTech and Oxford/AstraZeneca. Now, as for you, J&J, Novavax, Merck, and all the others that are pushing into efficacy trials as fast as possible – don’t… Read More »The Vaccine Protocols

Supporting Clinical Trial Site Selection During the COVID-19 Pandemic Using WAVE, a Hybrid Epidemiologic Model

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This recent webinar covers a new model for planning trials, which will be illustrated through several case studies. The on-demand recording is now available. Overview During the COVID-19 pandemic, clinical trials of potential vaccines or treatments need to find study sites in areas that are… Read More »Supporting Clinical Trial Site Selection During the COVID-19 Pandemic Using WAVE, a Hybrid Epidemiologic Model

Monoclonal Antibody Data

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We have a bit of human clinical data from the Eli Lilly/Abcellera collaboration to make a monoclonal antibody therapy against the coronavirus. A full paper is coming soon, the press release says, but for now it looks like this is all we have to go… Read More »Monoclonal Antibody Data

Novartis Reports Results of Asciminib (ABL001) in P-III ASCEMBL Study for Chronic Myeloid Leukemia

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Shots: The P-III ASCEMBL study involves assessing of Asciminib (ABL001) vs bosutinib in patients with Ph+ CML-CP, prior treated with two or more TKIs The study met its 1EPs of superiority in major molecular response (MMR) rate @24wks. Asciminib (ABL001) is an investigational treatment specifically… Read More »Novartis Reports Results of Asciminib (ABL001) in P-III ASCEMBL Study for Chronic Myeloid Leukemia

Takeda and Ovid Report Results of Soticlestat (TAK-935/OV935) in P-II ELEKTRA Study for Dravet Syndrome or Lennox-Gastaut Syndrome

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Shots: The P-II ELEKTRA study involves assessing of soticlestat vs PBO in pediatric patients, aged 2-17 yrs., with highly refractory epileptic seizures associated with DS (convulsive seizures) or LGS (drop seizures) Results: meeting its 1EPs i.e. reduction in DS & LGS (27.8% vs 3.1% &… Read More »Takeda and Ovid Report Results of Soticlestat (TAK-935/OV935) in P-II ELEKTRA Study for Dravet Syndrome or Lennox-Gastaut Syndrome

Novartis’ Triple Regimen Fails to Meet the Primary Endpoint in P-III COMBI-i Study for Advanced Melanoma

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Shots: The P-III study involves assessing of spartalizumab (PDR001) + Tafinlar (dabrafenib) and Mekinist (trametinib) vs PBO + Tafinlar and Mekinist in previously untreated patients with unresectable or metastatic BRAF V600 mutation-positive melanoma The study was conducted in three parts while today’s results are from… Read More »Novartis’ Triple Regimen Fails to Meet the Primary Endpoint in P-III COMBI-i Study for Advanced Melanoma

Sharing oncology trial PROs to build the treatment of the future

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Could collecting, understanding, and disseminating patient-reported outcomes during trials be the key to advancing oncology treatments and improving cancer outcomes?  With our understanding of cancer accelerating at an unprecedented rate, and personalised medicines on the cusp of becoming mainstream, regulatory bodies need new ways to… Read More »Sharing oncology trial PROs to build the treatment of the future

Pfizer and BioNTech Plan for Regulatory Review of its COVID-19 Vaccine in October 2020

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Shots: The companies have shared additional P-I safety and immunogenicity data from their ongoing US study of the BNT162b2 against SARS-CoV-2, which has advanced into P-II/III evaluation. Across all populations, BNT162b2 was well tolerated with mild to moderate fever in fewer than 20% of the… Read More »Pfizer and BioNTech Plan for Regulatory Review of its COVID-19 Vaccine in October 2020

Castor Raises $12M to Advance COVID-19 Research Through Clinical Trial and Data Automation

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What You Should Know: – Castor raises $12M in Series A funding to further their support for COVID-19 research through clinical trial and data automation. – With 4,000 live studies and 2,000,000 enrolled patients across 90 countries, Castor will use the funding to further invest… Read More »Castor Raises $12M to Advance COVID-19 Research Through Clinical Trial and Data Automation

Strata Oncology Collaborates with Mirati Therapeutics to Broaden Enrollment in Clinical Trial of MRTX849 for Patients with Advanced Solid Tumors

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Shots: The multiple expansion cohort will assess the safety, tolerability, drug levels, molecular effects, and clinical activity of MRTX849 in patients with advanced solid tumors harboring a KRAS G12C mutation Strata Oncology will identify patients to be considered for enrollment into Mirati’s P-I/II study. The… Read More »Strata Oncology Collaborates with Mirati Therapeutics to Broaden Enrollment in Clinical Trial of MRTX849 for Patients with Advanced Solid Tumors

FDA, Syapse Expand Research to Generate Real-World Data Related to COVID-19 and Cancer

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What You Should Know: The FDA and Syapse announce research collaboration expansion to address urgent public health challenges including supporting FDA’s goal of rapid understanding of COVID-19. As part of the research, Syapse is partnering with FDA’s Oncology Center of Excellence to investigate methods to… Read More »FDA, Syapse Expand Research to Generate Real-World Data Related to COVID-19 and Cancer

The Russian Vaccine

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Many will have heard Russia’s announcement that they have approved a coronavirus vaccine. I’ve already had several people ask me what I think of it, so let me be clear: I think it’s a ridiculous publicity stunt. If it’s supposed to make Russia look like… Read More »The Russian Vaccine

Roche Report Mixed Results of Etrolizumab in P-III Studies for Patients with Moderately to Severely Active Ulcerative Colitis

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Shots: In the HIBISCUS I induction study, in patients without prior anti-TNF treatment, etrolizumab met its 1EPs while in HIBISCUS II study in the same kind of people, it did not meet its 1EPs. In the HICKORY study, in patients with prior anti-TNF treatment, therapy… Read More »Roche Report Mixed Results of Etrolizumab in P-III Studies for Patients with Moderately to Severely Active Ulcerative Colitis

Vaccine Data From Novavax

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Several days after making some headlines with a press release about the data, the Novavax vaccine effort has published on Medrxiv. The is the first look at human data we have at an approach using recombinant coronavirus proteins (plus an adjuvant, in this case a… Read More »Vaccine Data From Novavax

AstraZeneca, Eko Collaborate to Advance Innovation Around Heart Failure

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What You Should Know: – Eko today announced a global collaboration with AstraZeneca to accelerate the development of digital health tools for the earlier screening of cardiovascular diseases, including heart failure.  – Through the collaboration, AstraZeneca and Eko will explore accelerating the development of Eko… Read More »AstraZeneca, Eko Collaborate to Advance Innovation Around Heart Failure

W2O Acquires Discern Health to Strengthen Value-Based Care Capabilities

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What You Should Know: – W2O announced today the acquisition of Discern Health, a leading healthcare consultancy based in Washington, DC, and Baltimore, to strengthen its strategic capabilities in assisting clients with critical healthcare policy trends and value-based reimbursement models. – Discern Health brings experts with… Read More »W2O Acquires Discern Health to Strengthen Value-Based Care Capabilities

Moderna’s Phase I Data

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Well, it’s finally here – eight weeks to the day after press-releasing some top line results, the full paper is out on the Moderna mRNA vaccine candidate’s Phase I trial. I’m very glad to see it – it’s going to be very important for the… Read More »Moderna’s Phase I Data

Pfizer’s Progress

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I wanted to point out an interesting interview given by Pfizer’s CEO Albert Bourla to Time. I have made some pointed remarks about Pfizer over the years, but this is one of the better Q&A pieces like this that I have seen – you’ll see… Read More »Pfizer’s Progress

US FDA’s Coronavirus Treatment Acceleration Program (CTAP): Strategic Considerations for Investigational COVID-19 Drugs, Biologics, and Treatment Vaccines

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Click here to download printable PDF The Coronavirus Treatment Acceleration Program (CTAP) is a special emergency program instituted by the US Food and Drug Administration (FDA) in response to the COVID-19 pandemic The primary goal of the program is to expedite the availability of new… Read More »US FDA’s Coronavirus Treatment Acceleration Program (CTAP): Strategic Considerations for Investigational COVID-19 Drugs, Biologics, and Treatment Vaccines

Scripps Research, Repurpose.AI Partner to Develop COVID-19 Therapeutics

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What You Should Know: – Repurpose.AI, has partnered with Scripps Research to discover drug candidates that may be repurposed to treat COVID-19.  – The partnership will leverage Repurpose.AI’s ActivPred AI Drug Discovery Platform, an unbiased drug, target, and disease agnostic digital chemistry engine, to discover… Read More »Scripps Research, Repurpose.AI Partner to Develop COVID-19 Therapeutics

MedCity Pivot Podcast: An interview with Bari Kowal, vice president of global clinical operations, Regeneron

Bari Kowal, vice president of global clinical operations at Regeneron Pharmaceuticals, gives an update on the clinical trials ongoing to develop drugs to fight Covid-19 and provides insights on how the clinical trials landscape and pharma overall must change in the next episode of MedCity… Read More »MedCity Pivot Podcast: An interview with Bari Kowal, vice president of global clinical operations, Regeneron

Challenge Testing

OK, it’s time to address the topic of challenge testing against the coronavirus epidemic. Let’s define our terms: by this, I mean “deliberately exposing volunteers to infection by the virus in order to evaluate prophylactic treatments by comparison to controls”. I will say at the… Read More »Challenge Testing

How biopharmaceutical researchers are ensuring COVID-19 vaccines will be safe and effective­

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As the world continues to feel the impact of COVID-19, the biopharmaceutical industry is working around the clock to identify and develop safe and effective vaccines to prevent infection, while also researching and developing new therapies to treat those infected with the virus. Given the… Read More »How biopharmaceutical researchers are ensuring COVID-19 vaccines will be safe and effective­

A Systematic Approach to Assessing Real World Research Questions Supported by Digital Enablement

Download the white paper now https://bit.ly/evidera-digena Multiple strategies, each with their individual advantages and drawbacks, may be employed to answer a research question, but determining the optimal strategy – the one that will bring you to your answer in the most effective and efficient way possible – that is… Read More »A Systematic Approach to Assessing Real World Research Questions Supported by Digital Enablement

How Innovative Trial Models Keep Your Active Trials on Track

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Provided by: Elligo Health Research https://www.elligohealthresearch.com/ The ongoing COVID-19 pandemic continues to highlight the need for secure virtual capabilities and decentralized/hybrid approaches to clinical research models. Not only do these solutions maintain the momentum of current studies in times of disruption, but more importantly, they… Read More »How Innovative Trial Models Keep Your Active Trials on Track