FDA puts breakthrough tag on Roche, Lilly Alzheimer’s test
pharmaphorum
APRIL 11, 2024
Roche and Eli Lilly have been granted breakthrough status by the FDA for their pTau217 blood test for Alzheimer's disease.
tag testing 
Grand Rounds January 19, 2024: Why Are Imaging RCTs Different? Lessons From Chest Pain Evaluation Trials (Pamela S. Douglas, MD, MACC, FASE, FAHA)
Rethinking Clinical Trials
JANUARY 23, 2024
Feasibility and generalizability affect design choices including inclusion/exclusion criteria, flexibility of imaging intervention being tested, guidance/control of subsequent care after imaging, and endpoints and outcomes. When we evaluate imaging strategies for chest pain, is “usual testing” the appropriate comparator?
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New approach to improving clinical trial enrollment and diversity
Medical Xpress
MARCH 8, 2023
Before new therapies can reach patients, they must be tested in clinical trials in representative populations to show that they work and are safe. Failure to enroll enough participants in trials can delay the arrival of new therapies in the clinic and inflate their eventual price tags.
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STAT+: Cepheid faces fresh criticism over the pricing of its TB diagnostics
STAT News
AUGUST 16, 2022
At issue is a TB test developed by Cepheid, which reached a 10-year deal with the WHO in August 2012 to supply its GeneXpert diagnostic to dozens of low- and middle-income countries. million, which was provided by the WHO and others, the company agreed to supply its test for $9.98 In exchange for $11.1
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Grand Rounds October 20, 2023: A National Initiative to Eliminate Hepatitis C in the United States – Why This Matters to Clinical Trialists (Rachael L. Fleurence, PhD, MSc; Joshua M. Sharfstein, MD)
Rethinking Clinical Trials
OCTOBER 26, 2023
point of care diagnostic tests, provide broad access to curative Hepatitis C medications with a national subscription model, with Medicare co-pay assistance and commercial insurance coverage. PCORnet is engaging with sites to support the ITAP clinical study for de novo clearance of a qualitative POC HCV test-to-treat platform.
Roche’s Early Alzheimer’s Blood Test Gets FDA Breakthrough Device Designation
XTalks
APRIL 18, 2024
Roche has received Breakthrough Device designation from the US Food and Drug Administration (FDA) for its Elecsys pTau217 early Alzheimer’s blood test. This test, which is being co-developed with Eli Lilly, has the potential to facilitate earlier and more accurate detection of the disease.
Grand Rounds July 15, 2022: Overview of Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) Public-Private Partnership and Lessons Learned (Stacey J. Adam, PhD)
Rethinking Clinical Trials
JULY 22, 2022
We selected 35 and completed testing of 27 of them. Five agents are still in testing. Having the companies at the table, bringing the resources (man power, willingness to test, openness of conversation) was amazing and contributed to success of the program. The team reviewed 800 candidates over 2 years time. Discussion Themes.
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130 Grand Rounds April 14, 2023: RECOVER in Action – Status of Clinical Trial Protocols (Kanecia Zimmerman, PhD, MD, MPH)
Rethinking Clinical Trials
APRIL 18, 2023
This broad set of clinical conditions and varied underlying causes underscore the need for testing a broad portfolio of therapeutic agents. RECOVER is a patient-centered, integrated, adaptive research network. It seems the most severely affected people came from the early waves of COVID.
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Grand Rounds December 16, 2022: The Use of EHR-Agnostic Clinical Decision Support to Prevent Thromboembolism in Hospitalized Medically Ill Patients (Alex C. Spyropoulos, MD, FACP, FCCP, FRCPC; Jeffrey Solomon, BFA)
Rethinking Clinical Trials
FEBRUARY 9, 2023
This trial tested the hypothesis that the use of a platform-agnostic, EHR-embedded VTE risk model with integrated CDS would 1) increase rates of appropriate Thromboprophylaxis, and subsequently 2) reduce thromboembolism, compared to usual medical care in hospitalized, medically-ill patients.
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Grand Rounds July 22, 2022: ACTIV-6: 1-Year Later and Trial Results for Ivermectin-400 and Inhaled Fluticasone (Susanna Naggie, MD, MHS)
Rethinking Clinical Trials
JULY 27, 2022
ACTIV-6 is testing medication doses approved by the FDA for other purposes, i.e., repurposed drugs. Participants test positive for COVID-19 with a FDA-authorized test, register from home, are randomized remotely, receive study medication through the central pharmacy, and follow instruction until their clinical symptoms improve.
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169 Grand Rounds July 7, 2023: Implementing Virtual Strategies Across an Integrated Healthcare System: The IMPLEMENT-HF Study (Ankeet S. Bhatt, MD, MBA, ScM)
Rethinking Clinical Trials
JULY 13, 2023
Discussion Themes – How diverse were the settings where this was tested? The study team was interested in testing in a setting outside of a large academic hospital. We need to test in systems that might have an enhanced usual care arm. Learn more Read about the IMPLEMENT-HF study in JACC.
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Grand Rounds February 9, 2024: Pragmatic Recruitment of Underrepresented Groups – Experience From the Diuretic Comparison Project (Cynthia Hau, MPH)
Rethinking Clinical Trials
FEBRUARY 14, 2024
The preparation work started with an idea in 2010, which led to selection of the pilot study in 2014 to test out the system for randomizing patients within the existing infrastructure. How long did the start up for the trial take? The actual startup was about 18 months.
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WHO update on Omicron
The Pharma Data
NOVEMBER 29, 2021
1.1.529 a variant of concern, named Omicron, on the advice of WHO’s Technical Advisory Group on Virus Evolution (TAG-VE). The number of people testing positive has risen in areas of South Africa affected by this variant, but epidemiologic studies are underway to understand if it is because of Omicron or other factors.
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Grand Rounds July 8, 2022: Results From the COVID-OUT Trial, A Phase-3 Trial of Outpatient Treatment for Covid-19 Using Metformin, Ivermectin, and Fluvoxamine (Carolyn Bramante, MD, MPH; Thomas Murray, PhD; Jared Huling, PhD)
Rethinking Clinical Trials
AUGUST 22, 2022
Trial participants were adults ages 30-85, who tested positive for SARS-CoV-2 within 3 days, with fewer than 7 days of symptoms, no known prior infection with SARS-CoV-2, no severe kidney, liver, or heart failure. We used Google Ads and partnerships with some testing clinics. We also kept equal focus on follow-up.
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Grand Rounds July 29, 2022: Effect of Early Treatment With Single-Dose Pegylated Interferon Lambda Among Patients With COVID-19: Results From The TOGETHER Trial (Edward Mills, PhD, FRCP; Jeffrey S. Glenn, MD, PhD)
Rethinking Clinical Trials
AUGUST 4, 2022
For the overall trial, anyone over the age of 18 with a known risk factor for disease progression is eligible; they have to present at an outpatient care setting with an acute clinical condition consistent with COVID-19 and have a positive rapid test in the clinic. Learn more about TOGETHER. pctGR, @Collaboratory1.
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This week in drug discovery (24-28 October)
Drug Discovery World
OCTOBER 28, 2022
Click’ chemistry used to tag proteins made by cancer cells . A panel of investigational monoclonal antibodies (mAbs) targeting different sites of the Epstein-Barr virus (EBV) have been shown to block infection when tested in human cells in a laboratory setting. . . Millions invited to join UK’s largest health research programme .
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DDW Tech Theatre at ELRIG Drug Discovery 2022
Drug Discovery World
AUGUST 15, 2022
She is a Senior Enterprise Fellow at the University of Southampton and coordinates the AI 4 Scientific Discovery Network and the Future Blood Testing Network, in addition to running an Ethics working group.
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52 Grand Rounds September 16, 2022: Using Nationwide Registries to Conduct Pragmatic Randomized Trials: The DANFLU Program (Tor Biering-Sørensen, MD, PhD, MPH)
Rethinking Clinical Trials
SEPTEMBER 22, 2022
The DANFLU-1 trial is a large-scale pragmatic RCT that looked at high-dose vs standard-dose flu vaccine to test whether high-dose vaccines might reduce hospitalizations among the elderly, age 65 and older. The aim is to test communication strategies for optimizing the update of the flu vaccine. Learn more. Read about DANFLU-1.
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Scientists turn cancer cells into anticancer agents
Drug Discovery World
JANUARY 9, 2023
In this early research, Khalid Shah, Professor of Neurosurgery at Harvard Medical School and Brigham and Women’s Hospital, and colleagues tested the vaccine in an advanced mouse model of brain cancer glioblastoma, with promising results. The findings are published in Science Translational Medicine. .
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Grand Rounds February 17, 2023: The Heartline Trial: A New Paradigm in Conducting Virtual Clinical Trials (C. Michael Gibson, MS, MD)
Rethinking Clinical Trials
FEBRUARY 22, 2023
The question is can we pivot from very expensive trials to test cardiovascular drugs to at least a hybrid model that takes the best of what we have learned so far from the Heartline Trial? Tags #pctGR, @Collaboratory1 The post Grand Rounds February 17, 2023: The Heartline Trial: A New Paradigm in Conducting Virtual Clinical Trials (C.
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Grand Rounds May 19, 2023: Aspirin or Low-Molecular-Weight Heparin for Thromboprophylaxis After a Fracture (Robert O’Toole, MD)
Rethinking Clinical Trials
MAY 25, 2023
Researchers aimed to test the safety and effectiveness of Aspirin use as prophylaxis in orthopedic trauma cases. Tags #pctGR, @Collaboratory1 The post Grand Rounds May 19, 2023: Aspirin or Low-Molecular-Weight Heparin for Thromboprophylaxis After a Fracture (Robert O’Toole, MD) appeared first on Rethinking Clinical Trials.
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130 Grand Rounds January 20, 2023: Collaborative Pragmatic Trials in Action: EVOLVE-MI (Mikhail Kosiborod, MD)
Rethinking Clinical Trials
JANUARY 26, 2023
Tags #pctGR, @Collaboratory1 The post Grand Rounds January 20, 2023: Collaborative Pragmatic Trials in Action: EVOLVE-MI (Mikhail Kosiborod, MD) appeared first on Rethinking Clinical Trials.
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Grand Rounds July 14, 2023: Lessons From the COORDINATE-Diabetes Trial (Christopher B. Granger, MD; Neha J. Pagidipati, MD, MPH)
Rethinking Clinical Trials
JULY 19, 2023
The objective of COORDINATE-Diabetes trial was to improve the implementation and adoption of these therapies by testing the impact of a clinic-level, multifaceted intervention on the prescription of 3 key groups of evidence-based therapies. However, these therapies are highly underused in routine clinical practice. Granger, MD; Neha J.
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Clover biopharmaceuticals raises $230 M; BrainStorm after ALS; BARDA grants $5.65 M LightDeck for SARS-CoV-2 antigen test; Libtayo for first-line advanced NSCLC subset
Delveinsight
FEBRUARY 23, 2021
The company plans to use the capital to expand its pipeline of protein-based vaccines and biologic cancer therapies utilizing its innovative and proprietary Trimer-Tag technology platform. M from BARDA for SARS-CoV-2 Antigen Test. Moreover, the test is set to deliver the results in less than 6 minutes.
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Grand Rounds August 25, 2023: Pragmatic Trial of an EHR Application to Display Real-time PRO Data: Successes and Challenges (Gabriela Schmajuk, MD, MS)
Rethinking Clinical Trials
AUGUST 30, 2023
The RA PRO dashboard was tested as part of a stepped wedge, cluster randomized trial at the clinician level. The team collected focus group feedback from patients and clinicians and worked with IT professionals to pull data directly from the electronic health record and design an interface that could be used by all patients.
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Grand Rounds October 6, 2023: Hybrid Studies Should Not Sacrifice Rigorous Methods (David M. Murray, PhD; Moderator: Jonathan Moyer, PhD)
Rethinking Clinical Trials
OCTOBER 11, 2023
Through this initiative, 7 Clinical Centers are expected to test an evidence-based, multi-level intervention designed to reduce or eliminate cardiovascular and/or pulmonary health disparities. Tags #pctGR, @Collaboratory1 The post Grand Rounds October 6, 2023: Hybrid Studies Should Not Sacrifice Rigorous Methods (David M.
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Bluebird’s $2.8M Gene Therapy Zynteglo Wins Landmark FDA Approval for Beta Thalassemia
XTalks
AUGUST 19, 2022
The road to Zynteglo’s approval was a bit rocky and included an FDA delay (the most recent in June) over production test concerns. Zynteglo’s hefty price tag of $2.8 But bluebird bio has said such setbacks are expected for a company at the frontier of developing gene therapies for rare diseases.
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Scientists uncover secret to success in new class of cancer drugs
Drug Discovery World
NOVEMBER 7, 2022
Cereblon, the researchers determined, has a default ‘open’ conformation, but must be switched to a particular ‘closed’ conformation for the ubiquitin-tagging of target proteins. . So now they know, and they can test their drugs for this key property.” .
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3 ways pharma marketers can draw inspiration from digitally-native brands
pharmaphorum
SEPTEMBER 15, 2020
“Digitally native brands are typically agile businesses from the ground up, and agility and flexibility are part of their core makeup,” says Joe Holmes, vice president, marketing services, US at Tag. They also employ exceptionally high levels of ‘test and learn’ activities to understand which campaigns work and should be upscaled.
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Blue Note leukaemia DTx gets FDA breakthrough tag
pharmaphorum
JANUARY 11, 2022
It has since been joined by other products in the software as a medical device (SaaMD) category, including Pear Therapeutics’ alcohol-use disorder candidate Pear-009 and another Blue Note DTx, codenamed BNT001, which is also being tested for anxiety and depression in cancer patients.
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Grand Rounds August 18, 2023: Opportunities to Improve Clinical Trials: Draft Revision of the ICH Good Clinical Practice Guideline (E6R3) (Prof Sir Martin Landray, FMedSci; M. Khair ElZarrad, PhD, MPH)
Rethinking Clinical Trials
AUGUST 28, 2023
Its objective is to improve efficiency of new drug development and registration processes, in addition to promoting public health, preventing duplication of clinical trial in humans and minimizing the use of animal testing without compromising safety and effectiveness. The guidance should not remove the need to think.
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130 Grand Rounds August 18, 2023: Opportunities to Improve Clinical Trials: Draft Revision of the ICH Good Clinical Practice Guideline (E6R3) (Prof Sir Martin Landray, FMedSci; M. Khair ElZarrad, PhD, MPH; Adrian F. Hernandez, MD, MHS)
Rethinking Clinical Trials
AUGUST 28, 2023
Its objective is to improve efficiency of new drug development and registration processes, in addition to promoting public health, preventing duplication of clinical trial in humans and minimizing the use of animal testing without compromising safety and effectiveness. The guidance should not remove the need to think.
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130 Grand Rounds January 27, 2023: The PREPARE II Trial: Embedding a Pragmatic Trial Into Clinical Care During an Emergency Procedure (Derek W. Russell, MD; Matthew W. Semler, MD, MSc)
Rethinking Clinical Trials
FEBRUARY 2, 2023
The PrePARE Trial tested the initiation of a 500 mL crystalloid fluid bolus before induction in 9 U.S. Tags #pctGR, @Collaboratory1 The post Grand Rounds January 27, 2023: The PREPARE II Trial: Embedding a Pragmatic Trial Into Clinical Care During an Emergency Procedure (Derek W. This results in arbitrary variation in clinical care.
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FDA gives Daiichi Sankyo’s HER3 drug a breakthrough tag
pharmaphorum
DECEMBER 23, 2021
The Japanese drugmaker was originally developing patritumab as an antibody for NSCLC, but abandoned the drug after it showed little efficacy in mid-stage testing, pivoting to the ADC version. The post FDA gives Daiichi Sankyo’s HER3 drug a breakthrough tag appeared first on.
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Grand Rounds June 9, 2023: Emulating Randomized Clinical Trials with Non-randomized Real-world Evidence Studies: Results From The RCT DUPLICATE Initiative (Shirley V. Wang, PhD)
Rethinking Clinical Trials
JUNE 14, 2023
The second aim is to test the transparent and reproducible process with the FDA to evaluate Real World Evidence (RWE) studies. Tags #pctGR, @Collaboratory1 The post Grand Rounds June 9, 2023: Emulating Randomized Clinical Trials with Non-randomized Real-world Evidence Studies: Results From The RCT DUPLICATE Initiative (Shirley V.
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Rare Disease Spotlight – tracing the rise of orphan drug designations over almost 40 years
Pharmaceutical Technology
JUNE 29, 2022
For example, while orphan drug designations have more than doubled in the last decade compared to the previous one, only 16% of therapies with orphan tags have managed to gain FDA approval in some indications. Prior to the program, only 10 drugs were approved for a rare disease.
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ASH: Argenx cues up a second use for efgartigimod
pharmaphorum
DECEMBER 12, 2022
Vyvgart is already approved to treat generalised myasthenia gravis, getting a green light for that indication from the FDA a year ago, and launched with a $225,000 per annum price tag in competition with rival gMG drugs like AstraZeneca/Alexion’s C5 inhibitor Soliris (eculizumab).
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Targeting a human protein may stop Ebola virus in its tracks
The Pharma Data
MARCH 23, 2022
Back in 2018, researchers tested a broad-spectrum antiviral candidate called remdesivir/VEKLURY, which acts as a nucleotide decoy to get incorporated into the viral RNA genome and stop viral polymerase. To test this, the LJI team partnered with their long-term collaborator, the UTMB research group led by Professor Alexander Bukreyev, Ph.D.,
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FDA begins review of Samsung Bioepis/Biogen’s Lucentis biosimilar
pharmaphorum
NOVEMBER 19, 2020
Because Roche has never applied for Avastin to be used in wet AMD, clinics in the US have had to choose between the peace of mind offered by the regulatory process and Lucentis’ higher price tag, or the unapproved off-label formulation of Avastin at a lower price.
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With rivals threatening, Argenx scores key myasthenia gravis win
pharmaphorum
MARCH 23, 2022
Vyvgart (efgartigimod alfa) became the first drug in the FcRn class to be approved by the FDA last December, and despite a $225,000 annual price tag is predicted to make relatively modest sales in its IV version, which will compete with other IV gMG drugs like AstraZeneca/Alexion’s C5 inhibitor Soliris (eculizumab).
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Tackling the Challenges of Limited Resources During a Pandemic
The Pharma Data
MARCH 20, 2021
Whether the scale of these labs is at the national level, processing hundreds of thousands of samples a day, through to small-scale and agile laboratories testing at an organizational level, there is a place in the workflow to accommodate automation. testing platform to process up to 6,000 patient. The diagnostic test is run under.
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Clover Biopharmaceuticals Announces Positive Phase 1 Data for its Adjuvanted S-Trimer COVID-19 Vaccine Candidates
The Pharma Data
DECEMBER 3, 2020
Preliminary results from stability studies have demonstrated that S-Trimer is stable at 2-8 o C for at least six months (longer-term stability studies are ongoing) and stable at room temperature and 40 o C for at least one month, in line with the adjuvants tested. About Trimer-Tag © Technology. About COVID-19 S-Trimer Vaccine.
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Connecting lab automation to decision-making
Drug Discovery World
FEBRUARY 21, 2023
Ashwin Pillai is Test Engineer 3 in HTS & Assay Development at Ginkgo Bioworks, a company whose mission is to make biology easier to engineer. He says: “Organisms can be edited and synthesised to test out different mutations for improvement in function. There is also an issue with metadata during experiments.
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Immunocore’s Kimmtrak Gets FDA Approval as First Treatment for Rare Eye Cancer and First T Cell Receptor Therapeutic
XTalks
JANUARY 28, 2022
Kimmtrak has a price tag of $18,760 per vial, which amounts to a weekly dose. Related: Cancer Blood Test Developed by University of Oxford Researchers Can Detect Metastasis. The company is expecting approval from the European Medicines Agency (EMA) soon as it prepares for a European launch in the second quarter of this year.
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