Clinical Research Informer

Complexity in Early Phase Clinical Trials with Dr. Oren Cohen?

Clinical Trial Podcast

SEPTEMBER 26, 2022

To answer these two questions, regulatory authorities around the world require medical product manufacturers to conduct Phase I, also known as early phase clinical trials. The post Complexity in Early Phase Clinical Trials with Dr. Oren Cohen? And will this interaction be safe? To learn more, visit [link].

Clinical Trials

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WCG’s Unmatched Experience in Early Phase Hematology and Oncology

WCG Clinical

OCTOBER 25, 2023

Unmatched Experience in Early Phase Hematology and Oncology Discover unparalleled expertise in phase I hematology and oncology study reviews with WCG. As the foremost leader in ethical and scientific review services for oncology studies in the US, we have successfully conducted over 3,300 early phase oncology study reviews.

Clinical Trials

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Lonza opens early-phase development and manufacturing facility in Oregon

Outsourcing Pharma

JUNE 14, 2022

The company has completed its early-phase development and manufacturing facility in Bend, giving it 11 processing suites focused on first steps into the clinic.

Manufacturing

Manufacturing Development Contract Manufacturing

BMS Sees Early ROI for $14B Karuna Buy with Phase III Schizophrenia Win

BioSpace

APRIL 8, 2024

Fresh off of its $14 billion acquisition of Karuna Therapeutics, Bristol Myers Squibb on Saturday reported promising late-stage data for Karuna’s antipsychotic KarXT, which elicited significant symptomatic improvement in schizophrenia symptoms.

Running Decentralized Trials at Scale: Planning for Success

Yet, it’s important to note that there’s a significant learning curve for sponsors as these new methods graduate from early-phase into larger pivotal trials that must prove efficacy. There are pitfalls to avoid & key elements to keep front & center. Most trials won’t be fully virtual, but all trials will be more virtual.

Trials

Novo’s latest obesity pill spurs major weight loss in small trial

Bio Pharma Dive

MARCH 7, 2024

Early results from a Phase 1 study suggest the drug, amycretin, could be as potent as injectable medicines already sold by Novo and rival Eli Lilly.

Trials

Trials Medicine Drugs

AstraZeneca chases another liver cancer nod for Imfinzi with early phase 3 win, scraps Imfinzi-Lynparza combo study in lung cancer

Fierce Pharma

NOVEMBER 9, 2023

AstraZeneca chases another liver cancer nod for Imfinzi with early phase 3 win, scraps Imfinzi-Lynparza combo study in lung cancer zbecker Thu, 11/09/2023 - 11:02

PTC Cuts Early-Stage Pipeline but Pushes Forward on FA Drug After Phase III Flop

BioSpace

MAY 23, 2023

PTC Cuts Early-Stage Pipeline but Pushes Forward on FA Drug After Phase III Flop 5/24/2023

Drugs

FDA Backs BrainStorm’s Design for Phase IIIb Trial in Early-Stage ALS

BioSpace

APRIL 9, 2024

After BrainStorm Cell Therapeutics withdrew its BLA in October 2023 for NurOwn, the company announced Tuesday that the FDA has agreed to the design of a Phase IIIb trial for its amyotrophic lateral sclerosis candidate under a Special Protocol Assessment.

Trials

Eli Lilly supports Alto Neuroscience in $45m Series C round

Pharmaceutical Technology

NOVEMBER 22, 2023

The funding will go towards the development of the company's four CNS candidates, with Phase II study data readouts expected by early 2025.

Development

Boundless Bio breaks IPO lull with $100M fundraise

Bio Pharma Dive

MARCH 27, 2024

The startup’s performance will test investors’ appetite for early-stage drugmakers, as Boundless has only advanced as far as Phase 1 clinical trials.

Clinical Trials

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Early Phase

Syneos Health

DECEMBER 5, 2017

For more than 25 years, our specialized Early Phase team has been dedicated to tailoring solutions for navi Initial human data are a critical development milestone on the journey from lab to life.

Development

Lilly’s Cholesterol Pill Shows Early Promise in Phase I Study

BioSpace

AUGUST 28, 2023

Data from the first-in-human trial showed that Eli Lilly’s muvalaplin is safe and can cut significant levels of lipoprotein(a), a risk factor for atherosclerosis and related cardiovascular diseases.

Trials

Early phase support for plasmid DNA supply to secure future manufacturing

Drug Discovery World

NOVEMBER 23, 2022

The post Early phase support for plasmid DNA supply to secure future manufacturing appeared first on Drug Discovery World (DDW). Discover how to reduce batch-to-batch inconsistencies, improve plasmid purity, and enhance plasmid yield at every stage of upstream and downstream operations.

DNA

DNA Manufacturing Gene Therapy Gene

AbbVie, Alpine Agree to End Phase II Lupus Trial Early and Slash Option Exercise Fee

BioSpace

DECEMBER 21, 2023

Under the companies’ agreement, a previously disclosed option exercise fee of $75 million has been reduced to $10 million and the remaining pre-option development milestone has been removed.

Trials

Trials Development

#news #biotech Ixaka’s cell therapy clears early phase 3 data review

BioTech 365

SEPTEMBER 10, 2021

Biotechnology, Pharma and Biopharma News – Research – Science – Lifescience ://Biotech-Biopharma-Pharma: Ixaka’s cell therapy clears early phase 3 data review.Ixaka’s cell therapy clears early phase 3 data review ntaylor Fri, 09/10/2021 – 08:35 from FierceBiotech: Biotech [link].

Research

Alnylam, Regeneron to advance NASH drug after early signs of potential

Bio Pharma Dive

SEPTEMBER 16, 2022

A gene discovery four years ago led to a partnership between the companies, which plan to start a Phase 2 study later this year after encouraging early data.

Gene

Gene Drugs

Immunicum Announces Completion of Phase Ib Portion and Early Closure of ILIAD Study

BioTech 365

DECEMBER 3, 2021

Immunicum Announces Completion of Phase Ib Portion and Early Closure of ILIAD Study Immunicum Announces Completion of Phase Ib Portion and Early Closure of ILIAD Study Press Release Stockholm, Sweden, December 3, 2021 Immunicum Announces Completion of Phase Ib Portion … Continue reading →

AGC Biologics: how to optimize early phase manufacturing

BioPharma Reporter

SEPTEMBER 20, 2023

AGC Biologics is a global contract development manufacturing organization (CDMO) providing development and manufacturing services for protein-based biologics and advanced therapies.

Manufacturing

Manufacturing Protein Development

AGC Biologics: how to optimize early phase manufacturing

BioPharma Reporter

SEPTEMBER 20, 2023

AGC Biologics is a global contract development manufacturing organization (CDMO) providing development and manufacturing services for protein-based biologics and advanced therapies.

Manufacturing

Manufacturing Protein Development

Early Phase Trial Shows Promise of Amgen’s MariTide in Producing More Durable Weight Loss Results

Pharmaceutical Commerce

FEBRUARY 8, 2024

Data suggest that dosing of MariTide may be effectively tapered down and the drug may be taken less frequently over time compared with GLP-1 agonists such as Wegovy and Zepbound.

Trials

Trials Drugs

TRIO Enrols First Patient in Global Phase 3 Giredestrant Early Breast Cancer Trial

BioTech 365

AUGUST 31, 2021

TRIO Enrols First Patient in Global Phase 3 Giredestrant Early Breast Cancer Trial TRIO Enrols First Patient in Global Phase 3 Giredestrant Early Breast Cancer Trial EDMONTON, Alberta, Aug. 31, 2021 (GLOBE NEWSWIRE) — Translational Research in Oncology (TRIO), a … Continue reading →

Trials

Trials Research

FDA, under fire for Aduhelm approval, starts review of another Alzheimer's drug

Bio Pharma Dive

JULY 6, 2022

The regulator could clear Biogen and Eisai’s lecanemab by early January. A decision before Phase 3 results could amplify the criticism the agency already faces, however.

Regulation

Regulation Drugs

Pfizer Drops Early-Stage Obesity Drug Following Disappointing Phase I Data

BioSpace

JUNE 25, 2023

The company is dropping its GLP-1 receptor agonist candidate lotiglipron after it induced elevations in liver enzymes in patients treated with the investigational drug.

Drugs

New Phase III data support the benefit of Roche’s Tecentriq in early-stage lung cancer

BioTech 365

SEPTEMBER 20, 2021

New Phase III data support the benefit of Roche’s Tecentriq in early-stage lung cancer New Phase III data support the benefit of Roche’s Tecentriq in early-stage lung cancer Data presented at the 2021 ESMO Virtual Congress and the IASLC 2021 … Continue reading →

Sanofi and AstraZeneca Scrap Several Early-Stage Programs in Q1

BioSpace

APRIL 24, 2024

Sanofi is dropping its Sjögren’s syndrome candidate due to disappointing Phase II efficacy data, while AstraZeneca is stopping work on some early-stage assets amid a portfolio reprioritization.

Pfizer aims to restart late-stage trial of Duchenne gene therapy following safety setback

Bio Pharma Dive

FEBRUARY 10, 2022

Safety concerns, including the recent death of a patient in an early study, led the FDA to place a hold on the therapy and Pfizer to redesign its Phase 3 trial.

Gene Therapy

Gene Therapy Trials Gene

Exelixis Ends Phase III Trial Early Due to ‘Dramatic’ Benefits in Neuroendocrine Tumors

BioSpace

AUGUST 24, 2023

Following a late-stage victory on Monday, Exelixis on Thursday reported another Phase III win for its tyrosine kinase inhibitor Cabometyx—this time in advanced neuroendocrine tumors.

Trials

Why Proactive AME Studies are Critical to Accelerating Your Approval Journey

Worldwide Clinical Trials

FEBRUARY 21, 2024

While traditionally conducted during Phase 2 or later, the FDA has recently been requesting data sooner in the development process, making it critical to implement proactive AME studies to lay the groundwork for advanced phases of your clinical program.

Clinical Trials

Clinical Trials Clinical Trials Pharmacy Trials

FDA accept NextPoint Therapeutics IND for HHLA2 targeting mAb

Pharmaceutical Technology

DECEMBER 8, 2023

NextPoint plans to kickstart the first-in-human Phase I clinical trial in early 2024, investigating NPX887 in patients with HHLA2-positive tumours.

Clinical Trials

Clinical Trials Clinical Trials Trials

MaaT Pharma Announces Positive Interim Engraftment Data for Oral Formulation MaaT033 Allowing Early Termination of Phase 1b CIMON Study

BioTech 365

JANUARY 23, 2022

MaaT Pharma Announces Positive Interim Engraftment Data for Oral Formulation MaaT033 Allowing Early Termination of Phase 1b CIMON Study MaaT Pharma Announces Positive Interim Engraftment Data for Oral Formulation MaaT033 Allowing Early Termination of Phase 1b CIMON Study MaaT033 is … Continue reading →

ASH: Roche offers glimpse of Columvi-Polivy combo's early lymphoma data as phase 3 kicks off

Fierce Pharma

DECEMBER 10, 2023

. | As Roche’s blood cancer portfolio booms with new life thanks to the antibody-drug conjugate Polivy and bispecifics, the company is offering a look at data for two combinations of those drugs that support two phase 3 trials in diffuse large B-cell lymphoma.

Antibody

Antibody Drugs Trials

Groundbreaking Stem Cell Therapy Can Repair Vision After Eye Injury

AuroBlog - Aurous Healthcare Clinical Trials blog

AUGUST 30, 2023

Four patients with severe chemical burns to one eye have shown early positive results in a phase 1 clinical trial of a therapy based on their own stem cells.

Clinical Trials

Clinical Trials Clinical Trials Trials Research

#news #biotech J&J starts COVID-19 vaccine phase 3, eyes early 2021 approval

BioTech 365

SEPTEMBER 23, 2020

Biotechnology, Pharma and Biopharma News – Research – Science – Lifescience ://Biotech-Biopharma-Pharma: J&J starts COVID-19 vaccine phase 3, eyes early 2021 approval.J&J

Vaccination

Vaccination Vaccine Research

#news #biotech Sangamo’s Fabry gene therapy clears early clinical test, firing starting gun on preparations for phase 3

BioTech 365

NOVEMBER 4, 2021

Biotechnology, Pharma and Biopharma News – Research – Science – Lifescience ://Biotech-Biopharma-Pharma: Sangamo’s Fabry gene therapy clears early clinical test, firing starting gun on preparations for phase 3.Sangamo’s

Gene Therapy

Gene Therapy Gene Research

Andexxa Phase IV trial stopped early after achieving pre-specified criteria on haemostatic efficacy versus usual care

The Pharma Data

JUNE 7, 2023

1 The decision is based on achieving pre-specified stopping criteria of superior haemostatic efficacy, the ability to limit the expansion of a potentially life-threatening bleed in the brain, versus usual care.

Trials

Trials Medicine Scientist Marketing

MaaT microbiota drug shows survival advantage in GvHD

pharmaphorum

APRIL 17, 2024

MaaT Pharma's microbiota therapy MaaT013 shows survival benefit in acute GvHD in an early access programme, boding well for an ongoing phase 3 trial.

Drugs

Drugs Trials

Autism drug fails in late-stage trials, Servier says

Bio Pharma Dive

SEPTEMBER 8, 2021

The French drugmaker and its biotech partner Neurochlore agreed to end two Phase 3 studies early after finding no signs that treatment was effective.

Trials

Trials Drugs

Regenerative medicine: new focus on VEGF target?

Pharmaceutical Technology

MARCH 27, 2023

Regenerative medicines in early-stage development (preclinical, discovery, or investigational new drug [IND]/ clinical trial application [CTA] filed status) have seen a change in drug targets compared to therapies in late-stage development (Phase II to pre-registration stage).

Medicine

Medicine Gene Therapy Gene Dermatology

Alzheon Announces First Patient Dosed in APOLLOE4 Phase 3 Trial of Oral ALZ?801 in Patients with Early Alzheimer’s Disease

BioTech 365

JUNE 4, 2021

Alzheon Announces First Patient Dosed in APOLLOE4 Phase 3 Trial of Oral ALZ?801 801 in Patients with Early Alzheimer’s Disease Alzheon Announces First Patient Dosed in APOLLOE4 Phase 3 Trial of Oral ALZ?801 801 in Patients with Early Alzheimer’s Disease Study to … Continue reading →

Trials

AbCellera-Discovered Bamlanivimab Together with Etesevimab Reduced Hospitalizations and Prevented Death in Phase 3 Trial for Early COVID-19

BioTech 365

MARCH 10, 2021

AbCellera-Discovered Bamlanivimab Together with Etesevimab Reduced Hospitalizations and Prevented Death in Phase 3 Trial for Early COVID-19 AbCellera-Discovered Bamlanivimab Together with Etesevimab Reduced Hospitalizations and Prevented Death in Phase 3 Trial for Early COVID-19 Patients who received bamlanivimab and etesevimab … Continue reading (..)

Trials

Viking Touts Promising Phase I Data for Weight-Loss Pill Candidate

BioSpace

MARCH 25, 2024

The early-stage study showed that Viking Therapeutics’ oral obesity candidate VK2735, a dual agonist of the GLP-1 and GIP receptors, elicited a 3.3% The company plans to start a Phase II trial. reduction in mean body weight.

Trials

#news #biotech Denali makes ALS play, hustling Sanofi-partnered drug into phase 2 and sharing early data on internal program

BioTech 365

OCTOBER 7, 2021

Biotechnology, Pharma and Biopharma News – Research – Science – Lifescience ://Biotech-Biopharma-Pharma: Denali makes ALS play, hustling Sanofi-partnered drug into phase 2 and sharing early data on internal program.Denali makes ALS play, hustling Sanofi-partnered drug into phase 2 and … Continue reading →

Drugs

Drugs Research

#news #biotech As Johnson & Johnson kick-starts phase 3 COVID-19 test, early data show up its promise

BioTech 365

SEPTEMBER 28, 2020

Biotechnology, Pharma and Biopharma News – Research – Science – Lifescience ://Biotech-Biopharma-Pharma: As Johnson & Johnson kick-starts phase 3 COVID-19 test, early data show up its promise.As Johnson & Johnson kick-starts phase 3 COVID-19 test, early data show up … Continue reading →

Research

Complexity in Early Phase Clinical Trials with Dr. Oren Cohen?

WCG’s Unmatched Experience in Early Phase Hematology and Oncology

Trending Sources

Lonza opens early-phase development and manufacturing facility in Oregon

BMS Sees Early ROI for $14B Karuna Buy with Phase III Schizophrenia Win

Running Decentralized Trials at Scale: Planning for Success

Novo’s latest obesity pill spurs major weight loss in small trial

AstraZeneca chases another liver cancer nod for Imfinzi with early phase 3 win, scraps Imfinzi-Lynparza combo study in lung cancer

PTC Cuts Early-Stage Pipeline but Pushes Forward on FA Drug After Phase III Flop

FDA Backs BrainStorm’s Design for Phase IIIb Trial in Early-Stage ALS

Eli Lilly supports Alto Neuroscience in $45m Series C round

Boundless Bio breaks IPO lull with $100M fundraise

Early Phase

Lilly’s Cholesterol Pill Shows Early Promise in Phase I Study

Early phase support for plasmid DNA supply to secure future manufacturing

AbbVie, Alpine Agree to End Phase II Lupus Trial Early and Slash Option Exercise Fee

#news #biotech Ixaka’s cell therapy clears early phase 3 data review

Alnylam, Regeneron to advance NASH drug after early signs of potential

Immunicum Announces Completion of Phase Ib Portion and Early Closure of ILIAD Study

AGC Biologics: how to optimize early phase manufacturing

AGC Biologics: how to optimize early phase manufacturing

Early Phase Trial Shows Promise of Amgen’s MariTide in Producing More Durable Weight Loss Results

TRIO Enrols First Patient in Global Phase 3 Giredestrant Early Breast Cancer Trial

FDA, under fire for Aduhelm approval, starts review of another Alzheimer's drug

Pfizer Drops Early-Stage Obesity Drug Following Disappointing Phase I Data

New Phase III data support the benefit of Roche’s Tecentriq in early-stage lung cancer

Sanofi and AstraZeneca Scrap Several Early-Stage Programs in Q1

Pfizer aims to restart late-stage trial of Duchenne gene therapy following safety setback

Exelixis Ends Phase III Trial Early Due to ‘Dramatic’ Benefits in Neuroendocrine Tumors

Why Proactive AME Studies are Critical to Accelerating Your Approval Journey

FDA accept NextPoint Therapeutics IND for HHLA2 targeting mAb

MaaT Pharma Announces Positive Interim Engraftment Data for Oral Formulation MaaT033 Allowing Early Termination of Phase 1b CIMON Study

ASH: Roche offers glimpse of Columvi-Polivy combo's early lymphoma data as phase 3 kicks off

Groundbreaking Stem Cell Therapy Can Repair Vision After Eye Injury

#news #biotech J&J starts COVID-19 vaccine phase 3, eyes early 2021 approval

#news #biotech Sangamo’s Fabry gene therapy clears early clinical test, firing starting gun on preparations for phase 3

Andexxa Phase IV trial stopped early after achieving pre-specified criteria on haemostatic efficacy versus usual care

MaaT microbiota drug shows survival advantage in GvHD

Autism drug fails in late-stage trials, Servier says

Regenerative medicine: new focus on VEGF target?

Alzheon Announces First Patient Dosed in APOLLOE4 Phase 3 Trial of Oral ALZ?801 in Patients with Early Alzheimer’s Disease

AbCellera-Discovered Bamlanivimab Together with Etesevimab Reduced Hospitalizations and Prevented Death in Phase 3 Trial for Early COVID-19

Viking Touts Promising Phase I Data for Weight-Loss Pill Candidate

#news #biotech Denali makes ALS play, hustling Sanofi-partnered drug into phase 2 and sharing early data on internal program

#news #biotech As Johnson & Johnson kick-starts phase 3 COVID-19 test, early data show up its promise

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