The Pharma Data

SEPTEMBER 9, 2020

Roche is to begin expanding trials of Ocrevus in multiple sclerosis (MS) patients to defend its MS franchise from its rivals. . The company has also started a late stage trial for fenebrutinib in treating the same forms of MS, and the drug works by inhibiting the production of B-cells that attack the nervous system. Conor Kavanagh.

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Alta Sciences

MARCH 4, 2025

Despite having a final FDA guidance issued in 2017 , evolving drug development and treatment modalities continue to prompt important dialogue to adapt existing methods. Tags Clinical Trials Weight 16 I have spent the better part of my career working to make drugs safer. Get in touch to discover how me and my team can help.

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The Pharma Data

AUGUST 5, 2020

Following an interim analysis of the phase 2 ELARA trial, researchers found that Kymriah met the primary endpoint of complete response rate (CRR) – a standard measure of response to therapy in FL patients. Source link.

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Codon

JANUARY 21, 2024

Human challenge trials were an indispensable part of the development of the malaria vaccine, R21/Matrix-M, endorsed by the World Health Organization last October. But for all of their benefits, human challenge trials have their drawbacks. Jake himself has participated in both Zika and Shigella challenge trials.

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Vial

DECEMBER 5, 2023

In 2017, the Food & Drug Administration (FDA) approved the first gene therapy for cancer and for inherited diseases, the first multiplex NGS panel for companion diagnostics (CDx), and the first drug targeting a genetic signature though not a disease. Research through WGS and WES has provided novel insights into biological processes.

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Drug Target Review

NOVEMBER 17, 2023

Up until 2023 around 600 NK cell clinical trials have been reported and some 200 are clinically active and still recruiting patients. The vast majority (65/74; 88%) of those trials involved NK cells without CARs; while only 12 percent were CAR-NK studies. CAR-NK cell trials only commenced in 2017 and most are still recruiting patients.

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Drug Target Review

NOVEMBER 17, 2023

Up until 2023 around 600 NK cell clinical trials have been reported and some 200 are clinically active and still recruiting patients. The vast majority (65/74; 88%) of those trials involved NK cells without CARs; while only 12 percent were CAR-NK studies. CAR-NK cell trials only commenced in 2017 and most are still recruiting patients.

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The Pharma Data

NOVEMBER 12, 2020

The DETOUR1 trial is the first-in-man trial of the FDA-designated Breakthrough Device, The Detour System, evaluating the safety and effectiveness of the novel procedure and device system for treating long, complex lesions in the superficial femoral artery (SFA). An illustration of a completed Detour Procedure (Graphic: Business Wire).

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The Pharma Data

AUGUST 22, 2021

The trial accrued 25 cases of symptomatic COVID-19 at the primary analysis.There were no cases of severe COVID-19 or COVID-19-related deaths in those treated with AZD7442. The trial included 5,197 participants in a 2:1 randomisation AZD7442 to placebo. The trial was conducted in 87 sites in the US, UK, Spain, France and Belgium.

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Alta Sciences

MARCH 21, 2024

Top 5 Scientific Resources in CNS Clinical Trials blussier Thu, 03/21/2024 - 18:09 HTML CNS Center of Excellence Resource Library Altasciences has an extensive understanding of psychiatric and neurologic disorders, stemming from our decades of conducting complex studies in various therapeutic indications impacting the central nervous system.

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The Pharma Data

AUGUST 20, 2020

cases per 100,000 population in 2017. . Patient dosing has begun in a Phase III clinical programme investigating GlaxoSmithKline’s 5-in-1 meningitis (MenABCWY) vaccine candidate compared to licensed meningococcal vaccines, Bexsero and Menveo.

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The Pharma Data

JULY 21, 2021

(NYSE: PFE), today announced that they have completed recruitment for the Phase 2 trial, VLA15-221, of Lyme disease vaccine candidate, VLA15. The trial builds on previous positive Phase 2 trials and includes both adult and pediatric participants with the aim to support acceleration of the vaccine candidate’s pediatric program.

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Alta Sciences

JUNE 27, 2023

Cancer Treatments, Clinical Trials, and the Motivation to Innovate nbartlett Tue, 06/27/2023 - 20:58 Getting to the Heart of Science with Michelle Newby At the heart of science are stories—stories of courage, challenges, successes, lessons, and people. A: In December of 2017, I was diagnosed with two different types of stage III leukemia.

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Drug Target Review

JANUARY 25, 2024

Currently, they are exploring the drug’s potential for clinical trials. 2017 March 21 [2024 January 18]; Available from: [link] 2 Carey LA, Irvin WJ. The team also observed that the drug prevented in vitro cancer stem cells from self-renewing, which is a characteristic of aggressive cancer cells that supports treatment resistance.

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The Pharma Data

DECEMBER 14, 2020

The Phase II SBIR grant is a follow-on 2–year award that will support testing of Alume’s fluorescent nerve targeting agent in an ongoing Phase 1/2 clinical trial in patients undergoing Head and Neck Surgery. Alume previously received a Phase I SBIR grant in 2019 from the NINDS to develop nerve illumination agents for surgical use.

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The Pharma Data

JANUARY 19, 2021

The Phase 1 clinical trial is planned to be conducted in Canada and targeted to recruit up to 48 and 24 healthy volunteers for the single-ascending dose (SAD) and multiple- ascending dose (MAD) cohorts, respectively. This press release is provided “as is” without any representation or warranty of any kind.

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The Pharma Data

JANUARY 3, 2021

United Kingdom Medicines and Healthcare Products Regulatory Agency authorized Clinical Trial Application. With these important regulatory clearances for our first-in-human clinical trial for INZ-701 in subjects with ENPP1 deficiency, we have transitioned from a research-stage to a clinical-stage company. “We

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Drug Target Review

OCTOBER 26, 2023

Alipogene tiparvovec and voretigene neparvovec-rzyl, two recombinant AAV-based gene therapy products, were approved by the European Medicines Agency (EMA) to treat lipoprotein lipase deficiency in 2012 2 and by the US Food and Drug Administration (FDA) to treat inherited retinal dystrophy in 2017, respectively. Wang D, Tai PW, Gao G.

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The Pharma Data

JANUARY 11, 2021

The trial plans to enroll 99 boys aged 4 to 7 years across 55 sites in 15 countries. The agency previously granted the gene therapy Orphan Drug and Rare Pediatric Disease designations in 2017. Meanwhile, Sarepta Therapeutics reported disappointing top-line results from a phase 2 trial evaluating SRP-9001, its gene therapy for DMD.

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The Pharma Data

MARCH 16, 2022

AstraZeneca and Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced additional positive results from the Phase 3 OlympiA trial. The OlympiA trial is led by the Breast International Group (BIG) in partnership with the Frontier Science & Technology Research Foundation, NRG Oncology, AstraZeneca and Merck.

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The Pharma Data

JANUARY 31, 2021

Adjuvanted S-Trimer COVID-19 vaccine candidates demonstrated favorable safety and tolerability profiles and strong neutralizing immune responses in a phase 1 trial. Clover plans to initiate a global phase 2/3 trial in the first half of 2021 with an interim analysis for vaccine efficacy potentially in the middle of 2021.

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Drug Target Review

FEBRUARY 2, 2024

Also, adoption of 3D human tissue models will help reduce the number of failed clinical trials because ineffective drugs are weeded out pre-clinically. Lastly, by using 3D human tissue models, patients in clinical trials will be exposed to fewer ineffective drugs, reducing their risk of side effects without any benefit.

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The Pharma Data

JANUARY 31, 2021

Clover plans to initiate a global Phase 2/3 efficacy trial of its protein-based S-Trimer COVID-19 vaccine candidate adjuvanted with Dynavax’s CpG 1018 plus alum in the first half of 2021 with an interim analysis for vaccine efficacy potentially in the middle of 2021. EMERYVILLE, Calif. and CHENGDU, China , Feb.

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The Pharma Data

DECEMBER 30, 2020

Long-term safety profile consistent with previously completed controlled trials. Treatment with AXS-07, rapidly, substantially, and durably relieved migraine pain and associated symptoms in this trial. The study enrolled patients who had completed the previous pivotal studies of AXS-07: the MOMENTUM and INTERCEPT trials.

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Drug Target Review

OCTOBER 24, 2023

We identified these species as being important for treatment of UC by generating and analysing metagenomics data from a Faecal Microbiota Transplant (FMT) trial that was undertaken at the University of Adelaide. In addition to analysing metagenomics data, we also isolated bacteria from the healthy donor stool banked as part of that trial.

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The Pharma Data

APRIL 25, 2021

Nirsevimab demonstrate d protect ion against respiratory syncytial virus disease in healthy infants in Phase 3 trial. The overall safety profile of nirsevimab in the trial remains consistent with previously reported results. Lurie Children’s Hospital of Chicago, Illinois, US and primary investigator of the MELODY Phase III trial.

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Drug Target Review

JUNE 21, 2023

Strikingly, a strong genetic link between target and disease biology is emerging as a predictor for success in clinical trials. 2017 Mar 29;9(383):eaag1166. Why Clinical Trials Stop: The Role of Genetics. 2017 Aug 3;101(2):177-191. 2017 Jun 8;546(7657):307-311. Epub 2017 May 31. Sci Transl Med. 2017.06.004.

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New Drug Approvals

OCTOBER 12, 2024

Years later, a subgroup analysis of the trial data indicated a potential positive effect in participants who carried two copies of ApoE4 ( Abushakra et al., ALZ-801 is converted to homotaurine in vivo, but is more easily absorbed and lasts longer in the blood than tramiprosate. 2007 ; Kocis et al., 2016 ; Abushakra et al.,

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Drug Target Review

JANUARY 15, 2024

Onchilles Pharma has translated this breakthrough research into a proprietary set of therapeutics and plans to start first-in-human clinical trials for its first programme, N17350, in 2024 in skin cancers, head and neck cancer, and triple-negative breast cancer. Reference 1. Cui C, Chakraborty K, Tang XA, et al. Cell [Internet].

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Drug Target Review

OCTOBER 2, 2024

Early-phase clinical trials have shown the safety and efficacy of using stem cells for cardiac repair, encouraging further research and development. The complex nature of biologics, combined with innovative gene-editing techniques, raises concerns about long-term safety and efficacy, requiring more stringent and prolonged clinical trials.

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The Pharma Data

NOVEMBER 9, 2020

Trial Also Met the Primary Endpoint in Patients With Low Levels of Eosinophils. In the subgroup of patients with baseline eosinophil counts less than 300 cells per microliter, the trial met the primary endpoint with tezepelumab demonstrating a statistically significant and clinically meaningful reduction in AAER.

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The Pharma Data

JANUARY 25, 2021

agree to place handheld Ceribell Rapid Response EEG systems in hospitals in connection with its Phase 3 RSE clinical trial. Within the RAISE trial, it will allow clinicians to rapidly establish a diagnosis of nonconvulsive SE in the absence of immediate availability of conventional EEG. About the RAISE Trial. RADNOR, Pa.–(

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Drug Target Review

MAY 18, 2023

Tedesco Distinguished Chair of Paediatric Haematology and Oncology, are collaborating as co-principal investigators on a new clinical trial, which has been awarded a $2.3 The trial represents an early-stage effort to determine the viability of this approach. million grant from the National Heart, Lung and Blood Institute.

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New Drug Approvals

SEPTEMBER 13, 2024

2] As of July 2022, it is in phase 3 clinical trials for major depressive disorder. [2] hours following a single dose of 10 mg, which supported the 4 mg to 25 mg dosages that aticaprant is being explored at in clinical trials. [13] 22] [21] Janssen was also experimenting with esketamine for the treatment of depression as of 2017. [21]

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New Drug Approvals

NOVEMBER 13, 2023

WO 2017/208267A1, WO 2020/250133 Al and WO 2022/024072A1, which are hereby incorporated by reference, disclose methods of use of the compound of Formula I for the treatment of Parkinson’s disease, synucleinopathies and Alzheimer’s disease (AD) respectively. amcrasto@amcrasto /////////// Ref [1]. amcrasto@amcrasto /////////// Ref [1].

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The Pharma Data

DECEMBER 31, 2020

Tabibiazar co-founded private Aravive Biologics and served as the Chairman of its board of directors and as President and Chief Executive Officer from its inception to April 2017 and as Executive Chairman from May 2017 until October 2018. During that time, he led Aravive Biologics through a reverse merger with Versartis, Inc.,

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The Pharma Data

DECEMBER 20, 2020

Pending Health Canada’s approval, the Phase 1 trial is designed to test the safety, tolerability and pharmacokinetics of ALS-4 in healthy volunteers. The primary objective of the trial is to evaluate the safety and tolerability of SAD and MAD of ALS-4 administered orally to healthy subjects.

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