Drug Target Review

NOVEMBER 1, 2023

2 Implication of ATX in a large range of human diseases have been highlighted by both fundamental research and clinical trials. 1-5 Implication of ATX in a large range of human diseases have been highlighted by both fundamental research and clinical trials. 2012 Feb 1;40(1):31–6. J Med Chem. 2016 Jun 23;59(12):5604–21.

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Conversations in Drug Development Trends

NOVEMBER 27, 2023

In trials, Casgevy was shown to help prevent episodes of debilitating pain, known as vaso-occlusive crises, that often plague patients affected by sickle cell disease. The CRISPR technique was first published in 2012, outlining a method to harness the previously underappreciated bacterial immune system.

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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. Russell S, et al.

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FDA Law Blog: Biosimilars

NOVEMBER 27, 2023

According to the government, these companies knew as early as 2012 that their dehumidifiers were defective, in that they could overheat and catch fire. Gree USA’s Chief Executive Officer, Charley Loh, and the Chief Administrative Officer, Simon Chu, however, did not agree to the plea deal for the corporate entity, and elected to go to trial.

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Vial

MAY 1, 2024

The landscape of medical research is currently in the midst of an exciting transition wherein technology has rapidly become a critical tool for clinical trial management and patient data collection. in 2010 to 11.4% in 2020 to enable continuous remote monitoring of real-world patient health data. in 2010 to 11.4%

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Drug Target Review

JANUARY 8, 2024

Shinya Yamanaka, who was awarded the Nobel prize in 2012, discovered that four transcription factors Oct4, Sox2, Klf4 and c-Myc could reprogram mature, differentiated cells back into stem cells. The epigenome drifts with age, leading to dysregulated gene expression.

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The Pharma Data

JANUARY 10, 2021

The new year began with a fairly low level of clinical trial news. Arcturus Therapeutics got the FDA go-ahead for its Phase II trial of its COVID-19 vaccine candidate ARCT-021. The trial will enroll 600 participants, with 450 receiving ARCT-021 and 150 receiving placebo. Here’s a look. COVID-19-Related. Non-COVID-19-Related.

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Drug Target Review

MAY 27, 2024

Antibody-drug conjugates have seen explosive growth in the last few years which has materialised with numerous clinical trials demonstrating meaningful improvements in survival. How does the company see antibody-drug conjugates (ADCs) fitting into this approach?

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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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The Pharma Data

AUGUST 21, 2020

Janssen acquired the worldwide license to develop, manufacture and commercialise the drug through an agreement with Genmab in 2012. This treatment has been approved following the randomised, open-label Phase 3 CANDOR trial that included 436 multiple myeloma patients who had relapsed.

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Drug Target Review

NOVEMBER 27, 2024

2012 Dec 1;72(23):6097-101. 2012 Sep 18;12(9):12710–28. Outsourcing Biomarkers in Clinical Trials: Advantages and Disadvantages. Why your new cancer biomarker may never work: recurrent patterns and remarkable diversity in biomarker failures. Cancer research. Meso Scale Discovery – MSD – Pacific BioLabs [Internet].

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LifeSciVC

APRIL 26, 2024

This has long been a feature of biopharma (see 2012 and 2016 posts on oncology and immune-oncology , respectively), but has been exacerbated by the creation of so many new companies. Third, with the proliferation of startups, we’ve seen incredible crowding in hyper-competitive therapeutic categories and modalities.

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Eye on FDA

JULY 5, 2022

Most notably in 2012 the Food and Drug Administration Safety and Innovation Act (FDASIA) was signed into law, bring to bear among other things, breakthrough therapy designation. The most obvious impact is that of COVID-19 to recruiting and maintaining clinical trials. Since that time, there has been a healthy output of new treatments.

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The Pharma Data

SEPTEMBER 30, 2020

Roche eventually released its data in 2012, and based on this, Jefferson concluded that Tamiflu could reduce the duration of flu symptoms, as well as the number of symptomatic cases among infected people, but found it did not cut the risk of disease transmission or lower respiratory complications. billion on stockpiling the drug.

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The Pharma Data

NOVEMBER 10, 2020

The trial is a dose-ranging, open-label study that will enroll 60 patients in the U.S. 2012) Induction of immunological tolerance by oral anti-CD3. Clin Dev Immunol 2012, 425021. NEW YORK and LONDON, Nov. NEW YORK and LONDON, Nov. and Europe. Dr. Howard L. Grand View Research August 2018 ( [link] ). da Cunha, A. and Weiner, H.

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The Pharma Data

DECEMBER 29, 2020

Phase III BRIDGE open-label, switch-over clinical trial met key objectives for safety and efficacy. Protalix’s first product manufactured by ProCellEx, taliglucerase alfa, was approved for marketing by the FDA in May 2012 and, subsequently, by the regulatory authorities of other countries.

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The Pharma Data

JANUARY 21, 2021

The rest are in Phase I trials for ovarian cancer, AML, MDS, heart failure, HPV+ solid tumors and recurrent respiratory papillomatosis (RRP). Food and Drug Administration (FDA) gave the go-ahead for the company to initiate a Phase I trial of PRGN-2012 in adults with recurrent RRP. On January 5, 2021, the U.S.

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Vial

FEBRUARY 23, 2024

Adoption and usage over time By 2012, nearly 57% of healthcare institutions across the United States already had patient portals in place, with the survey reporting 71% of these institutions valuing the idea of integrating EMR systems with a patient portal offered by the EHR vendor.

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Drug Target Review

JUNE 12, 2023

With 13 preclinical candidates and three AI-designed drugs currently undergoing clinical trials, Insilico is spearheading a revolution in cancer treatment and beyond. 2021 – and a robust pipeline that includes 3 AI-designed drugs (for IPF, COVID-19 and cancer) currently in clinical trials.

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Agency IQ

APRIL 19, 2024

Committee discussions noted the potential for earlier readout and faster completion of studies, with an expectation that the FDA will ultimately require follow-through with confirmatory trials. The analysis included 20 trials for 12,926 patients with IPD.

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Agency IQ

AUGUST 2, 2024

While the work on the pharma package will likely take quite some time, another deadline is coming up fast: the full transition of all clinical trials from the Clinical Trials Directive to the Clinical Trials Regulation.

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The Pharma Data

JUNE 26, 2021

Together with our research partners, BIG conducts landmark, practice-changing trials that can have a significant impact on the lives of women with breast cancer,” sa id David Cameron , Chair of the BIG Executive Board. Adjuvant therapy helps prevent and delay the progression of disease into the later setting.

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Agency IQ

MARCH 29, 2024

FDA’s oncology advisory committee to consider MRD as a multiple myeloma endpoint Yesterday, the FDA announced that its Oncologic Drugs Advisory Committee would weigh in on the potential use of minimal residual disease (MRD) as an endpoint in multiple myeloma clinical trials. What’s new? The meeting will take place on April 12, 2024, 9 a.m.

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The Pharma Data

OCTOBER 26, 2020

. “Our study highlights how common the early and subtle signs of focal epilepsy are,” said study senior investigator Dr. Jaqueline French, a director of translational research and clinical trials for epilepsy at NYU Langone Health. Meanwhile, about 200 patients were diagnosed within two months of having motor seizures.

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The Pharma Data

DECEMBER 30, 2020

This regimen was shown in clinical trials to be safe and effective at preventing symptomatic COVID-19, with no severe cases and no hospitalisations more than 14 days after the second dose. We would like to thank our many colleagues at AstraZeneca, Oxford University, the UK government and the tens of thousands of clinical trial participants.”.

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Drug Target Review

NOVEMBER 6, 2023

Throughout his career, he has published more than 300 papers in peer-reviewed journals, served as the principal investigator of more than 60 clinical trials and led two independent National Cancer Institute–funded Specialized Programs of Research Excellence at MDACC and MSKCC. 2012);12(4):237-251. Front Pharmacol. 2018;9:1300.

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Agency IQ

DECEMBER 1, 2023

Q4 2023 Performance of pharmacovigilance activities for human medicines (update of Implementing Regulation (EU) 520/2012) [E.U.] A targeted amendment to Regulation (EU) No 520/2012 to harmonize the performance of pharmacovigilance activities; no action has yet been taken. Q2 2022 E.U.

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Drug Target Review

NOVEMBER 1, 2023

The mission of the CCDD is to discover novel small-molecule therapeutics for the treatment of cancer and progress them to hypothesis testing phase 1 clinical trials. I work in the Centre for Cancer Drug Discovery (CCDD) at The Institute of Cancer Research in London, which is an academic drug discovery centre.

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The Pharma Data

NOVEMBER 15, 2020

Most recently, she was a senior executive at Celgene Corporation, where she led corporate strategy from 2012 to 2017. drug development initiative from 2012 to February 2019. She earned a BA from Durham University, U.K., and an MBA from Harvard Business School. Before that, Ms.

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Drug Target Review

SEPTEMBER 21, 2023

Debrah, AY et al (2015) ‘Doxycycline Leads to Sterility and Enhanced Killing of Female Onchocerca volvulus Worms in an Area with Persistent Microfilaridermia after Repeated Ivermectin Treatment: A Randomized, Placebo-Controlled, Double-Blind Trial’, Clinical Infectious Diseases, 61(4), pp. doi: 10.1093/cid/civ363. Cotton et al., “The

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The Pharma Data

JANUARY 24, 2021

Meanwhile, the FDA has also approved the Investigational New Drug (IND) application for a global Phase III trial of Toripalimab in combination with Axitinib versus Pembrolizumab for the first-line treatment of patients with advanced mucosal melanoma (Combination Clinical Trial).

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FDA Law Blog: Biosimilars

FEBRUARY 29, 2024

If the confirmatory trial shows that the drug actually provides a clinical benefit, then the FDA grants traditional approval for the drug. If the confirmatory trial does not show that the drug provides clinical benefit, FDA has regulatory procedures in place that could lead to removing the drug from the market. That did not happen.

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Agency IQ

MAY 3, 2024

Two consultations on clinical trial considerations, one on advanced therapies and the other addressing non-inferiority and equivalence comparisons, are closing at the end of May. The pharma reform package remains in E.U. leaders’ eyesight as the Parliament winds down ahead of its June elections.

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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] 2] As of July 2022, it is in phase 3 clinical trials for major depressive disorder. [2]

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DrugBank

NOVEMBER 4, 2024

Gepotidacin has shown promising results in clinical trials for uncomplicated urinary tract infections and gonorrhea, demonstrating its potential to address the growing threat of MDR Gram-negative infections.  Push incentives, such as grants, tax breaks, and R&D subsidies, can help with the high costs of antibiotic development.

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Agency IQ

MAY 17, 2024

BY KIRSTEN MESSMER, PHD, RAC | MAY 15, 2024 10:23 PM CDT Background: Real-world data, real-world evidence and clinical studies A quick refresher on terminology: Real-world data (RWD) are data generated through general clinical practice or from other sources outside the controlled environment of clinical trials.

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The Pharma Data

AUGUST 19, 2020

The TARGIT-A trial involved 2,298 women with breast cancer in 10 countries being given either targeted therapy during surgery or a standard course of radiotherapy between 2000 and 2012. During the pandemic, NHS England has reduced the number of visits people need to make for standard radiotherapy after surgery to about five.

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