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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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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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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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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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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Clinical Trials Science Molecular Biology Bioinformatics 59

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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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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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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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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Clinical Trials Science Disease Trials 40

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

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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Clinical Trials Treatment Research Trials 52

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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Drug Target Review

OCTOBER 8, 2024

2012 Mar 2;287(10):7446–55. Immuno-PET Using Anticarcinoembryonic Antigen Bispecific Antibody and 68 Ga-Labeled Peptide in Metastatic Medullary Thyroid Carcinoma: Clinical Optimization of the Pretargeting Parameters in a First-in-Human Trial. Journal of Biological Chemistry. Journal of Nuclear Medicine. 2016 May 26;57(10):1505–11.

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Pharmacokinetics Engineering Treatment Science 52

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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Fragment Screening Biochemical Assays Small Molecule Biophysical Assays 96

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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The Pharma Data

DECEMBER 21, 2020

On Monday, the two companies said the investigational asset tezepelumab did not meet its primary endpoint in the Phase III SOURCE trial assessing the drug’s ability to generate a statistically significant reduction of corticosteroid use on top of standard of care treatment in some asthma patients. Tezepelumab is a once-per-month injection.

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Drugs Treatment Therapies Trials 52

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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Codon

AUGUST 26, 2024

One large-scale clinical trial found that it only reduces the relative risk of death by about ten percent in hospitalized patients. Companies may lack incentives to conduct human clinical trials for drug-free antivirals or repurposed drugs. Nor was remdesivir as effective as people hoped. Unsubscribe any time.

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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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The Pharma Data

NOVEMBER 18, 2020

Swati Chokalingam, a Boston-area obstetrician/gynecologist and Kaling’s mom, died in 2012 after getting a stage 4 diagnosis eight months earlier. WEDNESDAY, Nov. 18, 2020 — When actor, writer and producer Mindy Kaling’s mom was fighting pancreatic cancer , it was the biggest struggle the family had ever experienced.

Disease 52

Disease Treatment Research Trials 52

New Drug Approvals

AUGUST 21, 2023

7] A one-year trial did not demonstrate a significant benefit on lung density in moderate-to-severe emphysema secondary to severe α(1)-antitrypsin deficiency. [8] 18] In December 2022, the FDA declined to approve palovarotene for the fibrodysplasia ossificans progressive without additional clinical trial data. [19] August 2012).

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The Pharma Data

DECEMBER 13, 2020

About Junshi Biosciences Founded in December 2012, Junshi Biosciences (HK: 1877; SH: 688180) is an innovation-driven biopharmaceutical company dedicated to the discovery, development and commercialization of innovative therapeutics.

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Drug Target Review

MAY 31, 2024

She completed her PhD in Synthetic Organic Chemistry at Monash University and began her medicinal chemistry career at Cancer Therapeutics (CTx) in Melbourne, Australia in 2012. About the author Dr H Rachel Lagiakos Senior Principal Scientist, Therapeutics Group at Schrodinger Dr Lagiakos joined the company in 2018.

Organic Chemistry 45

Organic Chemistry Computational Chemistry Small Molecule Disease 45

Agency IQ

JULY 8, 2024

Device regulators have dropped important guidance recently , publishing guidance on alternative trial designs for orphan devices and updating how to carry out benefit-risk assessments on the use of toxic phthalates in medical devices. elections over, AgencyIQ is also anticipating the new European Parliament to start work again soon.

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The Pharma Data

DECEMBER 15, 2020

And during two testing periods — 2008/2010 and again in 2012/2014 — participants underwent repeated assessments (for an average of four years) designed to track changes in memory, language skills, concentration, attention, motor speed and mental “flexibility.”

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Clinical Trials Trials Research 52

Drug Target Review

AUGUST 24, 2023

Her discoveries on the first-in-class RNA-based innate immune receptor agonist RGT100, built the foundation for the initiation of a Phase I clinical trial as well as the successful acquisition of Rigontec by MSD (known as Merck & Co. 2012 Feb 1;24(1):107-15. in North America) in late 2017. Biophysical Journal.

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Treatment Therapies Clinical Development Cell Biology 98

Agency IQ

OCTOBER 6, 2023

The PFDD initiative, established in 2012 through the Food and Drug Administration Safety and Innovation Act (FDASIA), allows the FDA to receive patient perspectives through structured meetings which ask, among other things, how a patient feels about their condition, their tolerance for risk and what they would like to see in an ideal treatment.

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The Pharma Data

NOVEMBER 22, 2021

Important discoveries have included Francis Crick and James Watson’s DNA advance in 1953, and Professor Sir John Gurdon’s work on stem cells in 2012. Over the once century, roughly 50 Nobel Prize winners in chemistry and physiology or drug have been associated with Cambridge. region in the US, and Gothenburg in Sweden.

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