Worldwide Clinical Trials

JUNE 15, 2022

The pandemic has had a lasting impact on the ability of sites to participate in trials, particularly in the US. We need to consider how to use diverse populations in gene therapy trials. But it’s important we strive to find ways to include diverse patients so trial data can be representative of the wider population.

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Drug Discovery World

MARCH 26, 2024

More importantly, it also highlighted that significant challenges remain in selecting the right therapies for the right patients despite the progress made through genomic testing and implementation of circulating tumour (ct) DNA analyses. Results of that Phase I trial are expected to be presented later this year.

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RNA In-Vivo In-Vitro DNA 64

The Pharma Data

OCTOBER 19, 2020

We remain committed to further progressing our trial preparations, as we look forward to initiating a U.S. Phase 2 trial for Berubicin during the first quarter of 2021.” In addition to its manufacturing efforts, the Company has also made progress in its clinical trial preparations. .

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Clinical Trials Clinical Trials Manufacturing Trials 52

Drug Discovery World

AUGUST 14, 2023

For instance, in a trial where patients are selected based on a specific human leukocyte antigen (HLA) type, the FDA requires the use of a fully certified, FDA approved Companion Diagnostic. Despite this step, there remain divergent views on other regulatory aspects. Archiving samples from the early manufacturing stages is key.

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Gene Therapy Marketing Gene DNA 52

XTalks

APRIL 23, 2021

dMMR occurs when a cell is unable to repair errors made during cellular replication, owing to mutations in DNA mismatch repair genes such as MLH1 or MLH2 , resulting in high-frequency microsatellite instability (H-MSI). Dostarlimab and the GARNET Trial. percent with a complete response (CR) rate (disappearance of tumor) of 12.7

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FDA Approval Trials Antibody DNA 105

The Pharma Data

DECEMBER 16, 2020

The Company will initiate its trial during the first quarter of 2021 to investigate the efficacy of Berubicin in adults with GBM who have failed first-line therapy. and 2 trials planned by our sublicensee WPD in Poland. . and 2 trials planned by our sublicensee WPD in Poland. About CNS Pharmaceuticals, Inc.

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FDA Approval Drugs Clinical Trials Clinical Trials 52

Advarra

MARCH 31, 2023

The use of engineered genetic materials in clinical trials is rapidly expanding, with potential applications for genetic vaccines, gene-modified cellular therapies, and gene therapies. IPs containing engineered genetic materials may pose risks potentially not anticipated by the clinic’s standard infection control policies.

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Engineer Genetics Clinical Research Research 52

The Pharma Data

JANUARY 20, 2021

Nasdaq: INO), a biotechnology company focused on bringing to market precisely designed DNA medicines to treat and protect people from infectious diseases, including COVID-19, cancer and HPV-associated diseases, today announced the pricing of an underwritten public offering of 17,700,000 shares of its common stock at a public offering price of $8.50

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DNA Containment Immune Response Sales 40

The Pharma Data

JANUARY 21, 2021

.–( BUSINESS WIRE )– Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, today announced an oral presentation on updated efficacy, safety, and dosing management of poziotinib from Cohorts 1 and 2 of the ZENITH20 clinical trial.

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Clinical Trials Clinical Trials Licensing Licensing 52

Delveinsight

JULY 26, 2021

Pharma titan, GlaxoSmithKline is developing a triazaacenaphthylene bacterial type II topoisomerase inhibitor, Gepotidacin (GSK2140944), which works by selectively interacting with two key bacterial enzymes, DNA gyrase and topoisomerase IV (type II topoisomerases), responsible for bacterial replication.

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Marketing Bacteria Vaccination Vaccine 93

The Pharma Data

AUGUST 17, 2021

Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). Mismatch repair-deficient tumours contain abnormalities that affect the proper repair of DNA when copied in a cell [i]. by blinded independent central review. with a DoR range of 2.6-35.8+

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FDA Approval Antibody DNA Hormones 52

The Pharma Data

MARCH 30, 2021

Targeted radioligand therapy is a type of precision medicine combining two key elements: a targeting compound, or ligand, and a radioactive isotope, causing DNA damage that inhibits tumor growth and replication. We believe this technology has the potential to transform many patients’ lives.”. Disclaimer. Source link:[link].

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Protein Licensing Licensing Containment 52

pharmaphorum

JANUARY 18, 2023

The DNA of these so-called ‘genetic superheroes’ may contain clues about how to treat severe disease. In our experience of running 20+ precision medicine studies, there are a few design principles that every research programme – from biobanks to clinical trials – should consider. Giving participants something in return.

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Genetic Disease Genetics Research Genome 97

The Pharma Data

OCTOBER 18, 2020

(NASDAQ:CDXC) today highlighted a new study published in The European Molecular Biology Organization Journal looking at the effect of nicotinamide riboside (NR) on maintaining telomeres, the protective regions at the end of DNA strands. Telomeres are “caps” at the end of chromosomes that protect DNA from getting worn away as cells replicate.

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DNA Scientist Genetic Disease Research 52

The Pharma Data

DECEMBER 14, 2020

Many drugs fail in clinical trials because of their low blood brain barrier permeability. The current standard of care for GBM consists of de-bulking surgery followed by combined treatments with fractionated ionizing radiation (IR) and the DNA alkylating agent temozolomide (TMZ). . Lantern’s A.I.

Drugs 52

Drugs Genome Genomics DNA 52

Drug Discovery World

JANUARY 19, 2023

This paid-for advertorial by Catalent appeared in DDW Volume 24 – Issue 1, Winter 2022/2023 One significant challenge in the manufacturing of cell and gene therapies is the production of high-quality plasmid DNA (pDNA). coli cell bank that contains the plasmid. billion by 2030 (BioSpace, 11 August 2022).

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DNA Manufacturing Gene Therapy Gene 52

Drug Discovery World

AUGUST 3, 2023

Significantly, in January 2023, the FDA finalised a 2020 draft guidance outlining how sponsors and investigators can conduct clinical trials for certain drugs containing cannabis or cannabis-derived compounds without running afoul of federal law 2. This was the largest ever independent study into cannabis use 10.

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The Pharma Data

NOVEMBER 27, 2020

In Phase 3 clinical trials, 80 percent of patients with obesity due to POMC or PCSK1 deficiency achieved greater than ten percent weight loss and 45.5 In Phase 3 clinical trials, 80 percent of patients with obesity due to POMC or PCSK1 deficiency achieved greater than ten percent weight loss and 45.5 The company is based in Boston, MA.

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FDA Approval Genetic Disease Genetics Clinical Trials 52

The Pharma Data

NOVEMBER 24, 2020

Lynparza is the first biomarker-selected targeted treatment option approved in Canada , based on the Phase III PROfound trial of men with Homologous Recombination Repair mutated (HRRm) mCRPC. Approximately 32 patients from 12 Canadian centres have participated in the PROfound trial to date.

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Gene Hormones DNA Medicine 52

Delveinsight

JULY 29, 2020

The Government of India in order to contain the spread of novel coronavirus rolled out several guidelines and precautionary measures. BBIL has received the approval of Drugs Controller General of India (DCGI) for conducting the Phase I & II Human Clinical Trials. The cases since then are on a continuous rise.

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Vaccination Vaccine Clinical Trials Clinical Trials 62

Delveinsight

DECEMBER 13, 2020

Even though clinical trial results were promising, adverse events and serious complications were observed. Vosevi) to treat adult chronic hepatitis C of all genotypes previously treated with an NS5A inhibitor-containing regimen, or with genotype 1a or 3 previously treated with a sofosbuvir-containing regimen without an NS5A inhibitor.

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Genotype FDA Approval DNA Drugs 52

pharmaphorum

SEPTEMBER 8, 2022

However, there is a difference between the two: the toxic payloads of ADCs need to be absorbed into cancer cells, whereas radiopharmaceuticals can still do damage even when only bound to the cancer, and are particularly sensitive to radiation-induced DNA damage. Investment is flowing.

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Manufacturing Development Drugs Antibody 104

The Pharma Data

MARCH 18, 2022

By manipulating the microbes’ DNA, they programmed gene circuits that control the bacteria surface, building a molecular “cloak” that encapsulates the bacteria. Some trials had to be terminated due to severe toxicity.” ” The Ideal Bacteria. They injected E. coli iCAP leak out and migrate to uninjected tumors.

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Bacteria Engineer Drugs Research 52

Pfizer

JANUARY 27, 2023

In preclinical studies, nirmatrelvir did not demonstrate evidence of mutagenic DNA interactions. One carton contains five blister packs of PAXLOVID, as co-packaged nirmatrelvir tablets with ritonavir tablets, providing all required doses for a full five-day treatment course.

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Pharmaceutical Technology

OCTOBER 26, 2022

Gene therapy uses DNA to manipulate cells and correct defective genes, whereas cell therapy is the infusion or transplantation of cells into a patient. New doors were opened in the 2000s with the development of genome editing, such as CRISPR-Cas9, which introduces molecular tools to change existing DNA.

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Gene Therapy Gene Marketing Manufacturing 130

XTalks

DECEMBER 13, 2023

The company’s sustained investment in R&D has led to a rapid expansion of its pipeline in 2023, with notable milestones such as four infectious disease vaccines in Phase III trials, including the recently submitted respiratory syncytial virus (RSV) vaccine for regulatory approval. million, marking a significant increase from the $56.1

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Genetics Vaccination Vaccine DNA 111

The Pharma Data

SEPTEMBER 1, 2020

COVID-19 testing solutions that provide healthcare professionals and patients with a quick answer regarding their infection status are critical to contain the community-spread of the COVID-19 virus. Roche has an ongoing clinical trial program evaluating the role of Actemra©/RoActemra© (tocilizumab) in COVID-19 pneumonia.

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In-Vitro Antibody Medicine Clinical Trials 52

Roots Analysis

AUGUST 31, 2023

Gene switches can be regulatory proteins or specific DNA sequences that act to either switch on or off the expression of a gene. Basic Components of Gene Switch Gene switches are composed of noncoding DNA sequences and transcription factors.

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Gene Gene Therapy Gene Expression Regulation 40

The Pharma Data

AUGUST 3, 2021

Food and Drug Administration (FDA) has determined that OAV-101 intrathecal (IT) clinical trials for spinal muscular atrophy (SMA) patients may proceed, thereby lifting the partial clinical trial hold initiated in October 2019. Novartis today announced that the U.S. SVP, Chief Medical Officer, Novartis Gene Therapies. “We

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Clinical Trials Clinical Trials Gene Therapy Trials 52

XTalks

JANUARY 19, 2024

Radiobiological and Clinical Considerations from CRO and Emerging Biotech Radiopharmaceuticals are medicinal formulations containing radioisotopes that are used in the field of nuclear medicine primarily for the diagnosis and treatment of various diseases, particularly cancer. Guarnaschelli in the webinar.

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DNA Radiology FDA Approval Development 66

Pfizer

AUGUST 15, 2022

In preclinical studies, nirmatrelvir did not demonstrate evidence of mutagenic DNA interactions. One carton contains five blister packs of PAXLOVID, as co-packaged nirmatrelvir tablets with ritonavir tablets, providing all required doses for a full five-day treatment course. FDA Emergency Use Authorization Statement.

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Drugs Vaccination Vaccine In-Vitro 99

Pharmaceutical Technology

NOVEMBER 22, 2022

According to CEPI: “Achieving the 100 Days Mission would give the world a fighting chance of containing a future outbreak before it spreads to become a global pandemic.”. Messenger RNA vaccines contain nucleic acids that code for a specific protein, or target antigen, related to a virus or disease.

Manufacturing 130

Manufacturing Vaccination Vaccine RNA 130

XTalks

FEBRUARY 4, 2021

Bernard, executive vice president for research and chief research officer at Vanderbilt University Medical Center, shared his experience in helping set up a DNA and clinical data resource called BioVU. The project began in 2004, in the early days of biobanking for DNA, says Dr. Bernard, and has grown tremendously since.

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Research Biobanking Drugs Genome 98

The Pharma Data

DECEMBER 27, 2020

This year has been difficult, but it has reinforced the importance of our mission: to treat and potentially even reverse the effects of serious diseases and conditions by advancing our novel cell therapy product candidates through clinical trials and into the hands of physicians. Forward-Looking Statements.

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Drug Discovery World

DECEMBER 15, 2022

These platforms all induce double strand cuts in the chromosomal DNA that can be sealed by the cell, leading to a specific gene disruption, or resulting in a new target site for inserting DNA segments. Early phase clinical trials for gene editing therapies. Gene editing challenges and potential solutions.

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Gene Editing Gene In-Vivo Genome 52

Drug Discovery World

AUGUST 10, 2022

And now, with more than 600 CAR T trials recruiting or ongoing, these cells represent a majority of the cellular immunotherapies in development today. How ddPCR technology detects and quantifies DNA ddPCR technology is a highly sensitive and accurate tool used to detect and quantify known genetic sequences.

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Manufacturing Gene Genome Genomics 98

Pfizer

DECEMBER 13, 2022

In preclinical studies, nirmatrelvir did not demonstrate evidence of mutagenic DNA interactions. One carton contains five blister packs of PAXLOVID, as co-packaged nirmatrelvir tablets with ritonavir tablets, providing all required doses for a full five-day treatment course. For more information, please visit www.PAXLOVID.com. .

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