Antidote

APRIL 4, 2024

Before it is released onto the market, the development of any new drug or medical device must undergo rigorous testing , part of which involves clinical trials. Clinical trials are integral to making sure that any new therapy is both safe and effective for individuals, and volunteers are a vital part of the process.

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Fierce BioTech

AUGUST 14, 2024

Epilepsy Clinical Trials Finding an effective epilepsy treatment can be arduous. Download this brochure to delve into how IQVIA's expertise and innovative strategic approach can streamline the clinical trial process, helping to get new therapies to patients who need them sooner.

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Drug Discovery World

MAY 17, 2023

Leveraging historical trial databases has become commonplace in assessing the feasibility of trials in therapeutic areas with a large breadth of clinical development history. EHR data also has a key role to play in designing future clinical trials.

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Clinical Trials Trials Clinical Development Science 130

Drug Discovery World

AUGUST 14, 2024

The US Food and Drug Administration (FDA) has approved a Phase II clinical trial for Biosyngen’s BRG01, an EBV-specific CAR-T cell therapy. This marks the first cell therapy to enter Phase lI trials in both the US and China for the treatment of relapsed/metastatic EBV-positive nasopharyngeal carcinoma.

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Drug Discovery World

JULY 17, 2023

Analysis of 13,490 clinical trials finds almost a third have been cancelled during Phase II amidst an overall decline in clinical development productivity. Data analytics company Phesi has released the results of its mid-year global analysis of all clinical trials conducted in 2023 to date.

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Drug Discovery World

NOVEMBER 28, 2023

An international team of scientists has shown that a stem cell therapy for multiple sclerosis (MS) could prevent further damage to the brain. The early-stage clinical trial was the result of a collaboration between researchers at University of Colorado Anschutz Campus, the University of Cambridge and the University of Milano-Bicocca. “We

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Drug Discovery World

AUGUST 9, 2023

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted Aleta Biotherapeutics a clinical trial authorisation (CTA) to evaluate biologic ALETA-001 in a Phase I/II clinical trial in patients with B-cell malignancies who are relapsed/refractory to CD19 CAR T cell therapy.

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Drug Discovery World

NOVEMBER 1, 2023

Axicabtagene ciloleucel, Kite Two indirect comparative analyses of CAR T-cell therapy axicabtagene ciloleucel vs. bispecific antibodies epcoritamab and glofitamab, for relapsed/refractory diffuse large B-Cell lymphoma, showed improved progression-free survival (PFS). Median PFS was 4.4 months versus 3.7 with docetaxel and the ORR was 26.4%

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Drug Discovery World

AUGUST 30, 2024

As we gear up for Phase I clinical trials in the first half of 2024, we’re aiming to evaluate the safety of our innovative CD5 knockout strategy enabled by our novel cell therapy and manufacturing platform. Beyond VIPER-101, we’re developing subsequent programmes for autoimmune disease and solid tumours.

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Drug Discovery World

APRIL 5, 2023

CureSearch for Children’s Cancer, a national non-profit with a mission to end childhood cancer by driving targeted and innovative research in an accelerated time frame, will fund a Phase I clinical trial to bring new therapies to paediatric brain cancer patients, including those with limited or no treatment options.

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Drug Discovery World

APRIL 14, 2023

Clinical trials are, undoubtedly, an essential part of the drug development process, providing us with valuable information about the safety and efficacy of new treatments and therapies. of participants 2 Covid-19 vaccination trials. In fact, these demographics which make up 13.8%

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Drug Discovery World

NOVEMBER 16, 2023

The Medicines and Healthcare products Regulatory Agency (MHRA) has authorised the world’s first gene therapy for sickle-cell disease (SCD) and transfusion-dependent β-thalassemia (TDT). Trial results for Casgevy The authorisation is based on positive clinical trial data.

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Drug Discovery World

OCTOBER 9, 2023

Developed by gene therapy company Genprex, Reqorsa is a non-viral gene therapy that leads to expression of the TUSC2 tumour suppressor gene in cancers. The post Non-viral gene therapy shows early efficacy in lung cancer appeared first on Drug Discovery World (DDW).

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Antidote

NOVEMBER 9, 2023

Before any new treatment or therapy is able to be used by the patient population, it must go through the process of a clinical trial — this is the case for any new prescription drug, but also true for over-the-counter medications, medical devices, and more.

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Clinical Trials Trials Therapies Treatment 126

Drug Discovery World

JULY 24, 2024

CHOP identified a candidate antisense oligonucleotide (ASO) as a potential therapy for H-ABC. This extension to the companies’ collaboration agreement will see Evotec significantly broaden the pipeline with additional ASOs as candidate therapies. They are instrumental in supporting us as we prepare for those clinical trials.”

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Drug Discovery World

OCTOBER 18, 2023

Sara Donnelly, Director of Research Planning and Business Development at PhoenixBio USA explores why the right pre-clinical model is essential for teams wanting to advance adeno-associated virus vector-based gene therapies.

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Drug Discovery World

JULY 12, 2024

AB-1005 is an investigational adeno-associated virus 2 glial cell line-derived neurotrophic factor (AAV2-GDNF) neurorestorative gene therapy. The company’s Phase II REGENERATE-PD clinical trial is currently enrolling patients in the US with sites in the European Union and the UK planned to open later this year.”

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Drug Discovery World

APRIL 10, 2023

RESP-X, Infex Therapeutics’ anti-virulence therapy to treat Pseudomonas aeruginosa (Pa) infections in non-cystic fibrosis bronchiectasis (NCFB) patients, has shown a promising interim safety and tolerability profile in its ongoing first-in-human Phase I clinical trial.

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Drug Discovery World

DECEMBER 18, 2023

University College London (UCL) researchers have developed a new gene therapy to cure focal cortical dysplasia, which a new study shows can significantly reduce seizures in mice. The researchers plan to conduct a first-in-human clinical trial in the next five years.

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Drug Discovery World

MARCH 4, 2024

In an early phase clinical trial, a combination of antibody-based medications targeting the immune system generated promising safety data and anti-tumour activity in individuals with advanced cancer. Both medications tested in the trial support immune responses against tumour cells. Various dosing schedules of CS1002 (0.3,

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Therapies Immune Response Clinical Trials Trials 290

Drug Discovery World

JULY 5, 2024

AviadoBio has launched its Phase I/II ASPIRE-FTD clinical trial at the Ohio State University in the US. ASPIRE-FTD is evaluating investigational gene therapy AVB-101 in people with frontotemporal dementia (FTD) with progranulin (GRN) gene mutations (FTD-GRN).

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Drug Discovery World

JULY 19, 2024

Dr Gonzalez-Aseguinolaza said: “This is a tremendous honour, and I am very pleased that the RFS Society recognises my dedication and work in the field of gene therapy. She then moved into rare diseases and has been working on rare hepatic diseases for the last two decades, with a focus on the development of advanced therapies.

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Drug Discovery World

JANUARY 30, 2024

Viral vector manufacturing At the Advanced Therapies Awards ceremony, Dr Luigi Naldini, Director of the San Raffaele Telethon Institute for Gene Therapy, was awarded a Lifetime Achievement Award in recognition of ‘extraordinary contributions to gene therapy’, a field he has helped shape through his pioneering work on lentiviral vectors.

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Drug Discovery World

JANUARY 22, 2024

The UK is cementing its position as a global leader in cell and gene therapy (CGT), according to a new report released today by the UK BioIndustry Association (BIA), in collaboration with Citeline. The UK has 84 drugs in clinical development, surpassing all other European countries, with 23 CGTs are already approved for patient use in the UK.

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Fierce BioTech

OCTOBER 11, 2023

Discover how incorporating genetic counseling and genetic services can unlock larger, more diverse and better qualified patient populations for your clinical trials. png Listing Introduction Overcome clinical trial recruitment barriers. Click here to login. Listing Image GenomeMedical_ListingLogo_250x190.png

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Clinical Trials Trials Therapies Drugs 95

Drug Discovery World

AUGUST 5, 2024

Diana Spencer, Senior Digital Content Editor, DDW The post Retinoblastoma therapy gets FDA rare paediatric drug designation appeared first on Drug Discovery World (DDW).

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Antidote

JULY 13, 2022

Before a potential new therapy can be administered to patients, it must go through several clinical trial phases designed to test the drug or device for safety and effectiveness. For many new treatments, it will take approximately ten years for the therapy to progress from initial discovery to being approved.

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Conversations in Drug Development Trends

MAY 10, 2024

Over the past two decades, industry-sponsored clinical trials have targeted treatments for BPD, yielding some promising outcomes; however, broader psychiatric research often excludes BPD patients, a trend that extends to the emerging field of psychedelic studies.

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Clinical Trials Trials Treatment Drug Development 95

Drug Discovery World

AUGUST 8, 2024

Two veteran advocacy organisations, Reason for Hope and the Veteran Mental Health Leadership Coalition, have issued a joint statement urging the US Food and Drug Administration (FDA) to approve MDMA-assisted therapy for post-traumatic stress disorder (PTSD).

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Drug Discovery World

SEPTEMBER 12, 2022

If anything, this period has been a reminder that people are the primary reason we do what we do, and the Patient Access, Healthcare & People track at Advanced Therapies Europe 2022 allowed DDW’s Multimedia Editor Megan Thomas to share several reflections on the topic. . Never before was the whole world a potential patient.

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Drug Discovery World

AUGUST 12, 2024

In recent years, AAV vectors have been launched and are considered one of the main platforms for gene therapy, with more than 250 clinical trials conducted in the USA and in European countries.

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Drug Discovery World

AUGUST 23, 2022

A Phase I/II clinical trial targeting a treatment for Huntington’s Disease (HD) using a gene therapy has been given the clearance to go ahead in France. . There are currently no approved disease modifying therapies for Huntington’s Disease. In 2019, BV-101 was granted orphan drug designation in the European Union. .

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Drug Discovery World

AUGUST 19, 2024

CV6 Therapeutics has initiated patient dosing in Phase Ia clinical trial evaluating its investigational first-in-class, specific dUTPase inhibitor CV6-168 + infusional 5-fluorouracil (5-FU).

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Drug Discovery World

DECEMBER 7, 2022

A new report reveals steadily growing interest in the clinical applications of collagen over the last 10 years. . Data analytics company Phesi analysed 2,358 clinical trials involving collagen. In the first 10 months of 2022, there were more than 225 new trials, compared with 125 in 2012.

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Antidote

JULY 9, 2024

Though clinical trials are often discussed in the context of medications and therapies, the devices that administer these medications must also be approved by the FDA before they can be released to market.

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Clinical Trials Trials FDA Therapies 52

PPD

AUGUST 7, 2024

Clinical trials are the backbone of medical research, enabling the development of new treatments and therapies that can improve patient outcomes. However, conducting successful clinical trials requires efficient communication and coordination among various stakeholders.

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Clinical Trials Trials Compliance Clinical Research 52

Antidote

JANUARY 3, 2023

Before becoming available to patients, every medication, therapy, and intervention must undergo a rigorous approval process: the clinical trial. Clinical trials are divided into phases that are aimed at testing the safety and efficacy of every potential new treatment before it is able to enter the market.

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