BioPharma Reporter

MARCH 5, 2024

Neurogene, a clinical-stage company developing genetic medicines, is expanding its ongoing phase 1/2 clinical trial investigating NGN-401 as a treatment for female pediatric patients with Rett Syndrome.

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Pharmaceutical Technology

OCTOBER 25, 2022

Ast ellas Pharma has announced plans to make a strategic investment to back the development of Taysha Gene Therapies’ adeno-associated virus (AAV) development programmes for Rett syndrome and giant axonal neuropathy (GAN). This would allow the companies to boost the development of new therapy options for Rett syndrome and GAN patients.

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Pharma Mirror

APRIL 28, 2021

Catalent will provide process development and CGMP manufacturing of AavantiBio’s adeno-associated viral (AAV) vector-based therapeutic candidate for use in clinical trials in the U.S. and Europe. Catalent will further support process optimization and look to reduce material.

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STAT News

DECEMBER 10, 2022

NEW ORLEANS — An emerging class of genetically targeted drugs is inducing remissions in about one-third of patients with advanced leukemia, according to updates Saturday from separate clinical trials. Continue to STAT+ to read the full story…

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Pharmaceutical Technology

APRIL 13, 2023

Following the increased use of telemedicine during the Covid-19 pandemic, the potential of digital technologies in communication, data collection, and analysis has become increasingly realised by patients, healthcare systems, and clinical trial sponsors.

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Drug Discovery World

APRIL 15, 2024

Naobios has signed a partnership agreement with Sumagen, a Korean-Canadian biotechnology company developing an HIV-1 vaccine candidate, to manage the manufacturing process during its Phase II clinical trials.

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XTalks

MAY 17, 2023

The Foundation for the National Institutes of Health (FNIH) announced this week that the Accelerating Medicines Partnership Bespoke Gene Therapy Consortium (AMP BGTC) has selected eight rare diseases for its clinical trial portfolio. Of the more than 10,000 rare diseases, more than 80 percent are caused by genetic defects.

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XTalks

FEBRUARY 21, 2024

Black participation in clinical trials, and the underrepresentation of minority groups in general in trials, remains low. It is therefore important to work towards increasing Black participation in clinical trials, which begins with understanding the barriers to participation and taking steps to address them.

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Pharmaceutical Technology

JUNE 10, 2023

CIGB-128 is under clinical development by Center for Genetic Engineering and Biotechnology and currently in Phase I for Brain Tumor. GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data.

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Pharmaceutical Technology

JUNE 10, 2023

CIGB-128 is under clinical development by Center for Genetic Engineering and Biotechnology and currently in Phase I for Brain Tumor. GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data.

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XTalks

MARCH 20, 2024

When it comes to leadership in clinical trials today, what qualities are necessary to navigate the evolving landscape of clinical research effectively? Continue reading to explore effective leadership in clinical trials. Can you begin by telling us about your experience in clinical research?

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XTalks

MAY 16, 2023

Clinical trials for pulmonary fibrosis are being conducted to evaluate the effectiveness of novel therapies and interventions, providing hope for improved outcomes in the future. Exposure to substances like asbestos, silica dust and certain chemicals has been linked to the development of pulmonary fibrosis.

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Clinical Trials Clinical Trials Trials Research 98

Pharmaceutical Technology

DECEMBER 12, 2022

Gilead company Kite has entered an international strategic partnership with Arcellx for the joint development and commercialisation of the latter’s T-cell therapy, CART-ddBCMA, to treat relapsed or refractory multiple myeloma patients. Additionally, Kite will make other potential payments to Arcellx.

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Drug Discovery World

JUNE 8, 2023

Grown in vitro, these cells can provide patient specific human brain models from a large cohort of AD patients – to create a ‘clinical trial in a dish’. sAD has no specific family link and is caused by a combination of genetics, the environment and a person’s lifestyle.

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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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pharmaphorum

APRIL 26, 2022

Making sure clinical trials are diverse and representative of the populations they’re studying isn’t just the right thing to do to promote inclusivity and equity; it’s also just good science/clinical scientific practice. Potential barriers that exclude communities from clinical research.

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XTalks

MAY 17, 2024

Xtalks spoke with Richard Philipson, MD, Chief Medical Officer (CMO) at Calliditas Therapeutics, a Sweden-based company with full commercial operations in the US focused on developing treatments for rare diseases to learn more about the continuing evolution of rare disease drug development.

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XTalks

DECEMBER 14, 2023

In an insightful interview with Xtalks , Cassadie Moravek, the Senior Director of Clinical Trial Portfolio and Program Management at the Pancreatic Cancer Action Network (PanCAN) , shares her perspective on the organization’s efforts in advancing pancreatic cancer research and patient care. Read on to learn more from Moravek.

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Clinical Trials Clinical Trials Trials Doctors 52

STAT News

JULY 26, 2022

The Food and Drug Administration has agreed to review a treatment for a rare, genetically defined form of ALS developed by Biogen, even though results from a clinical trial failed to show a definitive benefit for patients. Biogen said Tuesday that U.S.

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Clinical Trials Clinical Trials Trials Genetics 98

Scienmag

FEBRUARY 18, 2022

Dignity Health in Arizona is launching the first research study in North America in which genetic testing is used to identify men and women at risk of developing heart disease based on the makeup of their DNA. If proven effective in clinical trials, this form of genetic testing may be adopted globally to prevent heart disease.

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Pharmaceutical Technology

AUGUST 16, 2022

Q32 Bio has signed a partnership and option agreement with Horizon Therapeutics for developing ADX-914 to treat autoimmune ailments. According to the deal, Horizon will provide the funding to develop the therapy until the conclusion of its two Phase II clinical trials. A fully human anti-IL-7R?

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pharmaphorum

MARCH 10, 2022

18 months after signing its first partnering deal with Genentech, Scenic Biotech has raised $31 million in first-round financing that it will use to take its own genetic modifier-targeted medicines into clinical trials. The post Scenic Bio raises $31m for genetic modifier platform appeared first on.

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pharmaphorum

JANUARY 18, 2023

In 2016, scientists behind a study called the Resilience Project analysed genetic data from 589,000+ people and found 13 adults who carried genetic variants that should have resulted in serious – even deadly – childhood disease, but who were apparently healthy. First, start co-development with participants early on in the process.

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Pharmaceutical Technology

DECEMBER 14, 2022

GSK has entered a strategic partnership with Wave Life Sciences to progress the discovery and development of oligonucleotide therapies for new genetic targets. The alliance will merge the PRISM oligonucleotide platform of Wave and the capabilities of GSK in genetics and genomics.

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Drug Discovery World

APRIL 14, 2023

By Lucy Radley , Senior Vice President, Head of European Regulatory Development at ProPharma Group. 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.

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Roots Analysis

MARCH 14, 2023

Clinical trials are a fundamental requirement for evaluating the safety and efficacy of novel therapeutic interventions. Initiating a clinical trial is a complex and time-consuming process, involving suitable planning and execution.

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Clinical Trials Clinical Trials Trials Clinical Research 52

Worldwide Clinical Trials

MAY 14, 2024

As the strategists for Worldwide Clinical Trials’ rare disease sponsors, we design customized solutions that make a difference in achieving successful outcomes. As we craft custom solutions, we harness an array of resources that amplify our trials’ effectiveness. Common goals empower change. Contact us !

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Trials Clinical Trials Clinical Trials Research 176

Pharmaceutical Technology

OCTOBER 26, 2022

SK bioscience has signed a new collaboration agreement with the Coalition for Epidemic Preparedness Innovations (CEPI) to develop messenger ribonucleic acid (mRNA) vaccines for infectious diseases. The company has obtained the newest vaccine platform technologies such as bacterial culture, cell culture and genetic recombination.

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Pharmaceutical Technology

DECEMBER 27, 2022

Along the way, mergers and acquisitions continued to happen, new drugs and devices got approved, and innovations in the clinical trial industry were introduced. Still, the country’s clinical trials sector remains insular. Tracking drug development. Tracking the news.

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Clinical Trials Clinical Trials Trials Vaccination 306

Pharmaceutical Technology

NOVEMBER 29, 2022

Researchers at City of Hope in the US have developed a new potential therapy to treat glioblastoma multiforme (GBM), a kind of brain cancer. These viruses are engineered genetically for killing cancer. The post City of Hope researchers develop new brain cancer therapy appeared first on Pharmaceutical Technology.

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XTalks

SEPTEMBER 11, 2020

Expanding minority Americans’ access to care and clinical trials isn’t just the right thing to do. Clinical Trials Don’t Reflect Demographics. Why, then, are clinical trials so stubbornly homogeneous? Why, then, are clinical trials so stubbornly homogeneous? What Clinicians Are Struggling With.

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Clinical Trials Clinical Trials Trials Drugs 98

pharmaphorum

JUNE 11, 2021

The development of vaccines for COVID-19 has been a masterclass in effective collaboration and applied digitisation in healthcare. Abel Archundia discusses how COVID-19 has highlighted the importance of securing clinical trials against cyber threats. billion doses were administered to people worldwide.

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Clinical Trials Clinical Trials Trials Compliance 111

Worldwide Clinical Trials

MAY 14, 2024

As the strategists for Worldwide Clinical Trials’ rare disease sponsors, we design customized solutions that make a difference in achieving successful outcomes. As we craft custom solutions, we harness an array of resources that amplify our trials’ effectiveness. Common goals empower change. Contact us !

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Trials Clinical Trials Clinical Trials Research 130

XTalks

NOVEMBER 7, 2022

Gleich, MD, FACS, Senior Vice President, Medical Department, and Dr. Christopher Huth, PhD, Senior Clinical Trial Manager, Clinical Trial Management. Liquid Biopsy Use in Oncology Clinical Trials. How personalized, targeted assays can be developed to detect somatic mutations from cfDNA. “A

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Pharmaceutical Technology

MARCH 14, 2023

Qdenga has been developed based on a live-attenuated dengue serotype 2 virus that offers the genetic backbone for four dengue virus serotypes and is designed to provide protection against any of these. The vaccine has received approval for preventing dengue disease in people aged four years to 60 years.

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Drug Discovery World

DECEMBER 13, 2022

PacBio, developer of sequencing solutions, has announced its HiFi sequencing technology will be used in a pilot project for the Children’s Rare Disease Cohorts Initiative (CRDC) at Boston Children’s Hospital. . The post Researchers investigate genetic variants linked to paediatric diseases appeared first on Drug Discovery World (DDW).

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Drug Discovery World

AUGUST 16, 2023

A new study has shed light on the genetic messages encoded by genes within ‘triple negative’ breast cancers (TNBC), and shows they could predict response to chemotherapy. The presence of these biomarkers could be used to accelerate the development of more personalised treatments for triple negative breast cancers.

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