XTalks

DECEMBER 29, 2023

New Drugs Approved for Small-Cell Lung Cancer Several drugs have received FDA approval for treating SCLC. In 2020, the FDA approved AstraZeneca’s Imfinzi (durvalumab) for use in combination with etoposide and either carboplatin or cisplatin as a first-line treatment for SCLC.

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Clinical Trials Clinical Trials FDA Approval Trials 119

XTalks

MAY 17, 2023

It included formulating a standardized therapeutic development model that would help accelerate clinical trial processes for new treatments. The NIH has the Rare Diseases Clinical Research Network (RDCRN) program which provides support for rare disease clinical studies by facilitating collaboration, study enrollment and data sharing.

Gene Therapy 98

Gene Therapy Clinical Trials Clinical Trials Gene 98

pharmaphorum

FEBRUARY 1, 2022

Attendees will learn more about how an SCA was used at the design and execution phases in a recent study of new treatments for relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL) and will also receive an eBook ‘How to harness the potential of AI and real-world data for clinical research’. About the panel.

Clinical Trials 93

Clinical Trials Clinical Trials Trials Engineer 93

XTalks

MARCH 25, 2021

Xtalks is proud to announce the launch of the Xtalks Life Science podcast. Subscribe to the Xtalks Life Science Podcast to never miss a new episode. Fresh Conversations About Life Science Topics. She focuses on news relating to the food industry and writes blogs on recruitment and HR in the life sciences.

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Life Science HR Clinical Trials Clinical Trials 105

XTalks

DECEMBER 14, 2023

The US Food and Drug Administration (FDA) has approved Iwilfin (eflornithine) to reduce the risk of relapse in adult and pediatric patients with high-risk neuroblastoma (HRNB) who have had at least a partial response to previous multiagent, multimodality therapy including anti-GD2 immunotherapy.

FDA Approval 52

FDA Approval Dermatology Drugs DNA 52

XTalks

MAY 17, 2024

The therapy is the first and only US Food and Drug Administration (FDA)-approved treatment that reduces the loss of kidney function in adults with the disease. He also traced his personal journey from the clinic to leading a rare disease biotech and winning FDA approval for a rare disease drug.

Development 52

Development Drugs Clinical Trials Clinical Trials 52

XTalks

AUGUST 4, 2022

Enrollment will be slower, and efficiency will not be what was expected,” says Dr. Satya Shreenivas, MD, Medical Director from the global clinical research organization (CRO) Medpace. Why Should We Care About Diversity and Equity in Clinical Research? In the same webinar, Dr. Hansie M.

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Clinical Trials Clinical Trials Trials Clinical Research 52

XTalks

DECEMBER 21, 2022

The past year has been a strong one for life sciences industries, from pivotal gene therapy approvals to continued innovations in the biotech and medical device spaces. Here are some of the top life science trends and topics from 2022. Gene Therapy Approvals. Manufacturer: bluebird bio Inc. AI/ML Technology.

Life Science 52

Life Science Gene Therapy Gene Clinical Trials 52

pharmaphorum

MARCH 2, 2022

But today this is rapidly changing as a greater number of companies and research institutes explore potential uses for mental health disorders. The founders of this VC fund had previously backed atai Life Sciences, which itself is a part owner of Compass Pathways.

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Life Science Clinical Trials Clinical Trials Trials 100

XTalks

DECEMBER 28, 2023

BillionToOne developed the UNITY Fetal Antigen CTA to assist in J&J’s AZALEA trial, and the US Food and Drug Administration (FDA) approved an investigational device exemption for it in April, enabling its use in the trial.

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Trials Clinical Trials Clinical Trials Antibody 97

pharmaphorum

AUGUST 31, 2021

For the innovators and early adopters of the life sciences industry, engineering a regulatory-grade ECA can be daunting. Lastly, we look to our life science partners themselves, who have undoubtedly spearheaded ECAs for their own pipelines. Myth 1: There are too many challenges with adopting an ECA. About the authors.

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Clinical Trials Clinical Trials Life Science Trials 67

XTalks

DECEMBER 22, 2022

NORD, along with its more than 330 member patient organizations, is committed to the identification, treatment and cure of rare disorders through education, advocacy, research and patient services. Since only about 5 percent of rare diseases have FDA-approved treatments, it is vital that we increase the pace of rare disease clinical research.

Clinical Trials 98

Clinical Trials Clinical Trials Trials Clinical Research 98

XTalks

MAY 9, 2024

As we explore Genmab’s strategic vision, technological advancements and the next frontier in antibody research, we gain insights into the future of medicine — a future where Genmab’s cutting-edge therapies are poised to transform patient care and meet the complex challenges of the next generation of healthcare.

Antibody 52

Antibody Clinical Trials Clinical Trials Medicine 52

XTalks

MARCH 7, 2023

With the FDA approval, it’s become the first and only treatment for the debilitating condition. The vision loss caused by geographic atrophy has a severely negative impact on quality of life. Syfovre is an eye injection designed to slow the progression of the disease that is administered once every 25 to 60 days.

FDA Approval 98

FDA Approval Drugs Sales Trials 98

XTalks

DECEMBER 20, 2023

I believe our innovative approach is the answer and we have now shown in our clinical studies that we can provide this strong analgesia with a product that is less ‘liked’ by those who may want to abuse opioids. What are key pipeline initiatives for Ensysce Biosciences in the coming years? Dr. Kirkpatrick: Our lead product is called PF614.

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Production Drugs Development Medicine 111

XTalks

NOVEMBER 7, 2022

“Liquid biopsies have demonstrated promising activity in multiple clinical settings, but the great enthusiasm and expectations around them can be harmful if not adequately managed,” said Dr. El Mustapha Bahassi, PhD, Director, Clinical Laboratory Sciences, at the global clinical research organization (CRO) Medpace.

Clinical Trials 98

Clinical Trials Clinical Trials Trials FDA Approval 98

pharmaphorum

JULY 8, 2022

“You can use a wearable device that is not regulated in a clinical study providing it’s not being used for benchmarking purposes but you cannot submit the data to the regulators. It needs to be performed with a benchmark, an FDA-approved device.”. About the interviewees. About the author.

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Clinical Trials Clinical Trials Trials Regulation 80

XTalks

APRIL 13, 2022

The webinar concluded with Kyle Haas, Associate Director, Clinical Trial Management, Medpace, speaking about the operational and study start-up considerations for pediatric rare disease clinical research. Aspects of Pediatric Medical Research. Challenges in Pediatric Rare Disease Clinical Trials.

Clinical Trials 98

Clinical Trials Clinical Trials Clinical Research Trials 98

pharmaphorum

NOVEMBER 22, 2021

Implementing clinical VR can improve access and availability of treatment and destigmatise mental illness, but more research still needs to be done. Pharma can also utilise VR technology to aid in their research, such as testing new medications for children with ADHD. About the author .

Clinical Trials 113

Clinical Trials Clinical Trials Gerontology Trials 113

XTalks

AUGUST 19, 2022

In a press release , bluebird said the approval of Zynteglo is “the culmination of nearly ten years of clinical research of gene therapy in patients with transfusion-dependent beta-thalassemia.”. Bluebird’s announcement of the FDA approval for Zynteglo led bluebird bio’s shares to jump seven percent this week.

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Gene Therapy FDA Approval Gene Clinical Trials 95

Drug Discovery World

DECEMBER 8, 2023

With human clinical trials with AI-designed drugs now ongoing, it’s only a matter of time until the FDA approves its first AI-designed drug. These measures collectively fortify the foundation upon which AI-powered advancements in healthcare and life sciences can confidently build their future.

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Gene Therapy Gene In-Vitro Development 64

Cloudbyz

MAY 19, 2021

Introduction Cell and gene therapy is an upcoming wave of therapeutic innovation in the healthcare and life sciences industry and is being pragmatically accepted worldwide. The gene therapy market reported its first market approvals back in 2017 and the evolution has been extensive ever since.

Gene Therapy 52

Gene Therapy Gene Manufacturing Production 52

XTalks

APRIL 24, 2023

“Rare disease clinical trials are complex due to the additional scientific, medical, operational and regulatory requirements of newly emerging advanced therapies, such as gene therapy,” says Dr. Terence Eagleton, MB BS, Senior Medical Director at the global clinical research organization (CRO) Medpace.

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Gene Therapy Gene Trials Clinical Trials 95

Drug Discovery World

AUGUST 3, 2023

Even still, these approved drug products require a licensed healthcare provider’s prescription. With these exceptions, no other cannabis, cannabis-derived, or cannabidiol (CBD) products are FDA-approved and therefore on the market 1.

Medicine 52

Medicine Scientist Production Regulation 52

XTalks

SEPTEMBER 17, 2020

While clinical researchers occasionally need to identify and validate a new surrogate endpoint for a given trial, choosing endpoints that have been previously used as the basis of NDAs and BLAs can clear the path to eventual approval. Nizoral is prescribed off-label, while the others are FDA approved.

Trials 98

Trials Gene Hormones Clinical Trials 98

pharmaphorum

SEPTEMBER 12, 2022

Reddy says one of LabCorp’s groundbreaking tests, OmniSeq INSIGHT, is an “all-in-one test that includes comprehensive genomics and immune profiling from a single tissue sample to identify all FDA-approved therapeutics, confirm immunotherapy eligibility for a patient, and identify appropriate nearby clinical trials.”.

Genome 104

Genome Genomics Clinical Trials Clinical Trials 104

XTalks

FEBRUARY 27, 2024

In 2020, 31 out of 53 novel drug approvals were for rare or orphan diseases​​. This focus continues, with 20 out of 37 novel drug approvals targeted towards rare diseases​ in 2022 and around 24 out of 55 in 2023. These regulations offer benefits such as tax credits, grant funding and extended market exclusivity for approved drugs.

Research 59

Research Drugs Gene Therapy Clinical Trials 59

XTalks

AUGUST 30, 2022

Clinical research experts from the CRO Medpace shared insights about the operational and regulatory considerations for neuroscience trials with direct CNS administration. Direct CNS administration is also FDA-approved for multiple small molecules and ASOs. Targeting the CNS directly has been successful in modern medicine.

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Trials Drug Delivery Drugs Gene 83

XTalks

DECEMBER 12, 2023

It serves to confirm eligibility for certain treatments or clinical trials and is invaluable in distinguishing Alzheimer’s disease from non-amyloid dementias, such as frontotemporal dementia (FTD). Importantly, FDA-approved products are now available for these PET imaging applications.

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Trials Clinical Trials Clinical Trials Genetics 111

XTalks

MARCH 13, 2023

For this reason, rare disease patient communities are hopeful for a new gene therapy that may result in long-term benefits to their quality of life and survival. Here are five key takeaways from the 90-minute FDA town hall that rare disease clinical research professionals need to know.

Gene Therapy 52

Gene Therapy Clinical Trials Clinical Trials Gene 52

Drug Discovery World

AUGUST 10, 2022

Finally, in 2017, after years of improving T cell engineering techniques, the first chimeric antigen receptor (CAR) T cell therapy received FDA approval. Since 2017, five CAR T cell therapies have been approved and have shown incredible success in the clinic. Marwan Alsarraj is the Biopharma Segment Manager at Bio-Rad.

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Manufacturing Gene Genome Genomics 98