XTalks

MARCH 6, 2023

Levation Pharma has initiated a Phase I/II trial to evaluate the preliminary safety and potential efficacy of their investigational topical gel LEV102 for acquired blepharoptosis in adults. This is the first clinical trial that the company has launched for LEV102. What Will This Clinical Trial Evaluate?

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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. Exosome-Based Liquid Biopsy in Oncology.

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Clinical Trials Clinical Trials Trials FDA Approval 98

XTalks

NOVEMBER 6, 2020

Canadian clinical-stage biotech company Symvivo Corporation has developed an oral COVID-19 vaccine that entered clinical trials this week. The first healthy volunteer was dosed with the vaccine in Australia as part of the bacTRL-Spike COVID-19 Phase I clinical trial. COVID-19 Clinical Trials.

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The Pharma Data

NOVEMBER 10, 2020

Phase1b/2 clinical study to be conducted in the United States and several European countries. The trial is a dose-ranging, open-label study that will enroll 60 patients in the U.S. This announcement contains inside information for the purposes of Article 7 of EU Regulation 596/2014. Billion by 2025. and Europe.

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XTalks

NOVEMBER 29, 2022

Xtalks interviewed Devon Adams to learn more about his work related to decentralized oncology trials as a senior analyst for legislative policy specific to clinical trials at the ACS CAN. Over half of cancer patients who are offered a clinical trial agree to participate regardless of race or ethnicity.

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Trials Clinical Trials Clinical Trials Development 98

pharmaphorum

JANUARY 27, 2023

The emergence of COVID-19 resulted in staffing challenges that have continued to have a sustained, negative impact on clinical trial workflows. The impact of burnout on clinical trials Each staff member involved in a clinical trial is essential to its success.

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XTalks

JANUARY 9, 2024

Moreover, users in the life sciences sector at Atropos Health can now conduct comprehensive real-world evidence (RWE) studies by using the extensive longitudinal research dataset offered by Arcadia within the Atropos Evidence Network.

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Life Science Clinical Trials Clinical Trials Trials 59

pharmaphorum

JANUARY 27, 2023

She knows only too well how understanding the importance of patient centricity is crucial to the success of any modern life sciences company – but how has the landscape changed since 2019? “I We talk a lot in clinical trials and drug development about benefit,” Dr Mullen said. But who is benefitting?

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Clinical Trials Clinical Trials Trials Development 96

XTalks

MAY 24, 2022

The FDA has allowed clinical trials assessing the injectable lenacapavir, an investigational long-acting HIV-1 capsid inhibitor in development by Gilead Inc., Now, Gilead has replaced the material of the container vial with aluminosilicate glass, proving it to be a good material for storage and compatibility. “We to continue.

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Drugs Clinical Trials Clinical Trials Trials 98

pharmaphorum

MAY 24, 2021

Having gone from being an innovation buzzword to becoming a core part of drug assessment processes it offers health technology assessment (HTA) bodies a way to assess the value and impact of drugs outside of an artificial clinical trial setting. That’s not to say that clinical trials are redundant.

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Drugs Clinical Trials Clinical Trials Doctors 82

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. It is true that RWD contains more potential bias as a result.

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Clinical Trials Clinical Trials Life Science Trials 64

pharmaphorum

SEPTEMBER 22, 2020

Life sciences commercial organizations can now forecast sales, predict churn, analyze brand propensity and launch new products with BirdzAI . P360 , a leading developer of technology for life sciences companies, today announced major updates to its sales enablement platform BirdzAI. To learn more about P360, visit P360.com.

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Sales Life Science Branding Production 63

XTalks

APRIL 24, 2023

Melanie Blank, clinical team leader for General Medicine Branch 1 at the US Food and Drug Administration’s (FDA) Division of Clinical Evaluation and Pharmacology/Toxicology (DCEPT), the agency is seeing one or two new applications coming in every week for new gene therapies for different diseases. Reference: Chung DC, et al.

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Gene Therapy Gene Trials Clinical Trials 95

XTalks

JUNE 6, 2023

Posluma contains a radioactive imaging agent, fluorine-18 ( 18 F), that is designed to specifically bind to the PSMA over-expressed on prostate cancer cells. The FDA’s approval of Posluma was based on two Phase III clinical trials, LIGHTHOUSE and SPOTLIGHT. How Does Posluma Work? Is Posluma Safe and Effective? percent.

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FDA Approval Clinical Trials Clinical Trials Marketing 96

XTalks

SEPTEMBER 28, 2023

XTALKS WEBINAR: A Step-by-Step Approach to eSource in Clinical Trials Live and On-Demand: Thursday, October 26, 2023, at 10am EDT (4pm CEST/EU-Central) Register for this free webinar to learn how to adopt an incremental approach to eSource (EHR to EDC integration) across multiple trial scenarios to overcome real and perceived challenges.

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XTalks

DECEMBER 22, 2023

This sterile implant, containing 75 mcg of travoprost, is inserted via a minimal, transparent incision in the cornea and secured at the iridocorneal angle in the sclera. Clinical trials have shown consistent IOP reductions in all study groups. How Does iDose TR Work?

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FDA Approval Clinical Trials Clinical Trials Trials 98

XTalks

OCTOBER 18, 2022

Related: Bimodal Neuromodulation for Tinnitus: Interview with Caroline Hamilton, Clinical Director of Neuromod Devices – Xtalks Life Science Podcast Ep. HFX iQ takes direct input from each patient on their pain and quality of life measures to get smarter over time and recommend program changes.”.

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FDA Approval Big Data Life Science Clinical Trials 98

XTalks

JUNE 3, 2022

The tip of the catheter contains sensors that send electrical impulses and can identify the area that is causing the arrhythmia. Register for this free webinar to learn about the value of electronic health record (EHR) data to inform research across the drug and device lifecycle for life sciences.

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Clinical Trials Clinical Trials Trials Life Science 98

The Pharma Data

DECEMBER 29, 2020

NEO:CYBN ) (“ Cybin ”), a life sciences company focused on psychedelic pharmaceutical therapies, announces the unaudited financial results of Clarmin Explorations Inc. Cybin is a life sciences company advancing psychedelic pharmaceutical treatments for various psychiatric and neurological conditions. 30, 2020 01:00 UTC.

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Life Science Bioavailability Clinical Trials Clinical Trials 52

Drug Discovery World

DECEMBER 14, 2023

The new hub will become a part of the already thriving life sciences sector in the Glasgow area, most of which is centred around the university, the Cancer Research UK Scotland Institute and the BioCity cluster, making Glasgow and its surrounds one of the most important regions for drug discovery and development in the UK.

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Drug Discovery World

APRIL 9, 2024

ImmunoBrain Checkpoint (IBC) is currently dosing patients in a clinical trial with its monoclonal antibody for Alzheimer’s disease (AD). MS : We are currently dosing patients in a Phase I clinical trial to evaluate our lead asset, IBC- Ab002, for safety, tolerability, and pharmacokinetics in patients with early-onset AD.

Antibody 59

Antibody Clinical Trials Clinical Trials Protein 59

XTalks

APRIL 25, 2024

The efficacy of the Revivent TC system is being evaluated through clinical trials, namely the LIVE trial and the ongoing ALIVE trial. The LIVE trial showcased the system’s potential to reduce ventricular volumes by approximately 25 percent and improve left ventricular ejection fraction by about 16 percent.

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Development Trials Clinical Trials Clinical Trials 111

XTalks

MAY 26, 2023

Brixadi is specifically indicated for patients who have already started treatment with a single dose of a transmucosal buprenorphine product (that enters across a mucous membrane) or are currently receiving treatment with a transmucosal buprenorphine-containing product. It is offered in two regimens: weekly and monthly.

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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.”. The mission was first put forward during the UK’s G7 Presidency of June 2021, with support from representatives of the life sciences industry.

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XTalks

JANUARY 3, 2024

XTALKS WEBINAR: Streamlining IRT in clinical trials: Simplify, optimise, succeed Live and On-Demand: Thursday, February 15, 2024, at 10am EST (4pm CET/EU-Central) Register for this free webinar to discover how streamlining interactive response technology (IRT) in clinical trials can help achieve business goals for accelerated study initiation, greater (..)

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FDA Approval Protein RNA Clinical Trials 105

Drug Discovery World

SEPTEMBER 28, 2023

In fact, the endometrial fluid contains peptides that may protect against a variety of fungi, bacteria, viruses, and other pathogens 4. Ongoing impactful trials are investigating the potential for microbiome-based diagnostic tests for endometriosis 5 and PCOS 6 using blood, faecal, vaginal, and/or endometrial samples.

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Clinical Trials Clinical Trials Regulation Bacteria 64

XTalks

AUGUST 18, 2023

Izervay is the only approved treatment for geographic atrophy that has demonstrated a significant decrease in the rate of geographic atrophy progression at the 12-month primary endpoint, based on results from two rigorous Phase III clinical trials. Izervay contains avacincaptad pegol sodium, an effective complement C5 inhibitor.

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FDA Approval Drugs Clinical Trials Clinical Trials 52

XTalks

OCTOBER 16, 2020

However, that outbreak was controlled before Regeneron’s drug could be tested in a clinical trial. A second Ebola outbreak occurred in August 2018 in the Democratic Republic of Congo (DRC), during which evaluation of Inmazeb was initiated in a large-scale clinical trial. Targeted Antiviral Treatment.

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Antibody Drugs Clinical Trials Clinical Trials 98

Drug Discovery World

OCTOBER 20, 2022

Kawasaki King Skyfront is an R&D center with a focus on life science and environmental fields—and the realisation of open innovation projects. CELLINK Corporation, the Japanese subsidiary, was established in 2020 in Kansai, a region renowned for life sciences research facilities and corporations 3. .

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Development Drugs Life Science Marketing 52

Drug Discovery World

JULY 20, 2023

There will probably already be some clinical data for the drug in question and this can save both time and money, as the company can secure regulatory approval without lengthy and costly early-stage clinical trials. This makes drug repurposing or reformulation very appealing.

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Pharma in Brief

MAY 29, 2023

Background A CSP can extend, for up to two years, patent protection for a drug containing a new medicinal ingredient or a new combination of medicinal ingredients. Health Canada has also updated its fee for CSP applications.

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Regulation Sales Clinical Trials Clinical Trials 59

XTalks

JUNE 14, 2023

The clinical trials consistently showed significant therapeutic improvements in ocular surface damage and associated symptoms, while pioneering visual function improvement analysis”, said John D. The solution of Vevye does not contain water, anti-microbial preservatives, oils or surfactants.

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Gene Silencing Drug Delivery FDA Approval RNA 97

pharmaphorum

JANUARY 27, 2021

Terms like “lab rats” and “guinea pigs” are often used in conversations about clinical trials. The approval and roll out of the COVID-19 vaccines have put the spotlight on clinical trials. I have never known the subject of clinical trials to be as discussed as much as it is right now.

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Research Clinical Trials Clinical Trials Vaccination 52

XTalks

AUGUST 7, 2023

He also thanked the 500 patients, caregivers, investigators and healthcare professionals involved in the Phase III trials and stated that Verrica’s commercial team is actively preparing for the product’s commercial launch in September 2023. Participants in these trials ranged in age from two to 60, with a median age of six.

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FDA Approval Dermatology Trials Clinical Trials 98

XTalks

NOVEMBER 23, 2020

The global trials are assessing the safety and efficacy of the vaccine in individuals aged 18 years or over from diverse racial and geographic groups who are healthy or have stable underlying medical conditions. Oxford-AstraZeneca COVID-19 Vaccine Induces Immune Responses in Early Clinical Trials.

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Vaccination Vaccine Clinical Trials Clinical Trials 97

Drug Discovery World

FEBRUARY 5, 2024

In life sciences, as well as being used to draft articles, the technology can assist researchers in generating scientific content or summaries. For generative AI to be trusted as a reliable ‘source of truth’ in life sciences applications, knowledge sources need be both transparent and validated, along with how connections have been made.

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XTalks

AUGUST 16, 2022

The vaccine, known as mRNA-1273.214 or Spikevax Bivalent Original/Omicron, is a next-generation bivalent vaccine that contains mRNA-1273 (Spikevax) and a vaccine candidate targeting the Omicron variant of concern (BA.1). 1) when compared to a 50 µg booster dose of mRNA-1273 in baseline seronegative participants.

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