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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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

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

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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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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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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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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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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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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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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FDA Approval Clinical Trials Clinical Trials Trials 105

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

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

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

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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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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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

Pharmaceutical Technology

MAY 24, 2023

By Luisa Sterkel & Joana Loureiro , Tenthpin Consultants The promise and potential of cell and gene therapies (CGT) has emerged in the recent past and currently over 1.500 CGT are registered for clinical trials holding great hope for the treatment of challenging and uncurable diseases.

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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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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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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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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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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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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

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

pharmaphorum

APRIL 13, 2021

Dr Cindy Jacobs, chief medical officer of Achieve Life Sciences discusses the potential of cytisinicline therapy for smoking cessation. . Dr Cindy Jacobs is president and chief medical officer of Achieve Life Sciences. Whether present in electronic or combustible cigarettes, nicotine is a highly addictive substance.

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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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XTalks

SEPTEMBER 8, 2020

AZD1222 is now in Phase III clinical trials which will enroll approximately 30,000 adult volunteers in 80 states in the US, to determine whether the vaccine can help prevent symptomatic coronavirus disease from spreading. The genetic material contains SARS-CoV-2 spike protein.

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Manufacturing Vaccination Vaccine Allergies 83

XTalks

MARCH 12, 2024

XTALKS WEBINAR: Engaging Patient Communities: A Pathway to Clinical Trial Success Live and On-Demand: Tuesday, April 16, 2024, at 11am EDT (4pm BST/UK) Register for this free webinar to explore best practices for engaging with patient communities to enhance recruitment, retention and overall success of a trial.

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pharmaphorum

DECEMBER 15, 2022

Co-chaired by Lord James O’Shaughnessy and Professor Mike Bewick, former deputy national medical director of NHS England (present online), the NHS Innovation and Life Sciences Commission Report launch took place at One Great George Street, Westminster, on 12th December 2022. The UK as a powerhouse of research.

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Pharma in Brief

OCTOBER 20, 2021

In the context of addressing Health Canada’s requirements for approvability, the submission was withdrawn, refiled and a market authorization was issued.

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pharmaphorum

OCTOBER 2, 2020

It’s the same indication targeted by Janssen with another medicine that drew inspiration from an illegal recreational drug – Spravato is an FDA-approved nasal spray containing esketamine, an isomer of ketamine. New partnership tests low-dose psilocybin.

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Medicine Life Science FDA Approval Development 120

XTalks

AUGUST 18, 2023

Elrexfio’s label contains a boxed warning for cytokine release syndrome (CRS) and neurologic toxicity (NT). The average monthly list price of Elrexfio is $41,500 and a full treatment regimen could be around $330,000 based on the duration of treatment as per its clinical trial.

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FDA Approval Drugs Antibody Trials 98

XTalks

MAY 7, 2021

Novavax published the latest results from a Phase IIb clinical trial conducted in South Africa evaluating the safety and efficacy of NVX-CoV2373, appearing in the NEJM ’s May 6, 2021 issue. NVX-CoV2373 contains purified protein antigen and can neither replicate, nor can it cause COVID-19. 1.351 variant.

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Protein Vaccination Vaccine Trials 97

XTalks

JANUARY 2, 2024

Filsuvez topical gel is a sterile botanical drug product designed for topical use, containing birch triterpenes within an oil base. The clinical study also highlighted the favorable tolerability profile of Filsuvez. Birch triterpenes constitute a botanical drug substance comprising a blend of pentacyclic triterpenes. Specifically, 41.3

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FDA Approval Gene Therapy Gene Trials 111

Drug Discovery World

OCTOBER 19, 2022

Ashley Rein , Global Market Manager for Topical Drug Delivery at Lubrizol Life Science Health (LLS Health), explains how by using mucoadhesive drug delivery, developers can bring novel drugs to market and maximise the efficacy of pre-existing APIs. . Drug discovery and development is a time-consuming and costly endeavour.

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