pharmaphorum

MAY 27, 2022

This is the second in a two-part series examining how pharma can embrace the DEI agenda to create more effective medicines through more representative clinical trials. The same principles are increasingly being applied to clinical trials to improve diversity, mitigate bias, and reinforce inclusion in clinical trials.

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XTalks

FEBRUARY 5, 2025

Marcondes is a licensed and trained physician, specializing in oncology and immune oncology. He was the Program Lead for early-stage assets at Nektar and manages clinical trial programs from Phase I through to Phase III. Subscribe to the Xtalks Life Science Podcast to never miss a new episode.

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XTalks

FEBRUARY 12, 2025

XTALKS WEBINAR: Overcoming Challenges in Clinical Trial Completion Live and On-Demand: Wednesday, March 19, 2025, at 10:30am EDT (3:30pm CET/EU-Central) Register for this free webinar to transform challenges into opportunities and optimize the crucial final stages of clinical trials.

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XTalks

JANUARY 16, 2025

Sling Therapeutics has positive topline results from its Phase IIb/III LIDS clinical trial evaluating its oral small-molecule therapy linsitinib for the treatment of thyroid eye disease (TED). Sling Therapeutics in-licensed linsitinib from Astellas Pharma at the time of its launch as a company in 2022.

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XTalks

DECEMBER 29, 2022

The life sciences and healthcare are among the biggest industries globally, and their significance was particularly highlighted during the past couple of years by the COVID-19 pandemic. Given the hyperfocus on the life sciences thanks to COVID, consumers appear to be more autonomous and vocal about their medical demands and choices.

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XTalks

DECEMBER 1, 2020

With this has come an increase in the size of the global clinical trials market, with an estimated worth of around $46.8 In the United States, Menarini Silicon Biosystems’ Pennsylvania-based lab is CLIA Certified and ISO 15189-accredited, with licenses from New York, California, Maryland, Pennsylvania, and Rhode Island.

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XTalks

APRIL 1, 2025

It also plans to start discussions with the FDA regarding a potential Biologics License Application (BLA) submission. Equillium plans to submit the full results for presentation at an upcoming medical conference. This includes meeting requests to discuss the potential for Accelerated Approval, with feedback expected during May 2025.

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XTalks

JANUARY 22, 2025

IXCHIQ is the only licensed chikungunya vaccine in the US for adults aged 18 and older at increased risk of exposure to the virus. This includes post-marketing studies, label extensions for younger populations and a licensing agreement with the Serum Institute of India to supply the vaccine in Asia at affordable prices.

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XTalks

APRIL 3, 2025

XTALKS WEBINAR: Keys to Success in Clinical Trials: A Strategic Guide for Biotechs and Startups Live and On-Demand: Thursday, May 22, 2025 , at 11am EDT (5pm CEST / EU-Central) Register for this free webinar to learn how biotechs can navigate endpoint challenges in clinical trials.

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XTalks

DECEMBER 18, 2024

Related: Arrowhead Pharmas New Rare Disease Campaign for FCS Highlights Importance of Lowering Triglycerides The FDAs approval of Crenessity was based on two randomized, double-blind, placebo-controlled trials in 182 adults and 103 children with classic CAH. billion in revenue by 2024.

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Pharma Business Blog

MARCH 15, 2023

Dears Please find hereinafter the latest news related to Clinical Trials in the EU with a respective indirect tax and pharma regulatory licensing impact: 1. The CTIS database is publicly available and leads to increased transparency for indirect tax & pharma regulatory licensing. •

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XTalks

AUGUST 10, 2022

In this episode, Ayesha discussed a new COVID-19 test technology that Innova Medical Group, world leader in at-home COVID-19 tests, has reached a licensing deal for with the University of Birmingham where the technology was developed. Subscribe to the Xtalks Life Science Podcast to never miss a new episode.

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XTalks

AUGUST 9, 2024

Pharmaceutical, life sciences and healthcare organizations have long had the desire to make their research programs more accessible and patient-centric. One of the key elements to the successful execution of a decentralized clinical trial (DCT) is providing patients access to in-home specimen collections and assessments.

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Clinical Trials Clinical Trials Trials Clinical Research 52

pharmaphorum

AUGUST 19, 2021

A common set of standards for randomised clinical trials (RCTs) aims to help researchers develop the drugs and interventions of the future – no matter what they do or where they are based. Many guidelines focus narrowly on clinical trials that are intended to generate data for regulatory submission to support a new drug license.

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XTalks

FEBRUARY 12, 2025

LIB Therapeutics has announced that the FDA has accepted its Biologics License Application (BLA) for lerodalcibep, a novel investigational treatment aimed at reducing low-density lipoprotein cholesterol (LDL-C) in a broad patient population.

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XTalks

MARCH 7, 2025

Scientific Breakthroughs and Ongoing Research In recent years, a surge in clinical trials for kidney disease has brought innovative therapeutic options to the forefront. Clinical trials demonstrated a 24% reduction in the risk of worsening kidney function and a 5% decrease in cardiovascular-related deaths among participants.

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The Pharma Data

SEPTEMBER 29, 2020

To do so, we will work to expand clinical trials to account for diverse representation including lower-income settings and endeavor to address the specific product characteristics needed for use in lower-income settings even after new innovations are brought forward. . Enable affordability for lower income countries.

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pharmaphorum

NOVEMBER 24, 2021

The pandemic has propelled issues for the pharmaceutical industry to the top of the political and public agenda, from clinical trial recruitment to the journey required for medicines or vaccines to reach patients. The new Life Sciences Vision details priority areas for enhancing regulation. Conclusion.

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pharmaphorum

AUGUST 27, 2020

The Biotechnology and Biological Sciences Research Council (BBSRC), part of UK Research and Innovation (UKRI), works with universities, research organisations, businesses, charities, and government to develop a supportive ecosystem. The common challenge is undertaking lengthy and capital-intensive phase II/III clinical trials.

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pharmaphorum

OCTOBER 16, 2020

These might be licensed drugs that could hold potential for a patent extension, or drugs which failed efficacy trials for an intended indication. By definition, however, trial master files represent a much richer and more detailed source of data on a drug and how it performs.

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XTalks

AUGUST 13, 2020

As the rush for a COVID-19 vaccine continues, healthcare services company Kaiser Permanente has joined in on the clinical testing of Pfizer Inc. and BioNTech’s lead vaccine candidate in a Phase III trial being conducted at sites in California and Oregon. Kaiser began Phase III trials of the vaccine at the end of July.

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XTalks

AUGUST 2, 2024

The ARCADIA trials reinforce nemolizumab’s potential as a transformative treatment for atopic dermatitis, offering new hope to patients seeking relief from this burdensome condition. The US Food and Drug Administration (FDA) has accepted their Biologics License Application (BLA) for review, with a decision expected by the end of this year.

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XTalks

MAY 20, 2022

Depending on the type of field or company, you can pursue clinical scientist jobs with a major in biology, medicine, medical technology, chemistry, immunology and other related life science and pre-medical degrees. A Clinical Scientist will perform a wide range of duties depending on the focus of their research.

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pharmaphorum

NOVEMBER 2, 2020

This followed a separate deal with Sanofi in July, where the pharma licensed Kiadis’ pre-clinical drug K-NK004 for multiple myeloma. Kiadis is drawing up plans to begin a phase 1/2a clinical trial of KNK-ID-101, its COVID-19 therapy in high risk patients, with funding from the French government.

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The Pharma Data

JANUARY 13, 2021

Germany-based Cevec Pharmaceuticals GmbH signed a licensing agreement with Biogen for the use of its proprietary ELEVECTA Technology for the manufacturing of adeno-associated virus (AAV) vectors for gene therapy applications. VLA2001 is currently the only inactivated vaccine candidate in clinical trials against COVID-19 in Europe.

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pharmaphorum

MARCH 24, 2021

It applies to marketing applications for all new active substances or new indications and could be extended to include new clinical trial applications after an initial “exploratory” phase, according to the regulator. The MHRA initiative has been welcomed by the Health Research Authority, which oversees NHS research in England.

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pharmaphorum

DECEMBER 9, 2022

(Nasdaq: AUTL), a clinical-stage biopharma and a portfolio company of Syncona Ltd., has announced that the pivotal phase 2 FELIX clinical trial of obecabtagene autoleucel (obe-cel) in relapsed/refractory (r/r) adult Acute Lymphoblastic Leukaemia (ALL) patients has met its primary endpoint of overall remission rate (ORR) at interim analysis.

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XTalks

MARCH 19, 2025

Beyond eneboparatide, AstraZeneca has continued its M&A activity including the acquisition of Esobiotec towards cell therapy innovation and a licensing agreement with Alteogen for subcutaneous formulations of oncology assets.

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XTalks

DECEMBER 2, 2020

The vaccine was shown to be 95 percent effective in large-scale Phase III clinical trials with no serious side effects reported. Moderna’s candidate COVID-19 vaccine is also mRNA-based and may be next in line for approval as it also posted positive clinical trial results last month.

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pharmaphorum

AUGUST 12, 2021

The DTx was first developed by researchers from King’s College London under the name Regul8, and was put through its paces in a 558-patient clinical trial in primary and secondary care in the NHS in England, with results showing that helped reduce symptoms when added to current therapies for IBS.

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pharmaphorum

OCTOBER 3, 2022

It suggested that Lilly and Innovent conduct multiregional clinical trials before reapplication. It is therefore an interesting development that sugemalimab was given an Innovation Passport in NICE’s Innovative Licensing and Access Pathway (ILAP) in October 2021. About CRA and the Life Sciences Practice.

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XTalks

JULY 17, 2023

Phase III Clinical Trials Underpinning the Applications The applications are grounded on two Phase III clinical trials, SPOTLIGHT and GLOW. In both trials, approximately 38 percent of the screened patients had CLDN18.2-positive

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Clinical Trials Clinical Trials Trials Antibody 95

XTalks

DECEMBER 13, 2024

The US Food and Drug Administration (FDA) has accepted a Biologics License Application (BLA) for Blenrep in combinations with BVd and pomalidomide plus dexamethasone (BPd), with a decision expected by July 2025. A day before GSKs announcement, Johnson & Johnson also released two promising clinical trial results.

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pharmaphorum

JULY 18, 2022

Convidencia’s injectable version was granted World Health Organization (WHO) Emergency Use Listing (EUL), and its inhalant counterpart, currently in phase three clinical trials, has shown enormous promise. Other plans include performing clinical studies in Malaysia and possibly Indonesia. Morgon, PharmD, LL.M,

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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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pharmaphorum

SEPTEMBER 29, 2022

She is the Co-Chair of the firm’s Health Care Practice Group, Co-Chair, Health Care & Life Sciences Sector – Medical Devices, and a core member of the firm’s life sciences and telemedicine industry teams. Kyle Faget is a partner and business lawyer with Foley & Lardner LLP.

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XTalks

MARCH 22, 2023

In October 2022, Xtalks celebrated two decades of bringing diverse stakeholders in the life science industry together through first holding physical events, then soon after, hosting exclusively online events. ICON acquired PRA Health Sciences in 2021, the same year that Inotiv acquired Envigo.

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