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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Trials Clinical Trials Clinical Trials Insulin 59

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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Clinical Trials Clinical Trials Trials Clinical Research 96

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.

Immune Response 59

Immune Response Vaccine Vaccination Trials 59

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.

Immune Response 94

Immune Response Trials Licensing Licensing 94

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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Clinical Trials Clinical Trials Trials Regulation 52

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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Trials Clinical Trials Clinical Trials Genetics 59

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.

Life Science 52

Life Science FDA Approval Drugs Licensing 52

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.

Clinical Trials 52

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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Trials Clinical Trials Clinical Trials Life Science 105

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.

Cardiology 59

Cardiology Trials Clinical Trials Clinical Trials 59

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.

Trials 105

Trials Clinical Trials Clinical Trials Life Science 105

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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Vaccine Vaccination Trials Clinical Trials 89

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.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Licensing 52

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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Scientist Life Science Clinical Research Doctors 105

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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Life Science Manufacturing Clinical Trials Clinical Trials 98

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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Drugs Clinical Trials Clinical Trials Trials 69

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.

Trials 98

Trials Clinical Trials Clinical Trials Gene Therapy 98

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.

Trials 59

Trials Hormones Engineer Licensing 59

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.

Life Science 92

Life Science Clinical Trials Clinical Trials Licensing 92

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.

Life Science 98

Life Science Marketing Manufacturing Drugs 98

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,

Vaccine 138

Vaccine Vaccination Development Immune Response 138

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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Development Regulation Production Life Science 104

XTalks

FEBRUARY 19, 2024

The team used the data and patient samples from a gB/MF59 Phase II trial in adolescent girls as a benchmark to assess the new mRNA-based vaccine. The comparison is particularly important as gB/MF59 demonstrated promise in Phase II clinical trials but did not advance to Phase III.

Vaccine 59

Vaccine Vaccination Trials Clinical Trials 59

XTalks

SEPTEMBER 5, 2023

Investigation of the possibility of VAED is crucial during clinical trials for decision-making on vaccine licensing by regulatory agencies. In the majority of cases, the risk of VAED is brought to light during preclinical stages or early clinical trial phases.

Vaccine 96

Vaccine Vaccination Development Clinical Trials 96

XTalks

APRIL 17, 2023

A Potential New Treatment for Atopic Dermatitis Biopharma company Almirall recently announced the publication of positive Phase III data from two clinical studies, ADvocate1 and ADvocate2 , that evaluated lebrikizumab as a monotherapy in adult and adolescent patients with atopic dermatitis.

Dermatology 97

Dermatology Antibody Clinical Trials Clinical Trials 97

pharmaphorum

MAY 17, 2021

Meanwhile, payers, regulators and policymakers need to advocate for changes in culture that ensure patient engagement is integrated at every step of the HTA process – as well as assessing alternative funding and reimbursement models to continue to improve patient access to licensed treatments.

Medicine 93

Medicine Life Science Marketing Clinical Trials 93

XTalks

NOVEMBER 29, 2021

The growing body of data we have compiled from clinical trials and real-world surveillance to date strengthen the base of evidence supporting the strong efficacy and favorable safety profile of our COVID-19 vaccine across adolescent and adult populations.”.

Vaccine 98

Vaccine Vaccination Trials Clinical Trials 98

XTalks

JULY 6, 2021

SER-109 “repopulates” the microbiome to induce compositional and functional changes that are critical to a sustained clinical response. As part of the deal with Nestlé, Seres will receive license payments of $175 million up front with an additional $125 million upon FDA approval of the drug.

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Marketing Drugs Bacteria FDA Approval 105

XTalks

AUGUST 25, 2020

Business as usual is anything but in the COVID-19 era, but as the pharmaceutical and clinical trials industries adjust, the US Food and Drug Administration (FDA) has received an influx of questions regarding site inspections and manufacturing-related queries.

Manufacturing 89

Manufacturing Clinical Trials Clinical Trials Production 89

XTalks

MAY 24, 2023

Miebo’s FDA approval was based on two Phase III clinical trials that involved a total of 1,217 patients with a history of dry eye disease and signs of MGD. In the latter half of 2019, the company secured an exclusive license for Miebo in the US and Canada for an undisclosed amount.

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FDA Approval Gene Therapy Gene Marketing 98

XTalks

JUNE 17, 2022

Olumiant is a Janus kinase (JAK) inhibitor that was first discovered by Incyte and then licensed to Eli Lilly. Related: FDA Authorizes Eli Lilly’s Bebtelovimab Which Demonstrates Activity Against Omicron. The drug was evaluated in 1,200 adult patients with severe AA.

FDA Approval 97

FDA Approval Gene Expression Cosmetics Trials 97

pharmaphorum

MAY 9, 2022

Patients can only access SparkRx through a licensed healthcare provider. She has served as Principal Investigator for Limbix’s clinical trials evaluating the safety and effectiveness of SparkRx. However, a significant difficulty with today’s US health system is finding access directly to a mental health provider.

Behavioural Health 135

Behavioural Health Production Life Science Development 135

XTalks

MARCH 21, 2023

Related: Gene Therapy Clinical Trials for Rare Diseases: 5 Key Takeaways from FDA’s Recent Town Hall Rett syndrome is typically caused by a genetic mutation on the MECP2 gene. Significant development regression associated with the disease occurs after a period of normal development from six to 18 months of age.

FDA Approval 94

FDA Approval Gene Therapy Gene Genetics 94

XTalks

AUGUST 21, 2023

Early detection can significantly help improve the longevity and quality of life of FOP patients. Ipsen is also concurrently working on an investigational FOP drug, BLU-782, which they have licensed from Blueprint Medicines Corp. Sohonos, the first and only approved drug, offers hope to those battling the disease.

Drugs 98

Drugs FDA Approval Genetics Clinical Trials 98

XTalks

JULY 25, 2022

Byondis announced that the US Food and Drug Administration (FDA) accepted their Biologics License Application (BLA) for [vic-]trastuzumab duocarmazine (SYD985), an investigational therapy being studied to treat HER2-positive unresectable locally advanced or metastatic breast cancer. Clinical Trial Results for [Vic-]Trastuzumab Duocarmazine

Antibody 59

Antibody Drugs Clinical Trials Clinical Trials 59

pharmaphorum

OCTOBER 4, 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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