Camargo

OCTOBER 15, 2020

Often, to gain clinical trial design insights, a sponsor reviews the physician package inserts from approved New Drug Applications (NDAs) and Biologics License Applications (BLAs) with similar indications or in the same therapeutic area. What is the FDA’s current thinking on the use of single-arm trials?

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Production Trials Development Clinical Trials 190

Pharmaceutical Technology

APRIL 3, 2023

The company conducted a Phase I pharmacokinetics (PK) bridging trial as part of the comprehensive submission package to the EMA. This trial compared the approved adalimumab 50mg/mL 2 with the 100 mg/mL HCF.

Marketing 264

Marketing Medicine Packaging Packaging 264

AuroBlog - Aurous Healthcare Clinical Trials blog

JANUARY 12, 2023

Indian pharma sees immense value in US FDA’s insistence for aluminum content and labelling recommendations for the Small Volume Parenterals Drug Products and Pharmacy Bulk Packages. Pharma companies in the country have increasingly made a shift to nutritional based prescription and over the counter products.

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Packaging Packaging Pharmacy Pharma Companies 188

AuroBlog - Aurous Healthcare Clinical Trials blog

MARCH 12, 2024

Despite the availability of medical insurance, the penetration remains meagre with only a few people being able to access the high packages. Indian patient expenses make a strategic shift towards embedded finance access at point-of-care with options to aid out-of-pocket health expenses.

Packaging 188

Packaging Packaging Clinical Trials Clinical Trials 188

World of DTC Marketing

DECEMBER 29, 2020

These vaccines were developed using different “platform technologies” that involve slotting genetic material from the virus into a tried and tested delivery package. Another consideration is that while in traditional vaccine development, clinical trials are carried out in sequence. However, this is time-consuming.

Vaccine 307

Vaccine Vaccination Development Clinical Trials 307

XTalks

NOVEMBER 6, 2024

The FDA authorization of Valeda was based on clinical evidence from multiple trials, including the LIGHTSITE III study, which demonstrated improved visual acuity and contrast sensitivity in patients treated with Valeda. Worldwide, AMD cases are expected to grow by 20 percent, from 195.6 million in 2020 to 243.3 million by 2030.

Manufacturing 104

Manufacturing FDA Approval Packaging Packaging 104

Pharmaceutical Technology

SEPTEMBER 26, 2022

Clinical trials were thrown into turmoil on the morning of 24 February 2022, along with every aspect of life in Ukraine. In July, approximately a third of companies had paused a trial in the country. By August, 28 foreign-sponsored, multi-country trials were affected, almost half with sites in Ukraine and Russia. [1].

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Clinical Trials Clinical Trials Trials Regulation 130

pharmaphorum

SEPTEMBER 7, 2022

Brainomix has reeled in another pharma partner for its artificial intelligence-powered biomarker software, used to track the performance of therapeutic interventions in clinical trials. The post Bridge Bio will use Brainomix AI in lung fibrosis trial appeared first on.

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Trials Clinical Trials Clinical Trials Packaging 128

Fierce Pharma

OCTOBER 7, 2024

After winning a first-in-class nod for its two-drug inhaler Airsupra l | After winning a first-in-class nod for its two-drug inhaler Airsupra last January, AstraZeneca is bolstering the rescue treatment’s clinical package with new data showing it can cut the risk of asthma exacerbations regardless of patients’ disease severity.

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Regulation Packaging Packaging Trials 111

Rethinking Clinical Trials

JULY 18, 2023

Lynn DeBar and Dr. Natalia Morone In an interview at the annual NIH Pragmatic Trials Collaboratory Steering Committee meeting, Dr. Lynn DeBar and Dr. Natalia Morone had a conversation about sharing trial results with participant partners. It can also combat misinformation and promote trust. “I think we have that responsibility.”

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Trials Research Packaging Packaging 130

BioSpace

SEPTEMBER 21, 2020

Competition for resources is growing, and the usual supply chain partners may not have available capacity in the preferred timeframe.

Packaging 84

Packaging Packaging Trials 84

XTalks

MAY 9, 2023

Clinical trial manager jobs are vital for the development and execution of clinical trials, which are essential for developing new treatments for diseases. In this article, we discuss the job duties, education and experience requirements, outlook and salary expectations for clinical trial managers.

Clinical Trials 98

Clinical Trials Clinical Trials Trials Clinical Research 98

Cloudbyz

MAY 11, 2023

Clinical trials play a vital role in bringing new therapies and treatments to patients, but they can be expensive and resource-intensive endeavors. Understanding the factors driving clinical trial costs is essential for researchers, sponsors, and other stakeholders involved in the drug development process.

Clinical Trials 98

Clinical Trials Clinical Trials Trials Compliance 98

BioPharma Reporter

OCTOBER 5, 2023

Sharp, a commercial pharma packaging and clinical trial supply services firm, has acquired Berkshire Sterile Manufacturing (BSM), a Massachusetts-based fill finish contract development and manufacturing organization (CDMO).

Manufacturing 105

Manufacturing Pharma Packaging Packaging Packaging 105

Cloudbyz

OCTOBER 19, 2023

Clinical trials are the backbone of drug development, and managing these trials efficiently is paramount. In recent years, the need for a unified clinical trial management platform has become increasingly evident. Cost Efficiency: Centralized data management reduces administrative overhead, minimizing trial costs.

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Clinical Trials Clinical Trials Trials Compliance 104

Pharmaceutical Technology

JUNE 19, 2023

According to GlobalData’s clinical trials database, there are currently 1,231 planned and ongoing trials for gene therapies and gene-modified cell therapies alone. It is critical to understand the supply chain, plan your packaging, storage and distribution lanes, then test the entire process before patient shipments go live.

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Gene Therapy Gene Packaging Packaging 130

pharmaphorum

AUGUST 16, 2021

Over the past two years, the pharma industry’s demand for automated research solutions has increased significantly and, particularly when it comes to clinical trial design, the need has never been greater. The first is a lack of standardisation in trial design, which leads to delays in study setup. The future is automation.

Clinical Trials 98

Clinical Trials Clinical Trials Trials Compliance 98

pharmaphorum

JUNE 28, 2021

Preliminary results from a phase 1 trial run by Regeneron and CRISPR specialist Intellia Therapeutics – co-founded by Nobel Prize winner Jennifer Doudna – showed steep reductions in a biomarker of ATTR amyloidosis disease activity with a single dose of the NTLA-2001 drug. In three more patients treated at 0.1mg/kg levels fell by 52%.

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In-Vivo Gene Editing Trials Drugs 105

Rethinking Clinical Trials

NOVEMBER 21, 2022

Pragmatic Clinical Trials. In 2016, we published a pilot trial looking at high-flow nasal cannula (HFNC) therapy compared to CPAP in pediatric critical care. The step-up trial started recruitment in August 2019, 1,449 children were eligible, 600 children were randomized, and 595 consented. ? ? ? ? ? ? ? ?. Speakers. Key Points.

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Trials Clinical Trials Clinical Trials Packaging 100

Pharmaceutical Technology

DECEMBER 12, 2022

In this last 2022 edition of the series, which started in June , Pharmaceutical Technology is tracking major trial announcements and decisions by regulators and reimbursement agencies that have occurred since mid-October, as well as their potential impact on manufacturing plans. Regulatory decisions and clinical trial news.

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Manufacturing Drugs Packaging Packaging 147

Antidote

JULY 27, 2023

Before any new therapy can be put on the market, it must be tested to ensure its safety and effectiveness, and the research for this process is done through clinical trials.

Clinical Research 98

Clinical Research Research Clinical Trials Clinical Trials 98

Pharmaceutical Technology

MAY 1, 2023

The NDA is supported by the data package licensed to Ocumension by Nicox as well as the Phase III clinical trial in China. It has been approved to treat ocular itching that is associated with allergic conjunctivitis in the US.

Licensing 162

Licensing Licensing Sales Packaging 162

pharmaphorum

APRIL 11, 2022

Chris Garabedian, CEO of Xontogeny, describes how his past experiences as CEO of Sarepta Therapeutics have led him on an exploration for technology that can effectively leverage wearable data in clinical trials. How can this data be incorporated into clinical trials?”. How can this data be incorporated into clinical trials?”.

Clinical Trials 111

Clinical Trials Clinical Trials Trials Development 111

Camargo

MAY 2, 2021

First-in-human trial. Scope and design of definitive animal trials and clinical trials. A sponsor must provide concise detail in the meeting package and ask specific , targeted questions so that the FDA can provide meaningful guidance. Challenges due to unknown safety profiles.

Gene Therapy 155

Gene Therapy Gene Packaging Packaging 155

Rethinking Clinical Trials

MARCH 1, 2023

For the investigational ramucirumab plus pembrolizumab arm, the drugs are administered per FDA package insert and institutional standard in a 21-day cycle under one of the criteria for removal is met. One network is the lead, but the trial will be available in all four U.S. verses other immunotherapeutic agents)?

Clinical Trials 100

Clinical Trials Clinical Trials Trials Packaging 100

BioTech 365

AUGUST 31, 2021

Bn Clinical Trial Supplies Markets by Services (Manufacturing, Packaging, Logistics, Distribution), Phases (I to IV), Type (Small molecule, Biologics, Medical Devices) – Global Forecast 2026 – ResearchAndMarkets.com $2.9

Packaging 40

Packaging Packaging Clinical Trials Clinical Trials 40

Pharmaceutical Technology

JULY 26, 2022

A complete analytical, preclinical and clinical data package is part of the BLA and MAA submissions. In Phase I and Phase III Antelope trials that enrolled RRMS patients, primary endpoints were met, indicating that the biosimilar has efficacy, safety and immunogenicity in line with the reference medicine.

Medicine 162

Medicine Packaging Packaging Development 162

Pharmaceutical Technology

NOVEMBER 24, 2022

Additionally, the transfer of technology will build and validate capacity for scaling up Good Manufacturing Process (GMP), domestic production of clinical trial products and end-to-end vaccine manufacturing in Africa for regional and global use.

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Vaccine Vaccination Development Manufacturing 147

Pharmaceutical Technology

MAY 26, 2023

The submission was supported by a comprehensive analytical and clinical data package, including data from a Phase I PK/PD similarity study and the integrated Phase I/III ROSALIA clinical trial.

Marketing 130

Marketing Packaging Packaging Medicine 130

Pharmaceutical Technology

MARCH 30, 2023

The full approval is based on data from the Phase I/II KEYNOTE-051 trial, and Phase II KEYNOTE-158 and KEYNOTE-164 studies. On the same day, researchers presented new interim data from the Phase III RUBY trial of GSK’s PD-1 antibody Jemperli (dostarlimab) in patients with primary advanced or recurrent endometrial cancer.

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Trials Sales Packaging Packaging 130

Pharma Mirror

FEBRUARY 6, 2024

By Barbara Arone, Vice President, Real World Solutions, IQVIA The use of real-world evidence (RWE) in the development of pharmaceutical treatments has grown exponentially in the past 10 years, fueled by availability of higher quality data, trial competitiveness and growing investments in personalized and rare disease treatments.

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Production Packaging Packaging Clinical Research 100

pharmaphorum

APRIL 16, 2021

Activist investor Elliott Management has built a significant stake in GlaxoSmithKline, after a poor run of clinical trial results this year raised questions about management’s strategy to turn around the company’s fortunes. But that failed in a late-stage lung cancer trial comparing it with Keytruda in January.

Trials 69

Trials Sales Packaging Packaging 69

Cloudbyz

AUGUST 15, 2024

Randomization and Trial Supply Management (RTSM) play a pivotal role in the successful execution of clinical trials. As the complexity of clinical trials continues to increase, especially with the rise of multi-center, adaptive, and decentralized trials, the need for robust RTSM systems has become more critical than ever.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Compliance 52

Camargo

OCTOBER 14, 2021

Continued development of the use of complex innovative trial designs. The sponsors of the accepted proposals will submit a full package consisting of required toxicology and quality data, as outlined in the Federal Register. Improved predictability in Human Factors and User-Related Risk reviews. Container-closure changes. Orientation.

Development 189

Development Packaging Packaging Generic Drugs 189

Pharmaceutical Technology

MAY 25, 2023

The regulatory approval was based on a comprehensive data package of preclinical, analytical and clinical trials. The findings showed that Yuflyma and the reference product were similar in terms of pharmacokinetics, safety, efficacy and immunogenicity after 24 weeks and one year of treatment.

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FDA Approval Packaging Packaging Clinical Trials 130