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).

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Camargo

OCTOBER 20, 2021

From the regulator’s point of view, combination products are not restricted to combined biologics, drugs, and/or devices formed into a single entity (like a drug-eluting coronary artery stent). This will benefit both the FDA and the sponsor in a win-win situation.

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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. Non compliance with EU/EEA regulations lead to a potential supply chain disruption as well asl re-call of clinical trials material.

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Camargo

OCTOBER 15, 2020

As a sponsor designs clinical studies, the respective comparison control groups become a critical factor to consider. To approve a product, the FDA requires substantial evidence of effectiveness, consisting of adequate and well-controlled (A&WC) trials. What is the top regulatory concern when a single-arm study is employed?

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Camargo

AUGUST 11, 2021

However, global regulations are not one-size-fits-all, and sponsors aiming to market their products in multiple regions should be aware of the current standards and processes they may encounter during the development process. Meeting Package Due. Meeting Type. Meeting Purpose. Meeting Timing 1. from receipt of request).

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Clinical Trial Podcast

FEBRUARY 23, 2021

Almost everyone I’ve met in clinical research has accidentally discovered this hidden profession. Your interest in science and medicine somehow got you involved in clinical research and clinical trial management. But didn’t you wish you had a crystal clear understanding of “Who’s Who In Clinical Research?”.

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Cloudbyz

MAY 24, 2023

This is where unified clinical trial management solutions come into the picture, enhancing efficiency, reducing time to market, and ensuring high-quality, scientifically validated consumer products. A delay in trials or approval can significantly impact the product’s success and the company’s bottom line.

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Camargo

MAY 2, 2021

Advances in scientific knowledge and growth in the cell and gene therapy space have led to a new and exciting era of medicine for patients, as well as a new motivation for regulators to provide clear, efficient pathways for product developers. Scope and design of definitive animal trials and clinical trials.

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Cloudbyz

MARCH 3, 2023

Mid-size Clinical Research Organizations (CROs) play a significant role in the pharmaceutical and biotech industry by providing various services such as study design, clinical trial management, data management, and biostatistics. This can make it challenging to ensure compliance with the latest regulations and guidelines.

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pharmaphorum

JUNE 18, 2021

Teasing out complex relationships within data lies at the heart of any digital health intervention, but finding the algorithms to do so reliably – and making sure they will be acceptable to regulators – can be a challenge. The algorithms used in healthcare are becoming more complex as well.

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XTalks

FEBRUARY 10, 2023

According to a recent review published in Nature , as of April 2022 almost 1,800 active cell therapy clinical trials were listed in ClinicalTrials.gov, a 33 percent increase from 2021. In a recent webinar, Dr. Vassallo discussed the operational considerations for complex cell therapy clinical trials.

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Pharmaceutical Technology

NOVEMBER 21, 2022

A lower number of clinical trials and regulatory filings were other important influences behind the decision. In terms of the influence caused by negative changes in international investment in Japan, the pharmaceutical companies that decided to lower their business priority in Japan reported lower pharmaceutical sales.

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Advarra

SEPTEMBER 23, 2022

Whether the drug’s proposed labeling (package insert) is appropriate, and what it should contain. . In addition to granting new drug approvals, the FDA is also the gatekeeper for whether a sponsor can conduct the clinical investigations necessary to gather the data required for drug approval. The IND goes into effect; and .

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XTalks

AUGUST 29, 2022

The pre-clinical and clinical data they showcased at the meeting indicate that their cytokine immunotherapies are safe, potent and work for longer than other cytokine drugs for cancer. Based on these findings, Cytimmune will be moving these candidates into early clinical trial testing. What Are Nanomedicines?

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Advarra

JUNE 14, 2024

A regulatory binder is essential for managing clinical trial documents, ensuring regulatory compliance, and facilitating audits. It organizes critical documents; provides easy access for trial monitors, auditors, and regulatory authorities; and serves as a reference for the research team.

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pharmaphorum

JULY 13, 2021

The regulated content and labeling software firm has made three new customer-facing appointments and created a brand-new Customer Experience Team to provide enhanced, end-to-end customer support for medical device and clinical trial organizations.

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Pharmaceutical Technology

NOVEMBER 21, 2022

A lower number of clinical trials and regulatory filings were other important influences behind the decision. In terms of the influence caused by negative changes in international investment in Japan, the pharmaceutical companies that decided to lower their business priority in Japan reported lower pharmaceutical sales.

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Advarra

SEPTEMBER 8, 2022

As electronic documentation usage increases in clinical trials, organizations must make sure they’re still protecting participants’ health and safety without sacrificing quality or efficacy. One way to do so is to ensure the software platforms you are using to conduct research are in line with federal regulations.

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Camargo

JULY 30, 2021

They immediately stood up and said, “No, we’re doing six clinical trials in pediatrics now, specifically in the infant population, for something called pulmonary hypertension in these kids.” But now it’s a warning in their package insert. There were six Pfizer people in the audience.

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pharmaphorum

JANUARY 4, 2022

Provided as a cloud or on-premise solution, PRISYM 360 is designed specifically to address the unique complexities of medical device, clinical trial and pharmaceutical labeling and packaging artwork. PRISYM ID is a part of the award-winning Zebra® PartnerConnect program. About PRISYM ID. Media Contact: Andrew Baud, Distil,?

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ACRP blog

AUGUST 1, 2023

Untangling the web of regulatory expectations regarding who among sponsors, investigators, and vendors will be held responsible—and when and why—for different key aspects of decentralized clinical trials (DCTs) lies at the crux of comments submitted by the Association of Clinical Research Professionals (ACRP) to the U.S.

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ACRP blog

AUGUST 1, 2023

Untangling the web of regulatory expectations regarding who among sponsors, investigators, and vendors will be held responsible—and when and why—for different key aspects of decentralized clinical trials (DCTs) lies at the crux of comments submitted by the Association of Clinical Research Professionals (ACRP) to the U.S.

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Clinical Research Research Clinical Trials Clinical Trials 52

pharmaphorum

NOVEMBER 11, 2022

Several decisions are made in the early stages of clinical development that have key implications for entering markets successfully. However, for payers, as well as regulators, healthcare professionals, and patients, a new mode of action is not a value driver. Many therapies will be first in class with novel modes of action.

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XTalks

MAY 30, 2023

The healthcare industry has one of the heaviest environmental footprints, and manufacturers are increasingly faced with regulations to make more sustainable products,” said Mohammad H. There are also several ECG patches currently in clinical trials that could soon enter the market.

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Pharma Marketing Network

AUGUST 9, 2023

The pharmaceutical industry operates in a highly regulated environment, where marketing and advertising practices are subject to rigorous scrutiny. Stay Informed and Updated Regulations in the pharmaceutical industry are constantly evolving. Keep thorough records of approvals for future reference.

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The Pharma Data

AUGUST 24, 2020

The National Medical Products Administration has granted approval to the West China Hospital of Sichuan University in Chengdu to begin a clinical trial. The news comes after China said that companies and organisations must prove to regulators that vaccines have 50% efficacy. Conor Kavanagh. Source link.

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Cloudbyz

AUGUST 9, 2023

As it becomes more complex with growing volumes of data, evolving regulations, and the pressure for faster drug development, traditional methods of clinical research management are no longer sufficient. Let’s delve into why this method is paramount for the transformation of clinical research management.

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Clinical Research Research Clinical Trials Clinical Trials 52

XTalks

MARCH 25, 2021

Sydney writes about various food industry topics, including safety and regulation, grocery and foodservice, innovation and sustainability. Since joining Xtalks in 2015, she has written over 1,000 articles on diverse topics from remote clinical trials and rare disease to medical device sterilization and drug pricing.

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Pharma Marketing Network

AUGUST 9, 2023

The pharmaceutical industry operates in a highly regulated environment, where marketing and advertising practices are subject to rigorous scrutiny. Stay Informed and Updated Regulations in the pharmaceutical industry are constantly evolving. Keep thorough records of approvals for future reference.

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pharmaphorum

NOVEMBER 22, 2022

Ut comes just as FogPharma is preparing to start clinical trials of alpha-helical polypeptide candidate FOG-001. The Helicons are taken into cells using endocytic trafficking, a process which sees the compounds packaged into folds in the plasma membrane, forming vesicles that are then internalised.

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Pharmaceutical Technology

NOVEMBER 24, 2022

The ADME study results form an important part of the Investigational New Drug (IND) approval process in the US and for the submission of a national Clinical Trial Authorization (CTA) in the EU.

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Cloudbyz

MARCH 30, 2023

However, the development and delivery of cell and gene therapies present significant operational challenges that must be navigated carefully to ensure successful clinical trials. Regulatory compliance Regulatory compliance is critical to the success of cell and gene therapy trials, and there are many regulations to navigate.

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Advarra

JULY 19, 2022

The sponsor is the pharmaceutical company conducting the trial. If you mean using a different contract research organization (CRO) for the different phases of clinical trials – that’s different. For good clinical practice (GCP), refer to ICH E6 (R2) Section 5 and address all quality elements. Could you please confirm?

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Cloudbyz

DECEMBER 9, 2021

Co-authored by Reeshav Mittal (Clinical Trial Subject Matter Expert). Within the clinical trial industry, Risk-Based Monitoring (RBM) is another rising trend that empowers research teams and stakeholders to conduct clinical trials with greater flexibility in monitoring visits whilst continuing to gather reliable data.

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XTalks

SEPTEMBER 16, 2024

HAE is caused by a deficiency or dysfunction of the C1-inhibitor, a protein involved in regulating inflammation. The compelling data included in our NDA package show that sebetralstat has the potential to significantly alter the way people treat and manage their disease,” he said.

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WCG Clinical

NOVEMBER 3, 2023

HHS and FDA regulations require that the study participant is provided with “A description of any reasonably foreseeable risks or discomforts to the subject;” (45CFR 46.116(a)(2)) (21 CFR 50.25(a)(2)) see Is this an Interventional Clinical Trial or Observational Study? a)(2)) within the consent form.

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Pharmacy Checkers

DECEMBER 12, 2019

The FDA’s continuing problems with inspections of drug manufacturing plants, as well as the relative comparative strength of other drug regulators, ought to inspire serious reflection, even introspection, among drug safety policy professionals about whether or not, and how, we have the gold standard. Both the EU and the U.S.

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