Outsourcing Pharma

FEBRUARY 6, 2024

Phesiâs artificial intelligence (AI) driven platform, Trial Accelerator, has reached a milestone and now contains global data from more than 100 million patients.

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Pharma in Brief

JANUARY 26, 2022

The Federal Court has confirmed that issues of infringement, including by inducement, may be decided by summary trial in an infringement action under the Patented Medicines (Notice of Compliance) Regulations (the Regulations ). The Defendant moved to have the issue of infringement determined on summary trial.

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STAT News

JANUARY 19, 2023

We will leave it to you to guess what it contains. As for us, we are foraging for interesting stories and quaffing cups of stimulation, as you might have guessed. Our choice today is a Mardi Gras blend. And how is your morning going? Is your schedule filled with meetings and deadlines and what-not? To help you along, here are some tidbits.

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Cloudbyz

SEPTEMBER 16, 2023

Addressing data privacy and data protection concerns when implementing ChatGPT in clinical trial operations management is crucial to maintain compliance with regulations, safeguard sensitive patient information, and build trust among stakeholders. This may involve conducting regular audits and assessments to maintain compliance.

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Pharmaceutical Technology

NOVEMBER 9, 2022

Each booster dosage contains 15?g The approval came after the vaccine was found to satisfy the standards of safety, quality and effectiveness of the medicines regulator in the UK. 1 vaccine as well as the safety results from a clinical trial underway.

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pharmaphorum

SEPTEMBER 2, 2020

European regulators have begun a speedy review of dexamethasone as a treatment for adults hospitalised with COVID-19, a potentially cheaper option to aid recovery than Gilead’s Veklury. In July, Gilead’s Veklury (remdesivir) became the first drug cleared by EU regulators to treat symptoms in patients hospitalised with COVID-19.

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pharmaphorum

SEPTEMBER 14, 2020

AstraZeneca has resumed UK trials for its coronavirus vaccine, after the country’s medicines regulator gave the all-clear following a safety scare. A UK safety committee has concluded its investigations and recommended to the country’s Medicines and Healthcare products Regulatory Agency (MHRA) that trials are safe to resume.

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CTTI (Clinical Trials Transformation Initiative)

JANUARY 10, 2024

Timely, accurate, and complete registration and reporting of summary results information for applicable clinical trials on ClinicalTrials.gov allows access to current research and evidence for all partners in the clinical trials enterprise, including patients, providers, sponsors and investigators, regulators, payers, and health system leaders.

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XTalks

APRIL 24, 2023

Rare disease clinical trials are complex due to the additional scientific, medical, operational and regulatory requirements of newly emerging advanced therapies, such as gene therapy,” says Dr. Terence Eagleton, MB BS, Senior Medical Director at the global clinical research organization (CRO) Medpace. Reference: Chung DC, et al.

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Cloudbyz

JUNE 16, 2023

Clinical trials are crucial for advancing medical research and developing innovative treatments. Effective clinical trial data archiving is essential to ensure data integrity, regulatory compliance, and seamless access. Data Complexity: Clinical trial data often comes in diverse formats, such as text, images, audio, and video.

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Cloudbyz

FEBRUARY 26, 2023

A Trial Master File (TMF) is a comprehensive collection of documentation that provides a complete record of a clinical trial. The TMF contains all essential documents related to the trial, such as study protocols, informed consent forms, investigator brochures, and monitoring reports.

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The Pharma Data

SEPTEMBER 14, 2020

. AstraZeneca has confirmed that clinical trials assessing its Oxford University partnered coronavirus vaccine AZD1222 have resumed in the UK, following a green light by the Medicines Health Regulatory Authority (MHRA). Source link.

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Advarra

FEBRUARY 24, 2023

In most cases, the results you are really looking for and trying to prove in a trial can be complex. How do you strategically plan your therapy and research objectives to improve the chances you will satisfy what the regulators are looking for and ultimately get your therapy approved for marketing?

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Drug Discovery World

FEBRUARY 1, 2023

Big pharma is helping to shape the focus The good news is that clinical trials are on the increase and market education is upping pace. Nothing is definitive yet, and these are complicated trials, but the world wants to move to safer alternatives that don’t impede daily life or cause further issues.

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Pharma in Brief

MAY 29, 2023

The CSP Guidance was revised to reflect amendments to the definition of “authorization for sale” in the Certificate of Supplementary Protection Regulations ( CSP Regulations ) and to reflect changes to Health Canada’s administrative practices. Certificate of Supplementary Protection Regulations , SOR/2017-165

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pharmaphorum

JANUARY 14, 2021

Healthcare technology firm Seqster has introduced a new version of its service that aims to help pharma companies work with patients’ data while on virtual clinical trials. What Seqster does for pharma clinical trials is it brings together in real time a health record for participants. The new Seqster 7.1

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Cloudbyz

FEBRUARY 21, 2023

A Trial Master File (TMF) is a comprehensive collection of documentation that provides a complete record of a clinical trial and proves that a clinical trial has been conducted following Good Clinical Practice (GCP) guidelines and all regulatory requirements and also demonstrates that the integrity of trial data has been maintained.

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Advarra

OCTOBER 26, 2023

Controlled Environment and IP Containment The potential for a release, and the risk associated with a genetically engineered IP, are part of the IBC’s assessment purview under National Institutes of Health (NIH) Guidelines. The containment must then prevent spills or leaks if the IP is dropped. Size matters.

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XTalks

NOVEMBER 7, 2022

Gleich, MD, FACS, Senior Vice President, Medical Department, and Dr. Christopher Huth, PhD, Senior Clinical Trial Manager, Clinical Trial Management. Liquid Biopsy Use in Oncology Clinical Trials. Regulators may ask at some point to provide that documentation, so it’s important to track that across the study.

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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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Advarra

SEPTEMBER 23, 2022

Whether the drug’s proposed labeling (package insert) is appropriate, and what it should contain. . In other words, the FDA also regulates whether investigational products may be manufactured, shipped, and administered to human subjects who participate in clinical investigations. . The IND goes into effect; and .

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The Pharma Data

OCTOBER 25, 2020

NASDAQ: PTCT), today announced the initiation of a registration-directed Phase 2/3 clinical trial to evaluate vatiquinone (PTC743) in patients with mitochondrial epilepsy, the highly morbid condition of refractory seizures in children with inherited mitochondrial disease. . SOUTH PLAINFIELD, N.J. , Peltz , Ph.D.,

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The Pharma Data

APRIL 3, 2021

The CoVIg-19 Plasma Alliance today announced that the Phase 3 Inpatient Treatment with Anti-Coronavirus Immunoglobulin (ITAC) clinical trial sponsored and funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), did not meet its endpoints. About the ITAC Trial.

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Pharmaceutical Technology

MAY 24, 2023

The regulator granted RMAT designation based on the data obtained from the ongoing Phase I RP-L301 clinical trial. It can correct several disease elements associated with PKD, a rare, monogenic red blood cell disorder caused by a mutation in the PKLR gene.

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XTalks

APRIL 25, 2024

Read on to learn more about the groundbreaking devices and trials shaping the future of heart failure management, as detailed by Medpace’s experts in the field. The efficacy of the Revivent TC system is being evaluated through clinical trials, namely the LIVE trial and the ongoing ALIVE trial.

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Cloudbyz

MARCH 30, 2023

Ensure Compliance: Life sciences organizations are subject to various data protection regulations, including GDPR, HIPAA, and CCPA. AI/ML-based redaction solutions can help organizations comply with these regulations by ensuring that sensitive data is not disclosed or transmitted in violation of regulatory requirements.

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XTalks

AUGUST 16, 2022

Health regulators in the UK have become the first in the world to approve Moderna’s next generation COVID-19 vaccine booster that includes targeting of the Omicron variant. 1) when compared to a 50 µg booster dose of mRNA-1273 in baseline seronegative participants.

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XTalks

JUNE 28, 2023

The approval is restricted to ambulatory patients within this narrow age range due to uncertainty around its effectiveness in older children, which Sarepta hopes to clarify in a confirmatory trial. As such, the agency is requiring Sarepta to confirm the therapy’s clinical benefit as part of the confirmatory trial.

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The Pharma Data

JANUARY 17, 2021

The treatment is based on the Grifols immunoglobulin Gamunex®-C, and contains anti-SARS-COV-2 polyclonal antibodies from plasma donors who have recovered from COVID-19. It could also help contain outbreaks in places where the vaccination hasn’t begun or is still underway. BARCELONA, Spain , Jan. and on the U.S.

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Drug Discovery World

MARCH 26, 2024

METTL1 inhibition leads to reduced tRNA methylation and stability of a subgroup of tRNAs and in several cancer cell lines impairs cell proliferation and cell cycle progression, accompanied by reduced expression of cell cycle regulators. Results of that Phase I trial are expected to be presented later this year.

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pharmaphorum

DECEMBER 13, 2022

This precipitated a shift from a centralised trial experience to a decentralised one, resulting in participants communicating electronically. BYOD in clinical trials. Historically, equivalency presented a primary hurdle in the adoption of eCOA BYOD for clinical trials. The benefits of BYOD in trials.

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Advarra

DECEMBER 15, 2022

As the research community continues to seek clinical trial efficiencies designed to bring therapies to patients faster, more governing bodies are pushing for single institutional review board (single IRB) review as one way to streamline efforts. Policies and Regulations Affecting Single IRB Review. Common Rule Single IRB Policy.

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FDA Law Blog

FEBRUARY 7, 2023

Lenz, Principal Medical Device Regulation Expert — For medical device start-up companies, understanding and successfully navigating applicable FDA regulations and requirements is an important part of the path to market. Part 814), and for conducting clinical trials (21 C.F.R. By Adrienne R.

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FDA Law Blog

AUGUST 4, 2023

Because anabolic steroids are also abused to enhance athletic performance and increase muscle strength, Congress has enacted three laws regulating anabolic steroids: the Anabolic Steroid Control Acts of 1990 and 2004, and the Designer Anabolic Steroid Control Act of 2014 (“DASCA”). DASCA became law, amending the CSA, on December 18, 2014.

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pharmaphorum

OCTOBER 6, 2021

Formedix has been strong advocates for the use of CDISC data standards in clinical and non-clinical research for decades, ever since we realized how it could transform our business by enabling the rapid design and build of clinical trials. Think of an Adverse Events dataset and the variables it contains. Think PDF or Excel.

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FDA Law Blog

JANUARY 1, 2024

Perhaps FDA wanted us to remember 2023 as the year FDA succeeded in uncovering critical defects in drug and device manufacturing, and in critical trials. Warning Letters, generally made public in a batch each Tuesday, are FDA’s public sanction that is most widely used to bring pressure on manufacturers and clinical trial investigators.

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Camargo

DECEMBER 13, 2021

Like with small molecules, clinical trials of biologics are designed to determine pharmacokinetics (PK), pharmacodynamics (PD), safety, and efficacy. The regulations regarding BLAs for therapeutic biological products are included in 21 CFR parts 600 , 601 , and 610. Expanded access to experimental biologics. BLA process (CBER).

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