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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Drug Discovery World

FEBRUARY 7, 2024

This submission brings us one step closer to the possibility of offering these patients a treatment that demonstrated improved survival and slowed disease progression compared to platinum-containing chemotherapy.” The sNDA is based on results from the Phase III EV-302 clinical trial.

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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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pharmaphorum

SEPTEMBER 2, 2020

The UK’s medicines regulator has published long-awaited guidance on regulation of medicines and medical devices as the UK approaches the end of its Brexit transition period at the end of the year. Companies face significant changes in how the complex environment for medicines regulations will operate in 2021. “If

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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. This comprises wide-ranging data on the safety and effectiveness of the initial vaccine, clinical findings from the bivalent original/omicron BA.1

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Vaccination Vaccine Regulation Medicine 264

pharmaphorum

OCTOBER 2, 2020

European regulators have started a first ‘rolling review’ of a COVID-19 vaccine, which is being developed by AstraZeneca in collaboration with the University of Oxford. In a separate announcement, AstraZeneca said that a trial of the vaccine has resumed in Japan after a safety scare in the UK.

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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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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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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

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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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

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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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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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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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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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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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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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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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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pharmaphorum

DECEMBER 13, 2022

The COVID-19 pandemic created an urgent need to reach out and connect with study participants without them coming into clinics and risking infection. This precipitated a shift from a centralised trial experience to a decentralised one, resulting in participants communicating electronically. BYOD in clinical trials.

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Clinical Trials Clinical Trials Compliance Trials 57

pharmaphorum

AUGUST 31, 2021

ECAs are being used to support the primary approval, label expansion of their assets and even go/no-go decisions for trials. The industry has looked to regulators for guidance, and the Food and Drug Administration (FDA) has been quick to respond. Myth 3: RWD is too imperfect to be used to as a comparator arm to a clinical trial.

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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.

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Advarra

APRIL 30, 2024

Maintaining complete and compliant documentation while managing the complex processes and interactions of clinical trial conduct is complicated. Investigator Site Files The ISF contains essential documents permitting evaluation of a clinical trial’s conduct. Form FDA 1572 The Form FDA 1572 is unique to U.S.-based

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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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pharmaphorum

SEPTEMBER 15, 2022

This enables regulatory reviewers to evaluate and process clinical trials more effectively. For example, an Adverse Events dataset and the variables it contains. PRM is the first stage in the clinical trial planning process. SDTM was developed to organize data collected in clinical 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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Clinical Trials Clinical Trials Regulation Research 52

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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Pharmaceutical Technology

MAY 24, 2023

By Luisa Sterkel & Joana Loureiro , Tenthpin Consultants The promise and potential of cell and gene therapies (CGT) has emerged in the recent past and currently over 1.500 CGT are registered for clinical trials holding great hope for the treatment of challenging and uncurable diseases.

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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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FDA Law Blog

MARCH 7, 2024

Tobolowsky & Véronique Li, Senior Medical Device Regulation Expert & David B. Moreover, DMCs are being used in trials of modest size and in the context of increased globalization of medical product development.

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pharmaphorum

JANUARY 27, 2021

Terms like “lab rats” and “guinea pigs” are often used in conversations about clinical trials. The approval and roll out of the COVID-19 vaccines have put the spotlight on clinical trials. I have never known the subject of clinical trials to be as discussed as much as it is right now.

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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. Additionally, the FDA said a “clinical benefit of Elevidys, including improved motor function, has not been established.”

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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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Drug Discovery World

JANUARY 11, 2024

Patients affected by the disease are found to also experience an imbalance of glutathione regulation, which is important for liver detoxification. mRNA contains instructions that direct the cells to make proteins.

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pharmaphorum

DECEMBER 7, 2020

Tuesday has been dubbed “V-day” in the UK, when the first doses of Pfizer/BioNTech’s coronavirus vaccine will be distributed to the public outside of a clinical trial. Pfizer’s vaccine needs to be stored at around -70C to retain its integrity, while its rival from Moderna that is under review by regulators needs to be stored at -20C.

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Drug Discovery World

AUGUST 21, 2023

Medications containing semaglutide such as Ozempic, licensed for diabetes, and Wegovy, for weight loss, are being studied to see if they can treat a range of different conditions, including addiction and dementia. However, these trials won’t be complete until 2026 at the earliest. It’s an exciting area,” he told The Guardian.

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WCG Clinical

NOVEMBER 20, 2023

FDA SR Device PMA Database FDA NSR Device 510K Database FDA Device Search FDA Medical Device Databases Class I and Class II Exempt Device listing If your device meets another exemption under the investigational device exemption (IDE) regulations, please provide a rationale for why your device qualifies as IDE exempt. a) (1) to (4).

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