The Pharma Data

SEPTEMBER 1, 2020

Explore how emerging trends in clinical trial investigations are bringing patients closer to medicine making them more patient-centric. The patient experience is an important consideration in trial design. Innovative ways regulators are implementing new clinical practices to measure the patient perspective.

Clinical Trials 52

Clinical Trials Trials Regulations Production 52

PPD

OCTOBER 17, 2024

There has also been an increase in government and regulatory support for CGT trials, in conjunction with an increase in investments for these products to get to market. They also need to have the medical competencies to manage adverse events often associated with these therapies.

Therapies 97

Therapies Clinical Trials Clinical Research Trials 97

Vial

FEBRUARY 21, 2024

Clinical trials are needed to determine whether a medical device can produce sufficient proof of its efficacy. However, medical device sponsors and developers are limited by the complex regulatory processes and the high costs associated with the design of running clinical trials for their products.

Clinical Trials 52

Clinical Trials Trials Compliance Regulations 52

Vial

JUNE 24, 2024

Contract research organizations (CROs) and pharmaceutical companies can leverage these cutting-edge technologies to streamline clinical trials and introduce automation in drug discovery. As clinical trials grow in complexity, the volume of data being gathered and utilized for these studies is expanding.

Clinical Trials 52

Clinical Trials Trials Clinical Research Treatment 52

Advarra

FEBRUARY 24, 2023

But what does “working” really mean when efficacy means something subjective, like quality of life, reduced psychiatric events, or less symptoms? In most cases, the results you are really looking for and trying to prove in a trial can be complex.

Clinical Trials 52

Clinical Trials Trials FDA Therapies 52

The Pharma Data

NOVEMBER 10, 2020

Brazil’s National Agency for Sanitary Surveillance (ANVISA) has suspended Beijing, China-based Sinovac’s phase 3 trial of its COVID-19 vaccine, CoronaVac, halting the study Tuesday to evaluate a serious adverse event that occurred. Source link.

Vaccine 40

Vaccine Trials Regulations Research 40

Advarra

NOVEMBER 14, 2024

In an era where clinical trials are increasingly global, it’s more imperative than ever to leverage international expertise. Data and safety monitoring boards (DSMBs), also known as data monitoring committees (DMCs), play a critical role in overseeing a clinical trial’s safety and efficacy.

Clinical Trials 97

Clinical Trials Trials International Clinical Research 97

LifeSciVC

APRIL 24, 2024

In the absence of a clinical trial result or FDA label to point to, how does one create the case and target product profile (TPP) around a new target? If adverse events are anticipated, it is important to understand gene dosage for such an effect (e.g., One example of such a genetics exercise is represented in Fig.

Production 111

Production Small Molecule Regulations Trials 111

Advarra

OCTOBER 1, 2024

Managing clinical trial budgets efficiently is necessary for the success and sustainability of clinical research sites. Effective budget management not only ensures trials are financially viable but also maximizes return on investment (ROI). the impact and value of the data produced).

Clinical Trials 52

Clinical Trials Trials Compliance Laboratories 52

Crucial Data Solutions

MAY 31, 2023

Clinical trials continue to move closer to patients. Improvements to data collection technologies and processes, a robust high-speed internet infrastructure, and pressure from regulators to make research more inclusive are converging, making exclusively site-based study designs increasingly rare. Luckily, there is one solution.

Clinical Trials 52

Clinical Trials Trials Compliance Research 52

Agency IQ

AUGUST 2, 2024

What we expect European regulators to do in August and September 2024 In this recurring feature, AgencyIQ, through public data and previous analysis, determines what European medicine and device regulators will likely do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods, and more.

Regulations 40

Regulations Clinical Trials Production Trials 40

Agency IQ

MAY 3, 2024

What we expect European regulators to do in May 2024 In this recurring feature, AgencyIQ, through public data and previous analysis, determines what European medicine and device regulators will likely do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods, and more.

Regulations 40

Regulations Clinical Trials Production Biosimilars 40

FDA Law Blog: Drug Discovery

APRIL 23, 2023

This Draft Guidance focuses on the use of patient-level data from other clinical trials or from RWD sources. For example, objective response rate is often used as a single-arm trial endpoint in oncology given the established understanding that tumor shrinkage rarely occurs without an intervention.”

Trials 49

Trials Clinical Trials FDA Treatment 49

The Pharma Data

SEPTEMBER 25, 2020

Johnson & Johnson Posts Interim Results from Phase 1/2a Clinical Trial of its Janssen COVID-19 Vaccine Candidate. Johnson & Johnson Posts Interim Results from Phase 1/2a Clinical Trial of its Janssen COVID-19 Vaccine Candidate. The full set of results will be published once the complete Phase 1/2a trial data are available.

Clinical Trials 52

Clinical Trials Vaccine Trials Immune Response 52

Agency IQ

MARCH 29, 2024

What we expect European regulators to do in April 2024 In this recurring feature, AgencyIQ, through public data and previous analysis, determines what European medicine and device regulators will likely do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods, and more.

Regulations 40

Regulations Production Clinical Trials Biosimilars 40

Agency IQ

JULY 8, 2024

What we expect European regulators to do in July 2024 In this recurring feature, AgencyIQ, through public data and previous analysis, determines what European medicine and device regulators will likely do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods, and more.

Regulations 40

Regulations Pharmaceuticals Production Vaccine 40

The Pharma Data

NOVEMBER 29, 2020

AstraZeneca’s COVID-19 vaccine candidate is facing another potential delay as the company plans to undertake a new global clinical trial to confirm the vaccine’s 90 percent efficacy based on a one-and-a-half-dose regimen. An additional trial could further delay AZ’s efforts to earn an EUA in the U.S., James Miessler. Source link.

Vaccine 52

Vaccine Trials FDA Clinical Trials 52

Agency IQ

MARCH 1, 2024

What we expect European regulators to do in March 2024 In this recurring feature, AgencyIQ, through public data and previous analysis, determines what European medicine and device regulators will likely do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods, and more.

Regulations 40

Regulations Biosimilars Clinical Trials Production 40

Agency IQ

MAY 31, 2024

What we expect European regulators to do in June 2024 In this recurring feature, AgencyIQ, through public data and previous analysis, determines what European medicine and device regulators will likely do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods, and more.

Regulations 40

Regulations Production Compliance Pharmaceuticals 40

Vial

DECEMBER 5, 2023

Among others, NGS has led to the identification of disease-causing variants and novel drug targets and an improved understanding of complex biological events, e.g., the heterogeneity of tumors. It has become a fundamental tool for researchers to explore the complexities of genetic information and conduct genetic-informed drug development.

Clinical Trials 52

Clinical Trials Trials RNA Bioinformatics 52

The Strateos Blog: Drug Discovery

DECEMBER 5, 2022

The Alliance fosters pre-competitive collaboration with members working together as equals on projects that will benefit the industry as a whole—whether it is identifying the root causes of inefficiencies, working with regulators to adopt new standards, or helping researchers implement AI effectively—and more!  The

Science 52

Science Clinical Trials Production Regulations 52

FDA Law Blog: Drug Discovery

DECEMBER 7, 2022

However, with this most recent approval, FDA did not leave the question of durability as something to be answered postapproval, which signals to us that this issue looms large in FDA’s preapproval regulation of gene therapies. We can see this evolution for requiring longer-term follow-up play out with this most recent approval of Hemgenix.

Therapies 119

Therapies FDA FDA Approval Treatment 119

Agency IQ

DECEMBER 1, 2023

What we expect European regulators to do in December 2023 In this new recurring feature, AgencyIQ, through public data and previous analysis, determines what European medicine and device regulators will likely do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods, and more.

Regulations 40

Regulations Clinical Trials Production Biosimilars 40

Codon

JANUARY 21, 2024

Human challenge trials were an indispensable part of the development of the malaria vaccine, R21/Matrix-M, endorsed by the World Health Organization last October. But for all of their benefits, human challenge trials have their drawbacks. Jake himself has participated in both Zika and Shigella challenge trials.

Vaccine 110

Vaccine Trials Disease Treatment 110

Drug Target Review

SEPTEMBER 25, 2024

BRAF and downstream mitogen-activated extracellular signal-regulated kinase (MEK) inhibitors are combined to treat BRAF-mutated melanoma, for example. Inhibiting KDM5A, a regulator of cell proliferation, poses another interesting approach.

Small Molecule 105

Small Molecule Therapies Regulations Treatment 105

Advarra

SEPTEMBER 23, 2022

In other words, the FDA also regulates whether investigational products may be manufactured, shipped, and administered to human subjects who participate in clinical investigations. . There are three types of amendments specified in these regulations: . The sponsor of the investigation submits an IND to the FDA; . 21 CFR 312.40(a)

Clinical Trials 52

Clinical Trials Trials FDA Regulations 52

Perficient: Drug Development

FEBRUARY 1, 2024

The SCOPE (Summit for Clinical Ops Executives) conference is a premier event in the field of clinical operations, providing a comprehensive platform for professionals to explore the latest trends and innovations in clinical research. The conference will take place on February 11-14, 2024, in Orlando, Florida. Still not registered?

Science 59

Science Clinical Research Clinical Trials Trials 59

The Pharma Data

NOVEMBER 8, 2020

FDA authorizes restart of AstraZeneca’s Covid-19 phase 3 trial. The US Food and Drug Administration (FDA) has authorized the restart of AstraZeneca ’s clinical trial for the Oxford coronavirus vaccine AZD1222 in the US, after regulators in the UK, Brazil, South Africa and Japan had already confirmed it was safe to proceed. .

Clinical Trials 40

Clinical Trials Trials FDA Vaccine 40

The Pharma Data

SEPTEMBER 23, 2020

September 23, 2020 – Johnson & Johnson (NYSE: JNJ) (the Company) today announced the launch of its large-scale, pivotal, multi-country Phase 3 trial (ENSEMBLE) for its COVID-19 vaccine candidate, JNJ-78436735, being developed by its Janssen Pharmaceutical Companies. NEW BRUNSWICK, N.J., In the U.S.,

Clinical Trials 52

Clinical Trials Vaccine Trials Pharmaceutical Companies 52

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.

Clinical Trials 40

Clinical Trials Trials Compliance FDA 40

The Pharma Data

NOVEMBER 11, 2020

LYON, France–( BUSINESS WIRE )– MaaT Pharma announced today that it treated its first patient in a Phase 1 clinical trial to evaluate the safety and tolerability of MaaT033, a capsule formulation of the company’s lead biotherapeutic, MaaT013, characterized by high microbial species diversity and richness.

Clinical Trials 52

Clinical Trials Trials Treatment Disease 52

Agency IQ

OCTOBER 27, 2023

What we expect European regulators to do in November 2023 In this new recurring feature, AgencyIQ, through public data and previous analysis, determines what European medicine and device regulators will likely do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods, and more.

Regulations 40

Regulations Pharmaceuticals Production Packaging 40

The Pharma Data

JANUARY 17, 2021

The clinical trial to evaluate the safety and efficacy of the plasma-derived medicine will have doctors Oriol Mitjà and Bonaventura Clotet as the principal researchers and is expected to begin in early 2021. BARCELONA, Spain , Jan. 18, 2021 /PRNewswire/ — Grifols (MCE: GRF, MCE: GRF.P, BARCELONA, Spain , Jan.

Clinical Trials 52

Clinical Trials Treatment Trials Virus 52

Agency IQ

APRIL 19, 2024

Meet C3TI, FDA’s new clinical trial innovation hub On April 14, FDA announced that its Center for Drug Evaluation and Research (CDER) is launching a new clinical trial innovation hub, the CDER Center for Clinical Trial Innovation (C3TI). In particular, regulations in both the U.S.

Clinical Trials 40

Clinical Trials Trials Science FDA 40

Conversations in Drug Development Trends

DECEMBER 19, 2024

At the recent World Orphan Drug Congresses (WODC) in Europe and the United States, Worldwide Clinical Trials Derek Ansel , Vice President, Therapeutic Strategy Lead, Rare Disease, facilitated roundtable discussions to explore the operational challenges and ethical barriers surrounding genetic testing.

Clinical Trials 52

Clinical Trials Regulations Drugs Trials 52

Codon

JULY 14, 2024

However, the subsequent death of another patient thrust Denys into a contentious trial. Despite the high costs, researchers in Kyoto generated enough cultured platelets in 2022 to transfuse a 55-year-old woman for an initial human trial. The results of the trial are expected at the end of 2024. Data from Rousseau G.F.

Production 133

Production Clinical Trials Trials Therapies 133

FDA Law Blog: Biosimilars

FEBRUARY 9, 2024

Lenz, Principal Medical Device Regulation Expert & Lisa M. Baumhardt, Senior Medical Device Regulation Expert — As an end of the year gift, FDA finalized its guidance document, Digital Health Technologies for Remote Data Acquisition in Clinical Investigations , in late December. By Adrienne R.

FDA 105

FDA Compliance Regulations Engineering 105