The Pharma Data

AUGUST 31, 2020

Johnson & Johnson Announces Agreement in Principle with Government of Canada to Supply its COVID-19 Vaccine Candidate. Johnson & Johnson Announces Agreement in Principle with Government of Canada to Supply its COVID-19 Vaccine Candidate. The Phase 1/2a first-in-human clinical trial of the vaccine candidate, Ad26.COV2.S,

Government 52

Government Vaccine Pharmaceutical Companies Clinical Trials 52

The Pharma Data

OCTOBER 15, 2020

Moderna is working with international regulators to accelerate approval of the company’s coronavirus disease 2019 (COVID-19) vaccine candidate, mRNA-1273, which is currently leading the global COVID-19 vaccine race alongside vaccine candidates from AstraZeneca, Pfizer and Johnson & Johnson. The Cambridge, Mass.-based In the U.S.,

Vaccine 52

Vaccine International Regulations Trials 52

The Pharma Data

AUGUST 5, 2020

Government for 100 Million Doses of Investigational COVID-19 Vaccine. Government for 100 Million Doses of Investigational COVID-19 Vaccine. Company working to ensure broad global access to COVID-19 vaccine candidate, following approval from regulators. government may also purchase an additional 200 million doses of Ad26.COV2.S

Government 52

Government Vaccine Pharmaceutical Companies Pharmaceuticals 52

Advarra

MARCH 21, 2023

Regulations for research involving devices, in vitro diagnostics (IVDs), and digital therapeutics differ from those governing pharmaceutical development. Interpreting evolving regulations for these devices is often a unique challenge for emerging biotech companies. In other words, what are the risks and benefits of the product?

Clinical Trials 52

Clinical Trials Trials Production Regulations 52

Agency IQ

APRIL 12, 2024

Landscape analysis: A look at the regulation of decentralized trials and what’s coming soon In the past few years, regulators and researchers have shown increased interest in leveraging decentralized trial methods – especially following the pandemic.

Regulations 40

Regulations Trials Clinical Trials Science 40

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

Agency IQ

JANUARY 12, 2024

device regulation timelines To kick off 2024, the British device regulator offered its medical device and IVD plans for this year and next, promising public action on the post-market surveillance regulation by mid-2024 and on the core regulations in late 2024 or early 2025. New roadmap sets out U.K.

Regulations 40

Regulations Government Compliance International 40

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.

Clinical Trials 52

Clinical Trials Trials Treatment Hospitals 52

FDA Law Blog: Biosimilars

JANUARY 15, 2024

Koblitz — You know a court decision is going to be worth reading when the judges compare FDA’s regulatory governance of flavored e-cigarettes to a Shakespearean gaslighting. Let’s just say, the smackdown—er, decision—eviscerates FDA’s approach to regulating flavored e-cigarettes. By David B. Clissold & Sara W.

FDA 115

FDA Production Marketing Regulations 115

The Pharma Data

MARCH 15, 2021

This involves conducting clinical trials in humans to evaluate the safety and efficacy of new pharmaceutical products. Food and Drug Administration (FDA), as well as those in many other countries, use the data gathered in these trials to determine whether or not to approve the drug for use in their countries. new medicines.

Clinical Trials 40

Clinical Trials Trials Clinical Development Clinical Research 40

Advarra

SEPTEMBER 14, 2023

In the clinical research space, GxP is a set of quality regulations and guidelines designed to establish the safety, efficacy, and integrity of pharmaceuticals, medical devices, and clinical trials. This blog explores key concepts, regulations, and the importance of GxP in delivering successful clinical trials.

Clinical Research 52

Clinical Research Research Compliance Clinical Trials 52

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

The Pharma Data

AUGUST 5, 2020

Company working to ensure broad global access to COVID-19 vaccine candidate, following approval from regulators. government for the large scale domestic manufacturing and delivery in the U.S. government may also purchase an additional 200 million doses of Ad26.COV2.S NEW BRUNSWICK, N.J., S under a subsequent agreement.

Government 40

Government Vaccine Pharmaceutical Companies Pharmaceuticals 40

Agency IQ

MAY 28, 2024

regulator lays out proposal for international device and diagnostics recognition The British medical device regulator just issued its promised framework on international recognition. law as the Medical Devices Regulation 2002 (UK MDR 2002). law as the Medical Devices Regulation 2002 (UK MDR 2002).

International 40

International Regulations Licensing Licensing 40

FDA Law Blog: Biosimilars

JULY 8, 2024

The court ruled that the Securities and Exchange Commission (SEC) may not impose fines to penalize securities in its administrative proceedings because that practice violates the Seventh Amendment “right of trial by jury” in all “suits at common law.” Here are some brief facts of the case. This did not end the analysis, however.

Government 59

Government Trials FDA Clinical Trials 59

Advarra

DECEMBER 1, 2022

In the past several years, Health and Human Services (HHS) Office of Human Research Protections (OHRP), the Food and Drug Administration (FDA), and the National Institutes of Health (NIH) have announced and/or implemented new regulations to address the challenges of conducting clinical trials involving multiple research sites.

Regulations 52

Regulations Compliance FDA Clinical Trials 52

FDA Law Blog: Biosimilars

MARCH 22, 2023

When an ambiguous law or regulation is presented to a court, it is the court’s job to decide what it means, no matter how ambiguous or inartful the provision may be. That commentary does not typically focus on the stakes for a defendant that believes it was right, goes to trial and loses.

Government 59

Government Trials Regulations 59

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.

Clinical Trials 52

Clinical Trials Regulations FDA Trials 52

The Pharma Data

NOVEMBER 9, 2020

Trial Also Met the Primary Endpoint in Patients With Low Levels of Eosinophils. In the subgroup of patients with baseline eosinophil counts less than 300 cells per microliter, the trial met the primary endpoint with tezepelumab demonstrating a statistically significant and clinically meaningful reduction in AAER.

Trials 52

Trials Production Clinical Trials Government 52

The Pharma Data

AUGUST 20, 2020

Poor regulation of antibodies tests – that could indicate if someone has had coronavirus – could be putting the public at risk, doctors have warned. “These regulations aren’t fit for purpose and don’t protect the public from bad tests,” he said. Image copyright. Getty Images.

Clinical Trials 52

Clinical Trials Regulations Doctors Government 52

The Pharma Data

JANUARY 13, 2021

Fast Track designation is well-timed, as we anticipate starting our Phase 2 clinical trial in hospitalized COVID-19 patients this month, and should help bring Brilacidin to patients faster in these dire times.”. Brilacidin, a versatile compound with broad therapeutic potential, is in a new chemical class called defensin-mimetics.

Clinical Trials 52

Clinical Trials Trials Treatment Pharmaceuticals 52

Advarra

NOVEMBER 10, 2022

The proposal “Protection of Human Subjects and Institutional Review Boards” would revise 21 CFR Part 50 and harmonize the FDA regulations to match the 2018 revised Common Rule across several inconsistent areas, including informed consent and continuing review. . Again, this is similar to what HHS regulations currently permit. .

Regulations 52

Regulations FDA Research Trials 52

Vial

DECEMBER 4, 2023

This change in perception may be largely attributable to the evolution of regulations and guidelines that govern clinical research. The Current Role and Impact of Patient Payments In the current landscape of clinical research, patient payments and incentives play a critical role in encouraging participation in clinical trials.

Clinical Research 52

Clinical Research Research Clinical Trials Regulations 52

The Pharma Data

DECEMBER 30, 2020

This regimen was shown in clinical trials to be safe and effective at preventing symptomatic COVID-19, with no severe cases and no hospitalisations more than 14 days after the second dose. The Company aims to supply millions of doses in the first quarter as part of an agreement with the government to supply up to 100 million doses in total.

Vaccine 52

Vaccine Clinical Trials Virus Trials 52

The Pharma Data

SEPTEMBER 23, 2020

First participants dosed in Phase 3 trial (ENSEMBLE) evaluating safety and efficacy of Janssen’s COVID-19 vaccine candidate, JNJ-78436735, also known as Ad26.COV2.S. We are committed to clinical trial transparency and to sharing information related to our study, including details of our study protocol.” NEW BRUNSWICK, N.J.

Clinical Trials 40

Clinical Trials Vaccine Trials Pharmaceutical Companies 40

The Pharma Data

JANUARY 17, 2021

By running multi-trial centre studies for our Phase IIa studies, we ensure that we have sufficient numbers to complete the trials more efficiently than if we ran the trials in Australia, alone. “By We look forward to a potential collaboration with the clinical trial investigators from this reputable institution.”.

Therapies 52

Therapies Clinical Trials Trials Hospitals 52

Vial

FEBRUARY 15, 2024

Clinical trials play a crucial role in advancing medical breakthroughs, but effective management is essential to unlock their full potential. Pharmaceutical companies often face challenges in conducting clinical trials due to the need for substantial knowledge, time, and resources. over the forecast period (2022-2030).

Pharma Companies 52

Pharma Companies Clinical Trials Compliance Trials 52

The Pharma Data

DECEMBER 30, 2020

The British government also decided to start giving as many people as possible a first dose of vaccines, rather than keeping supplies for second shots, expanding the number of people who will be vaccinated. Some people in clinical trials of the Oxford-AstraZeneca vaccine were given the two doses several months apart. WEDNESDAY, Dec.

Vaccine 52

Vaccine Clinical Trials Government Regulations 52

The Pharma Data

MAY 27, 2022

federal government spent an estimated $1.8 The FDA approves around 50 new drugs each year after clinical trials and data analyses demonstrate a drug’s safety and effectiveness. Under the program, drug companies are then required to demonstrate the drug’s clinical benefit through a confirmatory trial.

Clinical Trials 52

Clinical Trials Drugs FDA Government 52

The Pharma Data

MAY 4, 2021

. Big three drug distributors blame doctors, regulators in trial over opioid epidemic ( Reuters ). EU regulator begins real-time review of first Chinese COVID-19 vaccine ( Reuters ) ( EMA ). 2 respecting clinical trials for medical devices and drugs relating to COVID-19: Notice ( Health Canada ).

Vaccine 52

Vaccine FDA Approval FDA Licensing 52

Advarra

SEPTEMBER 20, 2023

Clinical trials receive a lot of oversight from regulatory agencies, as well as independent committees reviewing different aspects of the trial. Each committee plays an important role in providing trial oversight. DMCs are strenuously recommended for certain clinical trials by both U.S. What Is an Independent DMC?

Clinical Trials 52

Clinical Trials Trials FDA Regulations 52

FDA Law Blog: Biosimilars

OCTOBER 7, 2024

Constitution’s Seventh Amendment right to a jury trial. At the time we posted about the Jarkesy decision, we predicted that it would impact FDA-regulated industry: The impact on FDA matters could be significant. Bringing an administrative claim is typically much less demanding in time and resources than litigating a jury trial.

FDA 59

FDA Trials Clinical Trials Production 59

The Pharma Data

DECEMBER 21, 2020

21, 2020 /PRNewswire/ — Amgen (NASDAQ:AMGN) and AstraZeneca today announced the SOURCE trial did not meet the primary endpoint of a statistically significant reduction in the daily oral corticosteroid (OCS) dose, without loss of asthma control, with tezepelumab compared to placebo. THOUSAND OAKS, Calif. ,

Trials 40

Trials Production Clinical Trials Therapies 40

The Pharma Data

DECEMBER 9, 2020

We are delighted with our progress and anticipate that data from this trial will yield important insights that will be applied to our planned Phase 2b clinical trial, which is scheduled to begin in 2021.” In parallel with the completion of this dosing cohort, we have now dosed the first NASH patient in the 225 mg cohort.

Clinical Trials 40

Clinical Trials Trials Pharmaceuticals Pharmacokinetics 40

Advarra

SEPTEMBER 7, 2023

Together, these three principles form the foundation upon which HRPPs were established and provide the basis for laws, regulations, guidelines, and policies governing human subjects research. Typically, this is the office of sponsored programs or a clinical trials office.

Research 52

Research Clinical Trials Compliance Regulations 52

The Pharma Data

JUNE 17, 2022

In a Phase 2/3 clinical trial, the Pfizer-BioNTech COVID-19 Vaccine elicited a strong immune response in this age group Three 3-µg doses had favorable safety profile similar to placebo in young children ages 6 months through 4 years in Phase 2/3 clinical trial Pfizer-BioNTech COVID-19 Vaccine now authorized in the U.S. government.

Vaccine 52

Vaccine FDA Clinical Trials Immune Response 52

Drug Patent Watch

JANUARY 9, 2025

Are you in early-stage clinical trials, or are you gearing up for commercial launch? A: First, try to address issues through open communication and your established governance structure. Q: How can I ensure my CDMO is staying compliant with evolving regulations? Your timeline will significantly impact your CDMO requirements.

Compliance 52

Compliance Drug Development Therapies Pharma Companies 52