Advarra

AUGUST 8, 2024

Unacceptable risk AI systems are banned outright, while high-risk systems must comply with stringent requirements, including transparency, data governance, registration with the central competent authorities, and human oversight. Here are some key requirements for “high risk” AI systems as they relate to clinical trials.

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Codon

FEBRUARY 13, 2025

Traditionally, scientists discover enzymes in nature and adapt them through trial and error. By training PLACER on structures stored in the Protein Data Bank, the team taught the model to predict atom arrangements that follow the physical and chemical rules governing protein-small molecule interactions. Credit: Lauko A.

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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,

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The Pharma Data

AUGUST 14, 2020

The UK Government has signed a new deal with Johnson & Johnson and Novavax to secure 90 million orders of their vaccine candidates to protect against COVID-19 infection. . As part of the deal, the UK Government has the option to purchase a further 22 million doses of the vaccine if required.

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The Pharma Data

NOVEMBER 19, 2020

Russia’s Gamaleya Research Institute has reportedly resumed dosing in a phase 3 trial evaluating its COVID-19 vaccine, Sputnik V., but a Russian government spokesperson denies that the study was ever paused. Source link.

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PPD

DECEMBER 16, 2024

Cost and complexity go hand-in-hand The rising costs and growing complexity in clinical trials are deeply linked, with patient recruitment, extended timelines and meeting regulatory demands emerging as some of the key drivers. Nearly half (49%) of clinical trial sponsors surveyed identified rising costs as their foremost concern in 2024.

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The Pharma Data

OCTOBER 26, 2020

COVID-19 Vaccine Trials. 26, 2020 — Drugmakers AstraZeneca and Johnson & Johnson are ready to resume paused COVID-19 vaccine trials after health scares, CNN reported. The AstraZeneca trial was stopped in early September, and the Johnson & Johnson trial was paused earlier this month. MONDAY, Oct.

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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. The government has also enacted strict trade compliance policies that limit genetic materials, such as patient cells, leaving and entering China.

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The Pharma Data

OCTOBER 28, 2021

GOVERNMENT AN Fresh 50 MILLION PEDIATRIC Boluses OF COVID-19 VACCINE TO SUPPORT Farther PREPAREDNESS FOR FUTURE NEEDS. government has bought 50 million further boluses of the companies’COVID-19 vaccine. government has exercised its final purchase option under its beingU.S. PFIZER AND BIONTECH TO GiveU.S. With this order, theU.S.

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The Pharma Data

OCTOBER 18, 2020

UK-based contract research organization Open Orphan said it is in advanced negotiations with the British government and other partners for a human challenge trial of a COVID-19 vaccine.

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The Pharma Data

OCTOBER 15, 2020

UK-based contract research organization Open Orphan said it is in advanced negotiations with the British government and other partners for a human challenge trial of a COVID-19 vaccine.

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Conversations in Drug Development Trends

AUGUST 10, 2023

The event provided a unique opportunity to interact with a large and diverse group of fellow stakeholders, expanding my perspective on the impact of psychedelic clinical trials. Psychedelic Research at Worldwide Since 2017, Worldwide Clinical Trials have supported a myriad of sponsors leading the way in psychedelic research programs.

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The Pharma Data

SEPTEMBER 25, 2020

A trial of a new vaccine that appears to train the immune system to fight coronavirus has begun in the UK. The trial on 10,000 people will now see if the vaccine can prevent people getting ill. The trial on 10,000 people will now see if the vaccine can prevent people getting ill. Image copyright.

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ProRelix Research

JANUARY 12, 2023

In India, the Central Drugs Standard Control Organization (CDSCO) under the Directorate General of Health Services, Government of India is the National Regulatory Authority (NRA) responsible for the approval of […].

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The Pharma Data

DECEMBER 23, 2020

In the context of a substantial amount of COVID-19-related research and the launch of numerous clinical trials, the French government created this steering committee to prioritize and accelerate high potential clinical trials. This Phase IIa trial follows a preliminary study conducted by Prof.

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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).

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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. 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.,

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Conversations in Drug Development Trends

AUGUST 15, 2023

You have access to our senior leadership, enabling effective project governance. With regular governance meetings and our executive oversight, you can be confident you have the access you need, and your study gets the attention it deserves. Discover the difference we can make for your trial.

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The Pharma Data

DECEMBER 20, 2020

UK drug developer Scancell said it has chosen a COVID-19 vaccine candidate, SN14, from more than a dozen potential products to advance to a clinical trial. . In October, Scancell signed a manufacturing deal for SN14 with Cobra Biologics, a Cognate BioServices subsidiary, ahead of a planned phase 1 trial in 2021.

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The Pharma Data

SEPTEMBER 9, 2020

Global trials for AstraZeneca’s much-hyped COVID-19 vaccine, currently in development in partnership with the University of Oxford, have been halted after an unexplained illness was identified in one of the participants. In large trials illnesses will happen by chance but must be independently reviewed to check this carefully.

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The Pharma Data

SEPTEMBER 2, 2020

. Sanofi and GSK have begun a Phase I/II clinical trial testing their adjuvanted COVID-19 vaccine in healthy adults. The randomised, double blind and placebo-controlled trial is designed to evaluate the safety, reactogenicity (tolerability) and immunogenicity (immune response) of the experimental COVID-19 vaccine candidate.

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The Pharma Data

AUGUST 27, 2020

Moderna has announced that its coronavirus vaccine candidate has shown promise in generating an immune response in elderly patients in an early-stage clinical trial. . Earlier this month, the US Government announced that it would purchase 100 million doses of the Moderna vaccine in a deal worth $1.53

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The Pharma Data

AUGUST 12, 2020

Mexico aims to conduct late stage trials for coronavirus vaccines designed by US and Chinese companies. Ebrard said he hoped that trials would start between next month and January if they get approval from Mexico’s food and drug agency. Photo by Ken Kistler ([link].

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FDA Law Blog: Biosimilars

NOVEMBER 27, 2023

According to the government, these companies knew as early as 2012 that their dehumidifiers were defective, in that they could overheat and catch fire. Gree USA’s Chief Executive Officer, Charley Loh, and the Chief Administrative Officer, Simon Chu, however, did not agree to the plea deal for the corporate entity, and elected to go to trial.

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The Pharma Data

OCTOBER 27, 2020

Trial of Antibody Drug for COVID-19 Stopped for Lack of Effectiveness. National Institute of Allergy and Infectious Diseases, which sponsored the Lilly study, pulled the plug on the trial Monday — not because of any safety problem, but because there was only a slight chance that the drug would be effective. Professional.

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The Pharma Data

AUGUST 7, 2020

The governing body claims this proposal could have positive effects on mitigating burdensome requirements for gene therapy clinical trials in the future. In this light, Pharma IQ’s weekly round-up focuses on advancing therapies and clinical trials to combat Covid-19. Dr. Francis S.

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Advarra

MARCH 21, 2023

Regulations for research involving devices, in vitro diagnostics (IVDs), and digital therapeutics differ from those governing pharmaceutical development. The greater the risk, the more likely a series of trials for market clearance or approval will be required. In other words, what are the risks and benefits of the product?

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The Pharma Data

DECEMBER 16, 2020

(Nasdaq: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced an Advance Purchase Agreement with the government of New Zealand for the purchase of 10.7 NVX-CoV2373 is being evaluated in an ongoing Phase 3 trial in the U.K. and Australia. About Matrix-M.

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The Pharma Data

DECEMBER 5, 2020

.–(BUSINESS WIRE) December 5, 2020 — Syros Pharmaceuticals (NASDAQ:SYRS), a leader in the development of medicines that control the expression of genes, today announced new clinical data from its Phase 2 trial evaluating SY-1425, its first-in-class selective retinoic acid receptor alpha (RAR?)

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The Pharma Data

AUGUST 13, 2020

A trial of the English coronavirus app is getting under way. Those involved in the trial must enter a code to begin, and will then be told if they should self-isolate and for how long – based on when their symptoms started. And that means financial support needs to be provided by the government.”

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The Pharma Data

JULY 23, 2021

government has purchased an additional 200 million doses of the Pfizer-BioNTech COVID-19 Vaccine. government under its existing supply agreement to 500 million. government with 500 million doses of the companies’ COVID-19 vaccine for donation to the world’s poorest nations. This press release features multimedia. Eligible U.S.

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PPD

APRIL 30, 2024

31, 2022, the EU Clinical Trial Regulation (EU CTR) 536/2014 became applicable, heralding a new era for clinical trials in the European Union (EU). In addition, the constant evolution of EMA and Clinical Trials Coordination Group (CTCG) guidelines requires constant attention.

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Drug Patent Watch

DECEMBER 9, 2024

This includes: Preclinical studies Clinical trials Regulatory approval Manufacturing and marketing Throughout this process, pharmaceutical companies seek to protect their investments through patents. This patent was later revoked after the Indian government challenged it, citing ancient Ayurvedic texts that documented this use of turmeric.

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The Pharma Data

NOVEMBER 16, 2020

November 16, 2020 — An independent data and safety monitoring board (DSMB) overseeing the Phase 3 trial of the investigational COVID-19 vaccine known as mRNA-1273 reviewed trial data and shared its interim analysis with the trial oversight group on Nov. 37% of trial volunteers are from racial and ethnic minorities.

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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

NOVEMBER 5, 2020

Regeneron announced today an update from the independent data monitoring committee (DMC) for the United Kingdom-based RECOVERY trial evaluating REGN-COV2 in hospitalized patients with COVID-19. The DMC letter is available here: [link]. Department of Health and Human Services under OT number: HHSO100201700020C.

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The Pharma Data

SEPTEMBER 12, 2020

Food and Drug Administration to expand the enrollment of their Phase 3 pivotal COVID-19 vaccine trial to up to approximately 44,000 participants which also allows for the enrollment of new populations. The pivotal trial is event-based and there are many variables that will ultimately impact read-out timing.

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