Agency IQ

MARCH 1, 2024

Explainer: What a government shutdown would mean for the FDA (Updated) With Congress again debating the passage of appropriations legislation, the FDA is facing a potential shutdown of operations as of Midnight on March 1. What is a government shut down? If none of the 12 bills are completed, then all government operations shut down.

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The Pharma Data

SEPTEMBER 8, 2020

Government efforts to fight child obesity risk getting lost in reorganisations and delays, a report warns. Although the Department of Health and Social Care is responsible for setting and overseeing obesity policy in England, the cross-government nature of the child obesity programme means many projects are outside of its control.

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Drug Target Review

JULY 13, 2023

Dewpoint Therapeutics, a platform drug discovery company founded in 2018, has been at the forefront of this exciting field. To ensure specificity and minimise toxicity, Dewpoint has developed the condensate painting platform, which monitors the activity of small molecules against key condensates governing normal cell function.

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The Pharma Data

SEPTEMBER 10, 2020

A 2018 study published in Neurology, which analysed more than 30 years of data on US vaccines, found 119 cases of the condition in 29 men and 90 women, with half being recorded after vaccinations for hepatitis B. . It is an illness that has been associated with vaccinations before, although it is rare.

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Broad Institute

JULY 10, 2023

Prior to becoming president, she spent five years leading Harvard’s Faculty of Arts and Sciences as the Edgerley Family Dean, having served previously as dean of social science from 2015 to 2018. Gay was recruited to Harvard in 2006 as a professor of government. Cowett Professor of Government in 2015. She was named the Wilbur A.

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Common Sense for Drug Policy Blog

AUGUST 22, 2023

Drug Checking Services and Image and Performance Enhancing Drugs "The Global Commission on Drug Policy recently advised governments to make harm reduction measures, including drug checking services, widely accessible ( Bewley-Taylor & Tinasti, 2020 ; Buxton et al., 2018 ; Olsen et al., 2018 ; Olsen et al.,

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The Pharma Data

DECEMBER 17, 2020

In this study, data from the RADARS ® System’s Survey of Non-Medical Use of Prescription Drugs (NMURx) Program online cross-sectional general population national surveys are analyzed from 2018 from four countries, Germany, Italy, Spain, and the UK, with 45,000 total responses. For more information visit [link].

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Drug Channels

JUNE 9, 2020

That figure is an astonishing 23% higher than its 2018 counterpart. Medicaid rebates directly and transparently lower drug costs for the government, while 340B discounts disappear into providers’ financial statements. billion in 2019. Since 2014, purchases under the 340B program have tripled. It’s troubling and hard to defend.

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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. By David B. Clissold & Sara W.

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The Pharma Data

NOVEMBER 4, 2020

government study finds. Overall, 17% of Americans said they were following a special diet on any given day during 2017 to 2018. During 2015 to 2018, women were slightly more likely than men to say they were following a special diet. It’s hard to keep track. “About one-half of U.S.

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Advarra

DECEMBER 1, 2022

This rule was announced on June 21, 2016, with a compliance date of January 25, 2018. government to reduce “duplication of effort” in human subject protections, suggesting centralized IRB review as one way to do so. This policy change prompted many institutions to seek partnerships with external IRBs.

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Perficient: Drug Development

MARCH 26, 2024

Public Sector Regulations : Public sector bodies are mandated to comply with accessibility regulations like the Public Sector Bodies (Websites and Mobile Applications) Accessibility Regulations 2018 in the UK. Many governments and organizations require accessibility compliance as a prerequisite for procurement or business.

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The Pharma Data

APRIL 6, 2021

This announcement is an advertisement and is not a prospectus for the purposes of Regulation (EU) 2017/1129 (as amended, the “Prospectus Regulation”) or Regulation (EU) 2017/1129 as it forms part of domestic law by virtue of the European Union (Withdrawal) Act 2018 (the “UK Prospectus Regulation”).

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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. with compliance required beginning January 25, 2018. 21 st Century Cures Act.

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Advarra

JUNE 21, 2022

The best practice for growing biopharma organizations would be to fulfill this role with an experienced, part-time Acting Head of Pharmacovigilance who is integral to the safety governance model and has availability a few hours each week to oversee the medical and business aspects of the growing PV function. Safety governance model.

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The Pharma Data

SEPTEMBER 3, 2020

The world’s first gene-edited babies were born in China in November 2018. Much of the report – including a third of its recommendations – concerns governance, which is the focus of a separate genome editing project by the World Health Organization.” The committee was set up in response.

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DrugBank

OCTOBER 4, 2024

The growing middle class and government initiatives to improve access to medicines have created an ecosystem for pharmaceutical companies seeking growth opportunities. Emerging Markets Emerging markets, particularly in Asia and Latin America, have become increasingly attractive destinations for pharmaceutical M&A activity.

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Advarra

NOVEMBER 10, 2022

These notices proposed harmonization with the Health and Human Services (HHS) 2018 Common Rule (also referred to as the revised Common Rule ).?This The changes could even lead institutional review boards (IRBs) to be able to relax their requirements to distinguish between studies governed by FDA regulations versus OHRP regulations.

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The Pharma Data

APRIL 10, 2021

Chair of the Corporate Governance Committee. From 2001 through 2018 Mr. Jones was the President, Chief Executive Officer and a director of City Scene Management Company, a real estate management company. Mr. Jones is the Lead Independent Director and Corporate Governance Chair for Sempra Energy, an energy infrastructure company.

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The Pharma Data

APRIL 8, 2021

This announcement is an advertisement and is not a prospectus for the purposes of Regulation (EU) 2017/1129 (as amended, the “Prospectus Regulation”) or Regulation (EU) 2017/1129 as it forms part of domestic law by virtue of the European Union (Withdrawal) Act 2018 (the “UK Prospectus Regulation”).

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The Pharma Data

JULY 28, 2021

She will serve as Chair of the Board of Directors upon transformation of EUROAPI into a société anonyme , in compliance with applicable corporate governance regulations. She also served on the Board of Idorsia from 2018 to 2021.

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The Pharma Data

NOVEMBER 9, 2020

2018 for patients with severe asthma, without an eosinophilic phenotype. All aspects of the collaboration are under the oversight of joint governing bodies. Furthermore, Amgen’s research, testing, pricing, marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities.

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National Drug & Alcohol Research Centre Blog

JULY 13, 2021

In response to increasing concern about the personal, family, and community harms arising from methamphetamine use, the Australian government funded the National Ice Action Strategy.

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The Pharma Data

JUNE 18, 2023

This data echoes that of the 2018 Lancet Commission which described the lack of access to pain relief medication as ‘one of the most heinous, hidden inequities in global health’ with the richest 10% of countries possessing 90% of distributed morphine-equivalent opioids. “We

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Drug Target Review

APRIL 3, 2024

By actively addressing these challenges and implementing supportive measures, organisations, governments and institutions can create a more inclusive and equitable environment for women in natural sciences. She has established a track record as a successful leader and entrepreneur in the biotech industry.

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The Pharma Data

DECEMBER 14, 2020

government’s Operation Warp Speed, Moderna has been working with the National Institutes of Health’s National Institute of Allergy and Infectious Diseases (NIAID). government provided almost $1 billion for research and other preparations while agreeing to acquire 200 million doses for about $3.1 billion worth of vaccines.

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The Pharma Data

JANUARY 24, 2021

Pamer joined the University of Chicago from Memorial Sloan Kettering Cancer Center in New York City, where he served as head of the Division of Subspecialty Medicine from 2011 to 2018 and director of the Center for Microbes, Inflammation and Cancer from 2010 to 2019. For more information, visit www.orasure.com.

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Agency IQ

JULY 8, 2024

5 USC Sec 702 governs challenges to agency rules, with the statute permitting any person harmed by an agency’s action to pursue the agency in court over the specific harm. These civil suits against the government are subject to a six-year statute of limitations. Past that, a person cannot file a successful claim against the government.

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Codon

OCTOBER 13, 2024

is just over $3 billion dollars — profitable enough that the federal and Florida state government spent over $1.3 In 2018, for example, the U.S. The citrus industry in the U.S. billion between 1995 and 2006 attempting to eradicate citrus canker alone. imported $2.8 billion worth of bananas, more than any other country.

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The Pharma Data

NOVEMBER 5, 2021

Alongside the emblem, other ESG data orchestrated from different sources – similar as government agencies and monitoring and compliance companies – is used to check, for illustration, deforestation and labor conformities. Hops by Bayer, the impact investment arm of Bayer, also shared in investment rounds for Grão Direto in 2018 and 2021.

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The Pharma Data

APRIL 7, 2023

It was the first business delegation of the German government in Ukraine since the beginning of the war. The plant was inaugurated in 2018 and operates with around 100 on-site employees and about 250 to 300 seasonal workers.

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The Pharma Data

DECEMBER 21, 2020

In September 2018 , the US Food and Drug Administration granted Breakthrough Therapy Designation for tezepelumab in patients with severe asthma, without an eosinophilic phenotype. All aspects of the collaboration are under the oversight of joint governing bodies. government, Amgen could become subject to significant sanctions.

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Drug Target Review

MAY 23, 2023

The legislation governing this list is for consumer protection and also applies to algae that are intended for use as food. 2018) Chemically-Induced Production of Anti-Inflammatory Molecules in Microalgae, Marc Drugs, 16 (12), 478, [link] Aldars-Garía et al. Regulation (EU) 2017/2470 maintains this list within the novel food catalogue.

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Agency IQ

SEPTEMBER 29, 2023

Questions asked about the general strategy, data governance and secondary use of data, high-value data sets and regulatory considerations for cloud computing. Two intertwined proposals have been laid out – a regulation on data governance and the proposed data act. needs to invest in technology and infrastructure.

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Agency IQ

APRIL 8, 2024

Background: the PFAS MDL and litigation history In 2018, the South Carolina District court consolidated many cases covering PFAS contamination of local and municipal drinking water supplies into a single multi-district litigation (MDL). This includes, but is not limited to, cities in the AFFF MDL in South Carolina.

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The Pharma Data

AUGUST 5, 2020

Poster presentation at: ECTRIMS; October 2018; Berlin, Germany. Ofatumumab versus teriflunomide in relapsing multiple sclerosis: baseline characteristics of two pivotal phase 3 trials (ASCLEPIOS I and ASCLEPIOS II). Multiple sclerosis: a primer and update. Adv Studies Pharm. 2007;4(11):313-317. Multiple Sclerosis International Federation.

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PPD

DECEMBER 14, 2023

Case Study: Staffing Medical Writers Across Regions Using an FSP Model In January 2018, PPD FSP Medical Writing solutions engaged with a European pharmaceutical company to provide medical writing services using resources in the Asia-Pacific region.

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