Antidote

JULY 29, 2022

Between 2009 and 2018, U.S. The process of getting a new drug to market is an expensive one. biopharmaceutical companies spent about $1 billion per drug according to an analysis published in JAMA , and other studies have found that it can cost up to $2.8 billion to bring a new therapy to market.

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Clinical Trials Trials Therapies Pharmaceuticals 96

keypoint

SEPTEMBER 6, 2023

Established in 2009, Keystone Symposia’s Fellows Program has become a premier professional advancement opportunity for rising scientists from diverse backgrounds.

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Government Science Research 103

Science Daily: Pharmacology News

MAY 31, 2023

There's an intriguing exoplanet out there -- 400 light-years out there -- that is so tantalizing that astronomers have been studying it since its discovery in 2009. One orbit for WASP-18 b around its star that is slightly larger than our Sun takes just 23 hours. There is nothing like it in our Solar System.

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biobide

AUGUST 18, 2023

In 2009 this ban was expanded to include a ban on the use of any ingredient tested on animals for cosmetic products. With an increased focus on animal welfare , the beauty industry has undergone a shift towards the 3Rs Principle application and all surrounding regulations.

Regulations 92

Regulations Animal Testing Production Treatment 92

keypoint

SEPTEMBER 11, 2024

Established in 2009, the Fellows Program has become a highly competitive premier professional advancement opportunity for rising scientists, providing support tailored to meet the unique challenges at these pivotal career stages.

Science 67

Science Research 67

Eye on FDA

OCTOBER 19, 2022

And FDA made tacit acknowledgement of the fact when it held a public Part 15 meeting in April 2009 to put forth a framework for the discussion of regulating social and digital media, with the aim of developing a guidance related to the unique challenges offered up by new media shortly thereafter. In fact, the medium does matter.

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FDA Regulations Research Production 89

Drug Target Review

FEBRUARY 9, 2024

Dr Scheer earned his medical degree from New York Medical College and subsequently completed his Surgical internship at Mount Sinai Beth Israel, followed by training in neurological surgery at the Albert Einstein College of Medicine until 2009.

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Therapies Immune Response Clinical Trials Treatment 105

The Pharma Data

NOVEMBER 10, 2020

10, 2020 — Even before the coronavirus pandemic began, Americans were already suffering: A new study reports that alcohol and drug misuse were up dramatically, and suicidal thoughts and behaviors were up 170% between 2009 and… Source link. TUESDAY, Nov.

Disease 52

Disease Drugs 52

FDA Law Blog: Biosimilars

FEBRUARY 26, 2024

This of course, make sense—after decades of experience implementing the Hatch-Waxman, Congress and FDA had learned a few new tricks by 2009/2010. FDA replied that its definition of strength including concentration was clear even in 2009. mg) and the concentration (e.g., mg/mL) for liquid parenteral drug products.

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FDA Biosimilars Production Regulations 59

Eye on FDA

JANUARY 26, 2022

Here are a few other facts to put this letter into context: This one, as was the last one , is an Untitled Letter, considered the less serious of the two types of letters sent out by OPDP; The product involved was one for diabetes, one of 7 letters issued since 2003 by OPDP regarding a diabetes product covering 10 different communications vehicles (..)

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FDA Production Drugs Disease 108

thought leadership

JULY 2, 2024

In this respect, a clinical trial with a GMO must also comply with either the contained use Directive (2009/41/EC) or the deliberate release Directive (2001/18/EC). The Directive that actually applies to a clinical trial with GMOs is dependent upon the individual Member States (MS) (see Figure 1).

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Therapies Trials Clinical Trials Regulations 52

The Pharma Data

DECEMBER 3, 2020

Shivani Bakre, from the University of Michigan in Ann Arbor, and colleagues conducted a retrospective cohort study involving 135,152 Medicare beneficiaries on long-term dialysis between 2009 and 2016. Trends in alignment to an ACO were compared to those of the general Medicare population.

Research 52

Research Disease 52

Eye on FDA

SEPTEMBER 28, 2022

Given the 2009 framework for addressing the regulatory issues associated with digital and social communications and the huge migration by consumers to those platforms and the vigorous use of the Internet in health-seeking information, it would make sense for the research to follow suit.

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Research Pharmaceutical Companies FDA Production 69

Perficient: Drug Development

JULY 3, 2023

Behind the Award The Best Places to Work program was created back in 2009 and is a project of the Orange County Business Journal in partnership with Workforce Research Group, a third-party survey administrator. This program was designed to identify, recognize and honor the best places of employment in Orange County, California.

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Research 96

Broad Institute

AUGUST 11, 2023

When the Broad Institute became independent in 2009, she established the Broad’s animal research program and human subjects compliance office, and helped establish the Broad’s CLIA lab, where she serves as a key staff member.

Bioethics 52

Bioethics Compliance Science Research 52

The Pharma Data

AUGUST 20, 2020

Our commitment to the MS community stems all the way back to our initial investment in 2009 to bring a first generic Copaxone to market, which we achieved in 2017,” commented Mylan President Rajiv Malik. Mylan was quick to celebrate the decision and what it means for MS patients, though no information on the price of the drug was forthcoming.

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FDA Approval FDA Treatment Production 52

Perficient: Drug Development

JULY 31, 2024

Behind the Award The Best Places to Work program was created in 2009 by the Orange County Business Journal , in partnership with Workforce Research Group, to identify, recognize and honor the best places to work in Orange County, California.

Research 52

Research 52

The Pharma Data

OCTOBER 23, 2020

A leader in his field, Mr. Johnson has served as the president and the chief executive officer of the Parenteral Drug Association since 2009. Factors such as position, noteworthy accomplishments, visibility, and prominence in a field are all taken into account during the selection process.

Pharmaceuticals 52

Pharmaceuticals International Engineering Science 52

The Pharma Data

DECEMBER 22, 2020

from the University of Mississippi in Jackson, and colleagues explored the association between goal-striving stress (GSS) and RKFD among 2,630 African Americans using data from the Jackson Heart Study (2000 to 2004 and 2009 to 2013). Loretta Cain-Shields, Ph.D., The researchers found that the incidence of RKFD in this sample was 7.34

Disease 52

Disease Research 52

The Pharma Data

SEPTEMBER 30, 2020

billion in revenue in 2009 as the H1N1 flu spread. . This led Jefferson to file a suit under the US False Claims Act, alleging that Roche had falsely claimed Tamiflu’s benefit which led to the US Government spending $1.5 billion on stockpiling the drug. The act allows individuals to bring claims on behalf of the government.

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Government Trials Disease Production 52

The Pharma Data

MARCH 13, 2021

Between 2005 and 2009, she worked as an Assistant Professor in the Electrical and Computer Engineering Department of the University of Illinois Urbana-Champaign, and as an Assistant Professor of Computer Science at Princeton University. He became CEO in 1999 and then took on the additional role of Chairman two years later.

International 52

International Engineering Science Marketing 52

Eye on FDA

JANUARY 9, 2022

Back in 2009 you may recall that FDA issued 45 Untitled Letters aimed at 14 companies regarding the use of banner ads/sponsored links where clearly benefits of a branded product were available, but risk information only ascertainable by clicking on a link. in November 2009. The Substance: What triggered the enforcement actions?

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FDA Pharma Companies Pharmaceutical Companies Treatment 64

The Pharma Data

JANUARY 12, 2021

percent during 2009 through 2013 to 5.5 For the four leading cancers, long-term declines in mortality have ceased for prostate cancer, slowed for breast and colorectal cancers, and accelerated for lung cancer, which accounted for almost 50 percent of the decrease in total mortality from 2014 to 2018. percent for women, and from 2.4

Treatment 52

Treatment Research 52

The Pharma Data

AUGUST 21, 2020

The US regulator originally approved the drug in 2009 for the treatment of chronic lymphocytic leukaemia as an intravenous infusion with a high dose that was administered by a healthcare provider. Kesimpta targets and delivers B-cell therapy and has shown to have superior efficacy and safety profile compared to similar treatments.

FDA Approval 52

FDA Approval Disease FDA Drugs 52

Broad Institute

OCTOBER 17, 2023

Deik moved to the Broad in 2009 and joined Clish as a biochemist in the Platform, where she also serves as lab manager. In this #WhyIScience, we spoke with Deik about metabolomics (the large-scale systematic study of metabolites) and the intersectionality of being a woman of faith and a scientist.

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Research Small Molecule Science Disease 98

LifeSciVC

NOVEMBER 30, 2023

A much bigger drop happened in the Great Financial Crisis, where we saw a net reduction of nearly 20% of the public biotech arena between 2007-2009. A hangover from an overly euphoric technology bubble is very different, perhaps, than the contagion of a financial system meltdown, at least in terms of driving biotechs to disappear.

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Marketing Government Production 107

The Pharma Data

DECEMBER 10, 2020

from the Council of State and Territorial Epidemiologists in Atlanta, and colleagues examined the prevalence of COVID-19 deaths in the AI/AN population in light of disproportionate mortality experienced during the 2009 influenza A(H1N1) pandemic. Jessica Arrazola, Dr.P.H., times that among White persons (55.8 deaths per 100,000).

Disease 52

Disease Research 52

The Pharma Data

DECEMBER 7, 2020

based clinical trials investigating interventions for high blood pressure between 2009-2018, just 52 were exclusively in Black people. While the numbers grew over that decade – from 3.9% (3 of 77 trials) in 2009 to 6.2% (9 of 146) in 2018 – the increase was not enough to be statistically significant.

Treatment 52

Treatment Clinical Trials Trials Doctors 52

The Pharma Data

OCTOBER 26, 2020

from the Brown University School of Public Health in Providence, Rhode Island, and colleagues examined linked Medicare claims (2009 through 2016) with nursing home and home health assessment data from all U.S. MONDAY, Oct. 22 in JAMA Network Open. Momotazur Rahman, Ph.D.,

Nurses 52

Nurses Disease Hospitals Research 52

FDA Law Blog: Biosimilars

JANUARY 15, 2024

This story goes back to the 2009 Family Smoking Prevention and Tobacco Control Act, which prohibits manufacturers from selling any “new tobacco product” without authorization from FDA.

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FDA Production Regulations Marketing 115

Common Sense for Drug Policy Blog

AUGUST 22, 2023

The risk environments framework provides a theoretical foundation for doing so ( Rhodes, 2002 ), emphasising the importance of enabling contexts and resources in advancing harm reduction ( Duff, 2009 , 2011 ). Substance use, including AAS, is influenced by various interacting factors within a social context.

Drugs 52

Drugs 52

The Pharma Data

JANUARY 20, 2021

children and teens with type 2 diabetes increased by 30% between 2001 and 2009, with cases growing among youth aged 10 and older. . “The condition occurs when the body stops making the hormone insulin,” Eapen explained in a Hackensack Meridian Health news release. The number of U.S.

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Doctors Hospitals Treatment Disease 52

The Pharma Data

SEPTEMBER 30, 2020

Between 2009 and 2018, there were only 34 infections reported in the US. The Lake Jackson area has 27,000 residents, and Baker said that an investigation will be conducted to assess if there are any other places where unfiltered water could be entering the water system and potentially spreading the amoeba. .

Disease 52

Disease 52

Drug Target Review

OCTOBER 17, 2024

While its involvement in the do-not-eat-me signal from cancer has inspired therapeutic development of this pathway for oncology, the function of the innate immune checkpoint we identified in 2009 1 extends to both innate and adaptive immune responses. 2009 Mar 5;323(5922):1722–5. References Chen GY., Tang J, Zheng P, Liu Y.

Immune Response 52

Immune Response Clinical Trials Trials Therapies 52

FDA Law Blog: Biosimilars

OCTOBER 24, 2023

Previous iterations of this guidance from 2009 and 2014 (blogged on here and here ) were known as Good Reprint Practices (GRP).

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FDA Clinical Trials Trials Government 64

On Medicine

JULY 21, 2023

It prioritizes establishing a supportive alliance, exploring their narrative, and formulating a shared understanding of their self-harm.

Nurses 65

Nurses Trials Research Treatment 65

Common Sense for Drug Policy Blog

JUNE 4, 2023

2009 ; Krupski et al., Problematic drug use among this population has been extensively documented in the scientific literature (O'Flaherty et al., 2018 ; Paudyal et al., 2017 ; Van den Bree et al., 2015 ; Linton et al., 2013 ; Narendorf et al., 2018 ; Johnson & Chamberlain, 2008 ; Krupski et al.,

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Drugs 40