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 125

SCIENMAG: Medicine & Health

AUGUST 31, 2023

Since 2009, the number of veterans experiencing homelessness across the United States has shrunk by more than 50%, according to a 2022 Department of Housing report.

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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 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 84

Science Research 84

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.

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Regulations Animal Testing Production Treatment 92

New Drug Approvals

JUNE 11, 2025

5] It was submitted for the preregistration (NDA) phase again in May 2007 after adding additional information from clinical trials as the FDA required in 2009. Schatzberg AF, Nemeroff CB (2009). The FDA rejected approval for gepirone in 2002 and 2004. [5] National Institute of Child Health and Human Development. PMID 37856644.

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FDA FDA Approval Treatment Clinical Trials 62

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

JUNE 17, 2025

In 2009, he won the annual Illumina Innovation Award for the development of RTA, the on-instrument real-time primary analysis software for sequencing. Francisco’s experience includes almost 19 years at Illumina, most recently as Vice President of Software Engineering and Embedded Systems.

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FDA Law Blog: Biosimilars

MARCH 7, 2024

Sasinowski — In 2009 — 15 years ago — the National Organization for Rare Disorders (NORD) announced the first U.S. In 2009 I served as Chair of NORD and through the hard work of countless colleagues we inaugurated the first Rare Disease Day. By Frank J. recognition of Rare Disease Day.

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Disease Government FDA Drugs 69

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.

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Disease Drugs 52

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

New Drug Approvals

MAY 9, 2025

2] [4] Pharmacology Pharmacodynamics Elacestrant is an antiestrogen that acts as an antagonist of estrogen receptors , specifically targeting the estrogen receptor alpha (ER), which is the biological target of endogenous estrogens like estradiol. [1] 1] [8] Pharmacokinetics Elacestrant has an oral bioavailability of approximately 10%. [1]

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FDA Pharmacokinetics Therapies Treatment 62

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.

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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

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

Drug Patent Watch

JANUARY 14, 2025

Lessons from Past Pharmaceutical Negotiations Case Study: Merck and Schering-Plough Merger The 2009 merger between Merck and Schering-Plough, valued at $41.1 These may include: Pharmaceutical companies (big pharma and biotech firms) Contract research organizations (CROs) Regulatory bodies (e.g.,

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Pharmaceuticals Compliance Licensing Licensing 53

Common Sense for Drug Policy Blog

SEPTEMBER 8, 2023

When examining the historical trends of annual prevalence, we found a declining trend in reports of drug seizure from 7% in 2009 to 3% in 2012, while the prevalence between June 2019 and mid-March 2020 and between June and November of 2021 (4–5%) remained essentially the same as the annual prevalence in 2011–2012.

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Drugs Marketing 52

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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Common Sense for Drug Policy Blog

SEPTEMBER 8, 2023

In 2009–2012, 67.8% Odds of drug seizure were not significantly different between the two time periods (2019–2021 vs. 2009–2012) (AOR: 0.93; 95% CI: 0.64–1.35)." In multivariable analyses, factors significantly associated with drug seizure included: homelessness (adjusted odds ratio [AOR]: 1.98; 95% confidence interval [CI] 1.09–3.61),

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Drugs Marketing 40

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.

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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

Drug Target Review

NOVEMBER 7, 2024

References 1 Tinoco R, Otero DC, Takahashi AA, Bradley LM. PSGL-1: a new player in the immune checkpoint landscape. Trends in immunology , 38(5), 323-335. 2 Carlow DA, Gossens K, Naus S, et al. PSGL‐1 function in immunity and steady state homeostasis. Immunological reviews , 230(1), 75-96. 3 Aslam N, Lo SW, Sikafi R, et al.

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Disease Immune Response Regulations Engineering 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

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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.

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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

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.

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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

Elrig

APRIL 7, 2025

In 2009, heco-founded the European arm of Essen BioScience, playing a pivotal role in developing industrial-scale, live-cell imaging technology for drug discovery. With over30 years experiencein academic, biotech, and biopharma settings, Dr Trezise brings a wealth of expertise to ELRIG.

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Assay Development Laboratories Science Drugs 59

Drugs.com

MAY 5, 2025

children have died from the flu this season than in any year since the 2009 swine flu pandemic, according to a new federal report.So MONDAY, May 5, 2025 More U.S. far, 216 pediatric deaths have been reported to the U.S. Centers for Disease C.

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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

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.

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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