FDA Law Blog: Biosimilars

JUNE 13, 2024

Citing to a 2004 Supreme Court case, Verizon Commc’ns., 398 (2004), Teva argued that Amneal has no cause of action under antitrust law because the Hatch-Waxman Amendments impose a new statutory duty on a company to cooperate with competitors and established a remedy for breach of that obligation. of Trinko, LLP , 540 U.S.

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SCIENMAG: Medicine & Health

JULY 12, 2023

A study examining unemployment and underemployment figures and suicide rates in Australia has found both were significant drivers of suicide mortality between 2004-2016.

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Research 71

Elrig

MARCH 25, 2025

Collaboration is key to our success in thisnovel area of drug discovery so having a dedicated forum to share our learnings is of immense value and will help drive the development of targeted oligonucleotide therapies towards the clinic faster.

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RNA Bioinformatics Pharmacokinetics Science 59

Eye on FDA

AUGUST 2, 2022

The 4 letters issued this calendar year: Involved 3 Untitled Letters and 1 Warning Letter – a profile not out of proportion given that about 33 percent of letters issued since 2004 have been Warning Letters. One of the letters came to attention of FDA reviewers through the Bad Ad Program.

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Drug Target Review

OCTOBER 5, 2023

The first instance of aHSCT in this cohort dates to 2004, and the average age of these patients at the time of treatment was 31, with a majority of them being women, accounting for 64 percent of the group.

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NIOSH Science Blog: Drugs

SEPTEMBER 25, 2024

When the Nanotechnology Research Center (NTRC) first began in 2004, one of its biggest challenges was understanding exactly what to measure and how Although this change makes the materials useful for creating new products that benefit society, their small size presents challenges to protecting worker safety and health.

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NIOSH Science Blog: Drugs

FEBRUARY 1, 2024

The National Institute for Occupational Safety and Health (NIOSH) Nanotechnology Research Center (NTRC) has taken on a global leadership role on research and guidance for nanomaterials in the workplace since the formation of NTRC in 2004 [1].

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PPD

FEBRUARY 19, 2024

The European Union Clinical Trial Regulation (EU CTR) brings the biggest change in the regulatory landscape since the implementation of the EU Clinical Trials Directive in 2004, requiring vast changes in the way organizations are structured and conduct their day-to-day activities.

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Common Sense for Drug Policy Blog

FEBRUARY 22, 2024

"Leshner and others argued that broad societal acceptance of the BDMA would deliver more effective addiction treatments that health insurers would fund and make more accessible to persons with addictions ( Volkow and Li, 2004 , Dackis and O’Brien, 2005 , Leshner, 1997 ).

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FDA Law Blog: Biosimilars

SEPTEMBER 23, 2024

FDA responded to the Citizen Petitions on February 27, 2004, and issued a Press Release on March 2, 2004 (yeah, we saved that as well) concerning the PIV List. On October 4, 2000, a second Citizen Petition (FDA Legacy Docket No. 2000P-1556) was submitted by Hyman, Phelps & McNamara, P.C.,

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Drug Target Review

JUNE 19, 2024

Mr Culley served from 2007 to 2010 as Mast’s Chief Business Officer and Senior Vice President, from 2006 to 2007 as Mast’s Senior Vice President, Business Development, and from 2004 to 2006 as Mast’s Vice President, Business Development. From 2002 until 2004, Mr Culley was Director of Business Development and Marketing for Immusol, Inc.

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Therapies Small Molecule Pharmaceutical Companies Molecular Biology 84

The Pharma Data

NOVEMBER 16, 2020

Siu Long Lee, from University College London, and colleagues evaluated the association between loneliness and depressive symptoms using data from adults aged 50 years and older in England participating in seven waves of the English Longitudinal Study of Aging (2004 to 2017; 4,211 participants).

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NIH Director's Blog: Drug Development

OCTOBER 11, 2022

2001, 40 (11), 2004–2021 [2] A stepwise huisgen cycloaddition process: Copper(I)-catalyzed regioselective “Llgation” of azides and terminal alkynes. 2004, 126 (46), 15046–15047 [5] In vivo imaging of membrane associated glycans in developing zebrafish. 2004 Jul;11(7):1009-1016. Kolb, HC, Finn, MG, Sharpless, KB.

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Drug Target Review

NOVEMBER 17, 2023

Alan founded the Monash Immunology and Stem Cell Laboratories at Monash University (2004-7). He was a pioneer of human in vitro fertilisation (IVF) (1977-1996) and led the Australian team for the discovery of human embryonic stem cells in the late 1990’s and was awarded the first Australian Biotechnology of Excellence in 2003.

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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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Broad Institute

APRIL 26, 2024

Celebrating Broad’s 20th Anniversary By Maria Nemchuk April 26, 2024 Celebrating Broad’s 20th Anniversary In 2004, the Broad Institute was founded with an ambitious goal: to leverage the newly sequenced human genome and fulfill the promise of genomic medicine.

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International Research Disease 52

Broad Institute

AUGUST 27, 2024

where she served as a director, president, and CEO prior to the acquisition of ZYCOS by MGI PHARMA in 2004. At MGI, Hedley was EVP & CSO, responsible for R&D. Prior to her role at MGI, she was a co-founder of ZYCOS Inc., Hedley is an immunologist by training and graduated with a B.S.

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Sygnature Discovery

JULY 31, 2023

Founded in 2004, the company has successfully delivered over 40 novel drug candidates into pre-clinical development and 22 into clinical trials, with its scientists named on over 170 patent applications. Its staff of over 1,000, which includes 900 scientists, partners with global pharma, biotech and NFP organisations.

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Common Sense for Drug Policy Blog

OCTOBER 22, 2024

The number of injection-related admissions increased 33% per year from 1997 and 1998 through 2003 and 2004. 8 According to the Hospital Episode Statistics for England 1997–2016, about 6% (n = 63,671) of SSTIs and vascular infections are injection related. 9 The most common causes were cutaneous abscess, phlebitis, and cellulitis.

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Hospitals Drugs 52

Drug Target Review

SEPTEMBER 21, 2023

2004) ‘An investigation of persistent microfilaridermias despite multiple treatments with ivermectin, in two onchocerciasis-endemic foci in Ghana’, Annals of Tropical Medicine & Parasitology, 98(3), pp. doi: 10.1002/14651858.CD011146.pub2. Awadzi, K et al. doi: 10.1179/000349804225003253.

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Drug Target Review

DECEMBER 28, 2023

Sergio holds a PhD from Dartmouth Medical School and from 2004 to 2010 he held a post-doctoral position at Memorial Sloan-Kettering Cancer Center. In 2016 he co-led ground-breaking research supporting the key role of clonal tumour neoantigens in the immune response to cancer; research that underpins the Achilles approach.

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Drug Target Review

JULY 4, 2023

For instance, we can compare the data from the 2021 DESTINY gastric cancer trial using the ADC Trastuzumab Deruxtecan with data from a gastric cancer trial in 2004 using the small molecule Irinotecan. In both cases, the active ingredients are camptothecin-derived topoisomerase 1 inhibitors with similar proposed modes of action.

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The Pharma Data

NOVEMBER 6, 2020

Dr. Dryman continued her employment with the company as a manager from 2001 until 2004. Dr. Dryman’s professional experience has been recognized by Marquis Who’s Who since the 2004 version of Who’s Who in America. She was promoted to assistant director by the company in 1999.

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The Pharma Data

MAY 14, 2021

Delivering Hope & Healing, Since 2004. Delivering Hope & Healing, Since 2004. He is now the director of The Integrative Medicine Center of Santa Barbara, which balances conventional medicine with alternative healing modalities to achieve optimal wellness. If you are. before using our products. If you are.

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Testimonials Medical Schools Nurses Production 52

The Pharma Data

NOVEMBER 18, 2020

Between 2004 and 2020, 57 countries implemented surveys of HIV drug resistance using WHO-recommended methods (see map below), and 17 countries have plans to conduct surveys. Map of countries implementing national HIV drug resistance surveys, 2004–2020. .

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Laboratories Virus Therapies Government 52

Perficient: Drug Development

FEBRUARY 22, 2024

Tesla set out in 2004 to become the first all-electric automobile manufacturer. Nintendo continues to differentiate itself as more family-friendly with a focus on gameplay and portability. This has allowed them to retain a successful niche within a competitive market.

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The Pharma Data

SEPTEMBER 18, 2020

In September 2004, the FDA warned the company to stop using this data to make the claims about the drug’s fewer addictive qualities. . However, the DAWN data did not prove the drug was more or less addictive but simply showed that it was abused less in certain regions.

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PLOS: DNA Science

AUGUST 17, 2023

That was the case for the approximately 250,000 bodies that the Indian Ocean tsunami in 2004 scattered about, which rapidly decayed in the hot, wet climate. But even powerful mtDNA analysis fails in some circumstances.

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DNA Disease Science Research 98

Broad Institute

AUGUST 2, 2023

The design of STAR leverages unique characteristics of the 2004 tsunami to provide plausibly-causal estimates of the ramifications of disasters and traumatic exposures. The 2004 tsunami was a massive tragedy, with waves of over 30m impacting the coastline.

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Medical Schools Disease Science International 52

Sygnature Discovery

NOVEMBER 2, 2023

Since 2004, Sygnature Discovery has delivered over 40 novel pre-clinical and 22 clinical compounds, with its scientists named on over 170 patents. Its staff of over 1,000, which includes 900 scientists, partners with global pharma, biotech and NFP organisations.

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Science Disease Drugs Marketing 52

The Pharma Data

MARCH 4, 2021

In 2004, she was appointed Global Chief Procurement Officer for all global purchases at L’Oréal, and in 2012, General Manager for Travel Retail department.

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The Pharma Data

SEPTEMBER 30, 2020

The claims about Mr McMinn surfaced in a leaked report by BMI Healthcare, which ran the hospital until June this year when Circle Health Group took it over, The Independent reported.

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FDA Law Blog: Biosimilars

AUGUST 4, 2023

Because anabolic steroids are also abused to enhance athletic performance and increase muscle strength, Congress has enacted three laws regulating anabolic steroids: the Anabolic Steroid Control Acts of 1990 and 2004, and the Designer Anabolic Steroid Control Act of 2014 (“DASCA”).

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Pharmaceutical Development Group

AUGUST 9, 2021

Biotechnology and genomics businesses were projected to perform around one-fifth of all pharmaceutical research and development in 2004. (R&D). Many pharmaceutical goods would not have been possible without the use of biotechnologies over time.

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Pharmaceuticals Pharmaceutical Companies FDA Approval Production 52

Sygnature Discovery

AUGUST 20, 2024

Since 2004, Sygnature Discovery has delivered over 40 novel pre-clinical and 25 clinical compounds, with its scientists named on over 170 patents. Additional sites are located in Alderley Park, Macclesfield, and Glasgow (UK), as well as Montreal and Quebec City (Canada).

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PLOS: DNA Science

MARCH 28, 2024

It “could have been easily repurposed for DMD,” said Pier Lorenzo Puri at Sanford Burnham Prebys Medical Discovery Institute in San Diego, who has been working on the drug development since 2004. Research also took place in two facilities in Italy, with sponsorship from Italfarmaco S.p.A.

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Sygnature Discovery

SEPTEMBER 14, 2023

Since 2004, Sygnature Discovery has delivered over 40 novel pre-clinical and 22 clinical compounds, with its scientists named on over 170 patents. Additional sites are located in Alderley Park, Macclesfield, Glasgow, Montreal and Quebec City.

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