STAT

MAY 2, 2024

Back in 2004, Gilead explained its decision by maintaining the medicines were not sufficiently different, but internal documents produced in court suggested the company made this move in order to maximize profits.

Documentation 129

Documentation 129

Blog: Ask a Student Pharmacist

OCTOBER 4, 2023

Minneceutics Newsletter eomizowh Wed, 10/04/2023 - 12:47 Current Newsletter Expand all + Archive 1993 1994 1995 1999 2000 2001 2002 2003 2004 2006 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021

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STAT

JULY 10, 2023

A district manager for a convenience store chain, he first noticed symptoms in 2004 when his voice would suddenly falter while speaking to large groups of employees. It took Richard Huckabee nine years to get a Parkinson’s diagnosis. “It’s probably just stress,” Huckabee remembered his doctor saying.

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STAT

DECEMBER 1, 2023

between 2004 and 2020 found that those who had cranial surgery, which involves removing or disconnecting the brain portion where seizures occur, were 83% more likely to be alive after 10 years. The study of 18,000 children who were treated at 49 pediatric hospitals in the U.S.

Insurance 132

Insurance Hospitals 132

STAT

NOVEMBER 15, 2023

Between 2004 and 2021, a U.S. Food and Drug Administration were more frequently invalidated due to information misrepresented or withheld from patent examiners than any other industry sector, according to a new analysis.

FDA 125

FDA 125

STAT

DECEMBER 2, 2022

In 2004, Mike Rossner and Kenneth Yamada, two top editors at the Journal of Cell Biology, wrote an editorial alerting readers to what they saw as an emerging problem in science: Thanks to Photoshop, researchers could prettify the images in their manuscripts in ways that might cross the line into deception in an effort to clear the bar of peer review. (..)

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112

STAT

DECEMBER 7, 2023

Celgene later submitted study data to the Food and Drug Administration in its application for regulatory approval, but did not simultaneously seek additional patents on these other forms for another five years — in 2004.

FDA 125

FDA Compounding Pharmaceutical Companies Pharmaceutical Companies 125

STAT

MARCH 30, 2023

Since 2004, Barnes has been running the Minority Aging Research Study, one of the nation’s largest studies of Alzheimer’s focused exclusively on Black people and has created a brain bank used by other researchers to understand the illness in this population.

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STAT

SEPTEMBER 3, 2024

Between 1998 and 2004, the five-year survival rate for the disease has increased from 33% to 61%, according to the MMRF. The group has raised more than $600 million for research, launched nearly 100 clinical trials, and helped bring more than 15 new drugs to market.

Insurance 145

Insurance 145

STAT

FEBRUARY 21, 2023

billion worth of Humira in the Netherlands between 2004 and 2018, when its patents provided a monopoly. In making its case, the Pharmaceutical Accountability Foundation argued AbbVie allegedly overcharged the Dutch health care system by up to $1.2 billion by “abusing” its position in the marketplace and keeping prices high.

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96

Pharmafile

MARCH 13, 2023

Gilead set up the Advancing Access medication assistance programme (MAP) in 2004 which aimed to provide eligible, uninsured people with free medication to protect them from contracting HIV. read more

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European Pharmaceutical Review

JULY 4, 2024

4,6 Traditional Herbal Registration The Traditional Herbal Medicines Directive (Directive 2004/24/EC) is implemented in the UK by the Medicines (Traditional Herbal Medicinal Products for Human Use) Regulations 2005 and came into force on 30 April 2011. 13 Currently, over 350 herbal remedies have been granted a THR licence. 2012/1916).

FDA 103

FDA Documentation Compounding Pharmaceutical Companies 103

The FDA Law Blog

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.

Dosage 113

Dosage FDA 113

European Pharmaceutical Review

AUGUST 11, 2023

Novartis said the decision to revoke the authorisation was based on a review of crizanlizumab under Article 20 of Regulation (EC) No 726/2004. If new data show that the medicine’s benefits no longer outweigh its risks, EMA can take regulatory action, such as suspending or revoking the marketing authorisation.

FDA 98

FDA 98

Hospital Pharmacy Europe

JANUARY 26, 2023

In the present study, researchers undertook a cohort study, including patients aged 18 years and older who were prescribed hydroxychloroquine between 2004 and 2020 and who participated in retinal screening. female) were included and who had used the drug between 2004 and 2014 and then continued for a further 5 years. Overall, 65.4%

Hospitals 52

Hospitals 52

STAT

MAY 3, 2024

Back in 2004, Gilead explained its decision by maintaining the medicines were not sufficiently different, but internal documents produced in court suggested the company made this move in order to maximize profits.

Documentation 101

Documentation 101

The FDA Law Blog

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.,

FDA 57

FDA Dosage 57

European Pharmaceutical Review

JULY 10, 2023

The assessment report of the Committee for Medicinal Products for Human Use (CHMP)’s Article 5(3) of Regulation (EC) No 726/2004 opinion on nitrosamine impurities in human medicinal products offers guidance and recommendations on mitigation and prevention of nitrosamine-contaminated human medicinal products.

Documentation 98

Documentation FDA 98

European Pharmaceutical Review

APRIL 14, 2023

stated that between 2004 and 2021, 23 NA therapeutics were approved. Gene therapy has offered exciting treatment opportunities for numerous severe and rare diseases that currently have no cure, the researchers noted. The current NA dosage forms and novel DDSs have enabled the successful launch of NA therapeutics globally. Ingle et al.

Dosage 105

Dosage Vaccines 105

pharmaphorum

MARCH 5, 2021

After studying engineering at Cambridge University, Boyle founded Owlstone Inc in 2004 with a focus on sensor technology for military and industrial applications. It could help diagnose a huge range of diseases, including lung, bladder and breast cancer.

Compounding 98

Compounding 98

STAT

FEBRUARY 15, 2024

An older version was approved in 2004 to treat pulmonary arterial hypertension, from a company now owned by Johnson & Johnson. The agency approved an Eicos Sciences intravenous drug, which works by opening up blood vessels, for reducing the risk of amputation for frostbitten fingers and toes.

Nursing Homes 78

Nursing Homes Hospitals 78

Hospital Pharmacy Europe

FEBRUARY 19, 2023

In addition to hospital admissions data, the team also collected information on COPD and asthma-related medicines prescribed between 2004 and 2020. increase the absolute number of COPD and asthma-related dispensed medicines between 2004 and 2020, which represented a 27.2% between 1999 and 2020 which represented a 59.1%

Hospitals 52

Hospitals 52

IDStewardship

JUNE 18, 2023

Adopting the name, “ IDPodcasts ,” the project (the term “podcast” was coined by a BBC journalist in 2004) sought to adapt infectious diseases presentations to a format recently popularized by the popular iPod music player of the 2000’s. ID Podcasts’ first podcast, “A Tour of the London Museum of Science,” was posted in June 2007.

Hospitals 217

Hospitals 217

ISPE

FEBRUARY 13, 2023

Bob came to ISPE in 2004, furthering an already distinguished career in the pharmaceutical industry and as a regulator. After having worked in industry as a senior Quality Assurance position he joined the Therapeutic Goods Administration (TGA), Australia in 1971 as a GMP inspector.

Documentation 98

Documentation FDA 98

European Pharmaceutical Review

JANUARY 29, 2024

During 2023, there were five revisions to the European Medicines Agency ’s (EMA’s) Questions and Answers (Q&As) for marketing authorisation holders/applicants on the CHMP Opinion for the Article 5(3) of Regulation (EC) No 726/2004 referral on nitrosamine impurities in human medicinal products. 2004; 29: 100298. J Pharm Sci.

FDA 111

FDA Vaccines Compounding 111

pharmaphorum

NOVEMBER 16, 2022

Cases of drug-resistant TB (DR-TB) rose 3% in 2021 over the previous year, the first increase since record-keeping started in 2004, according to the WHO report, which called for countries to move quickly to restore access to essential services to treat the disease, as well as greater investment in new vaccines and therapeutics.

Compounding 98

Compounding Vaccines 98

European Pharmaceutical Review

JUNE 24, 2022

Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (Text with EEA relevance).

Compounding 105

Compounding Packaging Dosage Communication 105

European Pharmaceutical Review

JULY 7, 2022

At the beginning of his career in 2004, Dr Hughes was responsible for early clinical research at Bristol Myers-Squibb Company and then at Schering-Plough Research Institute. .” Since September 2021, Dr Hughes has been Senior Vice President of Clinical Development and Translational Medicine at Vertex Pharmaceuticals, based in Boston.

Research Laboratories 98

Research Laboratories Pharmaceutical Companies Pharmaceutical Companies Hospitals 98

Hospital Pharmacy Europe

AUGUST 14, 2023

The use of a six-month regimen of FOLFOX (fluorouracil, leucovorin, and oxaliplatin) or CAPOX (capecitabine and oxaliplatin) became the standard adjuvant therapy in stage 3 disease from 2004 when trials convincingly showed that the addition of oxaliplatin improved overall survival.

Chemotherapy 97

Chemotherapy Mayo Clinic Hospitals 97

pharmaphorum

OCTOBER 20, 2021

The Method is a British-based company founded by Doyle and his business partner, John Keates, in 2004. “By living the life of a patient in one day, it unlocks a deeper understanding of patients’ needs that can be used to build more meaningful patient-centric strategies across all business units.”.

Communication 52

Communication 52

The Checkup by Singlecare

OCTOBER 1, 2024

In 2004, after nearly eight decades, the American Pharmacists Association (APhA) expanded that week into a month, and October has been coined American Pharmacists Month ever since. This celebration has been a yearly tradition since 1925 , when radio stations would broadcast special programming to highlight the role of pharmacists.

Patient Care 52

Patient Care Immunization Vaccines 52

European Pharmaceutical Review

FEBRUARY 10, 2023

Since joining Astellas Group (former Yamanouchi Group) in 2004, he has held various positions including Regional Senior Vice President, North Europe, Astellas Pharma Europe Ltd. He has experience in the commercial area at Schering and Bayer. Adam Pearson will be appointed as Chief Strategy Officer (CStO).

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The Checkup by Singlecare

NOVEMBER 30, 2023

Sources Acetaminophen hepatotoxicity and nonsteroidal anti-inflammatory drug-related gastrointestinal and renal toxicity , Center for Drug Evaluation and Research (2004). Paracetamol (acetaminophen) interaction NAPQI, the toxic metabolite of paracetamol, is an inhibitor of enzymes in the vitamin K cycle , Thrombosis, and hemostasis (2004).

Immunization 98

Immunization Vaccines FDA Labelling 98

pharmaphorum

DECEMBER 14, 2021

It has made cumulative loses of almost $650 million since being founded in 2004. .” Mesoblast said it was sitting on cash reserves of $116 million at the end of September, having spent just under $23 million in the prior three-month period. The post Mesoblast pummelled as Novartis exits COVID deal appeared first on.

Immunization 89

Immunization Vaccines FDA 89

pharmaphorum

AUGUST 27, 2020

Founded in 2004, Baltimore-headquartered Discern Health provides strategic direction and policy solutions to life sciences companies, government and non-profit agencies, and health insurers. We will truly be #BetterTogether.”.

Communication 59

Communication Insurance 59

pharmaphorum

APRIL 20, 2022

The suit focuses on alleged abuse of Gilead’s Advancing Access programme, a scheme set up in 2004 to provide HIV therapies at no charge to people who lack heath insurance and would be unable to get access to the drugs.

Insurance 69

Insurance 69

The FDA Law Blog

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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Controlled Substances Labelling 52