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.

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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

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

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.

Drug Pricing 286

Drug Pricing Compounding Pharmaceutical Companies Pharmaceutical Companies 286

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.

Drug Development 352

Drug Development 352

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 255

Documentation Diabetes 255

The Guardian - Pharmaceutical Industry

APRIL 21, 2024

Exclusive: NHS cost threshold has not been raised by National Institute for Health and Care Excellence since 2004 People with motor neurone disease have spoken of their devastation at a likely loss of access to a life-extending drug due to an NHS cost threshold that has not been raised since 2004.

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FDA Law Blog: Biosimilars

MARCH 18, 2025

Merck applied for a patent term extension on the reissued patent, claiming the start of the regulatory review period as April 2004 and termination at the approval of the BRIDION NDA in December 2015. With this long regulatory review period, the PTO granted the statutory-maximum five-year patent term extension. The plain text of 35 U.S.C.

Drug Pricing 59

Drug Pricing Pharmaceutical Companies Pharmaceutical Companies 59

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 238

Nursing Homes Hospitals 238

Express Pharma

MARCH 31, 2025

It was launched in 2004 with a $22 million endowment from Mark and Mary Stevens. Once we demonstrate this for brain cancer, the same approach could be used for any brain disease where theres a potential therapeutic effect, Chen said. USC Stevens works to move the discoveries of USC researchers from the lab to the marketplace.

Chemotherapy 66

Chemotherapy 66

ALiEM - Pharm Pearls

APRIL 10, 2023

2004 Jan;9(1):52-6. Treasure Island (FL): StatPearls Publishing; 2021 Jan-. Available from: [link] Lee LA. Neonatal lupus erythematosus: clinical findings and pathogenesis. J Investig Dermatol Symp Proc. doi: 10.1111/j.1087-0024.2004.00827.x. 1087-0024.2004.00827.x. PMID: 14870986.

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The Pharmacist

OCTOBER 18, 2023

Although the data going back to 2004 showed […] The post Painkiller use in inflammatory arthritis is ‘widespread’ despite no benefit appeared first on The Pharmacist.

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BioPharma Dive

DECEMBER 4, 2024

Thompson, 50, had been with UnitedHealth since 2004. The NYPD confirmed the shooting, which caused UnitedHealth to end an investor conference early on Wednesday.

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Pharmaceutical Technology

SEPTEMBER 10, 2024

The new biotech has inherited two T cell engager antibodies as part of a three-way merger with Vignette and TRC 2004.

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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

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).

Drug Development 103

Drug Development Biosimilars Documentation Compounding 103

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.

Dosage 116

Dosage 116

ALiEM - Pharm Pearls

MARCH 29, 2023

2004 Mar 10;291(10):1261-2. Febrile infants 29-60 days old may be sent home after a negative workup with close follow-up. References: Roberts KB. Young, febrile infants: a 30-year odyssey ends where it started. PMID: 15010450. Biondi EA, Lee B, Ralston SL, et al.

Hospitals 360

Hospitals Documentation Inpatient Immunity 360

Pharma Pathway

JANUARY 10, 2023

Ltd was Established in the year 2004 as Custom synthesis laboratory by a team of Technocrats. Optimus Drugs Pvt. Walk-In Interview for Quality Control/ Microbiology 11th Jan’ 2023. Job Description. Optimus Drugs Pvt. It is one off the fastest growing Manufacturer in Active Pharmaceutical Ingredients (APIs) and dosages.

Dosage 78

Dosage 78

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.

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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

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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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.

Communication 88

Communication Pharmaceutical Companies Pharmaceutical Companies Documentation 88

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 Drug Development Drug Pricing Dosage 105

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 98

Express Pharma

JUNE 4, 2024

Waters pioneered ultra performance liquid chromatography (UPLC) in 2004 with the launch of the ACQUITY UPLC Column, enabling the optimal use of sub 2-µm particles for the first time.

Packaging 107

Packaging 107

Pharma in Brief

AUGUST 8, 2023

Beginning January 1, 2024, the Canadian Intellectual Property Office ( CIPO ) will implement the first substantial increases to its service fees since 2004. Many fees will increase by 25% of more, though some “low materiality fees” will remain capped at $150.

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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.

Immunity 101

Immunity Immunization Vaccines 101

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

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

RX Note

MARCH 31, 2025

Treatment of acne vulgaris with salicylic acid pads, 1992 The use of sulfur in dermatology, 2004 Tea tree oil is a product derived from the Australian Melaleuca alternifolia tree that possesses antimicrobial and anti-inflammatory properties.

Mayo Clinic 52

Mayo Clinic Community Pharmacies 52

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.

Drug Development 111

Drug Development Vaccines Compounding 111

Pharma Pathway

SEPTEMBER 13, 2022

Ltd was Established in the year 2004 as Custom synthesis laboratory by a team of Technocrats. Optimus Drugs Pvt. Openings for Engineering Department -Apply Now. Job Description. Optimus Drugs Pvt. It is one off the fastest growing Manufacturer in Active Pharmaceutical Ingredients (APIs) and dosages.

Dosage 52

Dosage Pharmaceutical Companies Pharmaceutical Companies 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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Pharmaceutical Business Review

AUGUST 9, 2024

JYNNEOS was also the first smallpox vaccine successfully developed under Project BioShield, a program created by the US Congress in 2004 to accelerate the research, development, procurement, and availability of medical countermeasures against biological, chemical, radiological, and nuclear (CBRN) agents through public-private partnerships.”

Vaccines 59

Vaccines 59

Pharma Pathway

JANUARY 25, 2023

Ltd was Established in the year 2004 as Custom synthesis laboratory by a team of Technocrats. Optimus Drugs Pvt. Walk-In Interview for Quality Control/ AQA On 28th Jan’ 2023 Job Description Optimus Drugs Pvt. It is one off the fastest growing Manufacturer in Active Pharmaceutical Ingredients (APIs) and dosages.

Dosage 52

Dosage 52

Pharma Pathway

JANUARY 5, 2023

Ltd was Established in the year 2004 as Custom synthesis laboratory by a team of Technocrats. Optimus Drugs Pvt. Walk-In Interview for Quality Control On 7th Jan’ 2023. Job Description. Optimus Drugs Pvt. It is one off the fastest growing Manufacturer in Active Pharmaceutical Ingredients (APIs) and dosages.

Dosage 52

Dosage 52