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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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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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 315

Drug Pricing Compounding Pharmaceutical Companies Pharmaceutical Companies 315

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.

Drug Pricing 244

Drug Pricing 244

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 362

Drug Development 362

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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Express Pharma

JUNE 12, 2024

Since joining Biocon in 2004 as a Management Executive, he has worked across all areas of finance within the Biocon Group. Biocon has appointed Mukesh Kamath as the Interim Chief Financial Officer and Key Managerial Personnel, with effect from June 11, 2024.

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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.

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Documentation Diabetes 259

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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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 204

Nursing Homes Hospitals 204

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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Pharmacy Times

FEBRUARY 14, 2024

Iloprost had also received Priority Review and Orphan Drug Designations for this indication, and FDA approval in 2004 for the treatment of pulmonary arterial hypertension.

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Express Pharma

NOVEMBER 13, 2024

In PHOENYCS GO, dapirolizumab pegol achieved the primary endpoint of achieving a BILAG 2004-based Composite Lupus Assessment (BICLA) response at Week 48. They will debut as a late-breaking abstract at the upcoming American College of Rheumatology (ACR) 2024 congress, which will take place from November 14 to 19, 2024.

Labelling 102

Labelling Immunity Immunization 102

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

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

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

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 113

Dosage 113

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

Big Molecule Watch

MARCH 3, 2023

According to the Complaint , Genentech granted Biogen a non-exclusive license to the patents in 2004. According to the Complaint , Genentech granted Millennium a non-exclusive license to the patents in 2004. Genentech filed its case against Biogen in the federal District Court for the Northern District of California (No. 2:23-cv-909).

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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

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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Pharma Pathway

SEPTEMBER 16, 2022

Ltd was Established in the year 2004 as Custom synthesis laboratory by a team of Technocrats. Optimus Drugs Pvt. Walk-In Interview for Quality Assurance/ Production On 17th Sept’ 2022. Job Description. Optimus Drugs Pvt. It is one off the fastest growing Manufacturer in Active Pharmaceutical Ingredients (APIs) and dosages.

Dosage 52

Dosage 52

Express Pharma

APRIL 18, 2024

Sanjeev Jain, MD, Akums Drugs & Pharmaceuticals, stated, “April 19, 2004 marks a significant milestone for Akums as we celebrate two decades of longstanding and trusted relationships. Notably, its market share in the Indian domestic CDMO market surged to 29.4 per cent by value in FY23, up from 26.7 per cent in FY21.”

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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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Pharma Pathway

SEPTEMBER 23, 2022

Ltd was Established in the year 2004 as Custom synthesis laboratory by a team of Technocrats. -Walk-In Interview for Freshers & Experienced in Quality Assurance/ Process Development Department On 24th Sept’ 2022. Job Description. Optimus Drugs Pvt.

Dosage 52

Dosage 52

Pharma Pathway

SEPTEMBER 16, 2022

Ltd was Established in the year 2004 as Custom synthesis laboratory by a team of Technocrats. Optimus Drugs Pvt. Walk-In Interview for Freshers & Experienced in QC Dept. On 17th Sept’ 2022. Job Description. Optimus Drugs Pvt. It is one off the fastest growing Manufacturer in Active Pharmaceutical Ingredients (APIs) and dosages.

Dosage 52

Dosage 52

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.,

Dosage 57

Dosage Drug Pricing 57

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 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.

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Documentation 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.

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Dosage Vaccines 105

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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Communication Pharmaceutical Companies Pharmaceutical Companies Documentation 88

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 99

Packaging 99

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.

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Drug Development 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.

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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).

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Compounding Drug Development Drug Pricing Dosage 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.

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Research Laboratories Pharmaceutical Companies Pharmaceutical Companies Hospitals 98