T-cell targeting Candid Therapeutics launches with $370m
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.
2004 Related Topics 
Lung cancer deaths decline but.
World of DTC Marketing
FEBRUARY 17, 2022
In recent years, early detection and treatment improvements have helped boost the 3-year survival rate for lung cancer from 21% in 2004 to 31% in 2015 through 2017. In recent years, early detection and treatment improvements have helped boost the 3-year survival rate for lung cancer from 21% in 2004 to 31% in 2015 through 2017.
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FDA Approves Iloprost Injection For the Treatment of Adults With Severe Frostbite
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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Botanical drugs – what is the best way forward for regulatory and market approval?
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).
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Optimus Drugs Pvt. Ltd.-Walk-In Interview for Quality Control/ Microbiology 11th Jan’ 2023
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.
Optimus Drugs Pvt. Ltd.-Openings for Engineering Department -Apply Now
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.
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European Commission revokes marketing authorisation for Novartis’ crizanlizumab
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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Optimus Drugs Pvt. Ltd.-Walk-In Interview for Quality Control/ AQA On 28th Jan’ 2023
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.
Optimus Drugs Pvt. Ltd.-Walk-In Interview for Quality Control On 7th Jan’ 2023
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.
Optimus Drugs Pvt. Ltd.-Walk-In Interview for Quality Assurance/ Production On 17th Sept’ 2022
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.
EMA revises guidance on nitrosamine impurities
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.
Optimus Drugs Pvt. Ltd.-Walk-In Interview for Freshers & Experienced in Quality Assurance/ Process Development Department On 24th Sept’ 2022
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.
Navigating delivery challenges of nucleic acid therapeutics
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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Optimus Drugs Pvt. Ltd.-Walk-In Interview for Freshers & Experienced in QC Dept. On 17th Sept’ 2022
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.
Pharmaceutical industry: 2023 in retrospect
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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A Pharma Marketing Pioneer, Sander Flaum, Passed Away
Contrarian Sales Techniques
DECEMBER 14, 2022
He then launched Flaum Navigators in 2004, which was a consultancy that sought to help clients embrace innovation in medical sales and marketing. In 1988, he transitioned to the agency side of the organization and became the CEO of Euro RSCG Becker. He earned his undergraduate and MBA degrees from The Ohio State University.
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2022 spells change for EU pharmaceutical legislation
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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As resistant tuberculosis rises, GSK says trial backs novel antibiotic
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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Teva appoints Eric Hughes as head of R&D and Chief Medical Officer
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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Astellas and Bayer announce management changes
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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Aiming for ‘Magic Bullets’ in Medicine: Are We Shooting Ourselves in the Foot?
Clarivate
SEPTEMBER 25, 2024
2004 2004/04/01;3(4):353-9. [7] Available online at: [ [link] ]. [6] 6] Roth BL, Sheffler DJ, Kroeze WK. Magic shotguns versus magic bullets: selectively non-selective drugs for mood disorders and schizophrenia. Nature Reviews Drug Discovery. 7] Mencher SK, Wang LG. BMC Clin Pharmacol. 2005 Apr 26;5:3. [8]
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New Bill could enhance UK clinical trial regulation
European Pharmaceutical Review
OCTOBER 27, 2023
Mansfield also listed the main elements of The Future Clinical Trials Bill.
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EU proposes new blood, tissues and cells Regulation
European Pharmaceutical Review
JULY 25, 2022
The new Regulation will replace the rules for safety and quality set out in Directives 2002/98/EC for blood and blood components and 2004/23/EC for tissues and cells, in addition to their implementing acts. .
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Remembering the extraordinary life of Dr. Henk F. Moed (1951-2021)
Clarivate
NOVEMBER 1, 2021
These include Handbook of Quantitative Science and Technology Research (2004), Citation Analysis in Research Evaluation (2005), Applied Evaluative Informetrics (2017), Handbook of Science and Technology Indicators (edited with W. His books became the cornerstone of bibliometrics education. Glänzel, U. Schmoch and M.
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Trial bias concern scuppers Y-mAbs brain cancer drug in FDA vote
pharmaphorum
OCTOBER 30, 2022
The two groups were also separated by a sizeable time difference, with data from the control group ranging between 1990 and 2015, while Study 03-133 started enrolling patients in 2004. Changes in standard and supportive care over the time period could also have skewed the results, said the FDA reviewer.
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Pharma responds to proposed EU pharmaceutical legislation reform
European Pharmaceutical Review
APRIL 28, 2023
Pinsent Masons Charlotte Weekes, Senior Associate at Pinsent Masons shared with EPR : “The Commission’s ambitious pharma legislation review is the first significant review of the European system since 2004.” “It
Interchangeability of biosimilars in the EU – the industry impact
European Pharmaceutical Review
DECEMBER 19, 2022
This is reflected in the legal basis for biosimilars under Article 6 of Regulation 726/2004 and Article 10(4) of Directive 2001/83 (as amended by Directive 2004/27). Information guide for healthcare professionals, EMA and EU Commission updated 2/10/2019. Directive 2001/83 (as amended). EMA Biosimilars Q&A.
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CHMP meeting highlights – July 2022
European Pharmaceutical Review
JULY 26, 2022
The review was carried out under Article 20 of Regulation (EC) No 726/2004, which is triggered for centrally authorised medicines in case of quality, safety and efficacy issues.
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Nitrosamines: the beginning of the end?
European Pharmaceutical Review
SEPTEMBER 5, 2023
Questions and answers 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. Org Process Res Dev. 2023; 10.1021.acs.oprd.3c00008. Section 22.
Realising milestones with gene therapy for SMA
European Pharmaceutical Review
MAY 11, 2023
Sitra joined Eli Lilly and Company in 2004 and held roles first in Pharmacovigilance for two years and then for nine years in CNS drug development across various indications, including a dual role as Medical and Project Leader accountable for a portfolio of metabotropic Glutamate receptor modulators at various stages of development.
How to get acquisition ready – a seller’s guide to merger and acquisition in pharma
pharmaphorum
DECEMBER 28, 2022
In addition, she worked as head of inspectorate and licensing for the MHRA from 2004-2006. She joined NSF in 2017. The post How to get acquisition ready – a seller’s guide to merger and acquisition in pharma appeared first on.
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Uncover Hidden Consumer Insights & SEO Opportunities with Google Trends
Healthcare Success
OCTOBER 31, 2022
Google Trends offers search ranges from '2004 to the present,' to the past four hours. Expanding your search to include all countries allows you to identify which countries or continents are searching for particular topics. For example, the search volume for “drug rehab” is highest in Trinidad & Tobago and the United States.
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Demonstrating socioeconomic impact – a historical perspective of ancient wisdom and modern challenges
Clarivate
APRIL 14, 2024
In 2004, when I chaired the EC Monitoring Committee for the Evaluation of FP6, we were provided with a spread of data on assessments prior to funding, data monitoring on progress, and traditional evaluations as projects approached outcomes.
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Specialty pharma’s next big opportunity: it’s time for patient access to adopt an open protocol
pharmaphorum
NOVEMBER 1, 2022
healthcare facilities were found to have an EHR system fully implemented by 2004. The Institute of Medicine first advocated a shift from paper-based to electronic medical records in 1992 , yet, only 13% of U.S. Many are still making the transition. Today, specialty drug sales represent more than half of all drug spending.
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Celebrating Highly Cited Researchers: National Cheng Kung University, Taiwan
Clarivate
MARCH 8, 2022
In 2004, way before the greenhouse effect became a major focus and the concept of the circular economy emerged, Chang published the world’s first research paper on a zero-carbon emission biomass energy production system that uses microalgae as a carbon sink. Today, we speak with National Cheng Kung University (NCKU) in Taiwan.
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Sweeping changes in leaked EU pharma law draft reignite profit vs access conflict
Pharmaceutical Technology
FEBRUARY 24, 2023
Vouchers will grant one extra year of RDP, transferable to other drugs or sellable Stronger obligations for pharma companies to report shortages, and to offer a drug’s marketing authorisation to another company before withdrawing it from the market Requiring clinical trials in children where a drug is approved in adults for a different disease Introducing (..)
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New Prescription Migraine Drugs Aren’t Resonating with Patients—Here’s How Pharma Can Boost Uptake
PM360
JUNE 29, 2022
Among surveyed patients, nearly half (47%) couldn’t remember a single preventive migraine brand name, and the leading brand patients did recall— Topamax —is an older drug that was approved for migraine in 2004.
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The future of targeted alpha therapy development and manufacture
European Pharmaceutical Review
MARCH 7, 2024
He then worked at BCG from 2004 to 2011, where he developed expertise in the energy, engineering, and high-tech sectors. About the interviewee Julien Dodet is CEO and President of Orano Med. Julien began his career at Saint Gobain managing international industrial projects before moving to management control.
How can the pharma industry address the gap in talent recruitment and development?
pharmaphorum
AUGUST 4, 2022
In addition, she worked as head of inspectorate and licensing for the MHRA from 2004-2006. She joined NSF in 2017. The post How can the pharma industry address the gap in talent recruitment and development? appeared first on.
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PROTACs show promise for cancer treatment
Pharmaceutical Technology
JANUARY 25, 2023
According to the GlobalData deals database, the National Cancer Institute (NCI) in the US has issued 67 grants from 2021-2022 for PROTACs-related studies, while between 2004 and the end of 2018, the NCI issued just 45 grants for PROTACs-related studies.
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New quality requirements for tobacco products
European Pharmaceutical Review
JUNE 8, 2023
Assessment report Procedure under Article 5(3) of Regulation EC (No) 726/2004 Nitrosamine impurities in human medicinal products Procedure number: EMEA/H/A-5(3)/1490 EMA/369136/2020 Committee for Medicinal Products for Human Use (CHMP). Biochemistry, biology, and carcinogenicity of tobacco-specific nitrosamines. Chem Res Toxicol.
A glance back to Pharma Integrates, London 2022 – part ii
pharmaphorum
JANUARY 19, 2023
When Milburn and Blair introduced competition in 2004-2008 it did start to make a difference.” Highly unlikely.” GIRFT and competition He went on: “Improvement needs competition – everything else is a proxy; it doesn’t work well.
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API nitrosamines: method sensitivity issues
European Pharmaceutical Review
AUGUST 22, 2022
Procedure under Article 5(3) of Regulation EC (No) 726/2004. European Directorate for the Quality of Medicines & HealthCare. 2022 [cited 30 July 2022]. Available from: [link]. USP: <1469> Nitrosamine Impurities. Assessment report. Nitrosamine impurities in human medicinal products. 25 June 2020. EMA/369136/2020.
Biogen’s $900 million settlement signals scrutiny on speaker fees
Pharmaceutical Technology
OCTOBER 5, 2022
In 2009, Tysabri was performing well, having yielded $776 million in sales after being first approved in 2004, as per Biogen’s 2009 financial filings. However, new MS drugs like Novartis ’ Gilenya, were going to soon enter the market and increase competition within the MS therapeutic landscape.
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