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ICH M14 guideline on general principles on plan, design and analysis of pharmacoepidemiological studies that utilize real-world data for safety assessment of medicines Step 2b

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日曜日, 6月 2, 2024

Consensus, Sentinel, Real-World Evidence, NPV, Privacy, Smoking, Business analyst, Interest, Scope, Section 3, Missing data, Attention deficit hyperactivity disorder, World Health Organization, Thrombosis, Vaccination, Artificial intelligence, GVP, Element, ICD-10, ICD, Target, Clutch (eggs), MedDRA, Anaphylaxis, Data collection, Multi, Registry, Infant, International Society, Collection, Incidence, Clinical study design, FD, Replication (computing), Deference, Failure, CDM, Innovation Center station, Prevalence, Diagnosis, Mortality, Pregnancy, Person, Data analysis, Classification, Committee, Knowledge, Silver, PMID, Development, Roger Hawkins (drummer), Record, Len Bias, 1113, Polypharmacy, Sensitivity analysis, Protocol, Risk, European Medicines Agency, FDA, Real, Joint, Step, Quality control, Documentation, Standard of care, Health care, Accident, Checklist, Database, Birth weight, Statistics, Communication, Natural language processing, Table, Data Governance Act, Common data model, Study, Reproduction, Quality assurance, European, BMJ, Quality, Conducting, Comorbidity, NMPA, Knowledge Organization (journal), Drug development, DHT, Conceptual, ISPE, Adrenaline, Marketing, Cancer, EHR, Phenotype, Safety, Rehabilitation, Research design, HCPCS, Treatment, Allergy, Electronic health record, Validity, Death, MAH, Quality of life, 1128, Confidentiality, Selection bias, Prescription, Machine learning, Duration, CIOMS, Vaccine, ICMJE, Injury, Workplace, Section 5, National Cancer Institute, Bangladesh Technical Education Board, Interval (mathematics), Regulation, Data quality, Management, GCP, Digital, Software, Meta-analysis, SNOMED, Section 8, Use, Biology, QC, Uncertainty, Birth defect, PPV, FDN, Publication bias, Draft, Shareware, Frailty, Disulfiram-like drug, Guideline, Publishing, Gestational diabetes, De novo, Big data, Conduct, Medication, Bias, Immunodeficiency, EMA, Social media, International Classification of Diseases, History, Name, Data management, M10, Algorithm, Ageing, Natural history, SAP, Asian literature, Disability, QA/QC, Immortal, NDC, Book, Human voice, Central Statistics Office (India), Content, Birth, Frontiers Media, Metadata, RxNorm, Data governance, GPP, Structuring, Radiology, Benzodiazepine, Lash, User experience, Theft, Methodology, Objective, RWD, COMMUNICATION, DATA, Literature, Health information management, Clinical trial, Dependent and independent variables, Research, Patient, ATC, INTRODUCTION, TB, Section 13, Contraindication, Insurance, Concomitant, Data, Index, M14, Gestational age, Data curation, Biomarker, ICH, Paper, CHMP, Medical device

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Object Management Group Issues Request for Proposals for Statistical Metadata Interoperability

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水曜日, 5月 15, 2024

Object Management Group, Journalism, Organization, Health, Documentation, Statistics, Metadata, Letter, Public policy, Government, Education for librarianship, Bureau of Labor Statistics, Deference, OMG, RFP

BOSTON, MA, May 15, 2024 (GLOBE NEWSWIRE) -- Today, Object Management Group ® (OMG®) issued the Statistical Metadata Interoperability Request for Proposal (RFP) to develop a specification for documenting statistical datasets using machine-readable metadata.

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BOSTON, MA, May 15, 2024 (GLOBE NEWSWIRE) -- Today, Object Management Group ® (OMG®) issued the Statistical Metadata Interoperability Request for Proposal (RFP) to develop a specification for documenting statistical datasets using machine-readable metadata.
Many organizations worldwide (in government and public policy, healthcare, finance, and other domains) consume, produce, or publish enormous amounts of valuable statistical data.
Several commonly used specifications for documenting datasets are used, but not specifically for those with a strong statistical aspect.
You can download the Statistical Metadata Interoperability RFP from the OMG website.

Beam Therapeutics Reports Pipeline Updates and First Quarter 2024 Financial Results

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火曜日, 5月 7, 2024

Sentinel, Sickle cell disease, CTA, Medication, Investment, Security, Hematology, Deference, IND, Administration, Research and development, Patient, Lung, ESCAPE, Clinical trial, Biotechnology, G&A, AATD, Pharmaceutical industry

CAMBRIDGE, Mass., May 07, 2024 (GLOBE NEWSWIRE) -- Beam Therapeutics Inc. (Nasdaq: BEAM), a biotechnology company developing precision genetic medicines through base editing, today reported first quarter 2024 financial results and provided updates across the company’s hematology and genetic disease franchises.

Key Points:

The company expects to report data from multiple patients in the BEACON trial in the second half of 2024.
Beam expects to initiate the Phase 1/2 clinical trial for BEAM-302 in AATD in the first half of 2024.
Research & Development (R&D) Expenses: R&D expenses were $84.8 million for the first quarter of 2024, compared to $99.6 million for the first quarter of 2023.
General & Administrative (G&A) Expenses: G&A expenses were $26.7 million for the first quarter of 2024, compared to $23.5 million for the first quarter of 2023.

Miss Vickie's® Brings Calming Art to Commuters with 'Stroke of Goodness' Art Contest

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水曜日, 4月 3, 2024

Stroke, Miss, Goodness, Kroger, Walmart, Deference, Love, Creativity, Frito-Lay, Retail

PLANO, Texas, April 3, 2024 /PRNewswire/ -- Miss Vickie's® Kettle Cooked Potato Chips is hitting grocery and retail stores nationwide, allowing consumers to enjoy their favorite snack at home. To celebrate Miss Vickie's being available on store shelves, the brand is partnering with a special judge to kick off an art contest inspired by the expressive watercolor illustrations found on its packaging. Through the "Stroke of Goodness" contest, Miss Vickie's will choose one winner's original artwork to be featured on a billboard that will make an otherwise stressful situation – like traffic – a more enjoyable experience.

Key Points:

To celebrate Miss Vickie's being available on store shelves, the brand is partnering with a special judge to kick off an art contest inspired by the expressive watercolor illustrations found on its packaging.
"The art on Miss Vickie's packaging is reflective of our longstanding heritage, and we wanted to embrace that by inviting our fans to create original artwork to share with thousands of commuters."
Beginning today, fans across the country are invited to submit a piece of original artwork inspired by their favorite Miss Vickie's flavor.
Miss Vickie's has also brought in a surprise judge for the contest to lend their creative eye and help select the winning artwork.

Procedural advice for orphan medicinal product designation: Guidance for sponsors

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水曜日, 4月 3, 2024

Frequently asked questions ................................................................... 10

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Frequently asked questions ................................................................... 10
Procedural advice for orphan medicinal product designation
EMA/420706/2018

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1.
This Regulation lays down the procedure for
the designation of medicinal products as orphan medicinal products and provides incentives for the
development and placing on the market of designated orphan medicinal products.
The Regulation also
establishes the Committee for Orphan Medicinal Products (COMP) within the European Medicines
Agency (EMA), which is responsible for examining applications for orphan medicinal product
designation.
As of 28 April 2000, the date this Regulation entered into force, sponsors have been able to
submit applications for orphan medicinal product designation to the EMA.
Procedural advice for orphan medicinal product designation
EMA/420706/2018
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2.
Objectives
In examining an application for orphan medicinal product designation, the COMP will focus on
determining whether the sponsor has established that the designation criteria are met, i.e.
To assist in the development of a policy on orphan medicinal products, an expert network will
be built up by the Committee, with expert(s) identified as appropriate to be involved in the evaluation
of applications for orphan medicinal product designation.
?
The complete application should include:

Procedural advice for orphan medicinal product designation
EMA/420706/2018

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Document

Format

General administrative and scientific information completed online via the portal.
Important:
In preparing an application for orphan medicinal product designation, sponsors are requested to follow
the Commission guideline (2022/C 440/02) on the format and content of applications for designation
as orphan medicinal products.
Please refer to the Procedural advice on
appeal procedure for Orphan Medicinal Product Designation (EMEA/2677/01 Rev.3).
The grounds for the
Procedural advice for orphan medicinal product designation
EMA/420706/2018

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appeal should be based only on the original information provided in the application for orphan
designation.
?
The European Commission will enter the designated medicinal product in the Community Register
of Orphan Medicinal Products.
General advice
?
Full information on the procedure for orphan medicinal products designation is available on the
EMA orphan designation website.
In accordance with Regulation (EC) No 141/2000 of 16 December 1999, the sponsor may submit an
application for orphan medicinal product designation to the Agency at any stage of development of the
Procedural advice for orphan medicinal product designation
EMA/420706/2018

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medicinal product as long as the criteria for designation may be justified.
A request for orphan medicinal product designation may be made for
a new orphan indication for an already authorised medicinal product.
Procedural advice for orphan medicinal product designation
EMA/420706/2018
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Which are the sponsor?s options in case of negative outcome for orphan designation?

Singapore Exchange (SEL) Digital Transformation Strategy Analysis Report 2023: Innovation Programs, Technology Initiatives, Estimated ICT Budget, and Major ICT Contracts

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月曜日, 2月 5, 2024

Titan, Deference, Curriculum, AI, Digital, Ecosystem, Investment, Infocomm Media Development Authority, DLT, IMDA, SGX, Acquisition, MOU, ICT, Organization, Retail

DUBLIN, Feb. 5, 2024 /PRNewswire/ -- The "Singapore Exchange Limited - Digital transformation strategies" company profile has been added to ResearchAndMarkets.com's offering.

Key Points:

DUBLIN, Feb. 5, 2024 /PRNewswire/ -- The "Singapore Exchange Limited - Digital transformation strategies" company profile has been added to ResearchAndMarkets.com's offering.
This report provides insight into SGX's tech activities, including its digital transformation strategies, its innovation programs, its technology initiatives, its estimated ICT budget, and its major ICT contracts.
Singapore Exchange Limited (SGX) is a financial market "infrastructure," operating equity, derivatives, and fixed income markets.
SGX has embraced digital collaboration tools and services to support its digital transformation and developed digital curriculum to train employees on digital solutions.

Almaden Reports on Legal Developments in Mexico Regarding Ministry of Economy Efforts to Deny Twenty Year-Old Ixtaca Mineral Title Applications

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月曜日, 10月 16, 2023

As reported on February 22, April 13, and September 14, 2023, Economia made the Submission to the District Court seeking to deny the two mineral title applications which were first made by Almaden in 2002 and 2008.

Key Points:

As reported on February 22, April 13, and September 14, 2023, Economia made the Submission to the District Court seeking to deny the two mineral title applications which were first made by Almaden in 2002 and 2008.
The Submission claims that the applications contain technical faults, despite Economia’s previous statements to the contrary and its acceptance of the mineral title applications and grant of the mineral titles in 2003 and 2009.
By alleging technical faults in the mineral title applications, Economia appears to be arbitrarily seeking to deny the grant of the mineral titles and avoid the indigenous consultation ordered by the February 2022 decision of Mexico’s Supreme Court (“SCJN”).
Almaden has been advised that so long as the TFJA trial continues, its mineral title applications from 2002 and 2008 remain in place thus preserving the Company’s preferential rights to the mineral title.

Aetherium Announces Receipt of Nasdaq Notice of Additional Delinquency

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月曜日, 10月 2, 2023

Form, Rule, Deference, Staff, Letter, Notice

The Notice has no immediate effect on the listing or trading of the Company's common stock on the Nasdaq Global Market.

Key Points:

The Notice has no immediate effect on the listing or trading of the Company's common stock on the Nasdaq Global Market.
As a result of this additional delinquency, the Company has submitted an update to Nasdaq which indicates the Company's plan to remedy all delinquent filings and has indicated the progress the Company has made towards implementing the plan contained in its update.
The Company's management continues to work diligently to complete the Form 10-Qs and regain compliance with Listing Rule 5250(c)(1).
If it is unable to become compliant by November 20, 2023, the Company will file an appeal pursuant to the procedures set forth in the applicable Nasdaq Listing Rules.

Resultant named “Google Cloud Public Sector Partner of the Year – US State and Local Government”

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火曜日, 8月 29, 2023

Resultant, a leading consulting firm specializing in technology, data analytics and digital transformation, today announced that it has received the 2023 Google Cloud Public Sector Partner of the Year – US SLG Award.

Key Points:

Resultant, a leading consulting firm specializing in technology, data analytics and digital transformation, today announced that it has received the 2023 Google Cloud Public Sector Partner of the Year – US SLG Award.
“The opportunities for government agencies to solve complex challenges and improve the lives of citizens using cloud technologies and advanced data analytics has never been greater,” said Paul Bahl, Resultant director of Google Cloud Sales.
Further, Resultant and Google Cloud are also advancing health outcomes through the modernization of data systems at public health agencies.
“We're delighted to recognize Resultant as a 2023 Google Cloud Partner Award winner, and look forward to a continued strong partnership in support of our mutual customers.”
Resultant team members hold more than 95 Google Cloud certifications and credentials including Cloud Engineers, Cloud DevOps Engineers, Cloud Data Engineers, Machine Learning Engineers, Cloud Database Engineers, Cloud Developers, Cloud Architects, Google Workspace Administrators, Certified Educators and more.

Tonix Pharmaceuticals Completes Enrollment in Potentially NDA-Enabling Phase 3 RESILIENT Trial of TNX-102 SL for Management of Fibromyalgia

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火曜日, 8月 1, 2023

CMC, NDA, HCL, SL, Tablet, Patient, Fibromyalgia, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Deference, Food, Fatigue, Pharmaceutical industry, Tonix Pharmaceuticals

CHATHAM, N.J., Aug. 01, 2023 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a biopharmaceutical company, today announced that it has completed enrollment of its potentially final, confirmatory Phase 3 RESILIENT trial of TNX-102 SL (cyclobenzaprine HCL sublingual tablets) 5.6 mg in fibromyalgia and expects topline data next quarter. A total of 457 participants were randomized. TNX-102 SL is in development as a non-opioid, centrally acting analgesic, to be taken daily at bedtime for the management of fibromyalgia. If successful, we believe this will be the final, well-controlled efficacy trial required for submission of a New Drug Application (NDA) for approval by the U.S. Food and Drug Administration (FDA).

Key Points:

TNX-102 SL is in development as a non-opioid, centrally acting analgesic, to be taken daily at bedtime for the management of fibromyalgia.
“The completion of enrollment in our Phase 3 RESILIENT trial is a significant milestone for both Tonix and the fibromyalgia community,” said Seth Lederman, M.D., Chief Executive Officer of Tonix.
TNX-102 SL met its pre-specified primary endpoint in the Phase 3 RELIEF trial, significantly reducing daily pain compared to placebo (p=0.01) in participants with fibromyalgia.
TNX-102 SL was generally safe and well tolerated in patients with fibromyalgia, with overall adverse event profile comparable to prior fibromyalgia studies.