ASPET

OCTOBER 12, 2023

The Countering Emerging Threats - Rapid Acquisition and Investigation of Drugs for Repurposing (CET RAIDR) program within the JPM Medical is designed to rapidly tackle known, unknown, and emerging threats by utilizing late-stage or licensed therapeutics. Repurposing is one such method.

Therapies

Perficient: Drug Development

NOVEMBER 10, 2023

Depending on the size of the team and anticipated activity within a program, additional RDEs can also be provisioned, however, this may come at an additional licensing cost from Adobe. For more options and details on resetting the RDE for your program, review Adobe’s documentation on Experience League on this page.

Packaging

The Pharma Data

AUGUST 17, 2020

DF6002 is a monovalent IL-12 immunoglobulin Fc fusion protein proposed to achieve strong anti-tumor efficacy by establishing an inflammatory tumor microenvironment necessary for productive anti-tumor responses.

Licensing

The Pharma Data

NOVEMBER 4, 2020

Ltd (“Juyou”), a biotechnology company that develops and sells medical and cosmetic skincare products, for the commercialization and development of Pliaglis ® in mainland China (the “License Agreement”). million and US$1.8

Licensing

Agency IQ

AUGUST 4, 2023

New MHRA Windsor Framework documents guide post-Brexit flow of medicines for U.K., The document specifically notes that it applies to “medicinal products for human use intended to be placed on the market in Northern Ireland in accordance with Article 6 of Directive 2001/83/EC,” the current European pharmaceutical legislation.

Packaging

Advarra

APRIL 30, 2024

Maintaining complete and compliant documentation while managing the complex processes and interactions of clinical trial conduct is complicated. Investigator Site Files The ISF contains essential documents permitting evaluation of a clinical trial’s conduct. Form FDA 1572 The Form FDA 1572 is unique to U.S.-based based sites.

Licensing

Drug Channels

OCTOBER 5, 2021

Licenses for our DCI reports are regularly purchased by nearly every company involved in the drug channel: pharmaceutical manufacturers, wholesalers, pharmacists, pharmacy owners, hospitals, buyers, benefit managers, managed care executives, policy analysts, investors, lawyers, consultants, and more. There are an astonishing 537 (!)

Pharmaceuticals

Drug Channels

OCTOBER 11, 2022

Licenses for our DCI reports are regularly purchased by nearly every company involved in the drug channel: pharmaceutical manufacturers, wholesalers, pharmacists, pharmacy owners, hospitals, buyers, benefit managers, managed care executives, policy analysts, investors, lawyers, consultants, and more.

Pharmaceuticals

Drug Channels

MARCH 15, 2022

Licenses for our DCI reports are regularly purchased by nearly every company involved in the drug channel: pharmaceutical manufacturers, wholesalers, pharmacists, pharmacy owners, hospitals, buyers, benefit managers, managed care executives, policy analysts, investors, consultants, and more.

Pharmacy

FDA Law Blog: Biosimilars

JULY 29, 2024

Last week, FDA issued draft guidance to address the potential complications that arise when sponsors seek to modify products, production processes, or quality controls for approved biologics license application (BLA) biosimilar and interchangeable products.

Biosimilars

Perficient: Drug Development

JANUARY 19, 2024

This distribution utilizes licensed API keys, streamlining the process for customers to conveniently retrieve and access these containers in their local registries or incorporate them seamlessly into their CI/CD pipelines.

Compliance

The Pharma Data

DECEMBER 21, 2020

from the University of New Hampshire in Durham, and colleagues used data from the Current Population Survey (2010 to 2019) to document the rate of nursing and long-term care workers who hold second jobs. percent of licensed practical nurses and registered nurses held second jobs. Baughman, Ph.D.,

Nurses

Perficient: Drug Development

JUNE 1, 2024

Document the specific changes made to the permission set and assign it to a test user to check if the modifications are reflected correctly. Test with different license types : If the permission set is assigned to users with different license types, test it with each license type to ensure that the permissions work as expected.

Licensing

Perficient: Drug Development

FEBRUARY 15, 2024

Issues and Findings Management: Document issues and gaps identified during risk assessments and control testing, crucial for compliance. DFS500 Compliance Requirements Institutions falling under the purview of the DFS500 amendments encompass a diverse spectrum, all mandated to adhere to these regulations.

Compliance

Perficient: Drug Development

FEBRUARY 15, 2024

Issues and Findings Management: Document issues and gaps identified during risk assessments and control testing, crucial for compliance. Compliance Requirements Institutions falling under the purview of the NYSDFS Part 500 amendments encompass a diverse spectrum, all mandated to adhere to these regulations.

Compliance

FDA Law Blog: Biosimilars

AUGUST 9, 2023

Two licensed pharmacists must directly communicate the transfer. As with other required controlled substance records, electronic records documenting EPCS transfers must be maintained for two years from the transfer date by both the transferring and receiving pharmacies. cannot be altered during the transmission.

Pharmacy

The Pharma Data

DECEMBER 21, 2020

Johnson & Johnson (J&J) and Legend Biotech said they have begun submitting documents on a rolling basis to the FDA for a Biologics License Application for their investigational B-cell maturation antigen (BCMA)-directed chimeric antigen receptor T (CAR-T) therapy, ciltacabtagene autoleucel (cilta-cel), meant for adults suffering from relapsed (..)

Therapies

Advarra

JUNE 14, 2024

A regulatory binder is essential for managing clinical trial documents, ensuring regulatory compliance, and facilitating audits. It organizes critical documents; provides easy access for trial monitors, auditors, and regulatory authorities; and serves as a reference for the research team.

Clinical Trials

Conversations in Drug Development Trends

AUGUST 9, 2024

Managing this complexity highlights the importance of global communication plans and constant communication with global regulators and keeping all required documentation up to date. An import license is necessary for any intellectual property or equipment used during the trial.

Trials

Molecule Blog

JANUARY 18, 2023

The current NFT owner can legally prove that they’re holding the IP rights by downloading and verifying the attached legal documents on their own machine. This capturing step is necessary because the legal documents attached to the final IP-NFT are referring to the NFT’s token id that only becomes available after the mint has occurred.

Licensing

The Premier Consulting Blog

MAY 14, 2023

Instead, if the “Yes” box is ticked to include CRO information, a “Continuation Page for #16” button appears, and the continuation page appends to the end of the document, where the transfer information can be added. A: You may receive an “unsupported document” error when using DocuSign to sign the form. How can I resolve this?

FDA

Perficient: Drug Development

JULY 17, 2024

This process is well documented. I read through this documentation multiple times and did not really understand the process until I needed to implement it for myself. In order to identify a guest, we must send an “IDENTITY” event. If you have been confused by identity in CDP, read on! CDP allows the same behavior digitally.

Licensing

Molecule Blog

JANUARY 9, 2023

IP-NFTs upgrade our legacy intellectual system by unifying IP (patents, legal), underlying data (through decentralized storage and access control), and economics (royalties, license fees, sales) into one programmable, transactable, digital unit. ‍ Licensing fees and revenue generated flow back to the smart contract (eg.

Research

Perficient: Drug Development

JANUARY 18, 2024

To convert and compress the Sitecore license to base 64 string, run the script present in “ConvertTo-CompressedBase64String” method present in the upgrade guide. Review the readme and KCD Documentation file. Execute the scripts as mentioned in the documentation. DATABASE_UPGRADE_TO_VERSION=10.3.1

Licensing

Agency IQ

MAY 28, 2024

Additionally, companion diagnostics and combination products that contain medicinal substances that haven’t yet been licensed in the U.K. Other required documentation includes a PMS plan, PMS report or PSUR, any implant cards, and patient information leaflets. will not qualify. Notably, acceptance of the U.S. Note: The E.U.

International

The Pharma Data

JANUARY 10, 2021

Download the slideshow of meetings on the Company website, in the Documentation section dedicated to investors: www.valbiotis.com/en/documents/. Its products are intended to be licensed to players in the health sector. Its products are intended to be licensed to players in the health sector.

International

The Pharma Data

JANUARY 10, 2021

These forward-looking statements speak only as of the date of publication of this document. Given these uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements.

Clinical Trials

Perficient: Drug Development

NOVEMBER 7, 2023

Here we will outline several distinctions between two prominent tools: Acunetix and Burp Suite: Aspect Acunetix Burp Suite Scanner Vendor Acunetix by Invicti Security Burp Suite by PortSwigger User Interface User-friendly, guided scans Comprehensive, flexible interface Scanning Depth Deep scanning capabilities Deep and extensive scanning Automated (..)

Licensing

The Pharma Data

NOVEMBER 29, 2020

Y-mAbs Therapeutics has a target action date of November 30 for its Biologics License Application (BLA) for Danyelza (naxitamab) for patients with relapsed/refractory high-risk neuroblastoma. The drug was developed by researchers at Memorial Sloan Kettering Cancer Center and exclusively licensed to Y-mAbs.

FDA

Advarra

JULY 19, 2022

A: For all vendors, having documented qualifications prior to use is important. For GMP vendors, documented reviews of records such as analytical testing and batch records, is also important. The auditor prepares by reviewing relevant information, such as contracts, as well as select QMS documents and records.

Packaging

Agency IQ

AUGUST 25, 2023

Read AgencyIQ’s full analysis of the BsUFA Commitment Letter here.] Regulatory Context: Labeling for Biosimilar Products In 2018, the FDA released a guidance document entitled Labeling for Biosimilar Products. The exact text can be found in the guidance document and in an approved biosimilar product label.

Biosimilars

Perficient: Drug Development

JUNE 30, 2025

From licensing and credentialing to technology enablement and book of business transitions, the process is often a bottleneck for growth, especially for RIAs and broker-dealers looking to scale. Regulatory & Credentialing Compliance: Complete FINRA/SEC background checks, Form U4, and licensing (SIE, Series 7/66) to ensure legal readiness.

Compliance

The Pharma Data

DECEMBER 15, 2020

This is an important step towards a licensing agreement for Lipidor drug candidates, AKP01 and AKP02, for the treatment of psoriasis. According to the first target milestone, the production unit shall be ready to manufacture so-called stability batches for registration documentation during the first half of 2021.

Production

The Pharma Data

JANUARY 3, 2021

Based in Philadelphia, PA, our company has established a strategic collaboration and licensing agreement with the renowned University of Pennsylvania’s Gene Therapy Program to conduct our discovery and IND-enabling preclinical work.

Therapies

Perficient: Drug Development

MARCH 29, 2024

Each of them is developed, tested, and documented separately from the others, which simplifies the process of developing and maintaining the application as a whole. It provides the ability to run automated tests, analyze various interface states, work with mock data, create documentation, and even conduct code reviews.

Licensing

The Pharma Data

DECEMBER 12, 2020

Investors and security holders of Alexion are urged to carefully read the entire registration statement and proxy statement/prospectus or proxy statement and other relevant documents filed with the SEC when they become available because they will contain important information. Forward-looking statements.

Regulations

FDA Law Blog: Biosimilars

JUNE 27, 2024

DEA recently revoked the registration of Coconut Grove Pharmacy (“Coconut Grove”), like Gulf Med Pharmacy also in Florida, for its failure to resolve prescribing red flags and document such resolution. It also states that “[t]he pharmacist shall record any related information indicated by a licensed health care practitioner.” Id.

Pharmacy