The Pharma Data

MAY 6, 2022

NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced they have submitted a supplemental Biologics License Application (sBLA) to the U.S. The booster schedule is based on the labeling information of the vaccine used for the primary series COMIRNATY® (COVID-19 Vaccine, mRNA) is an FDA-approved COVID-19 vaccine made by Pfizer for BioNTech.

FDA Approval 52

FDA Approval Licensing Licensing FDA 52

Drug Target Review

NOVEMBER 28, 2024

As a result, organisations are left to adopt bespoke solutions for each data type, ultimately resulting in convoluted, hard-to-manage data infrastructures and out-of-control licensing and operational costs.

Science 59

Science Government Engineering Licensing 59

Drug Channels

FEBRUARY 21, 2023

Pharmacies and Pharmacy Benefit Managers is a definitive, nonpartisan resource that includes the most current information about pharmacy dispensing channels, third-party payers, pharmacy benefit managers (PBMs), patients’ financial contributions, government regulations, and much more. This 2023 edition includes substantial new material.

Pharmacy 97

Pharmacy Specialty Pharmacies Licensing Licensing 97

The Pharma Data

MARCH 30, 2021

Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise. Source link:[link].

Therapies 52

Therapies Licensing Licensing Protein Expression 52

Drug Channels

FEBRUARY 22, 2022

Pharmacies and Pharmacy Benefit Managers is a definitive, nonpartisan resource that includes the most current information about pharmacy dispensing channels, third-party payers, pharmacy benefit managers (PBMs), patients’ financial contributions, government regulations, and much more. Click to Enlarge]. d/b/a Drug Channels Institute.

Pharmacy 96

Pharmacy Specialty Pharmacies Biosimilars Licensing 96

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Last week, FDA issued draft guidance to address the potential complications that arise when sponsors seek to modify products, production processes, or quality controls for approved biologics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 64

Biosimilars Licensing Licensing FDA 64

Drug Target Review

SEPTEMBER 5, 2024

This role gave me a good understanding of how important IP/patent and global marketing are for the brand but also the importance of emerging markets and co-development and out-licensing to other pharma companies. See more information about Kristina here: [link]

Pharma Companies 112

Pharma Companies Licensing Licensing Disease 112

Perficient: Drug Development

SEPTEMBER 3, 2024

In the wake of VMware’s recent license cost increase under Broadcom’s new pricing model, many enterprises are facing the pressing need to reevaluate their IT strategies. Licensing is a critical yet often overlooked factor in cloud migration decisions. Sources: [link] [link]

Licensing 52

Licensing Licensing 52

Drug Channels

OCTOBER 5, 2021

This 2021-22 edition contains the most current financial and industry data along with detailed information about the strategies and market positions of the largest companies: AmerisourceBergen, Cardinal Health, and McKesson. The exhibits appear in all license versions. pharmaceutical distribution industry.

Pharmaceuticals 75

Pharmaceuticals Biosimilars Licensing Licensing 75

Agency IQ

JUNE 2, 2023

FDA unveils long-awaited Patient Medication Information proposed rule Since 2017, the FDA has been working on a proposal to create a new type of patient-focused labeling for certain outpatient drug products that would be specifically targeted for patient use. The FDA recently concluded its work on a proposed rule focused on PMI.

FDA 40

FDA FDA Approval Production Regulations 40

Drug Channels

OCTOBER 11, 2022

This 2022-23 edition contains the most current financial and industry data along with detailed information about the strategies and market positions of the largest companies: AmerisourceBergen, Cardinal Health, and McKesson. The exhibits appear in all license versions. pharmaceutical distribution industry.

Pharmaceuticals 74

Pharmaceuticals Biosimilars Licensing Licensing 74

Perficient: Drug Development

JANUARY 24, 2024

With that being said, I’ve had a lot of experience with healthcare companies, both payers, providers and life sciences organizations dealing with HIPAA regulations over the last decade and having seen the direction Sitecore has been moving to support healthcare companies, I wanted to share some of that knowledge and information.

Licensing 96

Licensing Licensing Production Regulations 96

Molecule Blog

AUGUST 6, 2021

Therefore, it is common to use license agreements to structure the terms surrounding the IP. Before and after the transaction, access to the IP and relating license agreements need to be managed by the parties. c) Permanence Lastly, transaction history and metadata information need to be permanently available to market participants.

Licensing 52

Licensing Licensing Marketing Research 52

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. Where the RDE Resides in a Program and the Deployment Lifecycle The RDE is generally available as an environment on a per-program basis.

Packaging 105

Packaging Licensing Licensing International 105

FDA Law Blog: Drug Discovery

DECEMBER 7, 2022

This product was developed by uniQure prior to being licensed to CSL Behring. We know, for example, the use of viral vectors results in antibody production that could inhibit future administration of gene therapies using the same or similar viruses, which will inform treatment decisions by patients with their doctors.

Therapies 119

Therapies FDA FDA Approval Treatment 119

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 98

Pharmacy Specialty Pharmacies Licensing Licensing 98

DrugBank

MARCH 22, 2024

Research is emerging at a never before seen rate, and it is causing challenges for researchers and scientists to not only stay on top of the latest publications, but to validate conflicting information. They also have a reputation of containing hidden inaccuracies and out-of-date information.

Licensing 73

Licensing Licensing Research Clinical Trials 73

Advarra

APRIL 30, 2024

A cross-check ensures curriculum vitae (CVs), and medical licenses (if appropriate) are on file and current. For example, most hospital radiology technicians are trained to perform scans for the hospital and/or PI for clinical trials based on the information in the test requisitions. Form FDA 1572 The Form FDA 1572 is unique to U.S.-based

Licensing 52

Licensing Licensing Pharmacy FDA 52

Broad Institute

MAY 14, 2024

Making medicine The T7 technology has also had immediate impacts in industry, with more than 900 biotech and pharmaceutical companies licensing it to produce therapeutics and vaccines. Visit merkinprize.org for more information. and around the world. Studier was also committed to guaranteeing access to his technology.

RNA 84

RNA Production Molecular Biology Laboratories 84

Agency IQ

JUNE 2, 2023

What we expect to be talking about in June: Supply chain information: Under the FDORA legislation, holders of Biologics License Applications are required to submit a one-time report to the FDA on June 25, 2023 regarding which of their biologic products are available for sale or have been withdrawn from the market.

FDA 52

FDA Science Licensing Licensing 52

Perficient: Drug Development

MARCH 5, 2024

Organizations want to leverage the productivity enhancements Microsoft Copilot for Microsoft 365 may enable, but want to avoid unintentional over-exposure of organizational information while users are accessing these Copilot experiences. Microsoft Copilot for Microsoft 365 requires add-on licensing on top of other Microsoft 365 licensing.

Government 52

Government Licensing Licensing Production 52

Perficient: Drug Development

AUGUST 19, 2024

Salesforce Experience Cloud, previously known as Community Cloud, is a digital experience platform designed to connect customers, partners, and employees with each other and the information they need. Licenses: Experience Cloud licenses. You will need: Permission: Salesforce Administrator access. Go to the Setup.

Licensing 52

Licensing Licensing 52

The Pharma Data

SEPTEMBER 10, 2021

Abrocitinib is licensed in Great Britain in recommended doses of 100mg and 200mg. SAFETY INFORMATION. For further safety information including warnings, precautions and adverse reactions, please refer to the Summary of Product Characteristics. -This is the first marketing authorization globally for abrocitinib-. Five placebo?controlled

Marketing 52

Marketing Licensing Licensing Small Molecule 52

Perficient: Drug Development

FEBRUARY 15, 2024

Key Dates and Regulation Enforcement Enforcement of the new DFS500 amendments is slated to commence on April 29, 2024, marking the dawn of a new era in compliance, particularly in domains such as risk assessments and asset inventory management for information systems.

Compliance 52

Compliance Licensing Licensing Regulations 52

National Institute on Drug Abuse: Nora's Blog

JANUARY 3, 2025

Consequently, the report enumerates recommendations for research that should be conducted by federal, state, and tribal agencies to provide greater clarity and inform policy, including several domains within the purview of the NIH. They can also help inform the development of cannabis product safety and quality standards.

Research 78

Research Production Licensing Licensing 78

LifeSciVC

APRIL 24, 2024

Human and mouse genetics can inform not only efficacy but also safety. Alternatively, are there potential existing assets that may be available for in-licensing, especially if the potential licensor has pivoted strategic directions (i.e., asset has not been de-prioritized due to safety or efficacy)?

Production 114

Production Small Molecule Regulations Trials 114

Perficient: Drug Development

FEBRUARY 15, 2024

These reports will provide insights into regulatory compliance, summarize remediation activities, and offer trend analysis to facilitate informed decision-making. Impacted institutions are subject to significant fines relative to the level of non-compliance identified by the regulators.

Compliance 52

Compliance Regulations Licensing Licensing 52

Perficient: Drug Development

SEPTEMBER 19, 2023

More information will be available in the coming weeks. Expanded Partnerships Google Salesforce and Google are expanding their partnership to further integrate their products.

Licensing 59

Licensing Licensing Production Marketing 59

FDA Law Blog: Biosimilars

DECEMBER 3, 2023

Manufacturers must also ensure that all electronic FDA listings and all NDC listings with the electronic database vendors used to process pharmacy claims, including information about discontinued drugs, are up to date for all applicable drug and selected drug NDCs. 1395w-114c(b)(4)(B)(i). See 42 U.S.C. 1395w-114c(g)(4)(B)(ii)(II)(bb).

Compliance 105

Compliance Drugs Pharmacy Licensing 105

Drug Target Review

APRIL 4, 2024

Clozapine induced a significantly different brain state and pimavanserin, the only licensed compound for PD-P, turned out to be more similar to Mesdopetam on the global scale. This comparison corroborated the hypothesis since the D3 reference compound and Mesdopteam showed greatest global similarity.

Disease 106

Disease Treatment Licensing Licensing 106

The Pharma Data

MAY 2, 2022

– Gilead to License Exclusive Worldwide Rights to the Investigational Candidate DF7001, a 5T4-Targeting NK Cell Engager for Solid Tumors –. – Gilead to Have Options to License Several Additional NK Cell Engager Programs –. For more information visit: www.dragonflytx.com [link] [link]. Gilead Sciences, Inc.

Licensing 52

Licensing Licensing Research Protein Expression 52

The Pharma Data

MAY 27, 2022

ViiV Healthcare and MPP are actively negotiating voluntary licensing terms to help widen access to innovative HIV prevention measure .

Licensing 52

Licensing Licensing Treatment Production 52

DrugBank

AUGUST 15, 2024

Data-sharing agreements must be carefully crafted to ensure both parties can access the necessary information to advance the research while protecting confidential or proprietary data. This highlighted the importance of defining patent scope and licensing terms in such collaborations.

Drug Development 80

Drug Development Clinical Trials Drugs Therapies 80

Broad Institute

JULY 25, 2024

However, these methods face challenges due to cost, complexity, and limited information about the tissue microenvironment, which is necessary for accurate DCIS progression assessment. By Nadya Karpova, Eric and Wendy Schmidt Center July 25, 2024 Credit: Sarahkayb, distributed under a CC BY-SA 4.0

Research 69

Research Disease Treatment Clinical Trials 69

The Pharma Data

MAY 16, 2021

You should do your own research and confirm the information with other sources when searching for information regarding health issues and always review the information carefully with your professional health care provider before using any of the protocols presented on this website and/or in the product sold here.

Production 52

Production Licensing Licensing Treatment 52

The Pharma Data

MAY 14, 2021

You should do your own research and confirm the information with other sources when searching for information regarding health issues and always review the information carefully with your professional health care provider before using any of the protocols presented on this website and/or in the product sold here.

Production 52

Production Licensing Licensing Treatment 52

Perficient: Drug Development

MAY 21, 2024

Einstein Copilot operates within the Salesforce environment, interacting with various data sources and applications to provide relevant information and perform actions. This can lead to more informed decision-making and better business outcomes. This may require specific licenses and permissions. How Does Einstein Copilot Work?

Licensing 59

Licensing Licensing Production Marketing 59