The Pharma Data

MAY 7, 2021

The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. Please see Emergency Use Authorization (EUA) Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) and Full EUA Prescribing Information available at www.cvdvaccine-us.com. IMPORTANT SAFETY INFORMATION FROM U.S.

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Licensing Licensing Vaccine FDA Approval 52

The Pharma Data

JULY 18, 2021

Food and Drug Administration (FDA) granted Priority Review designation for the Biologics License Application (BLA) for their mRNA vaccine to prevent COVID-19 in individuals 16 years of age and older. The Pfizer-BioNTech COVID-19 vaccine has not been approved or licensed by the U.S. Pfizer Inc.

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Licensing Licensing Vaccine FDA 52

Conversations in Drug Development Trends

OCTOBER 26, 2022

That’s because psychedelic trials are logistically heavy, requiring special licensing for drug handling, training for staff in Schedule I drug requirements, and standardized facilities. All parties need to be thoroughly informed about what to expect and agreed-upon boundaries should be set in case the session becomes challenging.

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Trials Clinical Trials Licensing Licensing 97

New Drug Approvals

APRIL 11, 2025

“International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 75” WHO Drug Information. Retrieved 29 March 2025. World Health Organization (2016). hdl : 10665/331046. Further reading Srivastava A, Rangarajan S, Kavakli K, Klamroth R, Kenet G, Khoo L, et al.

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Clinical Trials FDA FDA Approval Trials 107

Perficient: Drug Development

MARCH 25, 2025

Real technology spend includes observability tools, containers, data platforms, SaaS licensing, AI/ML, and peripheral services, sometimes hand-waved away as shadow IT or just life as part of an unavoidable cost center. Complexity is increasing: multicloud and hybrid environments are the norm.

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Engineering Production Licensing Licensing 52

FDA Law Blog: Biosimilars

JUNE 12, 2024

With input from medical professionals, stakeholder, trade associations, and patient advocacy groups, FDA provided a pathway to market for air-conduction hearing aids without a prescription or the involvement of a licensed professional. While helpful background, it’s not new information.

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FDA Regulations Treatment Licensing 111

Drug Hunter

JUNE 25, 2023

This edition includes Maze’s glycogen synthase 1 (GYS1) inhibitors that were recently licensed to Sanofi, allosteric androgen receptor (AR) modulators that may be of interest to targeted protein degradation researchers, and brain-penetrant HER2 and ROCK2 inhibitors. Get ahead now by requesting a trial. already a member?

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Targeted Protein Degradation Computational Chemistry Trials Licensing 130

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.

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Pharmacy Specialty Pharmacies Licensing Licensing 97

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.

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Science Government Engineering Licensing 59

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].

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Therapies Licensing Licensing Protein Expression 52

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.

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Biosimilars Licensing Licensing FDA 64

The Pharma Data

DECEMBER 14, 2020

15, 2020 (GLOBE NEWSWIRE) — Burning Rock Biotech Limited (NASDAQ: BNR, the “Company” or “Burning Rock”) today announced that it entered into an exclusive licensing agreement with Oncocyte Corporation (NYSE American: OCX) to bring DetermaRx , a risk stratification test for early stage lung cancer patients, to China. 1 Kratz et al.,

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Licensing Licensing Pharmaceutical Companies Treatment 52

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.

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Licensing Licensing Research Clinical Trials 98

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]

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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.

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Pharmaceuticals Biosimilars Licensing Licensing 75

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.

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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.

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Licensing Licensing Production Regulations 96

New Drug Approvals

MAY 9, 2025

Jump up to: a b “Orserdu Product information” Union Register of medicinal products. Archived from the original on 2 February 2023. Retrieved 1 February 2023. This article incorporates text from this source, which is in the public domain. 18 September 2023. Retrieved 1 October 2023. 9 October 2023. . 26 (9): 948956. PMC 4560273.

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FDA Pharmacokinetics Therapies Treatment 62

The Pharma Data

NOVEMBER 4, 2020

Bactiguard’s growth strategy for the coming five-year period up to 2025 is based on a continued roll-out of Bactiguard’s technology, with a focus on new license agreements and a broader product portfolio. We have several interesting licensing projects ongoing and see new, exciting business opportunities. unchanged).

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Licensing Licensing Production Marketing 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.

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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.

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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.

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Pharmacy Specialty Pharmacies Licensing Licensing 98

New Drug Approvals

MAY 15, 2025

. “International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 76” WHO Drug Information. “International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 77” WHO Drug Information. hdl : 10665/331020. World Health Organization (2017).

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FDA Approval FDA Treatment International 62

Policy Prescription

MAY 28, 2021

That New York Times piece included the following parenthetical disclaimer: “(My company, PharmacyChecker.com, helps Americans find information on obtaining lower-cost medications from Canada and other countries, so I have a financial stake in making sure the public is informed.)” and licensed by your state board of pharmacy.”

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Pharmacy Licensing Licensing Online Pharmacies 52

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.

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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.

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The Pharma Data

DECEMBER 21, 2020

percent of licensed practical nurses and registered nurses held second jobs. For registered nurses and licensed practical nurses, fewer hours were more strongly correlated with a second job. . Further Support and Information on COVID-19. The researchers found that on average, 6.41 © 2020 HealthDay. All rights reserved.

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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.

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Licensing Licensing 52

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

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Licensing Licensing Pharmacy FDA 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

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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.

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Compliance Licensing Licensing Regulations 52

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)?

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Production Small Molecule Regulations Trials 127

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.

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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.

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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.

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Licensing Licensing Production Marketing 59

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.

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Licensing Licensing Research Protein Expression 52

The Pharma Data

NOVEMBER 25, 2020

technology platform simultaneously identifies both targets and the antibodies that bind to them, generating many promising new drug candidates to fuel the Company’s own clinical development pipeline or for additional licensing and partnering. More information is available at www.bioinvent.com. BioInvent International AB (publ).

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