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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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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The Pharma Data

JANUARY 11, 2021

a San Diego-based biotechnology company with an array of technology platforms for antibody discovery and optimization, and novel NK and T cell engager generation, today announced licensing of a panel of its anti-SARS-CoV-2 antibody clones to IGM Biosciences for COVID-19 therapy development. For more information, visit www.avantgen.com.

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The Pharma Data

DECEMBER 20, 2020

Allecra, subject to the satisfaction of terms and conditions as set forth in the Exclusive Licensing Agreement, is to receive an upfront cash payment and is eligible to receive additional development and commercial milestone payments with an overall deal value of $78 million, in addition to royalties.

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The Pharma Data

DECEMBER 13, 2020

The FDA also recommended that Gamida Cell generate additional manufacturing-related data prior to requesting a pre-Biologics License Application (BLA) meeting. For more information on clinical trials of omidubicel, please visit www.clinicaltrials.gov. Cautionary Note Regarding Forward Looking Statements. Source link.

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Last week, FDA issued draft guidance to address the potential complications that arise when sponsors seek to modify products, production processes, or quality controls for approved biologics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

JANUARY 5, 2021

Due to the unforeseen delays, Targovax has extended the term of IOvaxis’s license option by 3 months, otherwise the agreement remains unchanged. To accommodate the delay caused by these unforeseen circumstances, Targovax has granted to IOVaxis an extension to the license option period by 3 months. SOURCE Targovax.

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The Pharma Data

NOVEMBER 17, 2021

The agreement will enable MPP to grease fresh product and distribution of the investigational antiviral, pending nonsupervisory authorization or blessing, by grantingsub-licenses to good general drug manufacturers, with the thing of easing lesser access to the global population. This press release features multimedia.

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The Pharma Data

DECEMBER 20, 2020

” Under the License Agreement, Peijia and HighLife will establish a joint review committee to enhance a mutual sharing of information about the development as well as commercialization of the TMVR products, further deepening cooperation between the two companies. SUZHOU, China and PARIS , Dec.

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The Pharma Data

AUGUST 17, 2020

For more information about Bristol Myers Squibb, visit us at BMS.com or follow us on LinkedIn, Twitter, YouTube, Facebook, and Instagram. For more information visit us at www.Dragonflytx.com , or follow us on LinkedIn and Twitter. About Dragonfly. Dragonfly has a deep pipeline of wholly owned programs developed using its platform.

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The Pharma Data

DECEMBER 16, 2020

NASDAQ: AUPH / TSX:AUP) (“Aurinia” or the “Company”) today announced it has entered into a collaboration and license agreement with Otsuka Pharmaceutical Co., These forward-looking statements or information include but are not limited to statements or information with respect to: the Company receiving up to $50 million U.S.

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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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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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The Pharma Data

NOVEMBER 30, 2020

1, 2020 /PRNewswire/ — Sosei Group Corporation (“the Company”) (TSE: 4565) announces it has entered into a global collaboration and license agreement with Biohaven Pharmaceutical Holding Company Ltd. (“Biohaven”, NYSE: BHVN). For more information, please visit [link]. About Biohaven. About CGRP.

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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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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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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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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]

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DrugBank

NOVEMBER 7, 2023

ASHP’s full suite of drug information has been integrated into and made available through DrugBank, bringing together both company’s offerings to provide streamlined access to a broader range of high quality products. For more information, visit ashp.org and ASHP’s consumer website, SafeMedication.com.

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The Pharma Data

DECEMBER 13, 2020

Conference Call Information. For more information, please visit www.relaytx.com or follow us on Twitter. Under the collaboration, Genentech will assume development of RLY-1971 with the potential to expand into multiple combination studies including with Genentech’s investigational inhibitor of KRAS G12C, GDC-6036.

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The Pharma Data

MAY 4, 2021

Lilly is offering donations of baricitinib to the Indian government through Direct Relief while simultaneously working with local Indian pharmaceutical companies to execute royalty-free voluntary licensing agreements to accelerate the manufacturing and distribution of the medicine in India during the pandemic.

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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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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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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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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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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.

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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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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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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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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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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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Advarra

JUNE 14, 2024

Centralization of Documents When multiple studies share regulatory documents, it is most efficient to centralize them, often done electronically in an eRegulatory management system (eReg).

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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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Perficient: Drug Development

JULY 17, 2024

Any time you collect a piece of information that identifies the person, you can send the IDENTITY event. CDP debug information showing the identifiers property with two providers You can send multiple provider/ids in the identifiers attribute of the IDENTITY event. Your guest profile is linked to your browser through a browser id.

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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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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.

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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?

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