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. FDA does, however, expect to issue a report on OTC hearing aid adverse events to Congress by August 2024.

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The Pharma Data

AUGUST 17, 2020

The forward-looking statements included in this document are made only as of the date of this document and except as otherwise required by applicable law, Bristol Myers Squibb undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances or otherwise.

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Perficient: Drug Development

AUGUST 12, 2024

Comprehensive and Unified Offering Azure Integration Services offers a comprehensive and unified suite of integration tools, including Azure Logic Apps, Azure Service Bus, Azure API Management, and Azure Event Grid. Businesses pay only for the resources they use, allowing for better cost control and budgeting.

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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 Patent Watch

OCTOBER 29, 2019

This article was originally published by Garth Boehm, Lixin Yao, Liang Hana, and Qiang Zheng in Acta Pharmaceutica Sinica under a creative commons license. Abstract The key events in the….

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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). . TOKYO and CAMBRIDGE, England , Dec. Biohaven Forward-looking statements.

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The Pharma Data

JANUARY 19, 2021

Ilan Sobel, CEO of BHSC, will host the event and discuss progress on Bioharvest’s Growth Plan, which will include highlights of the 2020 milestones achieved, key business capabilities built, and will provide an important overview of 2021 Priorities. Readers should not place undue reliance on forward-looking statements.

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Agency IQ

JUNE 2, 2023

What We Expect the FDA to do in June 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

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FDA Law Blog: Biosimilars

JANUARY 11, 2024

This day-long (FREE) seminar is a must-attend event for anyone in the pharmaceutical sector interested in understanding the “ins and outs” of doing business in the Territory, as well as an opportunity to interact with those who already have a keen understanding of doing business in Puerto Rico. HPM is a co-sponsor of the event.

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The Pharma Data

DECEMBER 13, 2020

In the event of regulatory approval of both RLY-1971 and GDC-6036 in combination, Relay Therapeutics is eligible to receive additional royalties. Relay Therapeutics retains the right to combine RLY-1971 with its selective FGFR2 and mutant-selective PI3K?

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Perficient: Drug Development

JULY 17, 2024

Sitecore CDP tracks user behavior by linking browsing session, events, and orders to a guest profile. In order to identify a guest, we must send an “IDENTITY” event. An identity event is a specific type of event that tells Sitecore CDP to begin the identity resolution process.

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The Pharma Data

MARCH 14, 2021

Following a recent concern raised around thrombotic events, AstraZeneca would like to offer its reassurance on the safety of its COVID-19 vaccine based on clear scientific evidence. This is much lower than would be expected to occur naturally in a general population of this size and is similar across other licensed COVID-19 vaccines.

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FDA Law Blog: Biosimilars

NOVEMBER 1, 2023

FDA recognizes that the FD&C Act exempts licensed healthcare practitioners from certain device regulations if they manufacture devices solely for use in the course of their professional practice. For example, FDA’s regulations have exempted from certain regulatory requirements (e.g.,

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FDA Law Blog: Drug Discovery

DECEMBER 7, 2022

This product was developed by uniQure prior to being licensed to CSL Behring. This was despite the 6-month data also demonstrating clinical benefits in reduction of bleeding events and declines in the use of FIX replacement therapy.

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LifeSciVC

APRIL 24, 2024

If adverse events are anticipated, it is important to understand gene dosage for such an effect (e.g., 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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Advarra

APRIL 30, 2024

For example, non-medical personnel should not assess adverse event causality or confirm the clinical significance of lab results. A cross-check ensures curriculum vitae (CVs), and medical licenses (if appropriate) are on file and current. Both the medical licenses and nurse licenses need to be up to date.

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The Pharma Data

OCTOBER 6, 2021

It is also licensed under the brand name Efluelda ® in Europe where it is indicated for adults aged 60 and older. It is also licensed under the brand name Efluelda® in Europe where it is indicated for adults aged 60 and older. About Sanofi. Sanofi is dedicated to supporting people through their health challenges.

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Perficient: Drug Development

MARCH 5, 2024

Assigning the Right License Access to objects is determined based on the license type, such as High-Volume Customer Community, Customer Community Plus, and Partner Community. Regularly Run Security Scans Tools like Salesforce event monitoring, IBM Qradar, and CheckMarx can conduct regular health scans.

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Perficient: Drug Development

SEPTEMBER 19, 2023

Last week, Perficient attended the largest AI event in the world, Dreamforce, in San Francisco. jobs by 2028.

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LifeSciVC

JANUARY 16, 2024

Rise of the best-in-class biologics plays: Are you looking to in-license or invest in “de-risked” biology that is already in the clinic? Probably challenging given Cmax-driven adverse event profile, safety requirements, and COGS constraints for an obesity or related indications. Join the club.

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FDA Law Blog: Biosimilars

JULY 18, 2023

Those include biological products licensed under Biologics License Applications (BLAs), approved drugs under New Drug Applications (NDAs), and generic products under approved Abbreviated New Drug Applications (ANDAs). Four specific kinds of events comprised over a third of the 900+ recalls.

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The Pharma Data

JANUARY 14, 2021

Before today’s announcement, physicians wishing to prescribe buprenorphine outside of opioid treatment programs had to take an eight-hour course and often waited 60 to 90 days to receive the waiver once the course is completed and the license application is submitted.

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The Pharma Data

DECEMBER 13, 2020

SELLAS’ lead product candidate, galinpepimut-S (GPS), is licensed from Memorial Sloan Kettering Cancer Center and targets the Wilms Tumor 1 (WT1) protein, which is present in an array of tumor types. All statements other than statements of historical facts are “forward-looking statements,” including those relating to future events.

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The Pharma Data

NOVEMBER 23, 2020

The information in this release is provided only as of the date of this release, and Synthetic Biologics undertakes no obligation to update any forward-looking statements contained in this release on account of new information, future events, or otherwise, except as required by law. . .

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The Pharma Data

SEPTEMBER 30, 2021

Anderson Professor of Chemical and Biomolecular Engineering, and his colleagues, are reporting in iScience the event of an intranasal subunit vaccine that gives durable local immunity against inhaled pathogens. But now, we’re one step closer. Navin Varadarajan, University of Houston M.D.

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The Pharma Data

JANUARY 21, 2021

Spectrum has a strong track record of successfully executing across the biopharmaceutical business model, from in-licensing and acquiring differentiated drugs, clinically developing novel assets, successfully gaining regulatory approvals and commercializing in a competitive healthcare marketplace.

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The Pharma Data

JANUARY 4, 2021

The program was licensed to Allergan in April 2016 , and Allergan was acquired by AbbVie in May 2020. The event reported today has no immediate impact on the consolidated financial results for the accounting period ending December 2021. ” About the License Agreement. TOKYO and CAMBRIDGE, England , Jan. Source link.

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The Pharma Data

SEPTEMBER 25, 2020

Furthermore, the drug’s safety profile was shown to be in line with previous findings, with a similar prevalence of adverse events. Gilead’s Japanese branch will hold the commercial license as well as handle supply of the product in Japan, while Eisai will be responsible for distributing it in the country for RA. “RA

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The Pharma Data

DECEMBER 29, 2020

is a medical device company with a novel and proprietary platform technology licensed from The University of Texas on behalf of MD Anderson Cancer Center. These statements relate to future events, future expectations, plans and prospects. .” Join our more than 200K subscribers here to follow the Company: [link].

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The Pharma Data

DECEMBER 28, 2020

This news release contains forward-looking statements relating to product development, licensing, commercialization and regulatory compliance issues and other statements that are not historical facts. No Securities Exchange has reviewed nor accepts responsibility for the adequacy or accuracy of the content of this news release.

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Perficient: Drug Development

NOVEMBER 28, 2023

Hexagonal Architecture and DevSecOps: Fundamentals of our operation The state-of-the-art of our ecosystem is defined by a hexagonal architecture , domain-driven design, and event-driven architecture. In the vehicular domain, our systems, connected to the Azure cloud via IoT, search for incident-related license plates in real time.

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The Pharma Data

OCTOBER 20, 2020

We look forward to successful commercialization and licensing of TLC’s programs across the globe under Mr. Bliss’s leadership, as well as to creating benefit and bringing value for all of TLC’s stakeholders.”. Contact Dawn Chi Corporate Communications dawn@tlcbio.com. Source link.

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The Pharma Data

JANUARY 31, 2021

is a medical device company with a novel and proprietary platform technology licensed from The University of Texas on behalf of MD Anderson Cancer Center. These statements relate to future events, future expectations, plans and prospects. Join our more than 200K subscribers here to follow the Company: [link].

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The Pharma Data

OCTOBER 14, 2020

Live Webcast : accessible from the Company’s website at www.eloxxpharma.com under Events and Presentations or with this link: [link]. We undertake no obligation to update any forward-looking statement in light of new information or future events, except as otherwise required by law. Domestic Dial-in Number : (866) 913-8546.

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The Pharma Data

JUNE 24, 2021

The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. Appropriate medical treatment used to manage immediate allergic reactions must be immediately available in the event an acute anaphylactic reaction occurs following administration of Pfizer BioNTech COVID-19 Vaccine.

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BMG Labtech

DECEMBER 20, 2024

The ability to measure reactive oxygen species can provide important information on, for example, cell signaling events including those that take place in bacteria and other cells. Such events may impact the control of gene expression and enzyme activities and lead to changes in metabolism in bacteria. and Hinshelwood, C.

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The Pharma Data

OCTOBER 19, 2020

CNS holds a worldwide exclusive license to the Berubicin chemical compound and has acquired all data and know-how from Reata Pharmaceuticals, Inc. These statements relate to future events, future expectations, plans and prospects. Any forward-looking statements contained in this press release speak only as of its date.

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