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. During the meeting, the FDA provided encouraging feedback regarding the Phase 3 study of omidubicel pertaining to the pre-specified primary and secondary endpoints.

Licensing 52

Licensing Licensing Clinical Trials FDA 52

The Pharma Data

OCTOBER 15, 2020

More than a month has passed since AstraZeneca’s phase 3 COVID-19 vaccine trial was paused due to a potential adverse event, but few solid details have emerged from ongoing safety reviews by the FDA and the UK drugmaker. was paused after a single UK patient experienced a serious adverse event ( DID, Sept.

Vaccine 40

Vaccine Trials FDA Licensing 40

The Pharma Data

MARCH 30, 2021

Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. You should not place undue reliance on these statements. Source link:[link].

Therapies 52

Therapies Licensing Licensing Protein Expression 52

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.

Licensing 52

Licensing Licensing Production Clinical Trials 52

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.

Compliance 105

Compliance Licensing Licensing Production 105

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.,

Licensing 52

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

FDA 111

FDA Regulations Treatment Licensing 111

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.

Small Molecule 40

Small Molecule Licensing Licensing Treatment 40

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.

Science 40

Science Production Licensing Licensing 40

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.

FDA 52

FDA Science Licensing Licensing 52

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.

Pharmaceuticals 59

Pharmaceuticals Licensing Licensing Compliance 59

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?

Licensing 40

Licensing Licensing Clinical Trials Small Molecule 40

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.

Licensing 52

Licensing Licensing International 52

The Pharma Data

JUNE 6, 2025

Treatment-emergent adverse events (TEAEs) occurred in 76.3% Food and Drug Administration (FDA) granted the therapy Priority Review status in May 2025 following its Biologics License Application (BLA) submission in March, reflecting the agency’s recognition of its potential to address a serious condition with limited treatment options.

Trials 40

Trials Treatment Therapies FDA 40

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.,

Laboratories 81

Laboratories FDA Regulations Licensing 81

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.

Vaccine 52

Vaccine Virus Licensing Licensing 52

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)?

Production 131

Production Small Molecule Regulations Trials 131

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.

Therapies 119

Therapies FDA FDA Approval Treatment 119

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….

Licensing 42

Licensing Licensing Drugs 42

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.

Vaccine 52

Vaccine Licensing Licensing Immune Response 52

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.

Licensing 59

Licensing Licensing International Regulations 59

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.

Licensing 52

Licensing Licensing Pharmacy FDA 52

Perficient: Drug Development

SEPTEMBER 19, 2023

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

Licensing 59

Licensing Licensing Production Marketing 59

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.

Small Molecule 143

Small Molecule Trials Therapies Disease 143

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.

FDA 52

FDA Licensing Licensing Laboratories 52

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.

Treatment 52

Treatment Licensing Licensing Hospitals 52

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.

Science 52

Science Licensing Licensing Production 52

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. . .

Compliance 52

Compliance Licensing Licensing Clinical Trials 52

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.

Vaccine 52

Vaccine Disease Immune Response Virus 52

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.

Pharmaceuticals 52

Pharmaceuticals Clinical Trials Licensing Licensing 52

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.

Licensing 40

Licensing Licensing Clinical Trials Disease 40

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

Licensing 40

Licensing Licensing International Treatment 40

Elrig

APRIL 29, 2025

The event is held in partnership with Drug Discovery News. She serves as the Director of Business DevelopmentSearch and Evaluation at AstraZeneca, focusing on licensing and collaboration opportunities for drug candidates targeting respiratory and immunology indications.

Drugs 52

Drugs Science Clinical Trials Doctors 52

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].

FDA 52

FDA Licensing Licensing Production 52

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.

Licensing 52

Licensing Licensing Compliance Virus 52

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.

Licensing 52

Licensing Licensing Government Production 52

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.

Licensing 40

Licensing Licensing Pharmaceutical Companies Pharmaceuticals 40