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.

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Drug Discovery World

OCTOBER 2, 2023

DDW’s Megan Thomas heard from attendees about their key takeaways from the event. Dr Mindy Miller, Lead Research Scientist, Terumo Blood And Cell Technologies Conversations and data shared at the CAR-TCR 8 th Annual Summit highlighted the importance of optimising the science behind the therapies to broaden patient access.

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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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Drug Discovery World

NOVEMBER 24, 2023

This means durvalumab was granted intellectual property (IP) and included in the Innovative Licensing and Access Pathway (ILAP), which aims to reduce the time it takes innovative treatments to be made available to NHS patients. Grade 3 or 4 treatment-related adverse events (AEs) were experienced by 60.9% 0.97, p=0.021). months to 12.9

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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

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].

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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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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

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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Drug Discovery World

MAY 29, 2024

Doors at pharma can open either with BD-to-BD outreach or scientist-scientist interactions at conferences and networking events. Clarify whether mid-level scientists who are eager to license or acquire the assets and leading the discussions still need to clear the case with a senior executive who may not be that interested in it.

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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

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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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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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., VICTORIA, British Columbia & ROCKVILLE, Md.–( –( BUSINESS WIRE )– Aurinia Pharmaceuticals Inc. Also, many of the factors are beyond our control.

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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 Discovery World

FEBRUARY 9, 2023

This means durvalumab is eligible for inclusion in the Innovative Licensing and Access Pathway (ILAP). This means durvalumab is eligible for inclusion in the Innovative Licensing and Access Pathway (ILAP). Grade 3 or 4 treatment-related adverse events (AEs) were experienced by 60.9% 4 Updated median OS was 12.9 versus 11.5%).

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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. BA HCP ISI 09JUL2020.

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FDA Law Blog: Biosimilars

AUGUST 29, 2024

Each party that violates or assists in the violation of this section shall forfeit and pay to the United States a civil penalty sufficient to deter violations of this section, but in no event greater than 3 times the value received by the party that is reasonably attributable to the violation of this section.

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

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Drug Discovery World

MARCH 13, 2024

of patients experienced adverse events (AEs), with no evidence of dose-dependent increase in AEs, including gastrointestinal disorders. The most frequently reported AEs were nasopharyngitis (18.1%), upper respiratory tract infection (9.7%) and Covid-19 (5.3%). Across JNJ-2113 treatment groups, 58.6%

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Drug Discovery World

SEPTEMBER 14, 2023

Moreover, in July 2023, AstraZeneca and Vaxess Technologies commenced a collaboration for the evaluation of a novel RNA-based pandemic influenza prototype vaccine in patch format.

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Drug Discovery World

AUGUST 21, 2023

Medications containing semaglutide such as Ozempic, licensed for diabetes, and Wegovy, for weight loss, are being studied to see if they can treat a range of different conditions, including addiction and dementia.

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The Pharma Data

NOVEMBER 29, 2020

Compared to conventional “occupancy-driven” pharmacological modality, the “event-driven” PROTAC technology has many advantages, such as high potency, high selectivity, with catalytic mode of action, and the ability to target undruggable proteins.

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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

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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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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Drug Discovery World

JULY 25, 2023

So far, we have produced three GMP batches with contract development and manufacturing organisations (CDMOs) and have a lot of inbound interest for licensing of the process especially from CDMOs that are trying to enter the mRNA space.

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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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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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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

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

AUGUST 15, 2021

6,9,10 Clinical studies demonstrated that TICOVAC was generally well-tolerated with no unexpected adverse events or vaccine-related serious adverse events observed. In clinical trials, the safety and immunogenicity of TICOVAC were assessed across two age groups (1-15 years of age and >16 years of age). in 1-15 year olds and 98.7-100%

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The Pharma Data

APRIL 27, 2023

The most frequently observed solicited adverse events were injection site pain, fatigue, myalgia, headache, and arthralgia. The most frequently observed solicited adverse events were injection site pain, fatigue, myalgia, and headache. Efficacy was 94.6% (95% CI, 65.9–99.9, These were generally mild to moderate and transient.

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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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FDA Law Blog: Biosimilars

JULY 5, 2023

Under section 503B, drugs compounded by an FDA-registered outsourcing facility under the supervision of a licensed pharmacist can qualify for exemptions from FDA approval, labeling with adequate directions for use, and certain drug supply chain security requirements, subject to specific conditions. Draft Guidance III.B.2(e)

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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

NOVEMBER 9, 2021

Among those treated with OLUMIANT, the overall prevalence rate of adverse events per 100 patient times of exposure was22.6, and the prevalence rate of serious adverse events was7.4. Priority check events included herpes zoster (3, n = 100), liver dysfunction (3, n = 100), serious infection (1.5, times and a outside exposure of9.3

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