The Pharma Data

DECEMBER 15, 2020

This is an important step towards a licensing agreement for Lipidor drug candidates, AKP01 and AKP02, for the treatment of psoriasis. This disclosure contains information that Lipidor is obliged to make public pursuant to the EU Market Abuse Regulation (EU nr 596/2014). Aurena Laboratories has already met the requirements of the U.S.

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The Pharma Data

NOVEMBER 24, 2020

Rolling Review, which means that a drug company can submit completed sections of its Biologic License Application (BLA) or New Drug Application (NDA) for review by FDA, rather than waiting until every section of the NDA is completed before the entire application can be reviewed. This information was brought to you by Cision [link].

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The Pharma Data

JANUARY 10, 2021

Download the slideshow of meetings on the Company website, in the Documentation section dedicated to investors: www.valbiotis.com/en/documents/. Its products are intended to be licensed to players in the health sector. Its products are intended to be licensed to players in the health sector.

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Advarra

JULY 19, 2022

For more information on key components of a fit-for-purpose, phase-by-phase QMS guidance download Advarra’s whitepaper Steps to Implementing a Quality Management System. The standard for the audit used depends on the type of vendor and would include the applicable regulations and ICH guidelines. IRBs are subject to 21 CFR 56 IRBs.

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The Pharma Data

JANUARY 25, 2021

. “ This marks our second strategic agreement with Asieris, a well-run and well-capitalized company that is executing ahead of plan on the clinical development of Cevira ®, which we licensed to them in July 2019. The following files are available for download: View original content: [link]. SOURCE Photocure. Source link.

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The Pharma Data

JANUARY 27, 2021

Entered an exclusive license and supply agreement with Accord Healthcare for ZUBSOLV® covering 29 European countries. is obliged to make public pursuant to the EU Market Abuse Regulation. The following files are available for download: View original content: [link]. Important events after the period.

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The Pharma Data

NOVEMBER 2, 2020

This condition is caused by a mutation in the fibroblast growth factor receptor 3 gene ( FGFR3 ), a negative regulator of bone growth. Europe, Latin America, the Middle East, and most of Asia Pacific, there are currently no licensed medicines for achondroplasia. This is approximately 25% of people with achondroplasia. In the U.S.,

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Agency IQ

MAY 10, 2024

That EO included some life sciences-specific standards and strategy development, including directing HHS to develop a new strategy on regulating the use of AI or AI-enabled tools in drug development and establish an HHS AI task force, which would focus on safety related to the various health-related uses of AI (e.g.,

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The Pharma Data

NOVEMBER 5, 2020

Background and reason Moberg Pharma is a Specialty Pharma company focused on developing and commercialising proprietary, acquired and licensed products globally, from clinical development of products based on proven substances to commercialisation. The following files are available for download: View original content: [link].

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The Pharma Data

OCTOBER 14, 2020

View original content to download multimedia: [link]. Harmony Biosciences Media Contact: Nancy Leone. 215-891-6046. nleone@harmonybiosciences.com. Harmony Biosciences Investor Contact: Lisa Caperelli. 484-539-9736. lcaperelli@harmonybiosciences.com. SOURCE Harmony Biosciences. Source link.

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Agency IQ

SEPTEMBER 29, 2023

Regulators wanted input on questions related to data access and re-use, to inform its legislative framework on common European data spaces. Two intertwined proposals have been laid out – a regulation on data governance and the proposed data act. Data intermediation service is defined in Regulation (EU) 2022/868.

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Codon

FEBRUARY 13, 2024

Phage-based products have been licensed for use as antibacterial agents in the sanitation , food production , and animal health industries. But one can only train a phage so much before it has changed, genetically, to the point where it is now considered a different phage to the one the regulator initially approved.

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The Pharma Data

DECEMBER 21, 2020

UBX1325 is developed from BM-962, a Bcl-xL inhibiting compound licensed to UNITY by Ascentage Pharma for the treatment of age-related diseases. This progress in clinical development qualifies Ascentage Pharma for a milestone payment according to the terms of the licensing agreement. View original content to download multimedia: [link].

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The Pharma Data

JANUARY 13, 2021

A preprint supporting Brilacidin’s COVID-19 treatment potential can be downloaded at the link below. Brilacidin for UP/UPS was licensed to Alfasigma S.p.A. Global COVID-19 Cases and Mortality An online tool tracking COVID-19 cases and mortality, both in the U.S. Source link.

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The Pharma Data

SEPTEMBER 16, 2020

We develop product candidates internally and through licensing collaborations, partnerships and joint ventures. Furthermore, our research, testing, pricing, marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities. View original content to download multimedia: [link].

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The Pharma Data

SEPTEMBER 20, 2020

We develop product candidates internally and through licensing collaborations, partnerships and joint ventures. Furthermore, our research, testing, pricing, marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities. View original content to download multimedia: [link].

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The Pharma Data

NOVEMBER 9, 2020

Amgen develops product candidates internally and through licensing collaborations, partnerships and joint ventures. Furthermore, Amgen’s research, testing, pricing, marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities. J Allergy Clin Immunol. 15 Fahy JV.

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The Pharma Data

JANUARY 21, 2021

Trademarks are owned by or licensed to Janssen and the ViiV Healthcare group of companies. View original content to download multimedia: [link]. . Oral therapy for patients who will miss planned injection dosing with CABENUVA (cabotegravir; rilpivirine) extended-release injectable suspensions. US Approval January 2021.

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The Pharma Data

DECEMBER 21, 2020

Amgen develops product candidates internally and through licensing collaborations, partnerships and joint ventures. Furthermore, Amgen’s research, testing, pricing, marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities. Available at: [link]. SOURCE Amgen.

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Drug & Device Law

JULY 31, 2023

2003), an Internal Revenue Service regulation, excluded liability for “product” refund, repair or replacement. While “strict products liability may apply to standardized and mass-downloaded software [it] does not apply to information or ‘expressive’ content.” However, licensed software can be a UCC sale of “goods.” 9 (S.D.N.Y.

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