Agency IQ

AUGUST 4, 2023

The document specifically notes that it applies to “medicinal products for human use intended to be placed on the market in Northern Ireland in accordance with Article 6 of Directive 2001/83/EC,” the current European pharmaceutical legislation. Article 54(o) of the existing E.U. Definitions from the existing E.U.

Packaging 40

Packaging Licensing Licensing Regulations 40

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. All types of activities encouraging women in STEM is important, like this article.

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Pharma Companies Licensing Licensing Disease 111

Drug Patent Watch

JULY 16, 2020

This article was originally published by Syed Sauban Ghani in Eclética Química under a Creative Commons license. ABSTRACT As scientific community worldwide is publishing a huge number of research articles….

Licensing 52

Licensing Licensing Research 52

Drug Target Review

DECEMBER 11, 2024

In this article, we share our hard-earned insights into overcoming these critical challenges. Despite these advancements, analysing biologically derived targets remains a formidable challenge due to interference from endogenous molecules.

International 52

International Laboratories Drugs Pharmacokinetics 52

Drug Target Review

MARCH 17, 2025

Donello was most recently Vice President of External Science & Innovation at Allergan/AbbVie, where he led R&D innovation efforts to develop strategic collaborations, in-license clinical-stage assets and evaluate M&A opportunities.

Treatment 52

Treatment Licensing Licensing Science 52

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 53

Licensing Licensing Drugs 53

Perficient: Drug Development

SEPTEMBER 25, 2023

Version Control in Salesforce Knowledge: When you want to update your article, it means you are creating a new version of it. And the old article does not vanish because it remains in the draft state carrying its version number. Let’s create a new version of the published article. Published articles can never be edited.

Licensing 59

Licensing Licensing 59

Drug Patent Watch

DECEMBER 21, 2020

This article was originally published by Sajna T. in Management Insight, 16(1):38-40 under a creative commons license. Abstract Business enterprises are an important organ of society. The impact of a…. The post Indian Pharma—Some Challenges and Acceptances appeared first on DrugPatentWatch - Make Better Decisions.

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Licensing Licensing 52

Drug Patent Watch

JANUARY 21, 2021

This article was first published by Elinevan Overbeeke, Sissel Michelsen, Mondher Toumi, Hilde Stevens, Mark Trusheim, Isabelle Huys, and StevenSimoens in Drug Discovery Today under a Creative Commons License. Highlights….

Marketing 52

Marketing Therapies Licensing Licensing 52

Drug Patent Watch

JANUARY 5, 2021

This article was originally published by Andreas Bender and Isidro Cortes-Ciriano in Drug Discovery Today under a Creative Commons license. Although artificial intelligence (AI) has had a profound impact on…. The post Artificial intelligence in drug discovery: what is realistic, what are illusions?

Licensing 52

Licensing Licensing Drugs 52

Drug Hunter

APRIL 20, 2023

3: YCT529 (University of Minnesota, Georg lab, licensed by YourChoice Therapeutics, 13%) In third place was YCT529 , from UMN/YourChoice Therapeutics. A recent preclinical study demonstrated that MRTX113 was able to reduce tumor size in KPC mice , a pancreatic cancer model that is resistant to every drug tested. LP0200 has completed a Ph.

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Small Molecule Clinical Trials Trials Licensing 130

Drug Target Review

NOVEMBER 28, 2024

As a result, organisations are left to adopt bespoke solutions for each data type, ultimately resulting in convoluted, hard-to-manage data infrastructures and out-of-control licensing and operational costs.

Science 59

Science Government Engineering Licensing 59

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.

FDA 52

FDA Science Licensing Licensing 52

Agency IQ

MAY 28, 2024

Additionally, companion diagnostics and combination products that contain medicinal substances that haven’t yet been licensed in the U.K. These include medical devices with risk Classes Is/m/r that have licenses in Canada or de novo or 510(k) clearance in the U.S. Devices with Canadian licenses or those cleared via the U.S.

International 40

International Regulations Licensing Licensing 40

The Pharma Data

JANUARY 12, 2021

Before it was licensed, the Merck Ebola vaccine was used under a “compassionate use” protocol to control outbreaks in Guinea and Congo, the AP reported. Associated Press Article. Nearly 7,000 doses are currently available. © 2021 HealthDay. All rights reserved. Posted: January 2021. More News Resources.

Vaccine 52

Vaccine Licensing Licensing Doctors 52

Policy Prescription

MAY 28, 2021

The title of one article in Kaiser Health News about PSM explains a lot: “Nonprofit Linked To PhRMA Rolls Out Campaign To Block Drug Imports.” and licensed by your state board of pharmacy.” state-licensed board of pharmacy licensed pharmacy.”. state-licensed board of pharmacy licensed pharmacy.”.

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Pharmacy Licensing Licensing Online Pharmacies 52

The Pharma Data

OCTOBER 22, 2020

The collaboration will make trusted, public health information available under the Creative Commons Attribution-ShareAlike license at a time when countries face continuing resurgences of COVID-19 and social stability increasingly depends on the public’s shared understanding of the facts. . About the World Health Organization.

Licensing 52

Licensing Licensing International Government 52

The Pharma Data

NOVEMBER 29, 2020

The forward-looking statements made in this article relate only to the events or information as of the date on which the statements are made in this article. You should read this article completely and with the understanding that our actual future results or performance may be materially different from what we expect.

Licensing 40

Licensing Licensing Small Molecule Clinical Trials 40

Agency IQ

MAY 28, 2024

The FDA-required labeling is the drug labeling that is submitted by the sponsor and reviewed and approved by the FDA as part of the drug’s marketing application (including a New Drug Application, Abbreviated NDA, or a Biologics License Application) and includes prescribing information (PI).

FDA 40

FDA Regulations Production Licensing 40

Agency IQ

JUNE 28, 2024

The FDA-required labeling is the drug labeling that is submitted by the sponsor and reviewed and approved by the FDA as part of the drug’s marketing application (including a New Drug Application, Abbreviated NDA, or a Biologics License Application) and includes prescribing information (PI).

FDA 40

FDA Regulations Production Licensing 40

FDA Law Blog: Biosimilars

SEPTEMBER 18, 2024

The phrase in subsection (ii) “authorized for investigation as a new drug” is generally accepted to mean that an IND is in effect.

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Production FDA Licensing Licensing 59

The Pharma Data

NOVEMBER 8, 2020

Sedor is actively engaged in discussions to license the rights to Sesquient for North America, Europe, and other territories except for the Peoples Republic of China, where it has already been successfully licensed. Sedor Pharmaceuticals, LLC identifies, acquires and develops acute care pharmaceutical assets for commercial licensing.

FDA Approval 52

FDA Approval FDA Long-Term Care Facilities Treatment 52

FDA Law Blog: Biosimilars

JANUARY 3, 2024

CVM does not regulate the practice of veterinary medicine (that’s a state licensing board) or vaccines for animal diseases (that’s USDA). Palmer & Riëtte van Laack — Most of us love our furry friends, and with the boom in pet ownership during the pandemic, it is no surprise that the market for pet products has become enormous.

Drugs 59

Drugs FDA Licensing Licensing 59

Molecule Blog

AUGUST 6, 2021

In this article, we are going to focus on the first technical implementation of a biopharma IPNFT. 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.

Licensing 52

Licensing Licensing Marketing Research 52

The Pharma Data

NOVEMBER 26, 2020

The EGM resolved on amendment of § 4 (share capital) and § 5 (number of shares) of the Articles of Association for the purpose of enabling the directed issue of shares and warrants, as resolved by the Board of Directors on 27 October 2020 subject to the approval by the EGM. § LUND, Sweden , Nov. LUND, Sweden , Nov. sammanläggning 1:25 ).

Clinical Trials 52

Clinical Trials Licensing Licensing International 52

Agency IQ

MARCH 7, 2024

DAVID GREENBERG of Sanofi provided perspective based on an industry questionnaire , saying the transition will require industry to “re-activate or re-submit more than 300 TIV licenses, submit nearly 1500 variations, and update quality data in 174 countries.”

Vaccine 40

Vaccine FDA Virus Licensing 40

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. SUZHOU, China and ROCKVILLE, Md. ,

Clinical Development 40

Clinical Development Disease Treatment Licensing 40

Agency IQ

SEPTEMBER 29, 2023

Essential requirements for interoperability of data spaces: The participants of the data space must sufficiently describe (in machine-readable format where applicable) the dataset content, use restrictions, licenses, data collection methodology and quality. app interfaces) automatically and through bulk download where technically feasible.

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Regulations Government Production International 40

Perficient: Drug Development

SEPTEMBER 11, 2023

If you read my last article, the big deal with headless , you know that the big deal is performance. Implementing Experience Edge requires additional licensing beyond the standard Sitecore licensing, reflecting the added performance enhancements it offers. The architecture you get leveraging a headless architecture with Next.js

Licensing 52

Licensing Licensing Packaging Marketing 52

Agency IQ

AUGUST 25, 2023

The FDA states that “certain text in the reference product labeling related to condition(s) of use for the reference product that are not licensed for the biosimilar product would generally not be included in the biosimilar product labeling.”

Biosimilars 40

Biosimilars FDA Production Licensing 40

Agency IQ

JANUARY 12, 2024

The regulator is also working on an Innovative Device Access Pathway (IDAP) that mirrors the pathway already in place for drugs (the Innovative Licensing Access Pathway, or ILAP). Canada, Japan, Brazil and Australia. Read AgencyIQ’s complete history and analysis of the lead-up to the proposed medical device regulations here.]

Regulations 40

Regulations Government Compliance International 40

Perficient: Drug Development

AUGUST 22, 2023

Salesforce Knowledge : If you want your bots to offer Knowledge Articles to customers, then enable Salesforce Knowledge. Licensing: Salesforce Einstein Bots require specific licensing to be used within your Salesforce organization. Salesforce Einstein Bots are primarily available with Service Cloud licenses.

Licensing 52

Licensing Licensing Production 52

Agency IQ

AUGUST 16, 2024

The June 2023 guidance recommends that studies involve two monitors (one with graduate-level professional training and clinical experience in psychotherapy, licensed to practice independently) to observe study participants during treatment sessions. Compass has studied psylocibin for PTSD in an open-label, Phase 2 setting.

FDA 40

FDA Trials Therapies Regulations 40

Agency IQ

JANUARY 4, 2024

The reorganization separates device surveillance from medicinal product surveillance , which is divided into two sectors – licensing and surveillance, and product authorization and vigilance. The sector will also oversee the use and processing of devices within hosptials. KAROLINE MATHYS is the head of the new sector.

Marketing 40

Marketing Regulations Clinical Trials International 40

Agency IQ

JANUARY 12, 2024

These windows depend on whether the new drug application (NDA) or biologics license application (BLA) is a new molecular entity, and if the application has received standard review (10 months, plus 2 months of administrative time) or priority review (6 months, plus 2 months of administrative time).

FDA 40

FDA Drugs Production Licensing 40

Agency IQ

SEPTEMBER 22, 2023

The FDA-required labeling is the drug labeling that is submitted by the sponsor and reviewed and approved by the FDA as part of the drug’s marketing application (including a New Drug Application, Abbreviated NDA, or a Biologics License Application) – and includes prescribing information (PI).

FDA 40

FDA Biosimilars Production Drugs 40

Agency IQ

JUNE 2, 2023

However, only licensed blood establishments would be required to submit PMI to FDA for approval.” As the FDA explains, “The requirement to create PMI and make it available for distribution to transfusion services applies to all establishments that collect blood and blood components for transfusion.

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