Drug Target Review

DECEMBER 11, 2024

By employing advanced analytical techniques like high-resolution mass spectrometry (HRMS) and carefully calibrating systems with optimal internal standards (IS), we effectively mitigate matrix effects and provide reliable preclinical toxicology data. These solutions must contain analytes and internal standards at known concentrations.

International 52

International Laboratories Drugs Pharmacokinetics 52

FDA Law Blog: Biosimilars

FEBRUARY 18, 2025

For pre-license or pre-approval inspections, the outcome of a shutdown is less draconian as these are under the auspices of a user-fee program. If the shutdown were to occur on Monday March 3 rd , inspectors may be recalled from active or on-going inspections to be placed on furlough.

Government 76

Government Compliance FDA Licensing 76

Drug Channels

APRIL 15, 2025

Whether you're building trust with customers, launching new products, or guiding internal teams, understanding the economic forces that shape drug distribution, reimbursement, and pricing is essential. We also offer licenses to our secure hosted learning environmentno internal setup required!

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Specialty Pharmacies Pharmaceuticals Pharmacy Licensing 52

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

NOVEMBER 4, 2020

Ltd (“Juyou”), a biotechnology company that develops and sells medical and cosmetic skincare products, for the commercialization and development of Pliaglis ® in mainland China (the “License Agreement”). million and US$1.8

Licensing 40

Licensing Licensing Production Engineering 40

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. But, why is this so important?

Science 59

Science Government Engineering Licensing 59

Agency IQ

MAY 28, 2024

regulator lays out proposal for international device and diagnostics recognition The British medical device regulator just issued its promised framework on international recognition. The MHRA also proposed to align its definitions for medical devices and IVDs with the International Medical Device Regulators Forum (IMDRF) definitions.

International 40

International Regulations Licensing Licensing 40

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

JANUARY 8, 2025

Here are some key strategies: File early and often Pursue multiple patent types Consider international patent protection Continuously innovate and file improvement patents By implementing these strategies, you can create a web of protection that’s difficult for competitors to navigate around.

Pharmaceutical Companies 52

Pharmaceutical Companies Pharmaceuticals Licensing Licensing 52

The Pharma Data

AUGUST 17, 2020

DF6002 is a monovalent IL-12 immunoglobulin Fc fusion protein proposed to achieve strong anti-tumor efficacy by establishing an inflammatory tumor microenvironment necessary for productive anti-tumor responses.

Licensing 52

Licensing Licensing Production Clinical Trials 52

Drug Channels

OCTOBER 5, 2021

Licenses for our DCI reports are regularly purchased by nearly every company involved in the drug channel: pharmaceutical manufacturers, wholesalers, pharmacists, pharmacy owners, hospitals, buyers, benefit managers, managed care executives, policy analysts, investors, lawyers, consultants, and more. There are an astonishing 537 (!)

Pharmaceuticals 75

Pharmaceuticals Biosimilars Licensing Licensing 75

The Pharma Data

DECEMBER 20, 2020

The TMVR technology developed by HighLife uses a transeptal approach to treat patients with MR, and is currently evaluated in international clinical studies in more than 20 sites on three continents. The terms also allow cross-licensing on future improvements of the products, encouraging both companies to focus on innovations.

Licensing 40

Licensing Licensing Production Treatment 40

Drug Channels

OCTOBER 11, 2022

Licenses for our DCI reports are regularly purchased by nearly every company involved in the drug channel: pharmaceutical manufacturers, wholesalers, pharmacists, pharmacy owners, hospitals, buyers, benefit managers, managed care executives, policy analysts, investors, lawyers, consultants, and more.

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Pharmaceuticals Biosimilars Licensing Licensing 74

Perficient: Drug Development

AUGUST 31, 2023

The syntax of Kotlin may not be exactly like Java Programming Language, however, internally Kotlin is reliant on the existing Java Class library to produce wonderful results for the programmers. Pre-Requisites Features of Kotlin Kotlin Architecture What is Kotlin? Kotlin is a programming language introduced by JetBrains in 2011.

Licensing 105

Licensing Licensing International 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

Drug Channels

MARCH 15, 2022

Licenses for our DCI reports are regularly purchased by nearly every company involved in the drug channel: pharmaceutical manufacturers, wholesalers, pharmacists, pharmacy owners, hospitals, buyers, benefit managers, managed care executives, policy analysts, investors, consultants, and more.

Pharmacy 98

Pharmacy Specialty Pharmacies Licensing Licensing 98

Perficient: Drug Development

NOVEMBER 10, 2023

Depending on the size of the team and anticipated activity within a program, additional RDEs can also be provisioned, however, this may come at an additional licensing cost from Adobe. If you’re planning to deploy to the RDE from an internal build mechanism such as Jenkins , then there are a few additional considerations to account for.

Packaging 105

Packaging Licensing Licensing International 105

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. GPCR – G protein-coupled receptors.

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Small Molecule Licensing Licensing Treatment 40

The Pharma Data

DECEMBER 13, 2020

To access the live call, please dial 1 (833) 540-1168 (domestic) or 1 (929) 517-0359 (international) and refer to conference ID 8792127. Relay Therapeutics will host a live webcast today beginning at 8:00 a.m. ET to discuss the collaboration.

Licensing 40

Licensing Licensing Clinical Trials Small Molecule 40

Policy Prescription

OCTOBER 3, 2023

That’s why, according to Salant, drug companies “[blur] the distinction between dangerous counterfeit drugs and safe drugs sold by pharmacies licensed in other high-income countries.” The theory covers four “stylized facts” of the international market in prescription drugs. First, drug prices in the U.S.

Pharmacy 84

Pharmacy International FDA Approval Government 84

LifeSciVC

JULY 6, 2023

After years of steady progress and tens of millions of dollars invested, Sanofi Genzyme corporate strategy shifted, and eventually a strategic decision was made to suspend the program, focus resources on immunology/immuno-oncology, and out license these assets. I hope that others in our industry maintain a similar focus on innovation.

Small Molecule 56

Small Molecule Licensing Licensing Science 56

FDA Law Blog: Biosimilars

JANUARY 11, 2024

Some of the other (but not all…) topics of interest at this day-long conference presented by US and Puerto Rico industry thought leaders include: Experiences and Challenges of Puerto Rico State Licensing Internal Investigations: Monitoring, Compliance, Enforcement Actions The State of the Pharmaceutical Industry in Puerto Rico Navigating Global Turbulence: (..)

Pharmaceuticals 59

Pharmaceuticals Licensing Licensing Compliance 59

New Drug Approvals

MAY 15, 2025

“International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 76” WHO Drug Information. “International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 77” WHO Drug Information. 29 March 2023. Retrieved 20 June 2023. hdl : 10665/331020.

FDA Approval 62

FDA Approval FDA Treatment International 62

Agency IQ

SEPTEMBER 1, 2023

MHRA introduces an expanded international recognition procedure, while planning to sunset the current EC reliance pathway Today, the U.K.’s The Access Consortium is a work-sharing initiative involving Australia, Canada, Singapore and Switzerland, to enhance international cooperation and increase regulator capacity. market more quickly.

International 40

International Regulations Production Marketing 40

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 25, 2020

26, 2020 /PRNewswire/ — Cantargia AB (OMXS: CANTA) and BioInvent International AB (OMXS: BINV), today announced that BioInvent has been contracted as manufacturer of Cantargia’s antibody CAN10 in preclinical development for the treatment of systemic sclerosis and myocarditis. BioInvent International AB (publ).

Clinical Trials 52

Clinical Trials Licensing Licensing International 52

The Pharma Data

JUNE 30, 2021

This strategic partnership combines Teva’s long-standing commercial presence, extensive distribution network and wide-reaching sales and marketing activities across Europe and international markets with Bioeq’s capabilities in the development of biosimilar drugs for highly regulated countries with stringent quality standards.

Biosimilars 52

Biosimilars International Licensing Licensing 52

Policy Prescription

MAY 28, 2021

and licensed by your state board of pharmacy.” state-licensed board of pharmacy licensed pharmacy.”. Licensed Canadian retail pharmacies cannot dispense medications in person or through the mail that are not approved for sale in Canada. state-licensed board of pharmacy licensed pharmacy.”. Emphasis added).

Pharmacy 52

Pharmacy Licensing Licensing Online Pharmacies 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. Along with the roles you can combine the sharing rules. Each Experience Cloud site has a dedicated guest user for sharing rules, maximizing its power.

Licensing 59

Licensing Licensing International Regulations 59

The Pharma Data

DECEMBER 8, 2020

9, 2020 /PRNewswire/ — The members of the Nomination Committee for BioInvent International AB :s (publ) (“BioInvent) Annual General Meeting in 2021 have now been appointed. Proposals to the Nomination Committee can be sent to Stefan Ericsson , by mail: BioInvent International AB (publ).), BioInvent International AB (publ).

Clinical Trials 40

Clinical Trials Licensing Licensing International 40

Drug Channels

MARCH 18, 2025

Pharmacies and PBMs, Examining $683 Billion Market Review pricing/license options and download the full 2025 report Order before March 31, 2025 to receive special discounted pricing! There are tons of internal hyperlinks to help you navigate and focus on what matters most to you. drug pricing, reimbursement, and dispensing system.

Pharmacy 52

Pharmacy Specialty Pharmacies Licensing Licensing 52

DrugBank

MARCH 22, 2024

Paid Knowledge Bases Paying for access or licensing a knowledge base can be a difficult decision to make. Often, paid knowledge bases provide users access to an internal support team, which can help shorten startup times and maximize value. Will the cost be worth it, and can’t you just get all that data on your own?

Licensing 98

Licensing Licensing Research Production 98

LifeSciVC

APRIL 24, 2024

Suggested resources for this first pass genetics diligence include OMIM, GWAS Catalog, DisGeNET, OpenTargets, Genebass, and the International Mouse Phenotyping Consortium. Alternatively, are there potential existing assets that may be available for in-licensing, especially if the potential licensor has pivoted strategic directions (i.e.,

Production 131

Production Small Molecule Regulations Trials 131

New Drug Approvals

SEPTEMBER 8, 2024

8] Brand names Palopegteriparatide is the international nonproprietary name. [9] “International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 86” WHO Drug Information. Palopegteriparatide is a pegylated synthetic peptide (molecular weight: ca. 48,000) consisting of 34 amino acid residues.

FDA 62

FDA International Trials FDA Approval 62

Metabolite Tales Blog

NOVEMBER 17, 2022

Due to internal hydrogen bonding, DELAQ is a linear, nonionized metabolite with a LogP of roughly 7. Figure 2: Internal hydrogen bonding of DELAQ In contrast to laquinimod, DELAQ is a very potent activator of the aryl hydrocarbon receptor (AhR). Teva Pharmaceuticals licensed laquinimod from Active Biotech. This was unexpected.

International 52

International Licensing Licensing Treatment 52

The Pharma Data

SEPTEMBER 2, 2021

Novartis will present 12 abstracts at the European Respiratory Society (ERS) International Congress 2021 for Enerzair ® Breezhaler ® (IND/GLY/MF*) and Atectura ® Breezhaler ® (IND/MF**) — for patients whose asthma is uncontrolled with LABA/ICS^ and ICS, respectively 1,2. g) and medium-dose (150/50/80?g) g) formulations.

Licensing 52

Licensing Licensing Treatment Therapies 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. Sosei Heptares will now conduct a full internal review to determine a strategy for the further development and re-partnering of the program. ” About the License Agreement. TOKYO and CAMBRIDGE, England , Jan.

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Licensing Licensing Clinical Trials Disease 40