FDA Law Blog: Biosimilars

FEBRUARY 18, 2025

The question that is always on the mind of folks in FDA-regulated industries is, what does that mean for my application/inspection/meeting? 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.

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FDA Law Blog: Biosimilars

NOVEMBER 1, 2023

Lenz, Principal Medical Device Regulation Expert & Sophia R. Gibbs — For more than three decades, FDA has claimed that the Federal Food, Drug & Cosmetic (FD&C Act) gives the agency legal authority to regulate laboratory developed tests (LDTs) as medical devices (see our prior post here ). Gaulkin & Jeffrey N.

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Laboratories FDA Regulations Licensing 81

Crown Bioscience

MAY 2, 2024

This post delves into some frequently asked questions about Omni Screen ™ and its unique capabilities in providing compliant, large-scale cell line screening solutions that are not only cutting-edge but also aligned with industry standards and regulations.

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Licensing Licensing Research Regulations 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.

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PPD

MAY 7, 2024

The European Union (EU) is on the verge of a significant shift as it prepares to implement new health technology assessment (HTA) regulations in 2025. Challenges and opportunities of the new EU HTA regulation The implementation of centralized HTA presents both opportunities and challenges for pharmaceutical companies.

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Drug Target Review

JUNE 11, 2025

Multimodality however can detect and connect trends (and in future generate content) across different modalities and therefore allows for better interpretability, which builds trust between regulators, researchers and industry stakeholders.

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Drug Patent Watch

JANUARY 14, 2025

From mergers and acquisitions to licensing agreements and pricing discussions, these complex interactions demand a unique blend of scientific knowledge, business acumen, and interpersonal skills. Negotiators must navigate complex compliance requirements, including anti-bribery laws, transparency regulations, and industry codes of conduct.

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Pharmaceuticals Compliance Licensing Licensing 54

Drug Target Review

MARCH 17, 2025

Neuropsychiatric disorders, affecting millions worldwide, disrupt the brain’s intricate processes of mood regulation, cognition and behaviour. Donello has led numerous international scientific collaborations, acquisition integrations, and the in-licensing and out-licensing of various drug programmes.

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Treatment Licensing Licensing Science 52

The Pharma Data

MAY 7, 2021

regulators to seek approval of our COVID-19 vaccine based on our pivotal Phase 3 trial and follow-up data.”. The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. “Following the successful delivery of more than 170 million doses to the U.S. CEO and Co-founder of BioNTech. “We

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Licensing Licensing Vaccine FDA Approval 52

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. law as the Medical Devices Regulation 2002 (UK MDR 2002). law as the Medical Devices Regulation 2002 (UK MDR 2002).

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LifeSciVC

APRIL 24, 2024

For KLK5 and KLK7 as well as their endogenous regulator (LEKTI, encoded by SPINK5 ) and one of their substrates (filaggrin, FLG ) there is evidence that KLK5 and 7 up-regulation is pathogenic and down-regulation protective in epidermal barrier dysfunction (especially for Atopic Dermatitis). in the case of CFTR for Trikafta).

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BMG Labtech

DECEMBER 20, 2024

The amounts of critical enzyme molecules and enzyme concentrations for example may be controlled by the regulation of the rate of protein synthesis and degradation as well as the regulation of gene expression. Researchers study quorum sensing since it can directly influence how certain bacteria regulate their metabolic activities.

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Drug Target Review

NOVEMBER 25, 2024

I saw an opportunity which others didn’t, to develop a small molecule targeting a well-known cancer pathway, a master switch of cancer Afterwards, I moved to Germany to work for Merck KGaA, where I headed up the licensing and business development team. I would also advise anyone, young women and men included, to always believe in themselves.

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Treatment Small Molecule Clinical Trials Trials 52

Agency IQ

JANUARY 12, 2024

device regulation timelines To kick off 2024, the British device regulator offered its medical device and IVD plans for this year and next, promising public action on the post-market surveillance regulation by mid-2024 and on the core regulations in late 2024 or early 2025. New roadmap sets out U.K.

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FDA Law Blog: Biosimilars

JULY 29, 2024

Last week, FDA issued draft guidance to address the potential complications that arise when sponsors seek to modify products, production processes, or quality controls for approved biologics license application (BLA) biosimilar and interchangeable products.

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Drug Channels

FEBRUARY 21, 2023

Pharmacies and Pharmacy Benefit Managers is a definitive, nonpartisan resource that includes the most current information about pharmacy dispensing channels, third-party payers, pharmacy benefit managers (PBMs), patients’ financial contributions, government regulations, and much more. Click to Enlarge] Thank you for your interest in our work.

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The Pharma Data

MARCH 30, 2021

In particular, our expectations regarding the FAP targeting agents, including FAPI-46 and FAPI-74,could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; global (..)

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FDA Law Blog: Biosimilars

AUGUST 8, 2024

Governors, state cannabis regulators, law enforcement groups and local governments weighed in, as did marijuana advocates and opponents, marijuana industry associations, Members of Congress, federal law enforcement groups, healthcare and human rights groups, unions and trade associations, and private individuals.

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The Pharma Data

JANUARY 18, 2021

“Efforts to regulate unlicensed retailers and reduce the density of marijuana retailers may be important factors to be considered when developing strategies to mitigate potential public health harms from expanded legal access to marijuana,” said lead author Eric Pedersen. © 2021 HealthDay. All rights reserved.

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Licensing Licensing Regulations Research 52

Perficient: Drug Development

JUNE 2, 2025

Creative Intelligence: Sensei in Adobe Firefly and Creative Cloud While other GenAI tools offer fast content, Adobe focuses on brand-safe, enterprise-ready creativity: Firefly generates images, illustrations, and design elements, trained on licensed content.

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Perficient: Drug Development

FEBRUARY 15, 2024

This blog was co-authored by Perficient Risk and Regulatory CoE Member: Alicia Lawrence The announcement of significant amendments to the New York State Department of Financial Services (NYSDFS) regulations on December 1, 2023, represents a pivotal moment for entities operating within New York’s financial sector.

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Compliance Regulations Licensing Licensing 52

Perficient: Drug Development

FEBRUARY 15, 2024

This blog was co-authored by Perficient Risk and Regulatory CoE Member: Alicia Lawrence Perficient’s Risk and Regulatory Center of Excellence (CoE) remains at the forefront of evolving financial rules and regulations, ensuring readiness to tackle emerging challenges and safeguard financial institutions and its customers.

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Compliance Licensing Licensing Regulations 52

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

DECEMBER 13, 2020

SHP2 is a critical signaling node and regulator that promotes cancer cell survival and growth through the RAS pathway, playing a key role in the way cancer cells develop resistance to targeted therapies. About RLY-1971. RLY-1971 is a potent small molecule inhibitor of Src homology region 2 domain-containing phosphatase-2 (SHP2).

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FDA Law Blog: Drug Discovery

DECEMBER 7, 2022

This product was developed by uniQure prior to being licensed to CSL Behring. However, with this most recent approval, FDA did not leave the question of durability as something to be answered postapproval, which signals to us that this issue looms large in FDA’s preapproval regulation of gene therapies.

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Conversations in Drug Development Trends

AUGUST 9, 2024

Managing this complexity highlights the importance of global communication plans and constant communication with global regulators and keeping all required documentation up to date. Harmonizing regulatory requirements and complying with all relevant regulations are crucial for the success of adaptive MRCTs.

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Trials Clinical Trials Regulations FDA 80

Perficient: Drug Development

JANUARY 24, 2024

Before I begin, I just want to caveat everything with the fact that HIPAA is a complex regulation open to interpretation, and in the end your legal and compliance teams need to be comfortable with how you handle data and the risk associated with those methods. This is because under the covers it is actually using the same instance.

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Licensing Licensing Production Regulations 96

The Pharma Data

NOVEMBER 4, 2020

Bactiguard’s growth strategy for the coming five-year period up to 2025 is based on a continued roll-out of Bactiguard’s technology, with a focus on new license agreements and a broader product portfolio. We have several interesting licensing projects ongoing and see new, exciting business opportunities. unchanged).

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LifeSciVC

JULY 17, 2024

It could also encourage more investment in the space and make us better partners to regulators and payors alike. Fortunately, AbbVie felt the same way, which is why we initiated discussions to in-license AbbVie’s most promising CF pipeline programs.

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Drug Target Review

MARCH 4, 2025

GLP-1 receptor agonists are a class of medications that mimic glucagon-like peptide-1 (GLP-1), a hormone that helps regulate blood sugar and appetite. During his career, Mark has negotiated and managed six M&A transactions, raised more than half a billion dollars in equity and debt financings, and negotiated numerous licensing agreements.

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Therapies Treatment Clinical Trials Science 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).

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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. Therefore, profiles can be employed to regulate access to objects, fields, and other elements.

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Licensing Licensing International Regulations 59

Agency IQ

AUGUST 4, 2023

government was put in place on February 27, 2023 and includes a number of proposed regulations to address trade relations between the E.U. First: all medicines for Northern Ireland must be approved by the MHRA The new regulation (EU) 2023/1182 applies to medicines that require marketing authorization. and the U.K.

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Packaging Licensing Licensing Regulations 40

Perficient: Drug Development

SEPTEMBER 19, 2023

Users can interact with the assistant in natural language, and it can offer additional actions beyond user queries, such as automatically completing tasks, providing recommendations, and answering questions. Free Data Cloud and Tableau Licenses Perhaps the biggest announcement to come out of Dreamforce, Salesforce is providing free Data Cloud (..)

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The Pharma Data

NOVEMBER 17, 2020

Lead Pharma has entered into a collaboration and license agreement with Roche , hoping to lead the way in the development of oral small molecules for immune-mediated diseases like rheumatoid arthritis, psoriasis and inflammatory bowel diseases. . Humans as well as cats and dogs can be affected. .

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The Pharma Data

MAY 4, 2021

. Big three drug distributors blame doctors, regulators in trial over opioid epidemic ( Reuters ). EU regulator begins real-time review of first Chinese COVID-19 vaccine ( Reuters ) ( EMA ). Gilead sues Russia over a compulsory license issued to a company making remdesivir ( STAT ).

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DrugBank

OCTOBER 4, 2024

However, ensuring that these structures comply with applicable tax laws and regulations is essential to avoid potential legal and reputational risks. This involves assessing the strength and breadth of patents, evaluating the potential for future patent challenges, and analyzing the value derived from licensing agreements and royalty streams.

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