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. Additionally, keeping sites, principal investigators (PIs), and patients informed of changes and updates can present challenges.

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The Pharma Data

NOVEMBER 4, 2020

5, 2020 /PRNewswire/ — Bactiguard presents updated financial targets for 2025 in connection with the company’s financial report for the third quarter of 2020. We have several interesting licensing projects ongoing and see new, exciting business opportunities. The presentation can be followed at www.bactiguard.com.

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Drug Target Review

APRIL 14, 2025

This model not only promises a broader market but also presents tangible benefits for patients. That means we engage regulators early, share data on quality, safety and consistency, and collaborate on adapting regulatory guidelines that were generally written for injected biologics for this novel therapeutic modality.

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BioPharma Drive: Drug Pricing

JUNE 23, 2025

Understanding GLP-1 drugs GLP-1, or glucagon-like peptide-1 receptor modulators, mimic natural hormones that regulate insulin and appetite. Originally developed in the 1970s to treat diabetes, these drugs—such as Ozempic, Wegovy, and Mounjaro—have become headline-makers for their ability to induce significant weight loss.

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SugarCone Biotech

JUNE 10, 2024

This is where things get interesting due to the complexity of the immune system and its regulation. 4-1BB enhances the response of activated T-cells to “foreign antigens”: protein fragments derived from infected, diseased or cancerous cells that are presented to T cells by antigen-presenting cells (APC). Let’s back up a bit.

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Agency IQ

MARCH 25, 2024

In proposed rule, FDA offers up a (surprisingly sparse) list of drugs that present demonstrable compounding difficulties FDA yesterday released a long-awaited proposed rule on a list of drug products that present demonstrable difficulties for compounding. The result was the addition of Section 503A to the FD&C Act.

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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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The Pharma Data

DECEMBER 13, 2020

A webcast of the conference call will be available under “News and Presentations” in the Investors & Media section of Relay Therapeutics’ website at [link]. To access the live call, please dial 1 (833) 540-1168 (domestic) or 1 (929) 517-0359 (international) and refer to conference ID 8792127. About RLY-1971.

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Advarra

APRIL 30, 2024

A cross-check ensures curriculum vitae (CVs), and medical licenses (if appropriate) are on file and current. The FDA 1572 Form, CV, financial disclosure form, and medical license should all show consistency regarding the PI’s name. In some countries, local regulations may indicate the sub-investigators need to sign as well.

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FDA Law Blog: Biosimilars

FEBRUARY 26, 2024

On February 23—the same day that the Agency licensed SIMLANDI (adalimumab-ryvk) Injection , the first interchangeable high-concentration, citrate-free biosimilar to HUMIRA, and that qualifies for First Interchangeable Exclusivity (“FIE”)—FDA denied the Boehringer Petition. FDA explained that its bioequivalence regulations at 21 C.F.R.

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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

The Pharma Data

OCTOBER 15, 2020

Data was presented at the International Society of Pediatric Oncology (“SIOP”) Virtual Annual Congress held October 14 through October 17, 2020 in Ottawa, Canada. N axitamab In a poster presentation, Dr. Mora presented data from the Company’s pivotal 201 multicenter study. About Y-mAbs.

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Licensing Licensing Production Treatment 52

Drug Target Review

FEBRUARY 28, 2024

2,3 However, unlike αβ T cells, which are activated by the presentation of antigens to their TCRs, γδ T cells do not require antigen presentation to become activated. Normality sensing licenses local T cells for innate-like tissue surveillance. Regulation of cutaneous malignancy by gammadelta T cells.

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FDA Law Blog: Biosimilars

APRIL 25, 2024

This Revised Draft Guidance provides considerations for manufacturers, packers or distributors (dubbed “firms”) of prescription biological reference products, biosimilar products, and interchangeable biosimilar products presenting data and information about such products in promotional materials in a truthful and non-misleading way.

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Biosimilars Production FDA Licensing 59

Policy Prescription

MAY 28, 2021

They have been getting it from Canada and are now wondering with this presentation, if that is dangerous.”. and licensed by your state board of pharmacy.” state-licensed board of pharmacy licensed pharmacy.”. state-licensed board of pharmacy licensed pharmacy.”. Emphasis added). over the past 20 years.

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Pharmacy Licensing Licensing Online Pharmacies 52

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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FDA Law Blog: Biosimilars

AUGUST 9, 2023

Houck — If a patient presents a paper prescription for a controlled substance to a pharmacy and the pharmacy cannot fill it, the patient can take that prescription to another pharmacy. Two licensed pharmacists must directly communicate the transfer. By Larry K. That is until August 28th when DEA’s final rule becomes effective.

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Pharmacy Regulations Licensing Licensing 52

Drug Target Review

NOVEMBER 22, 2023

These proteins in turn regulate gene expression through the activation of several transcription factors, including NF-κB. We will present some of the data at the end of the study at an international conference next year. We are also developing our own TGF-β pathway inhibitor, IOA-359, which was licensed into iOnctura earlier this year.

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DrugBank

FEBRUARY 9, 2023

1 Present address: Functional Genomics and Metabolism Research Unit, Department of Biochemistry and Molecular Biology, University of Southern Denmark, Denmark. Summary: This paper discusses the use of a data science approach to synthesize current knowledge on the pharmacological implications of epigenetic regulation of gene expression.

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The Pharma Data

DECEMBER 12, 2020

The presentation will be available at astrazeneca.com before the call takes place, and replay details after the call. Any failure to comply with this restriction may constitute a violation of such laws or regulations. UK : +44 203 481 5237. Sweden : +46 8 5052 0017. US: +1 301 715 8592. Webinar ID: 995 4603 8702. Password: 12121220.

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FDA Law Blog: Biosimilars

DECEMBER 11, 2023

1] Yet FDA’s conclusions about the Agency’s ability to regulate the entire laboratory industry are based on fundamentally flawed assumptions about the number of entities and tests that will be subject to FDA regulation. 5] This stratification, though, assumes that LDTs will follow the same pattern as IVDs currently regulated by FDA.

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Agency IQ

JUNE 29, 2023

What We Expect the FDA to do in July 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 23, 2020

The first one relates to the development of a Pharmaceutical grade version of Tauri-Gum , for nausea regulation (specifically designed to help patients that are subjected to ongoing chemotherapy treatment). Complementary to the Company’s retail business, are its two ongoing biotechnology initiatives.

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The Pharma Data

NOVEMBER 26, 2020

The first one relates to the development of a Pharmaceutical grade version of Tauri-Gum , for nausea regulation (specifically designed to help patients that are subjected to ongoing chemotherapy treatment). Complementary to the Company’s retail business, are its two ongoing biotechnology initiatives.

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The Pharma Data

JANUARY 10, 2021

This satellite event dedicated to biotechnologies brings together 350 companies that will be presented to international investors in the sector from January 11 to 14, 2021. Its products are intended to be licensed to players in the health sector. WAINWRIGHT BioConnect 2021 conference.

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The Pharma Data

NOVEMBER 27, 2020

This indication is approved under accelerated approval regulation based on overall response rate and duration of response. The FDA granted approval under the accelerated approval regulation. Researchers at Memorial Sloan Kettering Cancer Center (“MSK”) developed Danyelza, which is exclusively licensed by MSK to Y-mAbs.

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The Pharma Data

SEPTEMBER 16, 2020

16, 2020 /PRNewswire/ — Amgen (NASDAQ:AMGN) announced today that data from its oncology pipeline in solid tumors will be presented during the European Society of Medical Oncology (ESMO) Virtual Congress 2020, Sept. Amgen will present new data for AMG 510 (proposed INN: sotorasib) and AMG 160 during two oral presentations.

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The Pharma Data

JANUARY 13, 2021

Brilacidin’s robust antimicrobial properties might also help to fight secondary bacterial infections, which can co-present in up to 20 percent of COVID-19 patients. Brilacidin for UP/UPS was licensed to Alfasigma S.p.A. in July 2019, who have recently initiated a Phase 1 study with their formulation. Source link.

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The Pharma Data

JANUARY 19, 2021

The presentation will be approximately 35 minutes, followed by a live question and answer session. Projected sales of Cannabis will require the company to obtain production and / or export licensing which cannot be assured. Register at: [link]. All registrants will be emailed a recording of the session. Source link.

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Agency IQ

APRIL 26, 2024

For context, while prescription drug products are required to comply with FDA’s regulatory requirements around labeling and approval (see 21 CFR 201 ), promotional materials and advertisements are regulated differently (under 21 CFR 202.1(1)(2)

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The Pharma Data

AUGUST 5, 2020

In February, the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) accepted the company’s Supplemental Biologics License Application (sBLA) and Marketing Authorization Application (MAA), respectively, for ofatumumab for the treatment of relapsing forms of multiple sclerosis in adults. December 21, 2015.

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New Drug Approvals

OCTOBER 24, 2023

1 Therefore, S1P receptor modulators like etrasimod were investigated in treating immune-mediated diseases like ulcerative colitis where a high level of inflammatory T cells is present in the gastrointestinal tract, thus causing diffuse mucosal inflammation. “Velsipity (etrasimod) tablets, for oral use” (PDF). . ^ June 2019).

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Agency IQ

JULY 8, 2024

What We Expect the FDA to do in July and August 2024 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the months ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

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The Pharma Data

DECEMBER 14, 2020

I’m very excited by the opportunities presented by BetterLife’s experienced clinical research team enabling Transcend’s novel therapeutics to reach human beings in need of help.”. The regulatory hurdles and barriers associated with administering psychedelics to human subjects are staggering.

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The Pharma Data

FEBRUARY 4, 2021

“We successfully completed the transformative Allergan acquisition and delivered another year of strong results in 2020, despite the challenges presented by the global pandemic,” said Richard A. NORTH CHICAGO, Ill., Gonzalez , chairman and chief executive officer, AbbVie. ” Fourth-Quarter Results.

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New Drug Approvals

APRIL 25, 2025

The difluoromethyl group can interact with the hydroxyl group presented on Ser774 (conserved) in p110, which is 3.2 Members of the PI3K family regulate cellular processes such as cell growth and proliferation, survival, remodelling, and intracellular transport of organelles. [15]

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