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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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This Revised Draft Guidance provides considerations for manufacturers, packers or distributors (dubbed “firms”) of prescription biological reference products, biosimilar products, and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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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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Drug Channels

FEBRUARY 22, 2022

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. Download a free report overview for more details.

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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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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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Agency IQ

MARCH 1, 2024

What We Expect the FDA to do in March and April 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. Read AgencyIQ’s analysis of a lower court’s ruling.

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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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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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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. An updated Unified Agenda: The Unified Agenda is the U.S.

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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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The Pharma Data

NOVEMBER 29, 2020

MDM2 is a key regulator of the tumor suppressor p53 and one of the most potent inhibitors of apoptosis discovered thus far. 1 Meanwhile, these MDM2 inhibitors present some challenges, including dose-limiting hematological toxicities, thus the urgent need to develop new generation of MDM2-targeting therapies in the treatment of cancer.

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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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DrugBank

AUGUST 15, 2024

This drug, approved by the FDA in 2015, targets a protein that regulates cholesterol levels in the blood, offering a novel therapeutic approach for patients who do not respond adequately to statins. This highlighted the importance of defining patent scope and licensing terms in such collaborations.

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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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Agency IQ

JULY 12, 2024

BY LAURA DIANGELO, MPH | JUL 10, 2024 3:47 PM CDT Regulatory background: The FDA is responsible for overseeing information about regulated products. The FDA is responsible for ensuring that medical products are adequately labeled in accordance with federal regulations, including the product’s “intended use” and relevant safety information.

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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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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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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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Agency IQ

FEBRUARY 2, 2024

What We Expect the FDA to do in February and March 2024 (Updated) 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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FDA Law Blog: Biosimilars

MARCH 13, 2024

156 for certain FDA-regulated products, we know what you were thinking. 156(d) (and the PTO’s PTE regulations at 21 C.F.R. The PTE application states “[u]nder the terms of the AMENDED AND RESTATED DEVELOPMENT AND COMMERCIALIZATION LICENSE AGREEMENT between Pfizer Inc. exclusively licensed U.S. 27, 1995); aff’d , 109 F.3d

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Agency IQ

MAY 3, 2024

What We Expect the FDA to do in May and June 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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Agency IQ

AUGUST 16, 2024

By Amanda Conti | Aug 13, 2024 10:00 PM CDT Regulatory context: Psychedelic regulation and drug development A growing body of evidence suggests that psychedelics may provide clinical benefit for certain purposes, especially mental health conditions. Next, sponsor-FDA agreement on trial designs via SPA should be taken with a grain of salt.

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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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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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FDA Law Blog: Biosimilars

JUNE 27, 2024

Coconut Grove had noted “verified” on the prescriptions which DEA found “is not sufficient to identify and resolve any red flags that may be present.” The regulation requires that pharmacists “ensure that a reasonable effort is made to obtain” this information. 21 C.F.R. §§ 1306.04(a), a), 1306.06. Code § 64B16-27.800(1), (2).

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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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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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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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Agency IQ

JUNE 16, 2023

The 51 regulations that FDA is currently working on The FDA today unveiled its much-anticipated Spring 2023 Unified Agenda, a document outlining the regulations the agency plans to release in 2023 and beyond. The anticipated date of publication is June 2023, meaning we should see this regulation imminently.

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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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Agency IQ

SEPTEMBER 22, 2023

The goal of the framework , as described in a 2019 presentation from FDA staff on the subject, is to “provide prescription drug sponsors the flexibility to disseminate innovative software, while maintaining appropriate Agency oversight over the sponsors’ communications about their products.” This would be considered a type of drug labeling.

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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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The Pharma Data

DECEMBER 9, 2020

With the launch of Overland, we are creating a robust research and development engine in parallel with the significant growth and opportunity presented by Asia’s evolving biotech industry. This work has led to the identification of molecular components regulating crucial processes impaired in depression.

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Agency IQ

JANUARY 12, 2024

BY AMANDA CONTI | JAN 10, 2024 9:29 PM CST Quick background: Goal dates under the Prescription Drug User Fee Act (PDUFA) The FDA collects user fees as part of an essential bargain between regulators and industry. According to Downey, the timeline of pre-license inspections for biologics can create challenges.

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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. Presentation. After the presentation a Q&A will be held. is obliged to make public pursuant to the EU Market Abuse Regulation. Financial outlook provided for 2021, see page 14.

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