FDA Law Blog: Drug Discovery

MARCH 3, 2025

The American Conference Institutes 3rd Annual Forum on Advanced Therapeutics is scheduled to take place from March 19-20, 2025, at the Seaport Hotel in Boston, MA. Hyman, Phelps & McNamara, P.C.s

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Codon

SEPTEMBER 29, 2024

2025 While the broader life sciences community had pivoted towards working on traditional mechanistic interpretations of biology, one graduate student still believed there was something to be learned using the models of life so celebrated previously. The 2025 genetic network paper fit that bill exactly.

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PPD

NOVEMBER 30, 2023

As we approach the end of 2023, it’s time to reflect on the past 12 months and how advances in drug development shaped the pharma and biotech industries. Five Predictions for the Drug Development Industry in 2024 1. Stakeholders across the drug development sphere will unlock the transformative potential of AI.

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LifeSciVC

JANUARY 16, 2024

These are incredible forecasts and CAGRs, which if we assume directionally correct, rely not only on steady growth for approved therapies but also a substantial success rate of, and continued investment in, the development pipeline. Many thanks to Michelle Levine and Maurizio Fazio for their editorial advice.

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Conversations in Drug Development Trends

MAY 23, 2024

The Critical EU-CTR Transition Deadline The three-year transition period for clinical trials authorized under the CTD that are expected to continue beyond the critical deadline of 30 January 2025 are required to transition to the new EU-CTR via a transition application through the CTIS. However, they also bring unique regulatory challenges.

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LifeSciVC

AUGUST 21, 2024

At this point of the year, the JPMorgan conference seems like ancient history and you are looking into flights for JPM 2025. Drug development is a long process, and patients are waiting. For some, a Midsummer’s Madness can be a Midsummer’s Nightmare. These goals were believable and achievable. Was that only six months ago?

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Agency IQ

JUNE 21, 2024

Modeled on the Operation Warp Speed vaccine development communications approach, the pilot aims to test out a rapid communications approach for accelerating rare disease drug development. Marks also conceded that certain gene therapies might also have a different acceptable approach for confirmatory studies.

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Agency IQ

JULY 7, 2023

This study was developed to help establish a workable framework for using real-world evidence (RWE) for regulatory cases within the E.U., building off the EMA’s Strategy through 2025. Regulators at EMA have outlined their intent to “enable” RWE and “establish its value for regulatory decision-making” by 2025.

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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. This study is planned to start in late 2024 and conclude in late 2025.

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The Pharma Data

DECEMBER 2, 2020

million aggregate principal amount of 7.25% convertible senior notes due 2025 (the “notes”) in a private offering to qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended (the “Securities Act”). The notes will mature on December 1, 2025, unless earlier repurchased, redeemed or converted.

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Vial

APRIL 18, 2024

The study, projected to conclude by July 2025, anticipates enrolling approximately 500 participants. Our [ophthalmology CRO]( [link] team has extensive therapeutic knowledge to support all stages of ophthalmology drug development and clinical research.

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The Pharma Data

DECEMBER 2, 2020

Progenity’s vision is to transform healthcare to become more precise and personal by improving diagnoses of disease and improving patient outcomes through localized treatment with targeted therapies. The issuance and sale of the notes are scheduled to settle on December 7, 2020, subject to customary closing conditions.

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New Drug Approvals

SEPTEMBER 13, 2024

2] [3] [4] A regulatory application for approval of the medication is expected to be submitted by 2025. [2] 4] [6] Aticaprant was originally developed by Eli Lilly , was under development by Cerecor for a time, and is now under development by Janssen Pharmaceuticals. [2] Drug Discovery. nM vs. 24.0 nM vs. 24.0

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Agency IQ

JULY 22, 2024

BY AMANDA CONTI | JUL 17, 2024 9:49 PM CDT Background: New molecular entities (NMEs) AgencyIQ reviews drug approvals from the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER). CDER is the FDA office in charge of reviewing pharmaceuticals and therapeutic biologics.

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Agency IQ

JULY 8, 2024

The information below includes the event type and whether the meeting can be attended by the public (Open) or not (Closed).

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Agency IQ

OCTOBER 27, 2023

WUSF / AgencyIQ November 1 Initial deadline for NDSRIs Under a 2023 guidance document, the FDA has recommended that pharmaceutical companies assess Nitrosamine Drug-Related Substance Impurities for their products by November 1, 2023, with confirmatory testing due by August 1, 2025.

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Agency IQ

FEBRUARY 15, 2024

We have tried to sort guidance documents by topic area. If you’re looking for something specific, we recommend using the search function in your browser (Ctrl-F) to look for keywords of interest.

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Agency IQ

AUGUST 9, 2024

EMA’s psychedelic workshop leaves stakeholders with as many questions as answers Earlier this year, the EMA hosted a multi-stakeholder workshop to discuss regulatory issues surrounding drug development of psychedelic products. EMA has now published a report on the workshop; read on for AgencyIQ’s analysis.

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Agency IQ

FEBRUARY 2, 2024

Title Type Comments Close Digital Health Technologies for Detecting Prediabetes and Undiagnosed Type 2 Diabetes January 31 Advancing the Development of Therapeutics Through Rare Disease Patient Community Engagement Meeting February 12 Advisory Committee; Genetic Metabolic Diseases Advisory Committee; Establishment Notice February 12 Advanced Manufacturing (..)

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thought leadership

JANUARY 21, 2025

With regulatory agencies in the European Union (EU), United Kingdom (UK), and Switzerland continuing to refine their approaches, pharmaceutical developers seeking to enter these markets must stay informed of the latest updates and anticipate future requirements.

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Alta Sciences

DECEMBER 19, 2024

From AAV to BiomarkersYour 2025 Roadmap blussier Thu, 12/19/2024 - 18:55 HTML Support for Your Early-Phase Gene Therapy Program At Altasciences, we are committed to advancing gene therapies with precision and efficiency. SEE BIOMARKERS Ready to get your gene therapy development program started? Image alta-blog_4.jpg

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Drug Target Review

APRIL 1, 2025

Advances in biotechnology are driving significant progress in the treatment of rare diseases, making it possible to develop targeted therapies for previously untreatable conditions. Founded in 2021, SynaptixBio is working to develop therapies for TUBB4A leukodystrophies – a group of rare and severe neurological disorders.

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PPD

JANUARY 21, 2025

As 2025 kicks off, the biopharma and biotech industries find themselves at a pivotal juncture, navigating an era of rapid transformation marked by new technological advancements, evolving regulations and shifting industry priorities. However, amid this progress, the complexities of drug development have never been more apparent.

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Alta Sciences

MARCH 27, 2025

Altasciences Receives 2025 CDMO Leadership Award in Small Molecule Dosage Form Category pmjackson Thu, 03/27/2025 - 19:42 Laval, Qubec, March 27, 2025 Altasciences , a nine-time CRO Leadership Award winner, is proud to announce they have been awarded a 2025 CDMO Leadership Award in the Small Molecule Dosage FormNorth America category.

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Perficient: Drug Development

MARCH 10, 2025

Women’s day celebration 2025 is a benchmark event which was well received by all of us. Retail Shopping is a therapy for most of us. Who Run the world!!…Girls!!!…Rightly …Girls!!!…Rightly …Rightly said by Beyonce. A lot of chatting and laughter filled the air.

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Drug Target Review

MARCH 13, 2025

Planning the journey from data to deliverables The future of AI-enabled drug development benefits from the continued advancement of multimodality and clinical genomics, with a focus on integration, efficiency and personalisation to transform both care and R&D.

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LifeSciVC

FEBRUARY 18, 2025

Despite recent progress with AAV Gene Therapy and Antibody-Oligonucleotide Conjugates, a broad range of muscular dystrophies are still untreatable, and collectively represent an enormous unmet medical need. First, they provide guidance for the design and refinement of micro-dystrophin gene therapy constructs for DMD. 2024), Wan et al.

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FDA Law Blog: Biosimilars

JANUARY 16, 2025

Hyman, Phelps & McNamara PC, (HPM), which will mark its 45thAnniversary on March 17, 2025, is pleased to announce that it is increasing its directors, counsel, and associates as it starts the year. Marks work often deals with therapies for rare and serious diseases that face unique challenges and, therefore, require unique solutions.

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FDA Law Blog: Drug Discovery

FEBRUARY 11, 2025

On February 5, 2025, a press release caught our eye Arbor Biotechnologies announced that ABO-101, its investigational therapy for the treatment of primary hyperoxaluria type 1 (PH1), received a rare pediatric disease designation.

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Alta Sciences

JANUARY 21, 2025

Highlights From the 2024 American College of Toxicology 45th Annual Meeting pmjackson Tue, 01/21/2025 - 21:59 The ACT 2024 meeting took place at JW Marriott in Austin, TX My fellow Altasciences colleagues and I recently attended the 2024 annual American College of Toxicology (ACT) meeting in Austin, Texas.

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PPD

MARCH 19, 2025

The drug development landscape continues to grow in complexity and cost. Drug developers should consider several approaches when implementing an FSP partnership that is fit-for-purpose and positioned for optimal performance. Explore the current trends and innovations in FSP partnerships.

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Drug Target Review

NOVEMBER 27, 2024

Introduction Biomarkers are becoming increasingly essential in drug development and clinical practice, driving the need for more precise validation methods. 2 The biomarker development pipeline involves multiple stages, including discovery, analytical validation, clinical validation and regulatory qualification. only about 0.1

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Drug Target Review

MARCH 8, 2025

As Executive Director of CMC Regulatory Affairs at Biohaven , she leads efforts to develop innovative therapies from the clinic to market approval. Her expertise in regulatory strategy and process development has been instrumental in advancing important treatments. She is the head of CMC regulatory affairs at Biohaven.

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LifeSciVC

MARCH 12, 2025

This circumventing the wheel requires navigating around the roadblocks that hampered earlier drug development efforts to bring new treatment options forward for patients. ADCs are treatments comprised of three components: a drug payload joined by a linker to an antibody.

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Perficient: Drug Development

JANUARY 24, 2025

Additionally, GenAI can streamline clinical trial matching by identifying eligible patients and predicting trial success, accelerating the development of new therapies and interventions. References Francis, N. Jones, S., & Smith, D. Generative AI in higher education: Balancing innovation and integrity. link] Jindal, J. Lungren, M.

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Codon

FEBRUARY 5, 2025

Cynomolgus macaques, small primates native to Southeast Asia, are already widely used in drug development research. 7 There are attempts to develop disease-modifying treatments, like using stem cells to regrow neurons, but any therapies affecting the brain are necessarily complex and dangerous. Cite: Trevor Klee.

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