The Premier Consulting Blog

APRIL 13, 2025

On April 10, 2025, the US FDA announced that it has a long-term plan to eliminate conventional animal testing in drug development, starting with monoclonal antibodies (mAbs).[ Legislation with delayed implementation In 2021, the FDA Modernization Act 2.0 7] This was a landmark change in philosophy.

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Drug Target Review

APRIL 7, 2025

In a recent survey conducted by ICON, Plc, biomarker selection was identified by 35 percent of respondents as a top challenge among drug developers for phase I trials, second only to navigating regulatory compliance (- 38 percent). References FDA-NIH Biomarker Working Group. Clinical Pharmacology and Therapeutics. 113:9861002.

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thought leadership

JUNE 23, 2025

For drug developers leveraging the 505(b)(2) pathway, the FDA Pre-Investigational New Drug (Pre-IND) meeting is a strategic opportunity that can shape the trajectory of an entire development program.

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The Premier Consulting Blog

OCTOBER 30, 2024

It is recognized, however, that there is a learning curve across the industry and FDA that is inherent to the development of such novel technologies. To prevent this learning curve from becoming a roadblock on the path to regulatory approval, the FDA has developed several collaborative programs to support advanced manufacturing.

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FDA Law Blog: Biosimilars

APRIL 1, 2025

Naomi Lowy, Principal Drug Regulatory Expert Trade and national press have reported that recent changes in FDA staffing levels have already led to slower responses to calls and emails. This coupled with more recent reports raised the specter of FDA falling short of user fee goals. Therein lies the opportunity.

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Drug Target Review

JULY 7, 2025

Non-human primates (NHPs), such as macaques and cynomolgus monkeys, have long served as a cornerstone in preclinical drug development due to their close genetic, anatomical and physiological resemblance to humans. Food and Drug Administration (FDA). NIH Office of Laboratory Animal Welfare – Training Guidelines.

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Alta Sciences

MARCH 4, 2025

The CCALC is a grassroots organization that was founded by several pharmaceutical industry members seeking clarity around the conduct of abuse and dependence potential assessments for novel drugs in development. This was in 2006, at a time when the FDA guidances on these topics had not yet been published.

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The Pharma Data

JUNE 24, 2025

These standards are widely recognized by regulatory agencies such as the FDA and EMA for use in analytical method development, validation, and quality control. In this context, the USP’s mAb reference standards offer pharmaceutical manufacturers a critical benchmark.

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SugarCone Biotech

JUNE 19, 2025

The results were remarkable for this very sick patient population, with a median OS of 14 months at the dose of 10 mg given every 2 weeks: The data supported FDA approval, in May 2024, of tarlatamab for refractory ES-SCLC. The Next Wave: Targeting B7H3 – a drug development tsunami in the making? An awesome space to watch.

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The Pharma Data

JUNE 27, 2025

Food and Drug Administration (FDA) and the European Medicines Agency (EMA) —to expedite review and potential approval for this new indication. However, fenfluramine is not yet approved by any regulatory agency for the treatment of CDD , and the results of the GEMZ study will be central to UCB’s future regulatory submissions.

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Drug Target Review

NOVEMBER 25, 2024

I went on to complete my MBA and PhD at The Institute of Cancer Research (ICR) in drug development. Gender diversity is a hot topic in pharmaceutical and biotech drug development. It used to be the case that drugs were tested only on men. This will then naturally translate into our hiring practices.

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SugarCone Biotech

JUNE 27, 2025

No B7-H3-directed therapeutics have received FDA or other approvals yet but the wave is building, especially with ADCs. ADC: Antibody-Drug Conjugates First it is important to put this wave of drug development into perspective.

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The Pharma Data

JUNE 9, 2025

Food and Drug Administration (FDA) as a monotherapy for children with achondroplasia. Safety and Tolerability Safety remains a top priority in pediatric drug development, and the interim results offer reassurance. Administered once weekly, TransCon CNP is currently under Priority Review by the U.S.

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The Pharma Data

JULY 2, 2025

FDA Grants Accelerated Approval to Regeneron’s Lynozyfic™ (linvoseltamab-gcpt) for Relapsed or Refractory Multiple Myeloma Regeneron Pharmaceuticals has secured a critical milestone in oncology drug development with the U.S.

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Conversations in Drug Development Trends

JANUARY 21, 2025

Rigorous procedures to ensure that drugs are effective and safe. Regulatory bodies such as the FDA oversee clinical trials to ensure that studies’ design, conduction, analysis, and reporting are per established guidelines and laws. No matter how small, any lack of efficiency can snowball into costly delays in drug approval.

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DrugBank

JUNE 18, 2025

Drug development is a complex and highly regulated process. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and other global counterparts, set rigorous standards to ensure that drugs are safe, effective, and high-quality. Regulatory agencies, such as the U.S.

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New Drug Approvals

APRIL 2, 2025

1] [2] It was developed by Vertex Pharmaceuticals , [5] and was approved for medical use in the United States in January 2025. [2] 2] [6] Suzetrigine is the first medication to be approved by the US Food and Drug Administration (FDA) in this new class of pain management medicines. [2] Suzetrigine is taken by mouth. [1]

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The Pharma Data

JUNE 11, 2025

Ionis Pharmaceuticals has a well-established track record in the development of antisense therapies for neurological disorders. With ION582, the company aims to deliver a much-needed therapeutic option for individuals living with Angelman syndrome and reaffirm its role at the forefront of neurology drug development.

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BioPharma Drive: Drug Pricing

JULY 14, 2025

New data visualizations published by BioPharma Dive capture the year-to-date funding trends for 2025, which so far include a pullback in financings for cancer drug developers. You can unsubscribe at anytime. Track funding rounds here. inhibitors. Sign up A valid email address is required. Please select at least one newsletter.

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Conversations in Drug Development Trends

OCTOBER 29, 2024

Increasingly, patients and patient-led organizations are playing a pivotal role in shaping drug development, underscoring the importance of collaboration between patient organizations, CROs, and pharmaceutical and biotechnology companies.

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The Premier Consulting Blog

JANUARY 14, 2025

Main Goals Community Resources Conversations on Cancer A public panel discussion series Discuss cancer-related social issues with inclusive and diverse panel members from the US and within the FDA. Resulting ideas will be shared with those interested in implementing them.

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Conversations in Drug Development Trends

JULY 3, 2025

However, the FDA’s recent decision to remove the Risk Evaluation and Mitigation Strategy (REMS) requirements for certain approved Chimeric Antigen Receptor T-cell (CAR T) therapies could dramatically shift these numbers, making life-saving treatments more accessible to those in need.

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Drug Patent Watch

JANUARY 9, 2025

Navigating the complex landscape of drug development and manufacturing can be a daunting task. Enter the Contract Development and Manufacturing Organization (CDMO) a lifeline for many startups looking to bring their innovative therapies to market. A: It’s never too early to start considering CDMO partnerships.

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Quanticate

JUNE 13, 2025

By organising and analysing this information, researchers can extract actionable insights that improve patient outcomes, data accuracy, drug efficacy and speed up trials. Clinical research generates vast amounts of diverse data from laboratory tests, patients, medical equipment, and outside sources.

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SugarCone Biotech

JULY 6, 2025

It follows that HER3-targeting therapies have emerged as a class of anti-cancer treatments designed to treat various tumors that have developed resistance to EGFR or HER2-directed therapies or have emerged due to a NRG1 gene fusion. This is an active drug development landscape with a lot of recent news.

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Drug Target Review

JUNE 5, 2025

Currently, three FDA-approved disease-modifying drug therapies are available: hydroxyurea, crizanlizumab and L-glutamine, though each has limitations that affect patient compliance. The use of FDA-approved medications for preventing vaso-occlusive events in sickle cell disease. JAMA Netw Open. 2023 Nov 1;6(11):e2344546.

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The Pharma Data

JULY 3, 2025

“Her deep experience in managing government contracts, navigating regulatory pathways, and driving product development to FDA approval makes her an ideal leader. We are confident in her ability to deliver results and expand Synedgen’s impact across both biodefense and commercial healthcare sectors.”

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PPD

JULY 8, 2025

AI has applications from the simple to the complex; from automating mundane tasks and accelerating drug development, to increasing accuracy in documentation and uncovering complex correlations within vast datasets. Accelerate your clinical research with our drug development digital solutions from Thermo Fisher Scientific.

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LifeSciVC

APRIL 17, 2025

I realize this moment in time is especially jarring to be discussing failure, when so many of our core institutions for novel thesis generation (NIH), drug development and approval (FDA), and the basic tenets of our biotech economy are in flux.

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ACTO

DECEMBER 17, 2024

Such cross-functional collaboration ensures consistent implementation from drug development through commercialization. These councils bring together diverse expertise from scientists and researchers, data analysts and technology specialists, regulatory compliance experts, as well as commercial operations leaders.

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Conversations in Drug Development Trends

NOVEMBER 5, 2024

First, the beginning of the FDA’s START program, with the goal of accelerating the development of novel drugs and biological products for rare diseases. Selected sponsors will be able to obtain frequent advice and enhanced communication from FDA staff to address program-specific development issues within rare disease.

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BioPharma Drive: Drug Pricing

JUNE 26, 2025

Editors picks Retrieved from Vinay Prasad on May 08, 2025 Biotech is guessing how Vinay Prasad might change the FDA. CBER’s new chief has argued for more stringent measures of assessing drugs for cancer and rare diseases, suggesting he might push for higher standards in the review of medicines under his division's purview.

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FDA Law Blog: Drug Discovery

FEBRUARY 11, 2025

However, as we suggested in a recent blog post , the statute did not actually provide any limitations on FDAs authority to grant rare pediatric disease designations , only its authority to grant vouchers. In the meantime, the Pink Sheet confirmed that FDA was continuing to review rare pediatric disease designation requests.

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BioPharma Drive: Drug Pricing

JULY 10, 2025

Deep Dive Library Events Press Releases Topics Sign up Search Sign up Search Pharma Biotech FDA Clinical Trials Deals Drug Pricing Gene Therapy An article from Dive Brief Moderna COVID vaccine gets full approval for children The approval comes amid regulatory upheaval under HHS head Robert F. You can unsubscribe at anytime.

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BioPharma Drive: Drug Pricing

JULY 10, 2025

By Jonathan Gardner • Updated April 9, 2025 Latest in Marketing Soleno sales of new Prader-Willi drug rise faster than expected By Ben Fidler Lilly gets FDA OK of modified dosing for Alzheimer’s drug By Jonathan Gardner Medical groups, pregnant doctor sue RFK Jr. You can unsubscribe at anytime. You can unsubscribe at anytime.

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FDA Law Blog: Drug Discovery

DECEMBER 23, 2024

This means that, at the current moment, FDA cannot award any priority review vouchers for rare pediatric disease product applications unless it is for a drug that was designated as a drug for a rare pediatric disease not later than December 20, 2024, and such application is approved not later than September 30, 2026.

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Drug Patent Watch

JANUARY 14, 2025

The Thyroid Association’s Concerns The American Thyroid Association (ATA) had raised concerns about the FDA’s methods for determining bioequivalence between levothyroxine products[2]. Case Study 3: Modeling the Future of Generic Drugs Who says you need a crystal ball to predict the future? The results?

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