BioPharma Drive: Drug Pricing

JUNE 23, 2023

The FDA for the second time turned back Intercept’s application for approval of its drug obeticholic acid in the liver disease, spurring the restructuring.

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Science Daily: Pharmacology News

APRIL 15, 2024

Researchers have discovered that an FDA-approved epilepsy drug can prevent or slow the growth of NF1-linked optic gliomas in mice, laying the groundwork for a clinical trial.

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Drugs.com

JULY 1, 2024

dairy cows, reassuring new government research finds the pasteurization process widely used in the industry effectively kills all bird flu virus in milk.In MONDAY, July 1, 2024 -- As bird flu continues to spread among U.S. a health update posted.

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BioPharma Drive: Drug Pricing

JULY 5, 2023

The deal enables Sarepta to quickly cash in on the clearance of Elevidys, with $102 million in new funds to help bankroll its drug research.

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BioPharma Drive: Drug Pricing

DECEMBER 20, 2024

Elsewhere, Robert Temple became the latest FDA leader to leave the agency, and two biotechs cut research deals. The clearance of Tryngolza gives Ionis its first wholly-owned, marketed medicine.

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Science Daily: Pharmacology News

OCTOBER 23, 2024

Researchers have reduced scar formation and improved heart function in mouse models of heart failure using a monoclonal antibody treatment, similar to that approved by the FDA to treat other conditions.

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BioPharma Drive: Drug Pricing

JULY 19, 2023

The agency veteran, who led the Office of Tissues and Advanced Therapies during a boom in gene and cell therapy research, retired in March.

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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).[ 2] An overview of the 3Rs The FDA and other global regulatory health authorities have long embraced the 3Rs of animal research (replace, reduce, and refine).

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BioPharma Drive: Drug Pricing

SEPTEMBER 26, 2023

Once valued at more than $7 billion, the liver drug company couldn’t secure a long-sought FDA approval in NASH and last month said it would abandon that research.

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Conversations in Drug Development Trends

OCTOBER 29, 2024

By: Juliane Mills, Senior Director, Therapeutic Strategy Lead, Rare Disease The rise of patient-led clinical research, particularly in rare disease, represents a significant shift in the clinical trial landscape. Why Is There an Increase in Patient-Led Rare Disease Research?

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The Pharma Data

JUNE 25, 2025

FDA Approves Label Update for Lilly’s Amyvid, Expanding Its Role in Alzheimer’s Disease Diagnosis and Therapy Guidance In a major development for Alzheimer’s diagnostics, Eli Lilly and Company (NYSE: LLY) announced that the U.S. At the time, its use was primarily restricted to supporting the diagnostic process.

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BioPharma Drive: Drug Pricing

AUGUST 10, 2023

The drug, which will be sold under the brand name Talvey, is now cleared by the FDA to treat multiple myeloma, a blood cancer that J&J has identified as a research priority.

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Advarra

JULY 26, 2022

As such, we are seeing an uptick in research examining the therapeutic effects of cannabis and its constituents. While there isn’t a significant amount of research on cannabidiol (CBD), it’s easily accessible in the U.S. This can make research challenging, but not insurmountable. Funding Research on Cannabis.

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Drug Target Review

JULY 1, 2025

Chief Executive Officer Steve Herne has spent more than 25 years in clinical research, with senior roles at WCG, Bioclinica and Covance. The company worked closely with agencies including the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) from the outset, aligning its methodology with evolving guidance.

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Drug Patent Watch

MAY 15, 2025

"Unlocking the Secrets of the FDA's Orange and Purple Books: Insider Tips from a Drug Patent Research Expert As the pharmaceutical industry continues to evolve at breakneck speed, staying ahead of the curve requires more than just a keen eye for innovation it demands a deep understanding of the regulatory landscape.

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FDA Law Blog: Drug Discovery

NOVEMBER 10, 2024

Food and Drug Administration (FDA) plays a pivotal role in fostering the development of treatments for rare diseases through its Orphan Products Grants Program. Each year, FDA selects a limited number of clinical trials to fund to help sponsors pursue development of medical products for rare diseases and advance their field.

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The Pharma Data

JUNE 26, 2025

FDA Approves Streamlined Monitoring Requirements and REMS Program Removal for Bristol Myers Squibb’s CAR T Cell Therapies Breyanzi and Abecma, Marking Milestone Toward Expanding Access to Cancer Treatment In a significant regulatory development, Bristol Myers Squibb announced that the U.S.

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PPD

JULY 8, 2025

Generative artificial intelligence (AI) has captured global attention for its transformative potential across industries, and nowhere is the promise greater — or more fraught — than in health care and clinical research. These domains are ripe for innovation. Errors jeopardize patient safety, regulatory compliance and trust.

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ProRelix Research

AUGUST 3, 2023

Although the United States Food and Drug Administration (FDA) has always supported and advocated the idea of decentralized trials, the real adoption and application of decentralized aspects in trials has […] The post FDA Guidance on Advancement of Decentralized Clinical Trials appeared first on ProRelix Research.

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FDA Law Blog: Drug Discovery

JULY 17, 2024

Importantly, the Hub is intended to establish a new model within FDA, which leverages cross-Agency expertise in providing guidance and conducting reviews for products for rare disease populations. those reviewed by the CDER Division of Rare Diseases and Medical Genetics).

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FDA Law Blog: Biosimilars

JUNE 10, 2024

Walsh — Among FDA-regulated establishments and stakeholders, there is one word that makes everyone go on edge – the dreaded FDA “inspection.” In FY2023, FDA conducted over 1000 inspections under the BIMO program. We also detail some of our recommended best practices to achieve success when FDA comes knocking.

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Crown Bioscience

JUNE 6, 2024

In a significant development, the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) approved 55 new drugs in 2023. This marks the second-highest count in the past 30 years, with the highest being 59 new drug approvals in 2018 and represents an impressive 50% increase in drugs approved in 2022.

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FDA Law Blog: Biosimilars

JUNE 2, 2025

Michael Laposata and the Association for Molecular Pathology in the recent LDT litigation, the Federal, Food, Drug, and Cosmetic Act does not authorize FDA to regulate LDTs as medical devices. Just before this decisive event, though, FDA released a relatively rare Warning Letter to a manufacturer of research use only (RUO) reagents.

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BioPharma Drive: Drug Pricing

JUNE 16, 2023

The approval of Columvi adds another “bispecific antibody” to the market, highlighting the fast research progress for drugs that target two proteins rather than one.

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FDA Law Blog: Biosimilars

APRIL 3, 2025

Those decisions are changing the way agencies, including FDA, exercise their rulemaking and enforcement authorities. Consumers Research , consolidated with SHLB Coalition v. Consumers Research is a challenge concerning a constitutional legal principle called the nondelegation doctrine.

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Advarra

NOVEMBER 14, 2024

The February 2024 FDA draft guidance on DMCs highlights the necessity of incorporating diverse, global expertise into these critical oversight functions. This collaborative spirit can lead to developing novel methodologies and strategies for monitoring and evaluating clinical trials, ultimately advancing the field of clinical research.

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FDA Law Blog: Biosimilars

MAY 27, 2025

By Dr. Naomi Lowy, Principal Drug Regulatory Expert FDA recently announced, CEO Forums: An FDA Listening Tour to Engage Pharma CEOs. and Director of FDAs Center for Biologics Evaluation and Research, Vinay Prasad, M.D., and Director of FDAs Center for Biologics Evaluation and Research, Vinay Prasad, M.D.,

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Drug Target Review

SEPTEMBER 22, 2023

Organoid technologies are becoming an invaluable solution for preclinical research, with the ability to augment the development of personalised medicine, drug discovery and gene therapies. This recognition was codified by the United States Food and Drug Administration (FDA) in 2022 with the signing of the FDA Modernisation Act 2.0

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Eye on FDA

APRIL 28, 2023

In today’s Federal Register , the agency has announced that the Office of Prescription Drug Promotion (OPDP) is adding a new study effort to its research portfolio. The new research effort will look at actual-use disclosures in the medium of television advertising. Why is this noteworthy? Two things come to mind.

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SCIENMAG: Medicine & Health

OCTOBER 31, 2023

— A new drug developed by professors from the School of Pharmacy and Pharmaceutical Sciences at Binghamton University has received Food and Drug Administration (FDA) approval for the treatment of patients with Duchenne muscular dystrophy (DMD), a common genetic disease that mostly affects young boys. BINGHAMTON, N.Y.

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ProRelix Research

APRIL 27, 2023

Pharmacovigilance is defined by the World Health Organization (WHO) as “the science and activities relating to the detection, assessment, understanding, and prevention of adverse events or any other drug-related problems.” […] The post Pharmacovigilance Services for Signal Management: Process as per US FDA appeared first on ProRelix Research. (..)

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BioPharma Drive: Drug Pricing

OCTOBER 11, 2024

Elsewhere, Turnstone is trimming preclinical research and Gritstone bio is working on a bankruptcy deal. Itovebi is part of a push by Roche to make new inroads in breast cancer.

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Advarra

JULY 5, 2022

Individuals invest a great deal to participate in clinical research, undertaking risks and burdens, while giving of their time and energies to advance scientific knowledge and the public good. Aggregate and Individual Research Results. Reasons Supporting Return of Individual Research Results.

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ProRelix Research

AUGUST 13, 2023

Software as a Medical Device (SaMD) refers to a class of medical software intended to be used for medical purposes or that is designed to carry out medical functions without […] The post Software as a Medical Devices (SaMD) and US FDA Guidance for their Clinical Evaluation and Clinical … appeared first on ProRelix Research.

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FDA Law Blog: Biosimilars

APRIL 10, 2025

Food and Drug Administration (FDA) is already having ripple effects not just internally, but across the broader regulatory and life sciences communities and the public at large. However, not all information contained in FDA records is disclosable. By Sarah Wicks & Anne K. FOIA is a U.S.

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The Pharma Data

JUNE 25, 2025

FDA Orphan Drug Designation for Antibody-Mediated Rejection in Solid Organ Transplantation The U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to riliprubart , an investigational immunology therapy developed by Sanofi, for the treatment of antibody-mediated rejection (AMR) in solid organ transplantation.

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Conversations in Drug Development Trends

AUGUST 23, 2023

However, patients also play a vital role in engaging directly with the FDA. This engagement is often less understood and is underutilized by sponsors, meaning a significant element of the trial and drug experience is missed during sponsor engagement with the FDA.

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