FDA Law Blog: Drug Discovery

JULY 17, 2024

These are exactly the types of things that were addressed at ELF Scientific Workshop in May 2024 which addressed challenges in developing therapies for ultra rare diseases (see our blog about this here , which includes a link to the recording).

FDA 105

FDA Disease Clinical Pharmacology Science 105

Alta Sciences

OCTOBER 31, 2023

Whether as a standalone bioanalytical service or as part of an integrated program, Altasciences provides top-quality data for TK, PK, and PD determinations to support preclinical and clinical studies. All three laboratories across North America are uniformly designed and managed.

Laboratories 52

Laboratories Clinical Pharmacology Cell Based Assays Drug Development 52

Alta Sciences

JANUARY 23, 2024

With close to a decade of experience in the healthcare and pharmaceutical sectors, including clinical pharmacology, James will apply his knowledge to oversee the day-to-day management of clinical operations at Altasciences’ 140-bed, Phase I clinical pharmacology unit in Kansas City. “It

Clinical Pharmacology 40

Clinical Pharmacology Clinical Trials Drug Development Clinical Research 40

Alta Sciences

APRIL 10, 2025

We spoke to Dr. If youre ready to discuss your ophthalmic study requirements or explore opportunities for preclinical drug development in your pipeline, dont hesitate to contact us. Learn more about our comprehensive ophthalmic drug development services! Our team is here to support you.

Clinical Pharmacology 52

Clinical Pharmacology Drug Development Drugs Research 52

The Pharma Data

NOVEMBER 9, 2020

. “Our initial focus is to develop standardized drug formulations with precise, predictable and efficient API delivery for clinical study and therapeutic use.” Psilocybin has recently been designated twice as a “breakthrough therapy” by the U.S. ” Prof.

Drug Development 40

Drug Development Drugs Clinical Pharmacology Pharmaceuticals 40

Drug Target Review

MAY 7, 2024

Small patient populations often result in difficulty in determining a significant effect of a therapy, given the low confidence power associated with the statistics. How do AI-enhanced approaches accelerate the drug development process for rare diseases?

Disease 59

Disease Clinical Trials Clinical Pharmacology Trials 59

Alta Sciences

JULY 25, 2024

TOP MANUFACTURING AND ANALYTICAL SCIENTIFIC RESOURCES Podcast: Successful Manufacturing of Clinical Trial Supply Join our formulation and pharmacy experts as they share insider secrets for overcoming clinical trial challenges and resolving issues that could impact your drug development program's timeline. Read the eBook.

Science 52

Science Clinical Trials Clinical Pharmacology FDA 52

Alta Sciences

OCTOBER 30, 2023

TOP NONCLINICAL SCIENTIFIC RESOURCES eBook : Safety Assessment for Ophthalmic Products Designing preclinical studies for ocular therapies take a lot of deliberation. The Altascientist : Issue No. Read or listen now. Watch the video. Listen here.

Science 52

Science Clinical Trials Pharmacokinetics Pharmacy 52

Alta Sciences

OCTOBER 9, 2024

Dr. Setnik made the list of 100 honorees for her hands-on leadership and nearly 20 years of experience in clinical drug development, with a focus on abuse potential studies. For over 25 years, Altasciences has been partnering with sponsors to help support educated, faster, and more complete early drug development decisions.

Clinical Pharmacology 40

Clinical Pharmacology Drug Development Science Clinical Trials 40

Agency IQ

FEBRUARY 23, 2024

Workshop addresses oncology dose optimization across full span of development In a series of broad-ranging, frank discussions, attendees at a joint FDA-American Association of Cancer Research (AACR) workshop worked through opportunities and challenges for dose optimization across the span of cancer drug development activities.

Science 40

Science FDA Trials Clinical Pharmacology 40

New Drug Approvals

SEPTEMBER 13, 2024

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] 2] As of July 2022, it is in phase 3 clinical trials for major depressive disorder. [2] 2] However, development for these indications was discontinued. [2]

Treatment 62

Treatment Clinical Trials Pharmacokinetics Pharmaceuticals 62

The Premier Consulting Blog

JUNE 18, 2023

This has opened new opportunities in pharmaceutical drug development, such as the ability to evaluate large complex databases and to integrate information in useful ways. One exciting application of these technologies is the use of in silico trials in the development of novel therapies for rare diseases.

Drug Development 52

Drug Development Disease Clinical Trials Drugs 52

Alta Sciences

MAY 15, 2023

TOP 5 WAYS INTEGRATED DRUG DEVELOPMENT SOLUTIONS SAVE YOU TIME AND MONEY aasimakopoulos Mon, 05/15/2023 - 16:06 Since 2004, the average cost of bringing a new drug to market has increased from $800 million to about $2.6 billion , without, for the most part, shorter development timelines.

Drug Development 52

Drug Development Clinical Trials Laboratories Compounding Pharmacies 52

Alta Sciences

AUGUST 28, 2023

Importantly, the Principal Investigator determined that few adverse events were drug-related.” There are no TBI-specific therapies approved for the treatment of patients suffering brain injury, yet it is estimated that in the U.S. We are proud to support Ischemix in advancing this vital new therapy.” About Ischemix, Inc.

Trials 40

Trials Treatment Clinical Pharmacology Pharmacokinetics 40

Agency IQ

DECEMBER 11, 2023

The side effects of some anticancer treatments can result in dose interruptions or de-escalations, or even outright discontinuation of an efficacious therapy. subsequent superior/inferior supportive care, lifestyle changes, or use of additional therapies).

FDA 40

FDA Science Clinical Trials Trials 40

Agency IQ

FEBRUARY 15, 2024

If you’re looking for something specific, we recommend using the search function in your browser (Ctrl-F) to look for keywords of interest.

FDA 40

FDA Science Biosimilars Clinical Trials 40

Agency IQ

JUNE 2, 2023

Title Type Comments Close Notification of a Permanent Discontinuance or Interruption in Manufacturing Under Section 506C of the Federal Food, Drug, and Cosmetic Act Guidance June 5 Patient Preference Information—Submission, Review in Premarket Approval Applications, Humanitarian Device Exemption Applications, and De Novo Requests, and Inclusion in (..)

FDA 40

FDA Science Regulations Production 40

Agency IQ

MAY 3, 2024

Title Type Comments Close Key Information and Facilitating Understanding in Informed Consent Guidance for Sponsors, Investigators, and Institutional Review Boards Draft Guidance April 30 Early Alzheimer’s Disease: Developing Drugs for Treatment Draft Guidance May 13 Select Updates for the Premarket Cybersecurity Guidance: Section 524B of the (..)

FDA 40

FDA Science Regulations Clinical Trials 40

Agency IQ

OCTOBER 27, 2023

Title Type Comments Close Fixed-Combinations and Single-Entity Versions of Previously Approved Antiretrovirals for the Treatment or Prevention of Human Immunodeficiency Virus-One Under the President’s Emergency Plan for Acquired Immunodeficiency Syndrome Relief Guidance November 1 Post-Warning Letter Meetings Under GDUFA Guidance November 6 In-Home (..)

FDA 40

FDA Science Regulations Production 40

The Pharma Data

OCTOBER 15, 2020

The award honors McHutchison’s work in developing life-changing and curative therapies for patients with the hepatitis C virus. Mukul Agarwal, former vice president of Corporate Development, at Forty Seven, Inc., Axovant – Kristin Vuori was named to the board of directors at Axovant Gene Therapies Ltd. Source link.

Pharmaceuticals 52

Pharmaceuticals Clinical Pharmacology Medical Schools Vaccine 52

Agency IQ

SEPTEMBER 29, 2023

Title Type Comments Close Classification Categories for Certain Supplements Under BsUFA III Guidance October 10 Formal Meetings Between the Food and Drug Administration and Sponsors or Applicants of Biosimilar User Fee Act Products Guidance October 10 QTc Information in Human Prescription Drug and Biological Product Labeling Guidance October 10 Postmarketing (..)

FDA 40

FDA Science Regulations Production 40

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 (..)

FDA 40

FDA Science Clinical Trials Regulations 40

Agency IQ

MARCH 1, 2024

Title Type Comments Close Digital Health Technologies for Detecting Prediabetes and Undiagnosed Type 2 Diabetes Request for Information February 29 (Extended) Requests for Reconsideration at the Division Level Under the Generic Drug User Fee Amendments Draft Guidance March 11 Advanced Manufacturing Technologies Designation Program Draft Guidance March (..)

FDA 40

FDA Science Clinical Trials Regulations 40

Agency IQ

DECEMBER 1, 2023

Title Type Comments Close Optimizing the Use of Postapproval Pregnancy Safety Studies; Public Workshop RFI November 30 Medical Devices; Laboratory Developed Tests Rule December 4 Stimulant Use Disorders: Developing Drugs for Treatment Guidance December 4 Modernizing the Food and Drug Administration’s Premarket Notification Program Notice December (..)

FDA 40

FDA Science Regulations Production 40

Alta Sciences

MARCH 27, 2025

Altasciences CDMO site supports drug development with formulation, manufacturing, and analytical testingfrom discovery to commercialization. Altasciences CDMO facility supports all stages of drug development, from early-phase formulation to late-phase scale-up and commercial manufacturing.

Small Molecule 40

Small Molecule Clinical Pharmacology Drug Development Pharmaceuticals 40

Drug Target Review

JANUARY 20, 2025

The oncology drug development landscape is evolving rapidly, driven by the deployment of targeted therapies in precision medicine and regulatory initiatives like the FDAs Project Optimus. It also covers strategies for drug developers who have yet to identify a biomarker, helping them advance their programs effectively.

Clinical Trials 52

Clinical Trials Trials Drugs Drug Development 52

FDA Law Blog: Drug Discovery

OCTOBER 28, 2024

This Guidance explicitly excludes gene therapies (a change from the draft guidance), but instead makes reference to a separate guidance that has been in place since 2020 titled Considerations for Long-Term Clinical Neurodevelopmental Safety Studies in Neonatal Product Development.

Production 64

Production FDA Therapies Clinical Pharmacology 64

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. 1 The journey to qualifying biomarkers for clinical and regulatory use is fraught with challenges, leading to a remarkably low success rate.

Drug Development 52

Drug Development Regulations Laboratories FDA 52

New Drug Approvals

APRIL 21, 2025

New Drug Therapy Approvals 2024 (PDF). Food and Drug Administration (FDA) (Report). Retrieved 20 December 2024. ^ “FDA approves BridgeBio Pharma’s Attruby to treat rare heart disease ATTR-CM” PMLiVE. 25 November 2024. Retrieved 25 November 2024. ^ January 2025. Archived from the original on 21 January 2025.

FDA Approval 62

FDA Approval FDA Production Treatment 62