The Pharma Data

NOVEMBER 8, 2020

Absorption Systems is a leading scientific, non-clinical CRO that provides pharmaceutical, biotech, medical device companies and regulatory agencies with research and testing for small and large molecules, cell and gene therapies, ocular and medical device products. www.pharmaron.com.

Clinical Pharmacology 40

Clinical Pharmacology Laboratories Science Pharmaceuticals 40

Alta Sciences

MAY 15, 2023

Integrated Clinical Sites Accelerate Timelines Well-suited and qualified clinical pharmacology units (CPUs) for early phase trials are getting more expensive to run due to the growing complexity of required clinical procedures, and the precision around participants to be recruited.

Drug Development 52

Drug Development Clinical Trials Compounding Pharmacies Laboratories 52

The Pharma Data

OCTOBER 1, 2021

Deucravacitinib demonstrated efficacy no matter baseline characteristics, including weight , disease severity and former treatment with biologic or non-biologic therapies. Psoriasis may be a widely prevalent, chronic, systemic immune-mediated disease that substantially impairs patients’ physical health, quality of life and work productivity.

Disease 52

Disease Laboratories Clinical Pharmacology Treatment 52

Agency IQ

OCTOBER 6, 2023

As such, it doesn’t review things like vaccines, blood products or gene therapies – those products are instead reviewed by CBER. All products are received in one of two forms: A New Drug Application (or NDA, for pharmaceuticals) or a Biologics License Application (BLA, for biologics).

FDA 52

FDA Biosimilars Science Production 52

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. Axovant – Kristin Vuori was named to the board of directors at Axovant Gene Therapies Ltd. Trevi Therapeutics – Shashank Rohatagi was named vice president of Pharmacology and Clinical Phrarmacokinetics.

Pharmaceuticals 52

Pharmaceuticals Clinical Pharmacology Medical Schools Therapies 52

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Facilitating Understanding in Informed Consent Guidance for Sponsors, Investigators, and Institutional Review Boards Draft Guidance April 30 Early Alzheimer’s Disease: Developing Drugs for Treatment Draft Guidance May 13 Select Updates for the Premarket Cybersecurity Guidance: Section 524B of the (..)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

Metabolite Tales Blog

JULY 5, 2023

Current macrocycles in clinical use generally focus on treatment of infectious diseases, cancer and auto-immune disorders. Previously natural products have provided the source of up to 90% of macrocyclic drugs, not surprising given that 20% of natural product derived ring systems are macrocyclic [2]. Garcia Jimenez et al.,

Drugs 52

Drugs Metabolic Stability FDA Approval Treatment 52

Metabolite Tales Blog

JULY 5, 2023

Current macrocycles in clinical use generally focus on treatment of infectious diseases, cancer and auto-immune disorders. Previously natural products have provided the source of 80-90% of macrocyclic drugs, not surprising given that 20% of natural product derived ring systems are macrocyclic. [2] Garcia Jimenez et al.,

Metabolic Stability 52

Metabolic Stability Drugs FDA Approval Treatment 52

Agency IQ

OCTOBER 20, 2023

Biosimilars are biological products that are highly similar (but not identical) to a previously approved biological product and have “no clinically meaningful” differences relative to the original reference product. Hence, they are “similar” – not the same – as the reference product.

Science 40

Science Biosimilars FDA Production 40

Agency IQ

DECEMBER 11, 2023

BY RACHEL COE, MSC | DEC 6, 2023 5:27 PM EST The push and pull: Trends in oncology After the creation of the Accelerated Approval Pathway, several policies in the early 2000s were put in place with the goal of getting cancer products to patients faster. OCE has also been busy this year.

FDA 40

FDA Science Clinical Trials Trials 40

Agency IQ

SEPTEMBER 29, 2023

An avalanche of new legislation: Speaking of Congress, the House and Senate are back in session as of mid-September and we have already noticed a lot of legislative interest in the FDA – probably about two dozen bills related to drug shortages, generic drug competition, supply chain security, opioids, medical device recalls and orphan drug products.

FDA 40

FDA Science Regulations Production 40

The Pharma Data

FEBRUARY 8, 2021

1 Quality of life was comparable between treatment arms per Functional Assessment of Cancer Therapy–Prostate (FACT-P Total). v] ERLEADA ® is being studied in five Phase 3 clinical trials. . ‡ Thyroid replacement therapy, when clinically indicated, should be initiated or dose-adjusted. percent in the control arm.

Pharmaceutical Companies 52

Pharmaceutical Companies Treatment Clinical Trials Therapies 52

Agency IQ

JULY 8, 2024

FDA Regulations and guidance under OIRA review as of July The White House’s Office of Information and Regulatory Affairs (OIRA) is the regulator of regulators, tasked with ensuring that all federal policies and regulations adhere to laws, existing regulations, federal policies and the wishes of the President.

FDA 40

FDA Science Regulations Production 40

Agency IQ

FEBRUARY 23, 2024

BY CHELSEY MCINTYRE, PHARMD , KARI OAKES | FEB 21, 2024 7:48 PM CST Background: Dose-finding in oncology Traditionally, early development of oncology products has focused on identifying the maximum tolerated dose (MTD) of an investigational product.

Science 40

Science FDA Trials Clinical Pharmacology 40

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.

FDA 40

FDA Science Regulations Production 40

Agency IQ

JUNE 2, 2023

The proposed rule would require clear and concisely written prescription drug product information presented in a consistent and easily understood format to help patients use their prescription drug products safely and effectively.

FDA 40

FDA Science Regulations Production 40

The Anticancer Fund

JUNE 7, 2022

However, patients treated with subsequent therapies, including rechallenge with previous treatments some showed very encouraging responses - intriguingly suggesting the combination treatment may work to reverse drug resistance in this population with few other options.

Clinical Trials 40

Clinical Trials Drugs Trials Treatment 40

Agency IQ

SEPTEMBER 15, 2023

The monographs functioned as rule books for specific classes of OTC drugs, describing active ingredients, doses, indications, labeling and tests requires for covered OTC products to be generally recognized as safe and effective (GRASE). The FDA maintains a webpage with the full rulemaking history for OTC nasal decongestant drug products.

Science 40

Science FDA Clinical Trials Clinical Pharmacology 40

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

Agency IQ

FEBRUARY 15, 2024

CDRH FY2024 Guidance Agenda Administrative, Procedural Enforcement Policy for In Vitro Diagnostic Product for Immediate Response to an Emerging Outbreak of an Infectious Biological Agent Prior to a Declaration under Section 564 CDRH Draft By 10/1/24 New on CDRH’s guidance agenda. Priority A List. Called for under MDUFA. Priority A List.

FDA 40

FDA Science Biosimilars Clinical Trials 40

Agency IQ

DECEMBER 1, 2023

This is what OIRA is currently reviewing. Note: If a link no longer works, it is likely because OIRA has since cleared the document.)

FDA 40

FDA Science Regulations Production 40

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.

Science 52

Science Clinical Trials Pharmacokinetics Pharmacy 52

Agency IQ

MARCH 1, 2024

As it happens, EtO is essential for the sterilization of many medical devices, and the EtO final rule is expected to kick off a frantic period for regulators as they try to authorize substitute methods for device sterilization and ensure device products do not go into shortage. This is what OIRA is currently reviewing.

FDA 40

FDA Science Clinical Trials Regulations 40

The Pharma Data

NOVEMBER 9, 2020

He is also a current member of the Health Canada Scientific Advisory Committee on Pharmaceutical Sciences and Clinical Pharmacology and the Scientific Advisory Panel on Opioid Analgesic Abuse. Psilocybin has recently been designated twice as a “breakthrough therapy” by the U.S.

Drug Development 40

Drug Development Drugs Clinical Pharmacology Pharmaceuticals 40

Agency IQ

FEBRUARY 2, 2024

Legal Deadline March 7 Considerations for the Development of CAR T Cell Products FDA CBER March 15 Patient Listening Session: Patients with ADHD FDA March 22 Patient Listening Session: Patients with ADHD FDA March 25 Deadline to participate in the Quality Management Maturity Program Pilot. This is what OIRA is currently reviewing.

FDA 40

FDA Science Clinical Trials Regulations 40

FDA Law Blog: Drug Discovery

OCTOBER 28, 2024

Tobolowsky — The neonatal period is a unique and complex period of rapid growth and development throughout the body, thus creating unique and complex challenges in medical product development for this population. However, even products with single doses may require long-term safety assessments based on other considerations.

Production 64

Production FDA Therapies Clinical Pharmacology 64