The Pharma Data

NOVEMBER 8, 2020

HK) (“Pharmaron”), a fully integrated contract research and manufacturing organization offering laboratory, CMC and clinical development services for the life science industry, announced today that it has acquired 100% of the equity of Absorption Systems for up to US$137.5 BEIJING–( BUSINESS WIRE )– Pharmaron Beijing Co.,

Clinical Pharmacology 40

Clinical Pharmacology Laboratories Science Pharmaceuticals 40

The Pharma Data

NOVEMBER 1, 2020

Steve Jackson’s Cancer Research UK Laboratories at the University of Cambridge Gurdon Institute, and leading UK centres in neurodegenerative diseases. Suhail’s initial industry experience was at Pfizer, where he spent 12 years, initially in Sandwich, UK and then at Global R&D Headquarters in Connecticut, USA.

Clinical Pharmacology 52

Clinical Pharmacology Small Molecule Clinical Research Science 52

Agency IQ

DECEMBER 1, 2023

For such studies, the FDA recommended a primary endpoint of laboratory-confirmed SARS-CoV-2 infection with or without symptoms. While the concept of quantitative systems pharmacology (QSP) has been around for several decades, the prospect of actually using these models in regulatory applications is still quite new.

FDA 40

FDA Clinical Trials Vaccine Trials 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

Date Group Event Notable FDA Speakers February 28 TransCelerate Rapid RWD Analyses to Support Safety Signal Assessments February 28 White House Rare Disease Forum Julie Tierney March 1 Foundation Fighting Blindness PFDD Meeting on Dry Age-Related Macular Degeneration (Dry AMD) March 4 America’s Blood Centers 2024 Annual Meeting Peter Marks March (..)

FDA 40

FDA Science Clinical Trials Regulations 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. Altasciences has U.S.

Drug Development 52

Drug Development Clinical Trials Compounding Pharmacies Laboratories 52

Drug Discovery World

NOVEMBER 8, 2023

Adams, on a first-in-human study of ELU001, a targeted c’dot drug conjugate, in subjects with folate receptor α (frα) overexpressing solid tumours, and Groothuis on the non-clinical pharmacology of the MET-targeting ADC BYON3521. He will cover the evaluation of safety and efficacy of antibody therapies in PBMC humanised mice.

Engineering 162

Engineering Protein Expression Therapies Science 162

Drug Discovery World

AUGUST 15, 2023

However, many other drugs exhibit a more complex multichannel pharmacology 7 , which is much harder to interpret and cannot be easily modelled by screening against a single ion channel. Journal of Cardiovascular Pharmacology, 20: S96-105 Aktas et al. Clinical Pharmacology & Therapeutics. 12(3): 197-202. Tisdale et al.

Drugs 130

Drugs Clinical Pharmacology Disease Engineering 130

Drug Discovery World

NOVEMBER 9, 2023

The luncheon presentation will be given by Hans Gerstmans, Postdoctoral Researcher, Laboratory for Biomolecular Discovery & Engineering, KU Leuven, VIB, alongside Wai Long Tam, Head of Technology Watch at VIB, Technology Watch, VIB.

Engineering 130

Engineering Protein Production Therapies Science 130

Agency IQ

FEBRUARY 12, 2024

Accelerated Approval of Drugs and Biologics Administrative/ Procedural New Civil Monetary Penalties for Failure to Meet Accelerated Post Marketing Requirements Administrative/ Procedural Carried over from previous guidance agenda Exclusivity for First Interchangeable Biosimilar Biological Products Administrative/ Procedural Carried over from previous (..)

Biosimilars 40

Biosimilars Science Clinical Pharmacology FDA 40

Agency IQ

SEPTEMBER 29, 2023

July 2023 (Under OIRA Review) Medical Devices; Laboratory Developed Tests (Proposed Rule) This proposed rule would propose to amend the Food and Drug Administration’s regulations to make explicit that laboratory developed tests (LDTs) are devices under the Federal Food, Drug, and Cosmetic Act.

FDA 40

FDA Science Regulations Production 40

The Pharma Data

FEBRUARY 8, 2021

2% over placebo) from the randomized placebo-controlled clinical trials (TITAN and SPARTAN) were fatigue, arthralgia, rash, decreased appetite, fall, weight decreased, hypertension, hot flush, diarrhea and fracture. Laboratory Abnormalities — All Grades (Grade 3-4).

Pharmaceutical Companies 52

Pharmaceutical Companies Treatment Clinical Trials Trials 52

Agency IQ

JUNE 16, 2023

Perhaps the most important addition to FDA’s agenda is a proposed rule intended to clarify that Laboratory Developed Tests (LDTs) are to be regulated as medical devices under the Federal Food, Drug and Cosmetic Act (FD&C Act). Of those 51, just four are new to the Agenda, having never before been made public.

Regulations 40

Regulations FDA Science Production 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

Agency IQ

FEBRUARY 15, 2024

These topics include administrative, advanced manufacturing, the Animal Rule, antimicrobials, biosimilars, blood products, breakthrough devices, cell and gene therapy products, CGMP, clinical pharmacology, clinical trials, clinical/medical guidance, combination products, communication, compounding, cybersecurity, device software, digital health technologies, (..)

FDA 40

FDA Science Biosimilars Production 40

Agency IQ

DECEMBER 1, 2023

Comments on LDT Proposed Rule: On December 4, the comment period on the FDA’s Laboratory Developed Test proposed rule will close, and we will get a fuller picture of the extent to which the life sciences industry opposes the FDA’s proposal. Whatever the agency decides could result in new lawsuits or negative political attention.

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FDA Science Regulations Production 40