The Pharma Data

DECEMBER 9, 2020

The open-label Phase 2a ‘AMBITION’ study is designed to assess safety, tolerability, pharmacokinetics and biomarker analyses for early assessments of efficacy of 75 mg and 225 mg CRV431, administered orally to F2 and F3 NASH patients (n=18/dosing group), once daily for 28 days.

Clinical Trials 40

Clinical Trials Trials Pharmaceuticals Pharmacokinetics 40

The Pharma Data

DECEMBER 28, 2020

The primary objectives of the AMBITION trial are to assess safety and tolerability of CRV431, as well as to delineate pharmacokinetics. Investors should read the risk factors set forth in Hepion Pharmaceuticals’ Form 10-K for the year ended December 31, 2019 and other periodic reports filed with the Securities and Exchange Commission.

Clinical Trials 40

Clinical Trials Trials Pharmaceuticals Treatment 40

Metabolite Tales Blog

APRIL 4, 2023

Tapinarof is a topical aryl hydrocarbon receptor–modulating agent approved for the treatment of psoriasis by downregulating proinflammatory interleukin-17 and regulating expression of the skin-barrier proteins filaggrin and loricrin. Dermavant’s tapinarof is one such friend. 8 This is not the only point of interest. Br J Pharmacol.

Small Molecule 52

Small Molecule FDA Approval FDA Drugs 52

The Pharma Data

APRIL 27, 2021

In 2019, the U.S. The Phase 1/2 trial aims to evaluate the safety, pharmacokinetics and anti-tumor activity of oral mobocertinib in patients with non-small cell lung cancer (NSCLC). About the Phase 1/2 Trial.

FDA 52

FDA Treatment Pharmaceutical Companies Therapies 52

Agency IQ

SEPTEMBER 22, 2023

In 1972, when regulatory authority for biologic products was transferred from the National Institutes of Health (NIH) to the FDA, the agency extended the two-study framework to biologic regulation as well. Three drugs were approved based on no pivotal trials (such as in cases where an approval leveraged literature on use of the drug).

FDA 40

FDA Science Trials Clinical Trials 40

Agency IQ

FEBRUARY 2, 2024

In 2019 more than one in four (28%) of deaths in the E.U. EMA floated these updates through a Concept Paper in 2019 and subsequently issued a draft updated guideline for public consultation in late 2020. after ischemic heart disease and stroke. were from cancer. Even under the shadow of the Covid-19 pandemic, 1.2

Clinical Trials 40

Clinical Trials Trials Treatment Disease 40

The Pharma Data

FEBRUARY 8, 2021

IBRANCE is an oral inhibitor of CDKs 4 and 6, 1 which are key regulators of the cell cycle that trigger cellular progression. The pharmacokinetics of IBRANCE have not been studied in patients requiring hemodialysis. This extension does not include potential pediatric exclusivity. 2,3 In the U.S., About Pfizer Oncology.

Clinical Trials 52

Clinical Trials Treatment Therapies Production 52

The Pharma Data

FEBRUARY 8, 2021

Food and Drug Administration (FDA) approval for nmCRPC on February 14, 2018 and was approved for mCSPC on September 17, 2019. In a dedicated drug interaction trial, co-administration of ketoconazole, a strong inhibitor of CYP3A4, had no clinically meaningful effect on the pharmacokinetics of abiraterone. 2 ERLEADA ® received U.S.

Pharmaceutical Companies 52

Pharmaceutical Companies Treatment Clinical Trials Therapies 52

Agency IQ

SEPTEMBER 15, 2023

BY AMANDA CONTI SEP 13, 2023 1:58 PM CDT Quick background on nonprescription drug regulation Nonprescription drugs, also known as over-the-counter (OTC) drugs, are regulated differently than traditional prescription drugs. The committee also made recommendations regarding pharmacokinetic and safety assessments.

Science 40

Science FDA Clinical Trials Clinical Pharmacology 40

The Pharma Data

DECEMBER 20, 2020

Pending Health Canada’s approval, the Phase 1 trial is designed to test the safety, tolerability and pharmacokinetics of ALS-4 in healthy volunteers. The secondary objective is to assess the pharmacokinetic profile of SAD and MAD of ALS-4 administered orally to healthy subjects. About ALS-4.

Small Molecule 40

Small Molecule Clinical Trials Trials Treatment 40

Agency IQ

FEBRUARY 23, 2024

Since 2019, more than half of the population of Europe has been classified as overweight or obese. According to Eurostat, the prevalence of overweight and obesity in adults in 2019 (the most recent year with complete data) was 53%. The figures are lower for individuals meeting obesity criteria , with 2019 data showing just 16.3%

Drugs 40

Drugs Clinical Trials Pharmacokinetics Drug Development 40

The Pharma Data

APRIL 8, 2021

EVRYSDI was granted PRIME designation by the European Medicines Agency (EMA) in 2018 and Orphan Drug Designation by FDA and EMA in 2017 and 2019, respectively. Applications are under review with numerous regulators. At this time, EVRYSDI has been approved in 38 countries and submitted in a further 33 countries. Europe and Japan.

Clinical Trials 52

Clinical Trials Trials Disease Therapies 52

The Pharma Data

MAY 7, 2021

GSK and Vir continue discussions with global regulators to make sotrovimab available to patients with COVID-19. Sotrovimab is also under review by other global regulators including Health Canada under the expedited Interim Order application pathway for COVID-19 drugs. Review will support a formal Marketing Authorisation Application.

Treatment 52

Treatment Vaccine Virus Trials 52

The Pharma Data

MARCH 30, 2021

It is vital that we work together with health authorities, regulators and industry to ensure we can get this medicine to the patients who need it as soon as possible.’’. Evrysdi was granted PRIME designation by the European Medicines Agency (EMA) in 2018 and Orphan Drug Designation in 2019. The study met its primary endpoint.

Treatment 52

Treatment Clinical Trials Pharmacokinetics Trials 52

The Pharma Data

JANUARY 21, 2021

Results from these trials were presented at the 2019 Conference on Retroviruses and Opportunistic Infections (CROI). Hepatic Impairment: EDURANT ® should be used with caution in patients with severe hepatic impairment (Child-Pugh Class C) as pharmacokinetics of EDURANT ® have not been evaluated in these patients.

FDA Approval 52

FDA Approval Treatment RNA FDA 52

The Pharma Data

JANUARY 19, 2021

The secondary objective is to assess the pharmacokinetic profile of SAD and MAD of ALS-4 administered orally to healthy subjects. This announcement is not a prospectus within the meaning of the Regulation (EU) n°2017/1129 of 14 June 2017 as amended by Regulations Delegated (EU) n°2019/980 of 14 March 2019 and n°2019/979 of 14 March 2019.

Small Molecule 52

Small Molecule Clinical Trials Trials Pharmacokinetics 52

Agency IQ

FEBRUARY 15, 2024

CDRH FY2024 Guidance Agenda Clinical application Recommendations for Investigational and Licensed COVID-19 Convalescent Plasma CBER Final By 12/31/24 CBER CY 2024 Guidance Agenda Blood Considerations for the Development of Blood Collection, Processing, and Storage Systems for the Manufacture of Blood Components Using the Buffy Coat Method CBER Draft (..)

FDA 40

FDA Science Biosimilars Clinical Trials 40