Alta Sciences

APRIL 17, 2024

Psychedelics Psychedelic therapy (or psychedelic-assisted therapy) refers to the use of psychedelic drugs, such as psilocybin, MDMA, LSD, ketamine, and ayahuasca, to treat mental disorders, especially those that have no effective treatments available or are treatment resistant.

Drug Development 52

Drug Development Treatment FDA Approval Therapies 52

New Drug Approvals

OCTOBER 24, 2023

“Etrasimod as induction and maintenance therapy for ulcerative colitis (ELEVATE): two randomised, double-blind, placebo-controlled, phase 3 studies” Lancet. Peyrin-Biroulet L, Christopher R, Behan D, Lassen C (May 2017). Retrieved 13 October 2023. ^ [link] ^ World Health Organization (2017). 401 (10383): 1132–1133.

FDA 57

FDA FDA Approval International Pharmacokinetics 57

The Pharma Data

JANUARY 3, 2021

The Phase 1/2 clinical trial will primarily investigate the safety and tolerability of INZ-701 and characterize its pharmacokinetic and pharmacodynamic profile, including plasma pyrophosphate (PPi) and other biomarker levels, to establish a recommended dosing regimen for further clinical development. Demetrios Braddock, M.D.,

Clinical Trials 52

Clinical Trials Trials Treatment FDA 52

The Pharma Data

DECEMBER 15, 2020

The clinical responses were sustained by maintenance therapy with belimumab, an antibody to B-cell activating factor. The secondary outcome involves pharmacokinetic endpoints. 2 g/dl on three consecutive available visits during the 24-week treatment period, with the response not being attributed to rescue therapy.

Disease 52

Disease Clinical Trials Small Molecule Trials 52

The Pharma Data

SEPTEMBER 15, 2020

Of note, The Phase 1b study is a double-blind, placebo-controlled clinical trial evaluating the safety, tolerability and pharmacokinetics of PF-07304814, a phosphate prodrug that when administered intravenously is metabolized to the active compound PF-00835321, shown to be a very potent inhibitor of the SARS-Cov2 3CL protease in preclinical studies.

Vaccine 52

Vaccine Therapies Trials Clinical Trials 52

The Pharma Data

JANUARY 3, 2021

The pharmacokinetics of nasally administered Foralumab will also be evaluated. . The primary endpoint of this study was safety of the treatment, and secondary endpoints were to evaluate the effect of treatment on disease severity symptoms, nasal tolerance, sense of smell, and biomarkers for disease progression.

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Clinical Trials Science Treatment Trials 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). The NCCN Prostate Cancer Panel uses the term “castration-naive” even when patients have had neoadjuvant, concurrent, or adjuvant ADT as part of radiation therapy provided they have recovered testicular function.

Pharmaceutical Companies 52

Pharmaceutical Companies Treatment Clinical Trials Therapies 52

Agency IQ

FEBRUARY 23, 2024

Additionally, this approach is generally no longer applicable to new treatments that are more targeted in their effects, such as immunotherapies and targeted small molecule therapies. This workshop built on three prior workshops held by the FDA-AACR, which took place in 2015, 2016 and 2017.

Science 40

Science FDA Trials Clinical Pharmacology 40

The Pharma Data

NOVEMBER 6, 2020

Since October 2017 Biogen and Eisai have collaborated on the development and commercialization of aducanumab globally. Secondary outcomes were: (1) the effect of aducanumab on brain amyloid plaque content as measured by [18F]-florbetapir PET, (2) the pharmacokinetics of aducanumab and (3) the immunogenicity of aducanumab. About Biogen.

Disease 40

Disease FDA Clinical Trials Licensing 40

Agency IQ

DECEMBER 11, 2023

Oncology at FDA in 2023: A quick glance at the numbers First created under the 21st Century Cures Act of 2016 and launched in 2017, FDA’s Oncology Center of Excellence (OCE ) “unites experts across the FDA to conduct expedited review of medical products for oncologic and hematologic malignancies.”

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FDA Science Clinical Trials Trials 40

The Pharma Data

OCTOBER 27, 2020

Medtronic), the premarket approval application (PMA) for the ISR was approved by the FDA in December 2017. In October 2020 , we completed a second clinical study in healthy volunteers to compare the pharmacokinetics of Treprostinil Technosphere to Tyvaso. Autologous cell therapy for PAH — SAPPHIRE. ADVANCE OUTCOMES.

FDA 40

FDA Production Licensing Licensing 40

Agency IQ

AUGUST 16, 2024

However, the agency can describe a concomitant therapy in labeling for a product it has authority to regulate if it is essential for the therapeutic effect. While the ability to describe and specify aspects of the therapy is limited, the agency can specify the number and licensure of therapists who would participate in the MDMA treatment.

FDA 40

FDA Trials Therapies Regulations 40

The Pharma Data

MARCH 16, 2021

1,2 TREMFYA is the first and only IL-23 inhibitor therapy approved in the U.S. for the treatment of adults with moderate to severe plaque PsO in July 2017 and in July 2020 for adults with active PsA. Efficacy, safety, pharmacokinetic, immunogenicity and biomarker evaluations were performed in the study on a defined schedule.

Treatment 52

Treatment Disease Pharmacokinetics Therapies 52

The Pharma Data

APRIL 8, 2021

FDA and global approvals for our groundbreaking therapies in SMA and NMOSD, Roche’s data at AAN reflect our continued commitment to meaningful therapeutic progress for people living with neurological disorders,” said Levi Garraway, M.D., Following U.S. Roche’s Chief Medical Officer and Head of Global Product Development. Claims Database.

Clinical Trials 52

Clinical Trials Trials Disease Therapies 52

Agency IQ

SEPTEMBER 15, 2023

In 2017, the FDA expanded the restrictions , which include behind-the-counter sale requiring photo identification with a per-month individual purchase quota, to products containing ephedrine and phenylpropanolamine — effectively narrowing the decongestant drugs approved for over-the-counter sale.

Science 40

Science FDA Clinical Trials Clinical Pharmacology 40

Agency IQ

AUGUST 16, 2024

As opposed to the linear dose-response relationships of chemotherapies, the wide therapeutic indexes of many of these newer therapies means that doses can be increased without simultaneously increasing toxicities. Other issues also arise: Unlike conventional cytotoxic drugs where the relationship between early (e.g.,

Production 40

Production FDA Science Clinical Trials 40

The Pharma Data

NOVEMBER 9, 2020

The pharmacokinetic tail—will this be a significant risk for drug resistance? It also has a long pharmacokinetic. It is not yet understood if this long pharmacokinetic tail will have any significant effect on drug resistance. iii 2015 Guideline on when to start antiretroviral therapy and on pre-exposure prophylaxis for HIV.

Trials 52

Trials Pharmacokinetics Drugs Therapies 52

Agency IQ

FEBRUARY 15, 2024

We have tried to sort guidance documents by topic area.

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FDA Science Biosimilars Clinical Trials 40

The Pharma Data

FEBRUARY 25, 2021

FIREFISH, an open-label, two-part pivotal study, was designed to assess Evrysdi safety, tolerability, efficacy, pharmacokinetics (PK) and pharmacodynamics (PD) in patients aged 1 to 7 months with Type 1 SMA. Part 1 evaluated several doses of Evrysdi and determined the therapeutic dose of 0.2 mg/kg for Part 2.

Pharmacokinetics 52

Pharmacokinetics FDA Approval Treatment Disease 52

The Pharma Data

MARCH 16, 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. At this time, Evrysdi has been approved in seven countries and submitted in 57, including the EU 27 and Norway and Iceland. The study has completed recruitment (n=174).

Pharmacokinetics 52

Pharmacokinetics Treatment Clinical Trials Disease 52

The Pharma Data

SEPTEMBER 27, 2020

Evrysdi is being studied in more than 450 people as part of a broad and robust clinical trial programme in SMA, with patients ranging from birth to 60 years old, and includes pre-symptomatic patients and those previously treated with other SMA-targeting therapies. The study has completed recruitment (n=174). The study is currently recruiting.

Pharmacokinetics 52

Pharmacokinetics FDA Approval Treatment Clinical Trials 52