2019, Clinical Pharmacology and Therapies

Altasciences’ Chief Scientific Officer Named a PharmaVoice 100 Honoree

Alta Sciences

OCTOBER 9, 2024

Dr. Setnik joined Altasciences as Chief Scientific Officer in 2019, working with her team to develop new clinical methods to safely study compounds in early-phase drug development, and adapting clinical methods to establish a safe, comfortable, stimulus-controlled environment for study participants.

Clinical Pharmacology

Clinical Pharmacology Science Drug Development Clinical Trials

First clinical trial for MDMA and LSD combination set to go ahead

The Pharma Data

AUGUST 28, 2020

The Phase 1 trial will be conducted by MindMed later this year and will be the first to investigate what happens when you mix the two drugs to work as a therapy. Researchers are set to investigate a combined dose of LSD and MDMA to treat patients undergoing psychotherapy.

Clinical Trials

Clinical Trials Trials Clinical Pharmacology Therapies

Bristol Myers Squibb Data at the EADV 30th Anniversary Congress Highlight the Growing Body of Evidence on Deucravacitinib and Scientific Advancements for Patients with Serious Dermatologic Diseases

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. At therapeutic doses, deucravacitinib doesn’t inhibit JAK1, JAK2 or JAK3.

Disease

Disease Laboratories Clinical Pharmacology Treatment

Webinars

From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience

MORE WEBINARS

Metabolism of macrocyclic drugs

Metabolite Tales Blog

JULY 5, 2023

A combination therapy of glecaprevir and pibrentasvir has recently been implicated in a case of liver injury. Figure 2 Human metabolism of glecaprevir Involvement of gut bacteria Grazoprevir (MK5172) is also used as part of combination therapy to treat chronic hepatitis C. link] [9] PHARMACOLOGY/TOXICOLOGY NDA REVIEW AND EVALUATION.

Drugs

Drugs Metabolic Stability FDA Approval Treatment

Metabolism of de novo designed macrocyclic drugs

Metabolite Tales Blog

JULY 5, 2023

A combination therapy of glecaprevir and pibrentasvir has recently been implicated in a case of liver injury. Figure 2 Human metabolism of glecaprevir Involvement of gut bacteria Grazoprevir (MK5172) is also used as part of combination therapy to treat chronic hepatitis C. link] [9] PHARMACOLOGY/TOXICOLOGY NDA REVIEW AND EVALUATION.

Metabolic Stability

Metabolic Stability Drugs FDA Approval Treatment

ATICAPRANT

New Drug Approvals

SEPTEMBER 13, 2024

2] As of July 2022, it is in phase 3 clinical trials for major depressive disorder. [2] 2] Like other kappa opioid antagonists currently under clinical investigation for the treatment of major depression, its efficacy may be compromised by the countervailing activation of pro-inflammatory cytokines in microglia within the CNS. [7]

Treatment

Treatment Clinical Trials Pharmacokinetics Pharmaceuticals

Janssen Presents Results from Phase 3 ACIS

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). Food and Drug Administration (FDA) approval for nmCRPC on February 14, 2018 and was approved for mCSPC on September 17, 2019. v] ERLEADA ® is being studied in five Phase 3 clinical trials. . ‡

Pharmaceutical Companies

Pharmaceutical Companies Treatment Clinical Trials Therapies

Analysis Life Sciences Thank You What We Expect the FDA to do in October 2023

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

FDA Science Regulations Production

Analysis Life Sciences Thank You What We Expect the FDA to do in June 2023

Agency IQ

JUNE 2, 2023

The guidance, is an overdue requirement of the Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019. Was supposed to be finalized as of June 24, 2022.

FDA

FDA Science Regulations Production

Analysis Life Sciences Thank You What We Expect the FDA to do in November 2023

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

FDA Science Regulations Production

Analysis Life Sciences Thank You FDA’s nonprescription advisors find no efficacy for phenylephrine

Agency IQ

SEPTEMBER 15, 2023

FDA’s clinical pharmacology analysis challenged previous in vitro estimates of bioavailability for orally administered phenylephrine. First, Cathy Gelotte, a clinical pharmacology consultant, made the case that low bioavailability does not necessarily indicate a lack of efficacy.

Science

Science FDA Clinical Trials Clinical Pharmacology

Analysis Life Sciences Thank You 166 guidance documents the FDA is actively working on in 2024 (and beyond)

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

FDA Science Biosimilars Clinical Trials

Analysis Life Sciences Thank You What We Expect the FDA to do in December 2023

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

FDA Science Regulations Production

Drug Discovery Digest

Altasciences’ Chief Scientific Officer Named a PharmaVoice 100 Honoree

First clinical trial for MDMA and LSD combination set to go ahead

Bristol Myers Squibb Data at the EADV 30th Anniversary Congress Highlight the Growing Body of Evidence on Deucravacitinib and Scientific Advancements for Patients with Serious Dermatologic Diseases

Webinars

Metabolism of macrocyclic drugs

Metabolism of de novo designed macrocyclic drugs

ATICAPRANT

Janssen Presents Results from Phase 3 ACIS

Analysis Life Sciences Thank You What We Expect the FDA to do in October 2023

Analysis Life Sciences Thank You What We Expect the FDA to do in June 2023

Analysis Life Sciences Thank You What We Expect the FDA to do in November 2023

Analysis Life Sciences Thank You FDA’s nonprescription advisors find no efficacy for phenylephrine

Analysis Life Sciences Thank You 166 guidance documents the FDA is actively working on in 2024 (and beyond)

Analysis Life Sciences Thank You What We Expect the FDA to do in December 2023

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