2019, Clinical Pharmacology and Disease

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. Deucravacitinib is being studied in multiple immune-mediated diseases, including psoriasis, rheumatoid arthritis , lupus and inflammatory bowel disease.

Disease

Disease Laboratories Clinical Pharmacology Treatment

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 Drug Development Science Clinical Trials

TLC Provides Corporate Update at Investor Conference – Dec 18, 2020

The Pharma Data

DECEMBER 17, 2020

. The newly established subsidiary, InspirMed, will focus on inhalable liposomal treatments in both acute and chronic lung diseases. The Phase I clinical trial is ongoing in Taiwan in Australia, with results expected in 2021. Cautionary Note on Forward-Looking Statements.

Clinical Trials

Clinical Trials Trials Pharmaceutical Companies Clinical Pharmacology

Metabolism of macrocyclic drugs

Metabolite Tales Blog

JULY 5, 2023

However, in the quest to tackle challenging disease targets with difficult drug binding sites, there is revived interest in developing this compound type to offer unique solutions. Current macrocycles in clinical use generally focus on treatment of infectious diseases, cancer and auto-immune disorders. Balazs et al.,

Drugs

Drugs Metabolic Stability FDA Approval Treatment

Metabolism of de novo designed macrocyclic drugs

Metabolite Tales Blog

JULY 5, 2023

However, in the quest to tackle challenging disease targets with difficult drug binding sites, there is revived interest in developing this compound type to offer unique solutions. Current macrocycles in clinical use generally focus on treatment of infectious diseases, cancer and auto-immune disorders. Balazs et al.,

Metabolic Stability

Metabolic Stability Drugs FDA Approval Treatment

Article FDA Thank You In new contract notices, FDA seeks help on user fee commitments and moving opioid, oncology priorities forward

Agency IQ

JULY 28, 2023

The Centers for Disease Control and Prevention (CDC) explains that the first wave began with increased prescription of opioids in the 1990s. During the COVID-19 pandemic, the number of opioid-involved deaths climbed sharply, with mortality rates increasing by 38% between 2019 and 2020. Read the full AgencyIQ analysis here.

FDA

FDA Pharmacokinetics Clinical Pharmacology Government

Janssen Presents Results from Phase 3 ACIS

The Pharma Data

FEBRUARY 8, 2021

ACIS is a Phase 3 randomized, double-blind, placebo-controlled, multicenter clinical study evaluating the efficacy and safety of ERLEADA ® and ZYTIGA ® plus prednisone compared to placebo and ZYTIGA ® plus prednisone in 982 patients with chemotherapy-naïve mCRPC disease who received ADT. The primary endpoint of the study was rPFS.

Pharmaceutical Companies

Pharmaceutical Companies Treatment Clinical Trials Therapies

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

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

Agency IQ

SEPTEMBER 29, 2023

This would facilitate certain minimal risk clinical investigations to support the development of new products to diagnose or treat diseases or conditions and would harmonize, to the extent practicable and consistent with statutory provisions, with the HHS Common Rule waiver provision that has been adopted and successfully employed by other agencies.

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. July 1, 2023 MDUFA Finalize the draft guidance, “Content of Premarket Submissions for Device Software Functions,” by 18 months from close of the comment period. 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

12/29/2023 FDORA, Section 3607 Clinical Trials Modernization : FDA must issue or revise draft guidance regarding “the use of seamless, concurrent, and other innovative clinical trial designs.” The content will include both goals for enrollment of populations and rationales for those goals.

FDA

FDA Science Regulations Production

Analysis Life Sciences Thank You The 51 regulations that FDA is currently working on

Agency IQ

JUNE 16, 2023

This would facilitate certain minimal risk clinical investigations to support the development of new products to diagnose or treat diseases or conditions and would harmonize, to the extent practicable and consistent with statutory provisions, with the HHS Common Rule waiver provision that has been adopted and successfully employed by other agencies.

Regulations

Regulations FDA Science 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

If you’re looking for something specific, we recommend using the search function in your browser (Ctrl-F) to look for keywords of interest.

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

12/29/2023 FDORA, Section 3607 Clinical Trials Modernization : FDA must issue or revise draft guidance regarding “the use of seamless, concurrent, and other innovative clinical trial designs.” and Annex 1 Conference Joel Welch December 12 AgencyIQ Looking ahead to 2024: Regulatory Forecast for the U.S.

FDA

FDA Science Regulations Production

Analysis Life Sciences Thank You The 53 regulations that FDA is currently working on

Agency IQ

JULY 12, 2024

Specifically, FDA is proposing to classify blood irradiators intended for the prevention of transfusion-associated graft versus host disease into Class II and blood irradiators intended for prevention of metastasis by irradiating intra-operatively salvaged blood of cancer patients undergoing surgery into Class III. and the E.C.

Regulations

Regulations FDA Science Production

Beyond ELISA: the future of biomarker validation

Drug Target Review

NOVEMBER 27, 2024

5 Alzheimer’s disease: driving advancements with precision medicine In contrast, advanced technologies like MSD and LC-MS/MS offer enhanced precision and sensitivity for biomarker analysis. Clinical Pharmacology & Therapeutics. Outsourcing Biomarkers in Clinical Trials: Advantages and Disadvantages.

Drug Development

Drug Development Regulations Laboratories FDA

Drug Discovery Digest

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

Altasciences’ Chief Scientific Officer Named a PharmaVoice 100 Honoree

Trending Sources

TLC Provides Corporate Update at Investor Conference – Dec 18, 2020

Metabolism of macrocyclic drugs

Metabolism of de novo designed macrocyclic drugs

Article FDA Thank You In new contract notices, FDA seeks help on user fee commitments and moving opioid, oncology priorities forward

Janssen Presents Results from Phase 3 ACIS

ATICAPRANT

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 The 51 regulations that FDA is currently working on

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

Analysis Life Sciences Thank You The 53 regulations that FDA is currently working on

Beyond ELISA: the future of biomarker validation

Stay Connected