The Pharma Data

MAY 2, 2022

The companies expect to complete submission of the NDA for treatment of MDD in the second half of 2022; associated filing for postpartum depression anticipated in the first half of 2023. Food and Drug Administration (FDA) for zuranolone in the treatment of major depressive disorder (MDD). Sage Therapeutics, Inc.

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The Pharma Data

FEBRUARY 15, 2022

Treatment for MIBC typically combines cisplatin-based chemotherapy with radical cystectomy, or removal of the bladder, as well as pelvic lymph node dissection. Cohort H of the Phase 1b/2 EV-103 trial enrolled patients with MIBC who were eligible for surgical treatment, but ineligible for cisplatin-based chemotherapy. The most common (?20%)

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New Drug Approvals

DECEMBER 24, 2023

Eplontersen , sold under the brand name Wainua , is a medication used for the treatment of transthyretin-mediated amyloidosis. [1] 6] [7] [8] Medical uses Eplontersen is indicated for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults. [1] twitter +919321316780 call whatsaapp EMAIL.

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The Premier Consulting Blog

JUNE 18, 2023

One exciting application of these technologies is the use of in silico trials in the development of novel therapies for rare diseases. However, with rare diseases there may be no available treatments that could serve as SoC or active control in a clinical trial and assigning patients to placebo may be unethical.

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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 also demonstrated durable efficacy in scalp psoriasis through 52 weeks of treatment (Poster Number: P1391).

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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]

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The Pharma Data

FEBRUARY 8, 2021

No statistically significant difference was demonstrated for secondary endpoints including overall survival (OS), time to initiation of cytotoxic chemotherapy, chronic opioid use, and pain progression between treatment arms. Grade 3/4 treatment emergent adverse events (TEAEs) were reported in 63.3 percent in the control arm.

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Metabolite Tales Blog

JULY 5, 2023

Current macrocycles in clinical use generally focus on treatment of infectious diseases, cancer and auto-immune disorders. With metabolic stability in mind, we take a look at the metabolism of some FDA approved synthetic macrocyclic drugs, and a few of those that were/are in clinical development where metabolism data was available.

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Metabolite Tales Blog

JULY 5, 2023

Current macrocycles in clinical use generally focus on treatment of infectious diseases, cancer and auto-immune disorders. With metabolic stability in mind, we take a look at the metabolism of some FDA approved synthetic macrocyclic drugs, and a few of those that were/are in clinical development where metabolism data was available.

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Agency IQ

MAY 3, 2024

Title Type Comments Close Key Information and Facilitating Understanding in Informed Consent Guidance for Sponsors, Investigators, and Institutional Review Boards Draft Guidance April 30 Early Alzheimer’s Disease: Developing Drugs for Treatment Draft Guidance May 13 Select Updates for the Premarket Cybersecurity Guidance: Section 524B of the (..)

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The Anticancer Fund

JUNE 7, 2022

Treatment with DFMO aka eflornithine, already a high-profile repurposing candidate in neuroblastoma, decreased intracellular pH in TAMCs and was associated with improved survival, more so when combined with immunotherapy or radiotherapy. Patients were randomised to treatment or observation groups and followed for six months.

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Agency IQ

DECEMBER 11, 2023

The areas within oncology that have seen the most success in terms of new and effective treatment options are now entering a new paradigm where the terms “success” and “harm” are being redefined. In parallel, stakeholders have advocated for recognizing the importance of treatment tolerability when determining doses and regimens.

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Agency IQ

JULY 8, 2024

Title Type Comments Close Enforcement Policy for Certain In Vitro Diagnostic Devices for Immediate Public Health Response in the Absence of a Declaration Under Section 564 Draft Guidance July 5 Consideration of Enforcement Policies for Tests During a Section 564 Declared Emergency Draft Guidance July 5 Financial Transparency and Efficiency of the Prescription (..)

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Agency IQ

FEBRUARY 23, 2024

As the name implies, the MTD seeks to find the highest dose of a treatment that can both be tolerated and treat the cancer. 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.

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Science FDA Trials Clinical Pharmacology 40

Agency IQ

SEPTEMBER 29, 2023

Title Type Date Received by OIRA Legal Deadline Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, Neutral Manner in Advertisements in Television and Radio Format Final Rule May 19 None Communications from Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses (..)

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Agency IQ

OCTOBER 27, 2023

Title Type Date Cleared by OIRA Legal Deadline None Notable FDA Comment Periods Closing in November and December FDA comment periods are typically open for 30-60 days, unless they are extended.

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Agency IQ

SEPTEMBER 15, 2023

Background on oral phenylephrine as a nonprescription nasal decongestant Phenylephrine is an alpha-1 adrenergic agonist that is approved as a nonprescription oral treatment for temporary relief of nasal congestion , sinus congestion and pressure. The trials assessed change in nasal congestion score over one week of treatment.

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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, (..)

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Alta Sciences

OCTOBER 30, 2023

TOP NONCLINICAL SCIENTIFIC RESOURCES eBook : Safety Assessment for Ophthalmic Products Designing preclinical studies for ocular therapies take a lot of deliberation. The Altascientist : Issue No. Read or listen now. Watch the video.

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The Pharma Data

NOVEMBER 9, 2020

He is a German trained expert in biopharmaceutics with a focus on oral and inhalable nanoparticles for the treatment of cancer and infectious disease and is the former president of the Canadian Society for Pharmaceutical Sciences and vice chair of the United States Pharmacopeia Dietary Supplement Expert Committee.

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Agency IQ

DECEMBER 1, 2023

Title Type Date Received by OIRA Legal Deadline Drug Products or Categories of Drug Products That Present Demonstrable Difficulties for Compounding Under Sections 503A or 503B of the Federal Food, Drug, and Cosmetic Act Proposed Rule August 29 None Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations (..)

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Alta Sciences

JULY 25, 2024

Read the eBook. jpg Synopsis Discover 10 more essential life science resources, including expert insights, tips, case studies, webinars, podcasts, posters, scientific publications, videos, and more, that you may have missed from us!

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FDA Law Blog: Drug Discovery

DECEMBER 6, 2024

Valentine On November 19, 2024, FDA released a draft guidance titled Frequently Asked Questions Developing Potential Cellular and Gene Therapy Products. The draft guidance enumerates key considerations for selecting an animal species for both pharmacology and toxicology studies. Next, sponsors should consider no-treatment control.

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Conversations in Drug Development Trends

JANUARY 6, 2025

BioA plays a pivotal role in therapeutic development, facilitating progress in our understanding and treatment of complicated diseases through PK/PD, immunogenicity studies, and biomarker discovery. They guide patient selection by identifying subpopulations most likely to respond to treatment, ensuring more targeted and effective studies.

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Drug Target Review

JANUARY 20, 2025

The oncology drug development landscape is evolving rapidly, driven by the deployment of targeted therapies in precision medicine and regulatory initiatives like the FDAs Project Optimus. Genetic predispositions, such as BRCA mutations in hereditary cancers, influence treatment options and inform preventive measures.

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Drug Target Review

NOVEMBER 27, 2024

Introduction Biomarkers are becoming increasingly essential in drug development and clinical practice, driving the need for more precise validation methods. As the demand for personalised treatments grows, regulatory bodies are adapting their standards to support advanced techniques that go beyond traditional approaches. 174-177.

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