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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Drug Target Review

MAY 7, 2024

These algorithms can swiftly navigate extensive databases of clinical trial information to pinpoint potential matches between patients and trials, considering various factors such as treatment protocols and geographical considerations.

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Eye on FDA

JANUARY 5, 2022

One meeting of the Oncologic Drugs Advisory Committee is set for February 10 to discuss a new application for the proposed treatment of Non-Small Cell Lung Cancer (NSCLC. FDA has scheduled the first advisory committee meetings of 2022. In coming days, we will be doing more look-back’s at FDA activities during 2021.

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Alta Sciences

NOVEMBER 20, 2024

Innovative treatments, like MET-097i, could offer potential new treatment options for those affected by this complex condition. Obesity impacts millions of people worldwide and is a driver of serious health risks, including type 2 diabetes, heart disease, and certain cancers.

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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 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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The Pharma Data

NOVEMBER 1, 2020

Mission Therapeutics is an early-stage drug development company targeting the ubiquitin pathway for the treatment of kidney disease, neurodegenerative disease, rare mitochondrial diseases and fibrosis. The Company is managed by a team with broad international, commercial and clinical-science experience.

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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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Alta Sciences

SEPTEMBER 20, 2023

Steve Mason, Co-Chief Operating Officer, Altasciences, added: “The creation of AnQlar as a treatment, if successful, could be a huge leap forward in preventing the spread of influenza and similar viruses. We look forward to further collaboration with Virpax in the near-future.”

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New Drug Approvals

SEPTEMBER 10, 2024

. “A phase 1 study to evaluate the safety, tolerability and pharmacokinetics of TAK-041 in healthy participants and patients with stable schizophrenia” British Journal of Clinical Pharmacology. 88 (8): 3872–3882. doi : 10.1111/bcp.15305. PMC 9544063. PMID 35277995. S2CID 247407736. Rabiner, Eugenii A.; 64 (15): 11527–11542.

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The Premier Consulting Blog

JUNE 18, 2023

A Modern Twist for the Gold Standard of Clinical Research The gold standard for clinical research intended for regulatory approval is the randomized controlled trial that compares an investigational drug candidate to either a placebo, active control, or standard of care (SoC).

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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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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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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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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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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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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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The Pharma Data

DECEMBER 17, 2020

In addition, TLC is preparing for scale-up production of TLC590, as for complex lipid products, the manufacturing process and batch size used in pivotal clinical trials and New Drug Application submission must be the same as future commercial batches.

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Agency IQ

JULY 28, 2023

In 2020, the agency awarded a contract to “establish a COVID-19 Sub-Registry to collect data on the safety of drug products used for the prevention or treatment of COVID-19 infection.” Current guidelines recognize risks of malformation and fetal demise with anticancer treatments, especially conventional chemotherapy.

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Agency IQ

DECEMBER 1, 2023

That guidance, first issued in May 2020 , was released at a time when there were no FDA-approved drugs to treat Covid-19, and the standard-of-care for treatment relied on clinical management of symptoms and supportive care (e.g., Key documents COVID-19: Developing Drugs and Biological Products for Treatment or Prevention

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Agency IQ

JULY 8, 2024

Date Company Drug Indication July 7 Arcutis Roflumilast Atopic Dermatitis in Adults and Children Down to Age 6 July 15 Orexo OX124 High-dose rescue medication for opioid overdose July 19 Phathom VOQUEZNA Daily treatment of heartburn associated with Non-Erosive gastroesophageal reflux disease (GERD) in adults July 27 Alpha Cognition ALPHA-1062 Mild-to-moderate (..)

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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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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 12, 2024

Accelerated Approval of Drugs and Biologics Administrative/ Procedural New Civil Monetary Penalties for Failure to Meet Accelerated Post Marketing Requirements Administrative/ Procedural Carried over from previous guidance agenda Exclusivity for First Interchangeable Biosimilar Biological Products Administrative/ Procedural Carried over from previous (..)

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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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Alta Sciences

OCTOBER 30, 2023

Find out what the key factors are when developing nonclinical cell and gene therapies, including expert approaches to vindicating complex challenges, making your studies more efficient, and maximizing translational opportunities to first-in-human (FIH) trials. Read or listen now.

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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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Agency IQ

DECEMBER 1, 2023

12/29/2023 FDORA, Section 3202 Orphan Drug Program : FDA will convene a public meeting (or several) to solicit input from stakeholders regarding rare disease patient burdens, treatment options, side effects of treatments, etc. Within 180 days, FDA will release a report on the proceedings of the public meeting and any recommendations.

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Alta Sciences

JULY 25, 2024

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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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

Redefining clinical trial design Precision medicine is revolutionising oncology by delivering therapies tailored to individual patients based on genetic and molecular factors. This approach aims to improve treatment efficacy (compared to cytotoxic chemotherapy), minimise toxicity, and necessitates an evolution in clinical trial methodologies.

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FDA Law Blog: Drug Discovery

DECEMBER 6, 2024

The draft guidance includes FAQs covering topics from across disciplines: regulatory review; chemistry, manufacturing, and controls (CMC); nonclinical and pharmacology/toxicology (PT); clinical; and clinical pharmacology. Next, sponsors should consider no-treatment control.

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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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Alta Sciences

JULY 31, 2024

Similarly, Health Canada's guidance highlights the need to represent various demographic groups in clinical trials, ensuring that study results are broadly applicable for enhanced safety and efficacy of drug development. Furthermore, there are cases in which certain racial groups biologically react to particular conditions or treatments.

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