Drug Target Review

NOVEMBER 6, 2023

Before joining AstraZeneca, he served as the Chief of the Lymphoma Service at Memorial Sloan Kettering Cancer Center (MSKCC) and led a laboratory focused on drug development for patients with lymphoid malignancies. 2012);12(4):237-251. Front Pharmacol. 2018;9:1300. Published 2018 Nov 13. doi:10.3389/fphar.2018.01300

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Conversations in Drug Development Trends

NOVEMBER 27, 2023

In trials, Casgevy was shown to help prevent episodes of debilitating pain, known as vaso-occlusive crises, that often plague patients affected by sickle cell disease. The CRISPR technique was first published in 2012, outlining a method to harness the previously underappreciated bacterial immune system.

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NIH Director's Blog: Drug Development

JUNE 14, 2016

Several years ago, the Food and Drug Administration (FDA) recommended that drug developers take special care to show that potential drugs to treat diabetes don’t adversely affect the cardiovascular system [1]. 2012 Jul 6;337(6090):100-104. [4] 5] Clinical development success rates for investigational drugs.

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Vial

MAY 1, 2024

The landscape of medical research is currently in the midst of an exciting transition wherein technology has rapidly become a critical tool for clinical trial management and patient data collection. in 2010 to 11.4% in 2020 to enable continuous remote monitoring of real-world patient health data. in 2010 to 11.4%

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Drug Target Review

NOVEMBER 1, 2023

I work in the Centre for Cancer Drug Discovery (CCDD) at The Institute of Cancer Research in London, which is an academic drug discovery centre. The mission of the CCDD is to discover novel small-molecule therapeutics for the treatment of cancer and progress them to hypothesis testing phase 1 clinical trials.

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The Pharma Data

APRIL 25, 2021

Nirsevimab demonstrate d protect ion against respiratory syncytial virus disease in healthy infants in Phase 3 trial. The overall safety profile of nirsevimab in the trial remains consistent with previously reported results. Lurie Children’s Hospital of Chicago, Illinois, US and primary investigator of the MELODY Phase III trial.

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NIH Director's Blog: Drug Development

JULY 20, 2017

Helping to fuel this optimism are preliminary results released this week from early-stage clinical trials of three next-generation, triple combination therapies that modulate the function of CFTR. According to preliminary data from one Phase 1 and two Phase 2 clinical trials reported by Vertex Pharmaceuticals Inc.,

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Drug Target Review

JUNE 21, 2023

A significant challenge in developing novel therapies is the limited understanding of how the target gene influences the underlying disease biology, which contributes to the considerable attrition observed in investigative therapies. The druggable genome and support for target identification and validation in drug development.

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The Pharma Data

JANUARY 24, 2021

Meanwhile, the FDA has also approved the Investigational New Drug (IND) application for a global Phase III trial of Toripalimab in combination with Axitinib versus Pembrolizumab for the first-line treatment of patients with advanced mucosal melanoma (Combination Clinical Trial).

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The Pharma Data

NOVEMBER 15, 2020

Most recently, she was a senior executive at Celgene Corporation, where she led corporate strategy from 2012 to 2017. Prior to Celgene, she held leadership roles in marketing, sales and new business development from 2002 to 2011 at Johnson & Johnson. drug development initiative from 2012 to February 2019.

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NIH Director's Blog: Drug Development

MARCH 18, 2021

He and others had been working on closely related coronaviruses for years, inspired by earlier outbreaks, including SARS in 2002 and Middle East respiratory syndrome (MERS) in 2012 (although MERS apparently came from camels). This antibody is showing promise for treating COVID-19 [3], now in a phase 3 clinical trial in the United States.

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DrugBank

NOVEMBER 4, 2024

While the demand for novel antibiotics is undeniable, the industry still struggles with the harsh realities of antibiotic drug development. This costly, high-risk development pipeline has high attrition rates and uncertain market returns.   For instance, the U.S.

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Agency IQ

APRIL 19, 2024

Committee discussions noted the potential for earlier readout and faster completion of studies, with an expectation that the FDA will ultimately require follow-through with confirmatory trials. Despite the availability of treatments, there is still significant unmet need for patients with MM.

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Agency IQ

MARCH 29, 2024

FDA’s oncology advisory committee to consider MRD as a multiple myeloma endpoint Yesterday, the FDA announced that its Oncologic Drugs Advisory Committee would weigh in on the potential use of minimal residual disease (MRD) as an endpoint in multiple myeloma clinical trials. What’s new? to 4 p.m.

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NIH Director's Blog: Drug Development

APRIL 7, 2015

The biopharmaceutical company AstraZeneca, which has agreed to supply the drug for the trials, first developed the compound to target a family of enzymes called src kinases, which are involved in the spread of cancer. Although the oral drug proved safe in human clinical trials, its performance was not impressive against cancer.

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New Drug Approvals

SEPTEMBER 13, 2024

4] [6] Aticaprant was originally developed by Eli Lilly , was under development by Cerecor for a time, and is now under development by Janssen Pharmaceuticals. [2] 2] As of July 2022, it is in phase 3 clinical trials for major depressive disorder. [2] 2] However, development for these indications was discontinued. [2]

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Agency IQ

OCTOBER 6, 2023

The goals of the workshop were to examine trends in stimulant abuse, discuss drug development for treatments, and gather stakeholder knowledge to develop new ideas for advancing development in this area. This was followed by a patient-focused drug development (PFDD) meeting in October 2020 on substance use disorder.

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The Pharma Data

DECEMBER 9, 2020

(Tokyo, Japan) announced that Biogen has submitted a Japanese New Drug Application (J-NDA) to the Ministry of Health, Labor and Welfare (MHLW) for aducanumab, an investigational therapy for Alzheimer’s disease. million people live with dementia and about 4 million people live with Mild Cognitive Impairment (MCI) in Japan (2012).

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DrugBank

JUNE 27, 2023

The general notion is that patients should be viewed individually, rather than strictly as members of some larger general population, and that their specific genetic background, environment, and lifestyle choices should be considered throughout drug development to the point of treatment and continuing patient care. & Barbadilla, A.

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Agency IQ

JANUARY 19, 2024

As the FDA has previously acknowledged : “Many complex drug products did not exist” when the Hatch-Waxman Amendments was first passed into law. “As As drugs have increased in complexity in recent years, the scientific and regulatory roadmaps for drug development and approval may not be as well-established for more complex generics.”

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Agency IQ

JUNE 29, 2023

June 2023 Administrative Destruction of Certain Devices Refused Admission to the United States (Final Rule) Section 708 in the Food and Drug Administration Safety and Innovation Act (FDASIA), enacted in 2012, added FDA authority to section 801(a) of the FD&C Act to destroy any refused drug valued at $2500 or less (or such higher amount as the Secretary (..)

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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 (..)

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Agency IQ

OCTOBER 27, 2023

12/29/2023 FDORA, Section 3602 Clinical Trials Modernization : FDA is directed to require the submission of a “diversity action plan” for all Phase 3 clinical trials of new drugs. ” These include the use of expansion cohorts, concurrent trial conduct, and other designs. .”

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The Pharma Data

DECEMBER 27, 2020

Complete approval for these indications may be contingent upon results from ongoing randomized, controlled confirmatory clinical trials. Currently, 16 potentially registration-enabling clinical trials are being conducted in China and globally, including 12 Phase 3 trials and four pivotal Phase 2 trials.

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The Pharma Data

AUGUST 29, 2020

Basel , August 30, 2020 — Novartis today announced results from a post-hoc analysis of pooled data from the Phase III ORION-10 and -11 trials evaluating the individual responses of patients on low-density lipoprotein cholesterol (LDL-C) reduction with inclisiran, a first-in-class investigational treatment for hyperlipidemia in adults.

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Agency IQ

JULY 8, 2024

Device regulators have dropped important guidance recently , publishing guidance on alternative trial designs for orphan devices and updating how to carry out benefit-risk assessments on the use of toxic phthalates in medical devices. elections over, AgencyIQ is also anticipating the new European Parliament to start work again soon.

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Agency IQ

DECEMBER 1, 2023

12/29/2023 FDORA, Section 3602 Clinical Trials Modernization : FDA is directed to require the submission of a “diversity action plan” for all Phase 3 clinical trials of new drugs. ” These include the use of expansion cohorts, concurrent trial conduct, and other designs. .”

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Molecule Blog

OCTOBER 1, 2020

It is now known that specific cellular pathways likely underpin the aging process (Burgess, 2012). There are numerous global developments ongoing in the space with many well-funded companies and universities working towards using these techniques to treat disease, as well as slow-down or halt aging. Who should profit from them?

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Drug Target Review

JANUARY 16, 2025

These drugs, including grazoprevir and vaniprevir, were the result of macrocyclisation of acyclic precursors. 7 Another more recently developed macrocyclic drug is the oral PCSK9 inhibitor MK-0616, which Merck produced to combat atherosclerotic cardiovascular disease. 8 Why are there not more macrocyclic drugs?

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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. Given this, what’s holding drug developers back? Advanced techniques like MSD and LC-MS/MS offer unmatched precision and sensitivity at a fraction of the cost.

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FDA Law Blog: Drug Discovery

JANUARY 12, 2025

Since that time, it was formalized in FDA regulations (21 CFR 314 Subpart H) in 1992, codified in the Food, Drug, & Cosmetic Act by FDAMA (21 USC 356(c)) in 1997, revised by FDASIA in 2012, and described in guidance, most importantly, in the 2014 Expedited Programs for Serious Conditions Drugs and Biologics (2014 Guidance).

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Agency IQ

JULY 28, 2023

September 2023 Legislative deadlines in Q3 Legislation Program Tag Requirement Due Date FDORA, Section 3202 Orphan Drug Program FDA shall publish final guidance related to the draft guidance titled, “Rare Diseases: Common Issues in Drug Development.” The workshop will solicit and include industry and public feedback.

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