AuroBlog - Aurous Healthcare Clinical Trials blog

JANUARY 8, 2025

The Central Drugs Standard Control Organisation (CDSCO) and Indian Council of Medical Research (ICMR) have together released the draft standard evaluation protocols for the purpose of issuing license for in-vitro diagnostics (IVDs) under the Medical Devices Rules (MDR), 2017.

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Licensing Licensing In-Vitro Regulation 180

AuroBlog - Aurous Healthcare Clinical Trials blog

NOVEMBER 1, 2023

The Drug Controller General of India (DCGI) has added in-vitro diagnostic (IVD) medical devices including those for diagnosis of Covid-19, ribonucleic acid (RNA) and deoxyribonucleic acid (DNA) extraction kits, among others into the Class C risk category under the Medical Devices Rules (MDR), 2017.

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RNA DNA In-Vitro Drugs 189

Pharmaceutical Technology

FEBRUARY 23, 2023

In the last three years alone, there have been over 633,000 patents filed and granted in the pharmaceutical industry, according to GlobalData’s report on Artificial Intelligence in Pharmaceuticals: In-silico drug discovery. However, not all innovations are equal nor do they follow a constant upward trend.

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Drugs DNA In-Vivo In-Vitro 189

Pharmaceutical Technology

FEBRUARY 23, 2023

Biopharmaceutics is a scientific discipline that examines the interrelationship of the physicochemical properties of the drug, the dosage form in which the drug is given, and the route of administration on the rate and extent of systemic drug absorption ( Applied Biopharmaceutics and Pharmacokinetics, Shargel, Wu-Pong and Yu, 5th Edition ).

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Development Drugs Bioavailability In-Vivo 246

XTalks

NOVEMBER 25, 2024

Shorla Oncology has received US Food and Drug Administration (FDA) approval for Imkeldi, an oral solution of imatinib designed to treat specific forms of leukemia and other cancers. The drug also reduces exposure risks for healthcare workers by improving handling safety in oncology clinics.

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In-Vivo FDA Approval In-Vitro Drugs 105

Pharmaceutical Technology

JANUARY 4, 2023

The China National Medical Products Administration’s (NMPA) Center for Drug Evaluation (CDE) has granted clearance for Transcenta’s investigational new drug (IND) application for its TST003 to treat solid tumours. TST003 is a first-in-class Gremlin1 targeting humanised monoclonal antibody.

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Antibody In-Vivo In-Vitro Protein 242

Pharmaceutical Technology

MAY 4, 2023

Vertex Pharmaceuticals has received approval from the US Food and Drug Administration (FDA) for KALYDECO (ivacaftor) to treat children with cystic fibrosis (CF) aged between one and four months. This cohort showed a safety profile identical to that found in older children and adults.

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In-Vitro Genetic Disease Medicine Genetics 246

Pharma Mirror

FEBRUARY 18, 2021

Maculus plans to raise USD3 million on a USD8 million valuation for a 12-18 month period, including initial in-vivo animal studies and completion of in-vitro / in-vivo drug elution studies. Maculus achieved the breakthrough using a patented novel tunable biodegradable proprietary product, MacuBloc.

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Drug Delivery In-Vivo In-Vitro Drugs 130

Bio Pharma Dive

FEBRUARY 28, 2024

The company is still attempting to “monetize” its most advanced drug, a treatment to aid pregnancy via in vitro fertilization.

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In-Vitro Drugs 129

Scienmag

NOVEMBER 17, 2020

Researchers at Karolinska Institutet in Sweden report promising results from an in vitro combination therapy against COVID-19. Credit: Martin Stenmark.

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In-Vitro Medicine Trials Research 59

Scienmag

NOVEMBER 18, 2020

(November 18, 2020)–Researchers at the University of Tennessee Health Science Center working with colleagues at the University of New Mexico have identified three drugs, already approved for other uses in humans, as possible therapeutics for COVID-19, the illness caused by the SARS-CoV-2 virus.

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In-Vitro Research Drugs Medicine 93

Camargo

FEBRUARY 16, 2021

The Camargo Blog is publishing a four-part blog series highlighting those designation programs available specifically for products with rare disease indications: Orphan Drug Designation (ODD), Rare Pediatric Disease Designation (RPDD), and Humanitarian Use Device (HUD) designation. Criteria for Orphan Drug Designation.

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Production Drugs Marketing In-Vitro 130

BioTech 365

JANUARY 28, 2021

Charles River Announces Strategic Partnership with Cypre, Expanding 3D In Vitro Services for Cancer Immunotherapy and Targeted Therapy Drug Screening Charles River Announces Strategic Partnership with Cypre, Expanding 3D In Vitro Services for Cancer Immunotherapy and Targeted Therapy Drug Screening … Continue reading →

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In-Vitro Drugs 40

pharmaphorum

FEBRUARY 13, 2022

German drugmaker Merck KGaA has reached an agreement to pilot an artificial intelligence platform developed by Quris that aims to identify potential safety problems with new therapeutic candidates as early as possible in the drug discovery process.

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Drugs In-Vivo In-Vitro Pharma Companies 98

XTalks

APRIL 14, 2022

Conventional in vitro and in vivo studies are used in the drug development pipeline. This involves the use of an individualized computer simulation for medical device or drug development. Therefore, companies can evaluate their drug candidates or medical device products in “virtual patients” before assessing them in humans.

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Trials In-Vivo In-Vitro Clinical Trials 98

pharmaphorum

AUGUST 10, 2020

Gilead has filed its COVID-19 drug remdesivir with the FDA, to treat patients with severe disease, under the brand name Veklury. The drug is currently available to US patients under an Emergency Use Authorisation for treatment of hospitalised patients with severe COVID-19. Feature image courtesy of Rocky Mountain Laboratories/NIH.

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Drugs In-Vivo In-Vitro Contract Manufacturing 99

Medical Xpress

JANUARY 26, 2023

Bioengineered artificial skin has become an increasingly important and reliable platform for researchers to test the safety and efficacy of drugs and cosmetics. The most promising technologies for production of in vitro models include 3D bioprinting. It can be produced on a large scale and is a good substitute for animal testing.

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Cosmetics In-Vitro Drugs Production 75

Pharmaceutical Technology

MAY 31, 2023

According to GlobalData, Phase I drugs for Solid Tumor have a 54% phase transition success rate (PTSR) indication benchmark for progressing into Phase II. GlobalData’s report assesses how ZNA-1041’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.

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In-Vitro Clinical Trials Clinical Trials Drugs 130

Pharmaceutical Technology

MAY 5, 2023

TFF Pharmaceuticals and NIEHS will investigate the TFF-HMW-HA formulations’ therapeutic efficacy and pharmacokinetics using in vitro and in vivo models of respiratory diseases.

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Development In-Vivo In-Vitro Engineer 162

Pharmaceutical Technology

NOVEMBER 4, 2022

The staff in the US from the acquired business will be retained by Reaction to set up its presence in Hershey, which comprises in vitro and in vivo expertise. The staff in the US from the acquired business will be retained by Reaction to set up its presence in Hershey, which comprises in vitro and in vivo expertise. at closing.

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In-Vivo In-Vitro Genetics Drugs 130

Pharmaceutical Technology

MAY 16, 2023

Nuvectis Pharma has secured approval from the US Food and Drug Administration (FDA) for its investigational new drug application (IND) for NXP900. Nuvectis now has two precision oncology, clinical-stage drug candidates, each with several potential opportunities in cancers that represent serious conditions of unmet medical need. “We

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In-Vivo In-Vitro Clinical Trials Clinical Trials 130

Worldwide Clinical Trials

JUNE 21, 2024

This year, Matt Cooper, PhD , our Executive Director, Therapeutic Strategy Lead, Oncology, attended and found the presentations around antibody-drug conjugates (ADCs) and tumor-infiltrating lymphocytes (TILs) to be of great interest to the future of oncology therapeutics.

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Antibody Clinical Trials Clinical Trials In-Vitro 162

The Pharma Data

OCTOBER 16, 2020

This week’s round up features a digital solution for adapting clinical trials to ease the burden on the clinical research industry and an in vitro model that mimics the human airway epithelium using a newly developed technology platform. In vitro antiviral technology proves effective against SARS-CoV-2 in human airway infection model.

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In-Vitro Clinical Trials Clinical Trials Trials 52

Pharmaceutical Technology

FEBRUARY 1, 2023

The US Food and Drug Administration (FDA) has granted approval for Ellipses Pharma’s investigational new drug (IND) application for EP0042 to treat acute myeloid leukaemia (AML). The dual FLT-3 and Aurora kinase inhibitor EP0042 is being developed to treat AML patients who have developed FLT3 inhibitor resistance.

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FDA Approval In-Vivo In-Vitro Trials 130

Pharmaceutical Technology

APRIL 4, 2023

The Orbit platform will also conduct in vitro transcription conversion from DNA-encoded libraries on beads. The requirement for more direct screening technologies is key to successful drug development, and we see Orbit as a stepping stone in attaining our goals in a rapid timeframe.”

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Development In-Vitro DNA Drugs 130

pharmaphorum

JANUARY 17, 2022

Under the joint research plan, the Danish giant will work with EraCal to identify novel drug targets relevant for food intake regulation and additional metabolic phenotypes. Central nervous system-controlled behaviour, such as food intake, is notoriously difficult to explore in vitro.

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FDA Approval In-Vitro Regulation Hormones 123

Pharmaceutical Technology

APRIL 12, 2023

FoundationOne CDx is a sequencing-based in vitro diagnostic device that can identify alterations in 324 genes from tumour samples. BMS says it expects the orally administered drug, which was granted breakthrough therapy designation in May 2022, to be approved in the second half of 2023.

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Genomics Genome In-Vitro Gene 130

Pharmaceutical Technology

NOVEMBER 10, 2022

The funding proceeds will be used to progress the potential brain-penetrant small molecules of the company to studies that will facilitate the submission of an investigational new drug (IND) application. This could possibly stop or substantially slow down disease progression in Parkinson’s or ALS patients.

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Development In-Vitro Clinical Development Medicine 130

Pharmaceutical Technology

MAY 10, 2023

The research teams will examine the use of CytoMed’s allogeneic gdTc on multiple AML and breast cancer subtypes in vitro and in vivo. Data from the study are expected to support an investigational new drug application with the US Food and Drug Administration for the allogeneic use of gdTc to treat blood and solid cancers.

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Gene Therapy In-Vivo In-Vitro Gene 147

Scienmag

SEPTEMBER 21, 2020

(Boston)– Responding to the COVID-19 pandemic caused by the novel coronavirus, SARS-CoV-2, requires models that can duplicate disease development in humans, identify potential targets and enable drug testing.

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In-Vitro Research Development Drugs 75

Scienmag

FEBRUARY 9, 2021

The work, led by NYU Tandon and the New York Stem Cell Foundation Research Institute, could lead to efficient, detailed artificial bone tissue, opening doors to disease modeling, in vitro cell research on targeted therapies, drug screening and more.

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In-Vitro Research Drugs Engineer 75

FDA Law Blog

JANUARY 10, 2023

We are inclined to agree, given that the new Guidance applies to all products making health-related claims, including food, over-the-counter drugs, homeopathic products, health equipment, diagnostic tests, and health-related apps. For example, the substantiation standard remains competent and reliable evidence.

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Compliance Production In-Vitro Drugs 105

XTalks

JANUARY 9, 2023

recently announced in a press release that Sunlenca (lenacapavir) received approval from the US Food and Drug Administration (FDA) for use as a twice-yearly treatment option for people living with multi-drug resistant HIV (human immunodeficiency virus). Gilead Sciences, Inc.

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FDA Approval Drugs In-Vitro Clinical Trials 98

Pharmaceutical Technology

SEPTEMBER 22, 2022

According to the partnership, Celltrion will oversee the development of ABP 102, after Abpro concludes in vitro studies, as well as hold the global marketing rights. According to preliminary data, the antibody has demonstrated enhanced efficacy and reduced toxicity versus other treatments for HER2+ cancer indication. .

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Antibody Development Bioinformatics In-Vitro 130

FDA Law Blog

MARCH 19, 2024

(HP&M), the largest dedicated food and drug law firm in the U.S., Mullen’s extensive experience and contributions to the field of in vitro diagnostic (IVD) regulation. AMDM facilitates educational resources within the in vitro diagnostic industry. This prestigious appointment recognizes Ms.

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In-Vitro Manufacturing Regulation Development 59

Camargo

MARCH 25, 2021

The Camargo Blog is publishing a four-part blog series highlighting those designation programs available specifically for products with rare disease indications : Orphan Drug Designation (ODD), Rare Pediatric Disease Designation (RPDD), and Humanitarian Use Device (HUD) designation. Criteria for Rare Pediatric Disease Designation.

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Production Drugs In-Vitro Containment 130

Pharmaceutical Technology

JUNE 5, 2023

According to GlobalData, Phase II drugs for Pancreatic Cancer have a 25% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how Pralsetinib’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks.

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In-Vitro Drugs Clinical Trials Clinical Trials 100