Drug Discovery World

AUGUST 9, 2023

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted Aleta Biotherapeutics a clinical trial authorisation (CTA) to evaluate biologic ALETA-001 in a Phase I/II clinical trial in patients with B-cell malignancies who are relapsed/refractory to CD19 CAR T cell therapy.

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Drug Discovery World

AUGUST 4, 2022

It may seem counterintuitive to spend time and money on planning for containment and delivery systems for a drug in the earliest stages of discovery when the chances of that molecule making it to market are still quite low. The increasing complexity of drug products has raised concern among pharmaceutical developers.

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Worldwide Clinical Trials

FEBRUARY 21, 2024

Also known as a human radiolabeled mass balanced study, the AME study aims to determine the overall metabolism and excretion pathways of the NCE, as well as to identify and quantify circulating metabolites relative to parent or total drug-related exposure.

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XTalks

NOVEMBER 7, 2022

Gleich, MD, FACS, Senior Vice President, Medical Department, and Dr. Christopher Huth, PhD, Senior Clinical Trial Manager, Clinical Trial Management. Liquid Biopsy Use in Oncology Clinical Trials. Dr. Bahassi: There are several factors to consider when designing a trial that involves ctDNA detection.

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Drug Discovery World

FEBRUARY 1, 2023

Big pharma is helping to shape the focus The good news is that clinical trials are on the increase and market education is upping pace. Nothing is definitive yet, and these are complicated trials, but the world wants to move to safer alternatives that don’t impede daily life or cause further issues.

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Pfizer

FEBRUARY 16, 2023

These study participants, representing approximately half of the total recruited participants in the trial, are being discontinued following violations of Good Clinical Practice (GCP) at certain clinical trial sites run by a third-party clinical trial site operator.

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Pharma Mirror

FEBRUARY 18, 2022

By Christopher Weikart, Chief Scientist, SiO2 Materials Science Even though drugs are meant to save lives, the primary packaging used for delivering drug therapies and vaccines may actually be putting us in danger. The pharmaceutical industry works hard to create cutting-edge drugs to save lives and keep people healthy.

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STAT News

JANUARY 19, 2023

We will leave it to you to guess what it contains. Food and Drug Administration and the U.S. As for us, we are foraging for interesting stories and quaffing cups of stimulation, as you might have guessed. Our choice today is a Mardi Gras blend. And how is your morning going? To help you along, here are some tidbits.

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Advarra

FEBRUARY 24, 2023

Sometimes, it can be as simple to determine as comparing drug A to placebo and measuring the physiological result with an approved assay. In most cases, the results you are really looking for and trying to prove in a trial can be complex. All key questions to consider and address before the therapy even leaves the lab.

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XTalks

NOVEMBER 29, 2022

Xtalks interviewed Devon Adams to learn more about his work related to decentralized oncology trials as a senior analyst for legislative policy specific to clinical trials at the ACS CAN. Read on to learn more! Over 1,100 cancer patients and cancer survivors responded.

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Worldwide Clinical Trials

SEPTEMBER 29, 2022

Ensuring a seamless transition from preclinical to clinical stages in large molecule bioanalysis will help you reach crucial trial milestones on time and within budget. However, optimizing pharmacokinetics (PK) assays to bridge the preclinical-to-clinical gap requires some finesse. anti-human IgG).

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pharmaphorum

NOVEMBER 28, 2021

An investigator-led trial of Jazz Pharma’s cannabis extract-based drug Sativex in glioblastoma – an aggressive form of brain cancer – will get underway in the UK next year. Jazz acquired rights to Sativex when it completed its $7.2 billion takeover of Sativex’ developer GW Pharma earlier this year.

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Pharmaceutical Technology

SEPTEMBER 20, 2022

Unlike commercial pharmaceutical packaging, the primary consideration in clinical trial packaging is protecting the product quality and reliability for research. Finding the best clinical trial packaging services providers. Clinical trial packaging and labelling solutions.

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AuroBlog - Aurous Healthcare Clinical Trials blog

JULY 17, 2023

Food and Drug Administration approved a drugmaker’s application for the first daily over-the-counter birth control pill for people seeking to prevent pregnancy. On July 13, 2023, the U.S.

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Drug Discovery World

OCTOBER 31, 2023

UK regulatory authorities have approved the first trial of a gene therapy for young children with Hunter syndrome. The drug was developed over eight years by Brian Bigger, Professor of Cell and Gene Therapy at The University of Manchester.

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STAT News

DECEMBER 12, 2022

The Food and Drug Administration on Monday approved a second KRAS-blocking treatment for advanced lung cancer. However, hopes the drug might reach a large swath of patients — and grow into a commercial blockbuster for its maker Mirati Therapeutics — have dimmed in the wake of underwhelming clinical trial results.

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Drug Discovery World

JULY 21, 2023

The most impactful drug discovery news this week is all linked with scientific research data. Analysts Phesi revealed that a third of clinical development programmes are cancelled during Phase II, and there were significant trial results for drugs for head and neck cancer and Alzheimer’s disease.

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Drug Discovery World

AUGUST 25, 2023

The headline news this week reflects the high level of interest and investment in neuroscience drug discovery, particularly neurodegenerative diseases like Alzheimer’s; including positive clinical trial results for new immunotherapy and biotherapeutic candidates, and hopes that existing medications could slow the progression of dementia.

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XTalks

APRIL 24, 2023

Melanie Blank, clinical team leader for General Medicine Branch 1 at the US Food and Drug Administration’s (FDA) Division of Clinical Evaluation and Pharmacology/Toxicology (DCEPT), the agency is seeing one or two new applications coming in every week for new gene therapies for different diseases.

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The Pharma Data

OCTOBER 19, 2020

manufacturer, Pharmaceutics International, Inc. (“Pii”), has completed the manufacturing process for Berubicin Drug Product, its lead drug candidate for the treatment of glioblastoma multiforme (GBM), an aggressive form of brain cancer currently considered incurable. About CNS Pharmaceuticals, Inc.

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STAT News

JULY 18, 2022

Two members of an expert panel that recommended the Food and Drug Administration approve a fish-oil-based heart drug, Vascepa, said recently released data would have led them to reconsider their votes. Continue to STAT+ to read the full story…

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Advarra

SEPTEMBER 23, 2022

The Food and Drug Administration (FDA) is the federal entity in the U.S. charged with (among other things) “ensur[ing] that safe and effective drugs are available to improve the health of the people in the United States.” . Whether the drug’s proposed labeling (package insert) is appropriate, and what it should contain. .

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The Pharma Data

JANUARY 3, 2021

Food and Drug Administration cleared Investigational New Drug Application. United Kingdom Medicines and Healthcare Products Regulatory Agency authorized Clinical Trial Application. About the INZ701-101 Phase 1/2 Clinical Trial of INZ-701 in Adults with ENPP1 Deficiency. BOSTON, Jan.

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XTalks

MAY 24, 2022

There has been a lengthy search to find an HIV cure and there have been a few promising trials, including the stem cell transplantation reported at the 2022 Conference on Retroviruses and Opportunistic Infections (CROI-2022). During the early stage, the drug binds itself between two adjacent capsid monomers and stabilizes the capsid shell.

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The Pharma Data

JULY 8, 2021

Food and Drug Administration (FDA) has approved an updated label for ADUHELM (aducanumab-avwa) injection 100 mg/mL solution. The update includes an addition to the Indications and Usage section of the label (Section 1) to emphasize the disease stages studied in the clinical trials, as seen below ( italics to note updated language).

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Drug Discovery World

OCTOBER 9, 2023

Positive Phase I trial data indicates that Reqorsa (quaratusugene ozeplasmid) has shown early efficacy for the treatment of non-small cell lung cancer (NSCLC). The post Non-viral gene therapy shows early efficacy in lung cancer appeared first on Drug Discovery World (DDW).

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AuroBlog - Aurous Healthcare Clinical Trials blog

JUNE 12, 2023

The […]

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Drug Discovery World

JANUARY 31, 2024

Vera Therapeutics has announced positive 72-week data from the open label extension (OLE) period of its Phase IIb ORIGIN clinical trial of atacicept in participants with IgA nephropathy (IgAN). The post Drug shows disease-modifying effect in IgA nephropathy appeared first on Drug Discovery World (DDW).

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Pharmaceutical Technology

APRIL 12, 2023

The US Food and Drug Administration (FDA) has approved Takeda ’s supplemental Biologics Licence Application (sBLA) to expand the use of its HyQvia subcutaneous immune globulin (ScIG) for the treatment of primary immunodeficiency (PI) in children aged between two and 16 years. This was a primary endpoint of the trial.

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The Pharma Data

JANUARY 17, 2021

The treatment is based on the Grifols immunoglobulin Gamunex®-C, and contains anti-SARS-COV-2 polyclonal antibodies from plasma donors who have recovered from COVID-19. It could also help contain outbreaks in places where the vaccination hasn’t begun or is still underway. BARCELONA, Spain , Jan. and on the U.S.

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AuroBlog - Aurous Healthcare Clinical Trials blog

JUNE 29, 2023

The Drugs Technical Advisory Board (DTAB) has recommended to get comments and inputs from Indian Council of Medical Research (ICMR) for further action on restricting Nicotine Replacement Therapies (NRTs) containing upto 2 mg or 4 mg only through prescription of authorised medical practitioners, as proposed by the Tobacco Control Division (TCD).

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Pharmaceutical Technology

MARCH 28, 2023

On March 27, researchers presented new interim results from the Phase III RUBY clinical trial that could indicate a new standard of care for endometrial cancer treatment. GSK’s trial evaluated the programmed death receptor-1 (PD-1)-blocking antibody Jemperli (dostarlimab).

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The Pharma Data

JANUARY 25, 2021

agree to place handheld Ceribell Rapid Response EEG systems in hospitals in connection with its Phase 3 RSE clinical trial. Within the RAISE trial, it will allow clinicians to rapidly establish a diagnosis of nonconvulsive SE in the absence of immediate availability of conventional EEG. About the RAISE Trial. RADNOR, Pa.–(

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The Pharma Data

OCTOBER 25, 2020

NASDAQ: PTCT), today announced the initiation of a registration-directed Phase 2/3 clinical trial to evaluate vatiquinone (PTC743) in patients with mitochondrial epilepsy, the highly morbid condition of refractory seizures in children with inherited mitochondrial disease. . SOUTH PLAINFIELD, N.J. ,

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Drug Discovery World

JANUARY 25, 2023

Tom Brazier , Director Decentralised Clinical Trials, mdgroup and Stephanie Larimer, Q² Solutions discuss the opportunities for decentralised clinical trials and how common pitfalls can be avoided through communications and streamlined working. The market, worth an estimated $8.8 billion, by 2026 1.

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Pharmaceutical Technology

SEPTEMBER 14, 2022

Pharmaceutical drug research and development (R&D) activities are capital-intensive, which makes the outsourcing of clinical dose manufacturing and marketing popular. Find the leading clinical dose companies in contract marketing. Prospects of clinical dose companies in contract marketing.

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pharmaphorum

JANUARY 27, 2023

Late last year, pharmaphorum caught up with Dr Karen Mullen, chief medical officer and VP of clinical & medical affairs at global drug development consultancy Boyds. Clinical trials design and patient input The definition of patient centricity, in fact, and its benefits are now – finally – being defined by patients themselves. “We

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