XTalks

MAY 4, 2023

When a person with celiac disease eats something that contains gluten, their immune system attacks their small intestine, damaging the lining and interfering with the absorption of nutrients from food. As of now, the US Food and Drug Administration (FDA) has not approved any drugs for the treatment of celiac disease.

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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

APRIL 12, 2024

The cancer research news has been coming thick and fast from the American Association of Cancer Research (AACR) Annual Meeting in San Diego this week, so our Friday round-up focuses on drug discovery in oncology. The post This week in drug discovery (8-12 April) appeared first on Drug Discovery World (DDW).

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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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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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AuroBlog - Aurous Healthcare Clinical Trials blog

JUNE 12, 2023

The […]

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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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Pharmaceutical Technology

JUNE 9, 2023

Biopharmaceutical company Novaliq has received approval from the US Food and Drug Administration (FDA) for VEVYE (cyclosporine ophthalmic solution) 0.1% It has been designed to address the unmet needs of patients and to provide quick action and well-tolerated dry eye drug therapy. to treat the signs and symptoms of dry eye disease.

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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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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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Pharmaceutical Technology

OCTOBER 31, 2022

After decades of setbacks, the respiratory syncytial virus (RSV) vaccine field has bounced back with positive Phase III trial results in older adults. However, recent data from GSK’s sub-unit vaccine, GSK-3844766A, have pushed the candidate to the top, with the highest efficacy demonstrated in a pivotal trial to date.

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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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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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pharmaphorum

NOVEMBER 16, 2022

With cases of drug-resistant tuberculosis on the rise again around the world, GSK has sparked hopes of a new treatment option after reporting phase 2a data with a novel antitubercular drug for the disease. The post As resistant tuberculosis rises, GSK says trial backs novel antibiotic appeared first on.

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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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XTalks

AUGUST 18, 2023

After Johnson & Johnson’s US Food and Drug Administration (FDA) approval last week for its second multiple myeloma bispecific, Talvey (talquetamab), Pfizer received an FDA nod for its B-cell maturation antigen (BCMA)-directed therapy Elrexfio (elranatamab) in the same indication. Elrexfio is Pfizer’s first approved multiple myeloma drug.

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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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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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CTTI (Clinical Trials Transformation Initiative)

JANUARY 10, 2024

Timely, accurate, and complete registration and reporting of summary results information for applicable clinical trials on ClinicalTrials.gov allows access to current research and evidence for all partners in the clinical trials enterprise, including patients, providers, sponsors and investigators, regulators, payers, and health system leaders.

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Pharmaceutical Technology

APRIL 14, 2023

Ghana’s Food and Drug Authority (FDA) has approved R21/Matrix-M malaria vaccine in children aged 5 to 36 months, marking the first regulatory clearance for the University of Oxford-developed vaccine in any country in the world. The WHO, which has already recommended GSK’s RTS,S/AS01 malaria vaccine , is yet to recommend Oxford’s R21 vaccine.

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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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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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pharmaphorum

MAY 4, 2022

Testing drug compounds on a chip designed to mimic human organs sounds closer to science fiction than reality, yet the technology already exists and is already being put to use. The limits of animal models in drug discovery are well known. The limits of animal models in drug discovery are well known. Organ-on-a-chip.

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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. Preclinical assays designed to assess drug toxicity and safety must detect total drug. anti-human IgG).

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Cloudbyz

JUNE 16, 2023

Clinical trials are crucial for advancing medical research and developing innovative treatments. Effective clinical trial data archiving is essential to ensure data integrity, regulatory compliance, and seamless access. Data Complexity: Clinical trial data often comes in diverse formats, such as text, images, audio, and video.

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Drug Discovery World

JANUARY 9, 2024

Thirteen new-to-market therapeutics and drugs poised to launch in 2024 will achieve ‘blockbuster’ status by 2029 or deliver game-changing benefits to patients. The 2024 Drugs to Watch, are: 1. The therapy has shown positive results in Phase III trials in both breast and lung cancer.

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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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Pharmaceutical Technology

JUNE 5, 2023

Led by the investment company Temasek, the round will also be used to improve the company’s commercial readiness as its lead radiopharmaceutical candidate ITM-11 is being studied in Phase III trials in gastroenteropancreatic neuroendocrine tumours (GEP-NETs). Other investors included BlackRock, the Qatar Investment Authority, and Nextech.

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Pharmaceutical Technology

APRIL 28, 2023

The US Food and Drug Administration (FDA) has approved Pfizer’s 20-valent pneumococcal conjugate vaccine, PREVNAR 20 , to prevent invasive pneumococcal disease (IPD) in infants and children aged six weeks to 17 years. The latest approval is based on data obtained from the Phase II and Phase III trials of PREVNAR 20 for paediatric indication.

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Pharmaceutical Technology

APRIL 4, 2023

Merck has secured approval from the US Food and Drug Administration (FDA) for KEYTRUDA (pembrolizumab) in combination with Padcev (enfortumab vedotin-ejfv) for first-line treatment of some adult patients with locally advanced or metastatic urothelial carcinoma (la/mUC). The trial was jointly conducted by Seagen and Astellas.

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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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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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pharmaphorum

NOVEMBER 1, 2021

Novartis has claimed FDA approval for one of its ‘wild card’ drugs – Scemblix – a first-in-class STAMP inhibitor for patients with previously-treated chronic myeloid leukaemia (CML). The post Novartis’ ‘wild card’ drug Scemblix gets FDA nod for leukaemia appeared first on. Tasigna made sales of $1.56

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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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Drug Discovery World

JANUARY 6, 2023

It contains multiple long peptides spanning the most immunogenic regions of the PRAME protein. . In the two-part, open label Phase Ib/II trial, ISA103 will be tested in combination with standard of care checkpoint blocker immunotherapies. A total of 90 patients will be enrolled in the trial. .

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pharmaphorum

AUGUST 6, 2021

Psychiatric disorders in particular represent a trial area with significantly high drop-out rates and poor patient recruitment. Despite this, new strategies devised over the last five years are beginning to reverse the trend, and both reduce stigma and increase awareness to funnel new patients into these important trials. .

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Drug Discovery World

DECEMBER 6, 2022

As a result of clear US Food and Drug Administration (FDA) guidelines, the leading vaccine development programmes for Covid-19 were all remarkably similar. Indeed, few randomised trials of NPIs have been undertaken. Quasi-experimental and other randomised trial designs . Pre-specification of effect size .

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