Clinical Trials, Containment and Drugs - Clinical Research Informer

Microbiome drug to be tested in IBS clinical trial

Drug Discovery World

APRIL 4, 2024

EnteroBiotix, a Glasgow, UK based biotechnology company, has dosed the first patient in a clinical trial designed to evaluate EBX-102-02 for the treatment of irritable bowel syndrome (IBS). The trial will be delivered in partnership with the Functional Gut Clinic, a leading IBS diagnosis and treatment centre.

Clinical Trials

Clinical Trials Clinical Trials Trials Drugs

Deadly ‘Zombie Drug’ Believed to Contain Human Bones Wreaks Havoc in West Africa

AuroBlog - Aurous Healthcare Clinical Trials blog

JANUARY 17, 2024

A new drug called kush is wreaking havoc in west Africa, particularly in Sierra Leone where it is estimated to kill around a dozen people each week and hospitalise thousands. The drug, taken mostly by men aged 18 to 25, causes people to fall asleep while walking, to fall over, to bang their heads against […]

Containment

Containment Drugs Clinical Trials Clinical Trials

Health ministry releases 9th edition of IP containing 3,152 monographs

AuroBlog - Aurous Healthcare Clinical Trials blog

JULY 7, 2022

With an aim to improve the quality of drugs sold in the country, the Union health and family welfare ministry has released 9th edition of Indian Pharmacopoeia (IP) 2022 containing 92 new monographs for drugs, 12 new general chapters, 1,245 monographs for formulations, 930 monographs for active pharmaceutical ingredients (APIs) as well as dissolution (..)

Containment

Containment Drugs Clinical Trials Clinical Trials

Streamlining development with containment in early drug discovery

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.

Containment

Containment Development Drugs Production

Clinical Trials for Celiac Disease: Insights from Beyond Celiac’s Kate Avery

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.

Clinical Trials

Clinical Trials Clinical Trials Trials Immune Response

Clinical Trial Data Archiving: Ensuring Efficiency, Compliance, and Accessibility

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. Effectively managing and storing such large datasets presents logistical challenges.

Clinical Trials

Clinical Trials Clinical Trials Compliance Trials

CTTI and FDA Share Strategies for Improving Timely, Accurate, and Complete Registration and Reporting of Summary Results Information for Applicable Clinical Trials on ClinicalTrials.gov

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.

Clinical Trials

Clinical Trials Clinical Trials Trials Compliance

7 Problems with Using Borosilicate Glass to Package Drugs

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.

Packaging

Packaging Packaging Drugs Clinical Trials

Why Proactive AME Studies are Critical to Accelerating Your Approval Journey

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.

Clinical Trials

Clinical Trials Clinical Trials Pharmacy Trials

Biologic CAR T cell engager approved for UK clinical trial

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.

Clinical Trials

Clinical Trials Clinical Trials Trials Licensing

Predicting and improving clinical trial enrolment: A problem for psychiatry

pharmaphorum

AUGUST 6, 2021

Psychiatric disorders have historically had great difficulty onboarding and retaining patients for clinical trials. Major depression is one of the most prevalent and debilitating disorders which, in a 2015 review, showed a drop-out rate of almost 20% across 45 randomised clinical trials.

Clinical Trials

Clinical Trials Clinical Trials Trials Clinical Research

The US Just Approved The First Over-The-Counter Daily Birth Control Pill

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.

Hormones

Hormones Containment Branding Drugs

STAT+: Pharmalittle: India regulator finds 5% of drug samples are substandard; EMA claims new clinical trial registry is fixed

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.

Clinical Trials

Clinical Trials Clinical Trials Regulation Drugs

Pfizer and Valneva Issue Update on Phase 3 Clinical Trial Evaluating Lyme Disease Vaccine Candidate VLA15

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.

Clinical Trials

Clinical Trials Clinical Trials Vaccination Vaccine

Medicinal cannabis: Why more clinical trials and better access is needed

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. This data is proving useful in testing hypotheses before starting any clinical trials. Chronic pain meanwhile, is currently one of the main reasons people turn to cannabis 2.

Clinical Trials

Clinical Trials Clinical Trials Medicine Trials

STAT+: Mirati wins FDA approval for KRAS-blocking lung cancer drug, but blockbuster sales hopes have dimmed

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.

FDA Approval

FDA Approval Sales Drugs Clinical Trials

The Utility of Liquid Biopsy in Oncology Clinical Trials

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. Optimal methods for bioinformatic analysis are still needed. Exosome-Based Liquid Biopsy in Oncology.

Clinical Trials

Clinical Trials Clinical Trials Trials FDA Approval

The ABCs of Transitioning PK Assays from Preclinical to Clinical

Worldwide Clinical Trials

SEPTEMBER 29, 2022

Preclinical assays designed to assess drug toxicity and safety must detect total drug. For studies of humanized therapeutics (monoclonal antibodies [mAb], fusion protein, antibody-drug conjugates [ADC], bispecific antibodies, etc.), To measure free drug only, anti-idiotype (anti-ID) mAb testing may be the best choice.

Reagent

Reagent Clinical Trials Clinical Trials Antibody

STAT+: New data might have led to a different result for Amarin fish oil drug, FDA panelists say

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…

Drugs

Drugs Clinical Trials Clinical Trials Containment

MDC recommends prices of anti-diabetic drugs with off patented molecules

AuroBlog - Aurous Healthcare Clinical Trials blog

JUNE 12, 2023

The […]

Drugs

Drugs Containment Clinical Trials Clinical Trials

Leading clinical packaging companies in contract marketing

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.

Packaging

Packaging Packaging Marketing Clinical Trials

This week in drug discovery (17-21 July)

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.

Drugs

Drugs Clinical Trials Clinical Trials Trials

This week in drug discovery (21-25 August)

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.

Drugs

Drugs Clinical Trials Clinical Trials Trials

Multiple Dynamic Endpoints and the Role of Endpoint Adjudication Committees in Clinical Trials

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. How do you know your experimental therapy is working?

Clinical Trials

Clinical Trials Clinical Trials Trials Regulation

DTAB seeks ICMR’s views on restricting Nicotine Replacement Therapies through prescriptions

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).

Containment

Containment Drugs Research Clinical Trials

Drug shows disease-modifying effect in IgA nephropathy

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).

Drugs

Drugs Clinical Trials Clinical Trials Containment

Lenacapavir, Gilead’s Investigational HIV Drug, Gets Its Clinical Hold Lifted By the FDA

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.

Drugs

Drugs Clinical Trials Clinical Trials Trials

How the IND 30-day Hold Impacts Clinical Trial Activities

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. .

Clinical Trials

Clinical Trials Clinical Trials Trials Regulation

Inozyme Pharma Announces Authorization to Proceed in U.S. and U.K. with Phase 1/2 Clinical Trial of INZ-701 for the Treatment of ENPP1 Deficiency

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.

Clinical Trials

Clinical Trials Clinical Trials Trials Containment

CNS Pharmaceuticals Completes U.S. Manufacturing of Berubicin for Phase 2 Clinical Trial

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.

Clinical Trials

Clinical Trials Clinical Trials Manufacturing Trials

How patient-on-a-chip tech could be the future of drug discovery

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.

Drugs

Drugs Licensing Licensing Pharma Companies

Non-viral gene therapy shows early efficacy in lung cancer

Drug Discovery World

OCTOBER 9, 2023

We look forward to evaluating Reqorsa in combination with a checkpoint inhibitor to treat SCLC in our upcoming Acclaim-3 clinical trial, where we have both FDA Fast Track and Orphan Drug Designations for this patient population.”

Gene Therapy

Gene Therapy Gene Clinical Trials Clinical Trials

US FDA approves Takeda’s HyQvia to treat PI in children

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.

FDA Approval

FDA Approval Clinical Trials Clinical Trials Containment

Elrexfio Becomes Pfizer’s First Approved Multiple Myeloma Drug

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.

FDA Approval

FDA Approval Drugs Antibody Trials

FDA Approves Updated ADUHELM™ Prescribing Information to Emphasize Population Studied in Clinical Trials

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).

Clinical Trials

Clinical Trials Clinical Trials FDA Approval Trials

Leading clinical dose companies in contract marketing

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.

Marketing

Marketing Contract Manufacturing Sales Clinical Trials

This week in drug discovery (July 4-8)

Drug Discovery World

JULY 8, 2022

Spider venom heart attack treatment closer to clinical trials. A drug candidate for heart attacks which contains venom from a deadly spider has moved closer to clinical trials due to investment of $23 million. GSK completes acquisition of Sierra Oncology .

Drugs

Drugs Clinical Trials Clinical Trials Vaccination

This week in drug discovery (17-21 October)

Drug Discovery World

OCTOBER 21, 2022

The first and only oral contraception containing a new, synthetic version of a naturally occurring oestrogen has been launched in the UK. . Clinical study first step towards treating respiratory syncytial virus . Cancer drug shows promise in treating incurable lung disease . New antibiotic could kill resistant pathogens .

Drugs

Drugs Allergies Clinical Trials Clinical Trials

Grifols begins clinical trial of a new treatment that would provide immediate immunity against COVID-19

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.

Clinical Trials

Clinical Trials Clinical Trials Trials Containment

Cantex secures license to develop small molecule-drug for inflammatory lung diseases

pharmaphorum

FEBRUARY 24, 2022

Clinical stage pharmaceutical company Cantex Pharmaceuticals has obtained a global licence from Harvard University’s Office of Technology Development to develop the small-molecule drug azeliragon into a treatment for inflammatory lung diseases, including COVID-19. said Cantex CEO Stephen Marcus.

Licensing

Licensing Licensing Development Drugs

Leading API chemical companies in contract marketing

Pharmaceutical Technology

SEPTEMBER 15, 2022

Various factors have contributed to the need and growth of API chemical suppliers such as rising healthcare expenditure, increasing disposable incomes, growing geriatric population, increasing incidence of chronic diseases, patent expiration of blockbuster drugs, increased consumption of generic drugs, and intervention of the new generation APIs.

Marketing

Marketing Manufacturing Generic Drugs Containment

Drug repurposing: The benefits, risks and what we learned from Covid-19

Drug Discovery World

JULY 20, 2023

What are benefits of drug repurposing and why do clinical drug trials so often fail? Diana Spencer summarises the key messages from the ‘Drug Repurposing: Challenges and Opportunities’ Symposium held at the 19th World Congress of Basic & Clinical Pharmacology (WCP) 2023.

Drugs

Drugs Clinical Trials Clinical Trials Trials

Trial of Jazz’ cannabis drug in glioblastoma will start next year

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. The post Trial of Jazz’ cannabis drug in glioblastoma will start next year appeared first on.

Trials

Trials Drugs Clinical Trials Clinical Trials

PTC Therapeutics Announces Initiation of a Registration-Directed Clinical Trial to Evaluate Vatiquinone in Mitochondrial Epilepsy

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. ,

Clinical Trials

Clinical Trials Clinical Trials Trials Regulation

Microbiome drug to be tested in IBS clinical trial

Deadly ‘Zombie Drug’ Believed to Contain Human Bones Wreaks Havoc in West Africa

Trending Sources

Health ministry releases 9th edition of IP containing 3,152 monographs

Streamlining development with containment in early drug discovery

Clinical Trials for Celiac Disease: Insights from Beyond Celiac’s Kate Avery

Clinical Trial Data Archiving: Ensuring Efficiency, Compliance, and Accessibility

CTTI and FDA Share Strategies for Improving Timely, Accurate, and Complete Registration and Reporting of Summary Results Information for Applicable Clinical Trials on ClinicalTrials.gov

7 Problems with Using Borosilicate Glass to Package Drugs

Why Proactive AME Studies are Critical to Accelerating Your Approval Journey

Biologic CAR T cell engager approved for UK clinical trial

Predicting and improving clinical trial enrolment: A problem for psychiatry

The US Just Approved The First Over-The-Counter Daily Birth Control Pill

STAT+: Pharmalittle: India regulator finds 5% of drug samples are substandard; EMA claims new clinical trial registry is fixed

Pfizer and Valneva Issue Update on Phase 3 Clinical Trial Evaluating Lyme Disease Vaccine Candidate VLA15

Medicinal cannabis: Why more clinical trials and better access is needed

STAT+: Mirati wins FDA approval for KRAS-blocking lung cancer drug, but blockbuster sales hopes have dimmed

The Utility of Liquid Biopsy in Oncology Clinical Trials

The ABCs of Transitioning PK Assays from Preclinical to Clinical

STAT+: New data might have led to a different result for Amarin fish oil drug, FDA panelists say

MDC recommends prices of anti-diabetic drugs with off patented molecules

Leading clinical packaging companies in contract marketing

This week in drug discovery (17-21 July)

This week in drug discovery (21-25 August)

Multiple Dynamic Endpoints and the Role of Endpoint Adjudication Committees in Clinical Trials

DTAB seeks ICMR’s views on restricting Nicotine Replacement Therapies through prescriptions

Drug shows disease-modifying effect in IgA nephropathy

Lenacapavir, Gilead’s Investigational HIV Drug, Gets Its Clinical Hold Lifted By the FDA

How the IND 30-day Hold Impacts Clinical Trial Activities

Inozyme Pharma Announces Authorization to Proceed in U.S. and U.K. with Phase 1/2 Clinical Trial of INZ-701 for the Treatment of ENPP1 Deficiency

CNS Pharmaceuticals Completes U.S. Manufacturing of Berubicin for Phase 2 Clinical Trial

How patient-on-a-chip tech could be the future of drug discovery

Non-viral gene therapy shows early efficacy in lung cancer

US FDA approves Takeda’s HyQvia to treat PI in children

Elrexfio Becomes Pfizer’s First Approved Multiple Myeloma Drug

FDA Approves Updated ADUHELM™ Prescribing Information to Emphasize Population Studied in Clinical Trials

Leading clinical dose companies in contract marketing

This week in drug discovery (July 4-8)

This week in drug discovery (17-21 October)

Grifols begins clinical trial of a new treatment that would provide immediate immunity against COVID-19

Cantex secures license to develop small molecule-drug for inflammatory lung diseases

Leading API chemical companies in contract marketing

Drug repurposing: The benefits, risks and what we learned from Covid-19

Trial of Jazz’ cannabis drug in glioblastoma will start next year

PTC Therapeutics Announces Initiation of a Registration-Directed Clinical Trial to Evaluate Vatiquinone in Mitochondrial Epilepsy

Stay Connected