Sat.Feb 24, 2024 - Fri.Mar 01, 2024

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Overcoming Public Skepticism In Clinical Trials

Imperical Blog

With more than 65,000 clinical studies currently recruiting, our industry is constantly working hard to enroll participants and meet study timelines. Unfortunately, public skepticism in clinical trials can get in the way of those efforts. People enroll in studies for a variety of reasons, from… The post Overcoming Public Skepticism In Clinical Trials appeared first on Imperial Clinical Research Services Blog.

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Cancer Professional and Survivor: ‘Without Clinical Trials, People Like Me Would Have No Hope’

ACRP blog

If there wasn’t already a general awareness among the personnel of the Penn State Cancer Institute Clinical Trials Office that February is National Cancer Prevention Month , you may guess the fact that breast cancer survivor Doris Shank, BSN, MSN, administrative director of the office, is preparing for her second cancer-related surgery soon has brought the topic of prevention to mind for some of them in any event.

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Planning strategies for transitioning to the Clinical Trials Regulation

pharmaphorum

There is a pressing need for companies to transition their EU clinical trials that are ongoing under the “old” regulatory framework of the Clinical Trials Directive to the Clinical Trials Regulation. The risk for those that don’t meet the 30th January 2025 deadline for transition is that they will lose their legal basis.

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Survey reveals insights into physicians' perspectives on clinical trials and digitalization

Outsourcing Pharma

Last week (February 22), it was announced a recent survey conducted jointly by Climedo and Siteworks has shed light on the perspectives of more than 65 primarily European-based study physicians.

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Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research

Planning on running clinical trials in Japan? How can you reliably supply these studies? Discover Catalent’s clinical supply packaging facility in Shiga, Japan. Strategically located between Tokyo and Osaka, and one of largest in Japan, this 6,000 square meter facility offers comprehensive services including primary and secondary clinical packaging and labelling, comparator sourcing, cold chain storage, local and global distribution, local language support and white glove service to support stud

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Pharmaceuticals export grows 6.8% in January

AuroBlog - Aurous Healthcare Clinical Trials blog

Exports of drugs and pharmaceuticals during the month of January posted a growth of 6.84 per cent as compared to the same month of previous year. For the first 10 months of the current fiscal year pharma exports grew 8.07 per cent, according to the Central government.

Drugs 150
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Insights from Industry Experts: Examining the Patient Experience in Clinical Trial Design

Worldwide Clinical Trials

With the necessary prioritization of various factors when designing your clinical trial, the patient experience can be overlooked or improperly addressed in study design. However, incorporating the patient experience into your design is one of the best ways to ensure your drug development program is a commercial success. It plays a significant role in patient recruitment and retention, both of which are vital to maintaining timelines, decreasing program costs, and gaining market approval.

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Rare Disease Day: Enhancing clinical trial success in rare diseases

pharmaphorum

Rare Disease Day is an opportunity to highlight the importance of enhancing clinical trial success in rare diseases for the benefit of patients.

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India’s Tata Institute develops tablet for cancer recurrence prevention

Pharmaceutical Technology

India’s Tata Institute has developed a tablet combining resveratrol and copper that has the potential to prevent the recurrence of cancer.

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Viking data suggest obesity drug could rival Zepbound, Wegovy

Bio Pharma Dive

The biotech’s drug led to significant weight loss in a Phase 2 trial, causing shares to double as analysts compared results to the marks set by drugs from Eli Lilly and Novo Nordisk.

Drugs 306
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California Man Free of HIV And Cancer in Astonishing Medical Recovery

AuroBlog - Aurous Healthcare Clinical Trials blog

On the list of illnesses that nobody wants, cancer and HIV both rank pretty high, and Californian man Paul Edmonds had both. But ever since one particular treatment five years ago, he’s been free of both cancer and HIV.

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The New Age of Decentralized Clinical Trials

White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations

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Considering Master Protocol Use in Your Trial: Evaluating Basket and Umbrella Trial Designs

Worldwide Clinical Trials

With cost and timelines being two of the most significant factors influencing a study’s progression aside from efficacy and safety, master protocols offer an attractive option for study design. These designs facilitate streamlined trial logistics and centralized governance and create higher-quality data. But how do they work, and when are they appropriate?

Trials 171
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Beacon Therapeutics unveils promising interim results for gene therapy AGTC-501

Pharmaceutical Technology

AGTC-501 is in Phase II development for retinitis in the SKYLINE trial (NCT03316560) and addresses unmet needs within the retinitis space

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CDC panel mulls changes to RSV vaccine recommendation

Bio Pharma Dive

The expert committee is discussing whether, for certain older adults, to make a universal recommendation for vaccination, rather than the current policy of “shared decisionmaking.

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Microplastics Found in Every Human Placenta Tested, Study Finds

AuroBlog - Aurous Healthcare Clinical Trials blog

It’s been over three years since scientists first found microplastics swimming in four different human placentas, and as it turns out, that was just the tip of the iceberg. A few years later, at the start of 2023, researchers announced they had found microscopic particles of plastic waste in no fewer than 17 different placentas.

Scientist 186
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How Machine Learning Drives Clinical Trial Efficiency

Clinical trial data management is increasingly challenging as studies grow in complexity. Quickly accessing and analyzing study data is vital for assessing trial progress and patient safety. In this paper, we explore real-time data access and analysis for proactive study management. We investigate using adverse event (AE) data to monitor safety and discuss a clinical analytics platform that supports collaboration and data review workflows.

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February 28, 2024: A Randomized Trial of a Food-as-Medicine Program, in This Week’s PCT Grand Rounds

Rethinking Clinical Trials

In this Friday’s PCT Grand Rounds, Joseph Doyle of the Massachusetts Institute of Technology (MIT) will present “Effect of an Intensive Food-as-Medicine Program on Health and Healthcare Use: Evidence From a Randomized Clinical Trial.” The Grand Rounds session will be held on Friday, March 1, 2024, at 1:00 pm eastern. Doyle is the Erwin H.

Medicine 141
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Lutris wins FDA orphan drug tag for EGFR inhibitor-induced rash candidate

Pharmaceutical Technology

LUT014 is being investigated in an ongoing Phase II trial as a first-line treatment for EGFR inhibitor-induced acneiform rash, for which there is no approved drug.

Drugs 264
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Obesity drug from Boehringer, Zealand succeeds in MASH trial

Bio Pharma Dive

Zealand shares rose by more than one-third on the data, which provide further evidence so-called incretin drugs could help treat people with the liver disease.

Drugs 286
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Simple Experiment Reveals Why Your Next Antibiotics May Prove Useless

AuroBlog - Aurous Healthcare Clinical Trials blog

Do bacteria mutate randomly, or do they mutate for a purpose? Researchers have been puzzling over this conundrum for over a century. In 1943, microbiologist Salvador Luria and physicist turned biologist Max Delbrück invented an experiment to argue that bacteria mutated aimlessly.

Bacteria 187
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What the FDA's New Dosage Guidance Means for the Future of Clinical Research

Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.

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Moderna lays off parts of manufacturing team after resizing COVID footprint

Fierce Pharma

Moderna is laying off employees within its manufacturing unit, with the move tied to a resizing of its COVID production work. | Moderna is laying off some employees within its manufacturing unit after shaving COVID production costs. The company previously disclosed plans to rightsize its COVID vaccine production footprint.

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Bayer wins FDA breakthrough therapy designation for NSCLC candidate

Pharmaceutical Technology

Bayer’s oral tyrosine kinase inhibitor is currently in a Phase I trial estimated to enrol 460 patients.

Trials 331
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Gritstone to lay off 40% of workforce after costly study delay

Bio Pharma Dive

The restructuring comes ahead of a key study readout for Gritstone, which, like Moderna, is developing a type of personalized vaccine for cancer.

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Tiny Doses of LSD Boost Unique Signals in The Human Brain

AuroBlog - Aurous Healthcare Clinical Trials blog

Even small doses of LSD could have therapeutic benefits for mental health and task performance, a new study shows. Researchers from the US and Germany gave 21 adults either a placebo or 13 or 26 micrograms of LSD – small doses that rarely lead to hallucinatory effects.

Research 181
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Roles and Responsibilities of Specialized Clinical Supply Experts

When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial. However, there are human-based and knowledge-driven factors that are often overlooked that go beyond these basic physical capabilities and are integral to the development and delivery of high performing clinical supply chains.

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AstraZeneca finally drops roxadustat US rights after FDA rejection, trial failure

Fierce Pharma

AstraZeneca and FibroGen have finally reached the end of the road for their U.S. collaboration on the oral anemia drug roxadustat. | More than two years after a high-profile FDA rejection, AstraZeneca has backed out of a collaboration with FibroGen for the latter’s oral anemia drug roxadustat in the U.S. Still, AZ left the partners' China pact intact.

Trials 115
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Green granulation: Tracking energy efficiency in pharmaceutical granulation

Pharmaceutical Technology

Experts say that dry granulation is 10x more efficient than wet granulation, which could make substantial progress towards making this pharmaceutical process greener.

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Janux shares triple on early cancer immunotherapy data

Bio Pharma Dive

Analysts viewed results for one of Janux’s drug, a T cell engager aimed at metastatic prostate cancer, as potentially best-in-class in a field that’s crowded with competitors.

Drugs 276
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Panel asks govt to persuade private insurance companies to cover Ayush treatments

AuroBlog - Aurous Healthcare Clinical Trials blog

The Department-related Parliamentary Standing Committee on Health and Family Welfare has recommended to the government to persuade private insurance companies to include Ayurveda, Yoga, Unani, Siddha and Homoeopathy (Ayush) treatments in their products and look at global acceptance for these systems of medicines through legalisation and insurance support in other countries.

Medicine 166
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The New Age of Decentralized Clinical Trials

This new white paper defines and details the impact of Decentralized Clinical Trials on the Pharmaceutical industry and how the impact can be measured along with steps companies can take to ensure adoption.

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Amgen boots up Ohio 'smart facility' where it plans to employ 400—and a trio of robots, too

Fierce Pharma

Amgen is now open for business in Central Ohio after cutting the ribbon at its “most advanced facility to date.” | Amgen is now open for business in Central Ohio after cutting the ribbon at its “most advanced facility to date.” Dubbed “Amgen Ohio,” the nearly 300,000-square-foot biomanufacturing plant in New Albany, Ohio, is set to employ 400 full-time employees and leverage the “latest innovation and technology.

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Merck’s Keytruda regimen gains positive EMA CHMP opinion

Pharmaceutical Technology

Merck's KEYTRUDA has received a positive opinion from the EMA CHMP for use in combination with chemotherapy for non-small cell lung cancer.

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Pfizer, looking for a jumpstart, leans into cancer drug research

Bio Pharma Dive

Reeling from a difficult year financially, the pharma unveiled a new oncology division it says will produce eight billion-dollar medicines by 2030.

Research 299
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CDSCO declares around 5% of drug samples tested in January as NSQs

AuroBlog - Aurous Healthcare Clinical Trials blog

The Central Drugs Standard Control Organisation (CDSCO) has declared almost 5 per cent of the total drug samples it tested during the month of January, 2024 as Not of Standard Quality (NSQ). The number of samples tested, however, has declined during the month compared to the previous months.

Drugs 151
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Deliver Fast, Flexible Clinical Trial Insights with Spotfire

Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management. Learn how Revvity Signals helps drug developers deliver clinical trial data insights in real-time using a fast and flexible data and analytics platform to empower data-driven decision-making.