Rethinking Clinical Trials

MARCH 7, 2024

Dr. Stephanie Morain In a new report from the NIH Pragmatic Trials Collaboratory, a team of bioethicists and implementation scientists argue for a “presumptive default” that the results of pragmatic clinical trials should be incorporated into healthcare delivery processes. This responsibility arises from a key rationale for conducting pragmatic trials: that they can facilitate uptake of their results by relevant decision-makers.

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Clinical Trials Clinical Trials Trials Scientist 306

pharmaphorum

MARCH 21, 2024

On today’s podcast, host Jonah Comstock is joined by Meri Beckwith, co-founder of Lindus Health, a next-gen CRO that includes digital therapeutics among its specialties. They talk a little bit about the often unseen difficulties of validating a digital therapeutic through a clinical trial.

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Pharmaceutical Technology

MARCH 11, 2024

Upcoming regulatory events for pipeline AAV gene therapies, with a focus on neuromuscular and blood disorders, are setting high expectations for the space in 2024.

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BioSpace

MARCH 24, 2024

Ubiquitous potential, possible safety advantages and the recent growth of cell and gene therapy are driving investment in a different type of genetic editing.

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Gene Editing Gene Gene Therapy Genetics 141

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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

Clinical Research

pharmaphorum

MARCH 15, 2024

The ALS Association is partnering with myTomorrows to connect patients and physicians with clinical trials using a digital platform.

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Clinical Trials Clinical Trials Trials 111

pharmaphorum

MARCH 27, 2024

Incorporating the patient experience into observational studies can enhance the quality of real-world evidence gathered. Learn how patient-centred approaches can lead to stronger research outcomes.

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Research 119

Bio Pharma Dive

MARCH 8, 2024

The results have led Amylyx to pause promotion of Relyvrio and potentially pull it from the market in the coming weeks, a major blow to the company and ALS patients.

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Fierce Pharma

MARCH 15, 2024

Pfizer knew 2023 was going to be a challenging year of transition. But even the drugmaker was surprised by the plummeting demand for its COVID-19 products, missing badly on its 2023 guidance. | After a difficult year for Pfizer, in which its share price fell by 44%, CEO Albert Bourla’s compensation fell by 35% from $33 million in 2022 to $21.6 million in 2023.

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Production 145

BioSpace

MARCH 25, 2024

The National Institutes of Health claims BioNTech is in default regarding alleged royalty payments the agency contends it is owed in connection with the company’s COVID-19 vaccine Comirnaty.

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Vaccination Vaccine 145

Outsourcing Pharma

MARCH 11, 2024

On March 7, Celadon Pharmaceuticals plc, a leading UK-based pharmaceutical company specializing in cannabis-based medicines, unveiled promising findings from an early economic analysis of its chronic pain clinical trial, dubbed CANPAIN.

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Medicine Clinical Trials Clinical Trials Trials 124

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

Clinical Trials

pharmaphorum

MARCH 4, 2024

Inhaled cannabinoids have been shown to perform better than placebo in providing pain relief for people suffering from acute migraine in a clinical trial

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Clinical Trials Clinical Trials Trials 145

Pharmaceutical Technology

MARCH 18, 2024

Akums Drugs and Pharmaceuticals has introduced Hydroxyurea oral suspension, a room temperature-stable drug for treating sickle cell disease.

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Drugs 306

Bio Pharma Dive

MARCH 14, 2024

Rezdiffra’s clearance is a turning point in the fight against the liver disease. But its sales potential is unclear, and competition could emerge from popular weight loss drugs.

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FDA Approval Drugs Sales 315

Fierce Pharma

MARCH 25, 2024

Even as Germany's BioNTech deals with ongoing declines of its revenue and share price, it's facing another serious concern: U.S. | Even as Germany's BioNTech deals with ongoing declines of its revenue and share price, it's facing another serious concern: U.S. officials are pressing the company to pay royalties linked to the commercialization of its lucrative Pfizer-partnered COVID-19 vaccine.

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Vaccination Vaccine 141

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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.

Clinical Trials

BioSpace

MARCH 13, 2024

Madrigal Pharmaceuticals’ Rezdiffra (resmetirom) is the first-ever approved therapy for metabolic dysfunction-associated steatohepatitis—a decision experts say could signal a sea change in treatment of the disease.

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FDA Approval 145

Antidote

MARCH 27, 2024

MS is a chronic disease that is estimated to impact over a million Americans. The condition causes damage to the body’s central nervous system, leading to numbness, memory problems, sight issues, and difficulties with coordination.

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pharmaphorum

MARCH 26, 2024

Nanoscope Therapeutics is on the brink of filing for FDA approval of what could be the first gene therapy for incurable eye disease retinitis pigmentosa (RP) that can be used regardless of underlying genetic mutations.

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Gene Therapy Gene FDA Approval Genetics 128

Pharmaceutical Technology

MARCH 8, 2024

Participants cannot remain blind to their treatment arm due to the properties of TauRx's drug, which causes urinary discoloration.

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Drugs 299

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.

Clinical Research

Bio Pharma Dive

MARCH 11, 2024

Publicly traded companies raised nearly $10 billion in follow-on stock offerings in January and February, a financing surge that’s driving a “sector recovery,” the investment bank said.

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Fierce Pharma

MARCH 11, 2024

The decades-long wait for an effective treatment for metabolic dysfunction-associated steatohepatitis (MASH) has ended, as the FDA has approved the first drug for the fatty liver disease. | The decades-long wait for an effective treatment for metabolic dysfunction-associated steatohepatitis (MASH) has ended. The FDA has approved Madrigal's resmetirom under the brand name Rezdiffra as the first drug for the fatty liver disease.

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FDA Approval Drugs Branding 140

BioSpace

MARCH 20, 2024

As part of a sweeping reorganization, Bayer Pharmaceuticals on Wednesday shuffled its leadership roster, which included the creation of a new unit and role changes for its executives.

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Antidote

MARCH 12, 2024

For many people, participating in a research study presents an interesting opportunity with many benefits to volunteering. While there are many types of clinical research, all with distinct goals and timelines, trial volunteers will follow a similar path when taking part. Read on to learn more about the process.

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Trials Research Clinical Research 119

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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.

Clinical Supply

pharmaphorum

MARCH 21, 2024

There is no denying that artificial intelligence (AI) has captured the imagination of innovators working across the pharmaceutical sector. The drug discovery space is no different, with myriad applications promising to revolutionise the way that researchers and sponsors approach identifying and progressing new drug candidates.

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Drugs Research 126

Pharmaceutical Technology

MARCH 6, 2024

Demand for medicinal cannabis is increasing globally to treat a range of illnesses and conditions.

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Medicine 340

Bio Pharma Dive

MARCH 15, 2024

The company expects initial uptake of Rezdiffra, which costs $47,400 per year, to be slow as doctors and insurers establish the protocols needed to find patients eligible for treatment.

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FDA Approval Doctors Doctor Drugs 300

Fierce Pharma

MARCH 25, 2024

In 2023, Eli Lilly CEO David Ricks received a 24% boost in pay from $21.4 million to $26.6 million. The increase coincides with the company's booming sales.

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Sales 143

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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.

Clinical Trials

BioSpace

MARCH 26, 2024

While Pfizer has ended one of its two Phase III studies for inclacumab in sickle cell disease, the company is still eyeing an approval for the antibody in the inherited blood disorder by 2026.

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Antibody 144

XTalks

MARCH 26, 2024

World Bipolar Day, observed on March 30th each year, is an important global awareness day focusing on bipolar disorder and eliminating the social stigma often associated with mental health issues. March 30 is also the birthday of the well-known Dutch artist Vincent van Gogh who was posthumously diagnosed to have had bipolar disorder. World Bipolar Day started as a partnership initiative of the International Bipolar Foundation (IBPF), the Asian Network of Bipolar Disorder (ANBD) and the Internati

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pharmaphorum

MARCH 12, 2024

Discover why gut bacteria are considered the next frontier in medicine in this informative article. Learn about the importance of the microbiome, its impact on health, and how it relates to conditions like Clostridiales difficile.

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Bacteria Medicine 126

Pharmaceutical Technology

MARCH 28, 2024

According to the CDC, over 64 cases of measles have been documented in the US in 2024, already exceeding 2023's total of 58.

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Vaccination Vaccine 284

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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.

Clinical Trials