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March 28, 2024: Health Equity Core Provides Reference for Equitable Language in Pragmatic Trials

Rethinking Clinical Trials

Dr. Rosa Gonzalez-Guarda The NIH Pragmatic Trials Collaboratory’s Health Equity Core developed a written aid to offer guidance on inclusive language and terms to use when referring to specific people, groups, and communities. The Equitable Language Cheat Sheet is available on the Health Equity Core webpage and will be updated as terminology and guidance evolves.

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Viking stays in obesity drug race with early data for weight loss pill

Bio Pharma Dive

The results are from a small Phase 1 study, but suggest Viking’s oral GLP-1 drug may not come with high rates of gastrointestinal side effects.

Drugs 264
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FDA clears first-of-its-kind Duchenne drug for broad use

Bio Pharma Dive

The approval of Italfarmaco’s Duvyzat is the first for an oral, non-steroidal Duchenne drug and was issued for all patients at least six years of age, regardless of their genetic underpinnings.

Drugs 293
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FDA approves J&J’s OPSYNVI for pulmonary arterial hypertension

Pharmaceutical Technology

The US FDA approved Johnson & Johnson's (J&J) OPSYNVI for chronic treatment in adult patients with pulmonary arterial hypertension.

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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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BioNTech hit with 'notice of default' from NIH in COVID-19 vaccine royalty dispute

Fierce Pharma

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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Boundless Bio Launches $100M IPO to Advance Cancer Therapy Candidates

BioSpace

Continuing 2024’s biotech initial public offering rally, Boundless Bio will debut Thursday on the Nasdaq with the proceeds used to advance its pipeline of extrachromosomal DNA cancer assets.

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March 27, 2024: A Cluster Randomized Trial to Improve Kidney Transplant Access, in This Week’s PCT Grand Rounds

Rethinking Clinical Trials

Drs. Amit Garg and Stephanie Dixon In this Friday’s PCT Grand Rounds, Amit Garg and Stephanie Dixon of Western University’s Schulich School of Medicine and Dentistry will present “Effect of a Multicomponent Intervention to Improve Patient Access to Kidney Transplant and Living Kidney Donation: A Pragmatic, Cluster-Randomized Trial.” The Grand Rounds session will be held on Friday, March 27, 2024, at 1:00 pm eastern.

Trials 170
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US FDA grants approval for Alexion’s NMOSD treatment

Pharmaceutical Technology

The US FDA has approved Alexion’s Ultomiris to treat adults with AQP4 Ab+ neuromyelitis optica spectrum disorder (NMOSD).

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Nanoscope preps filing for retinitis pigmentosa gene therapy

pharmaphorum

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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Epigenetic Editing Explodes on the Heels of Gene Editing Success

BioSpace

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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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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Merck scores key FDA approval for pulmonary arterial hypertension drug Winrevair

Fierce Pharma

After three years, the crown jewel of Merck’s $11.5 billion acqu | After three years, the crown jewel of Merck’s $11.5 billion acquisition of Acceleron is ready to pay dividends. With the FDA’s approval of Winrevair (sotatercept) to treat pulmonary arterial hypertension (PAH), Merck is set to launch the first disease-modifying treatment for the condition.

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Cancer Research UK and CRIS fund lung cancer vaccine research

Pharmaceutical Technology

Cancer Research UK and the CRIS Cancer Foundation have awarded a £1.7m ($2.1m) grant for developing the lung cancer vaccine LungVax.

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Brainomix AI shows its worth in AZ pulmonary fibrosis trial

pharmaphorum

Brainomix's e-Lung AI can accurately identify idiopathic pulmonary fibrosis patients most likely to progress and could inform the clinical trial design for new therapies

Trials 104
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AstraZeneca’s Ultomiris Wins FDA Approval for Rare Autoimmune Disease

BioSpace

AstraZeneca’s Alexion on Monday secured the fourth indication for Ultomiris, which can now be used to treat the rare autoimmune condition neuromyelitis optica spectrum disorder.

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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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European study finds popular ALS drug ineffective

Bio Pharma Dive

The failure of a medicine known as TUDCA is yet another disappointment for ALS patients, as it comes just after Amylyx’s therapy Relyvrio proved unsuccessful in confirmatory testing.

Drugs 189
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With Merck's key PAH approval on tap, Johnson & Johnson wins nod for combo tablet

Fierce Pharma

With the FDA expected this week to approve a first-in-class treatment from Merck for pulmonary arterial hypertension (PAH), Johnson & Johnson has beaten its New Jersey rival to the punch with a | With the FDA expected this week to approve a first-in-class treatment from Merck for pulmonary arterial hypertension (PAH), Johnson & Johnson has beaten its New Jersey rival to the punch with a nod from the U.S. regulator for its newest PAH treatment.

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Measles cases continue to rise in US amid lagging vaccination rates

Pharmaceutical Technology

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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Dissatisfaction with NHS ‘at record high’

pharmaphorum

More than half (52%) of people who participated in a major survey of the GB public were dissatisfied with the NHS, as staff shortages, strikes, and record waiting lists take their toll. The results from the annual British Social Attitudes (BSA) survey came from 3,000 people interviewed across England, Scotland, and Wales and showed that less than a quarter (24%) were satisfied with the health service, a 29 percentage drop in three years.

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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 Secures Up to $750M in Funding from Blackstone to Advance Flu Program

BioSpace

Moderna has entered into a development and commercialization funding agreement with asset management firm Blackstone Life Sciences to help advance its pipeline of flu vaccine candidates.

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Gilead bets on Xilio cancer drug as biotech restructures

Bio Pharma Dive

Xilio will get just over $40 million from Gilead in return for a license to its experimental IL-12 immunotherapy. The biotech is also discontinuing other work and laying off staff.

Licensing 161
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In banner year, Lilly rewards CEO David Ricks with 24% boost in total pay to $26.6M

Fierce Pharma

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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FDA grants orphan drug status to HI-Bio’s felzartamab for AMR

Pharmaceutical Technology

The US FDA has granted ODD to HI-Bio's felzartamab to treat antibody-mediated rejection (AMR) in kidney transplant recipients.

Antibody 244
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2022 Research: The Rapid Rise of Ocean Freight Visibility

A research study conducted by The Journal of Commerce and FourKites surveyed hundreds of international shippers, exploring how their usage of global supply chain visibility technology has evolved since the onset of global disruptions caused by COVID-19. For international shippers, ocean freight visibility has evolved from optional to essential and satisfaction with visibility varies greatly depending on how it is obtained and delivered.

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Research uncovers how to target dormant breast cancer cells

Drug Discovery World

Scientists have discovered how breast cancer cells can ‘hibernate’ to avoid treatment and ‘wake up’ years later – causing a relapse that is more difficult to treat. Their research, published in the journal Cancer Discovery , reveals the role of epigenetics in controlling how cancer cells can become dormant – and suggests a strategy to target it before the cells wake up.

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FDA Authorizes Invivyd’s Pemgarda to Prevent COVID-19 in Immunocompromised People

BioSpace

The regulator has allowed for emergency use of Invivyd’s monoclonal antibody Pemgarda as a COVID-19 pre-exposure prophylaxis for moderately or severely immunocompromised patients.

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Biotech veteran Art Krieg postpones retirement to build an unorthodox drug startup

Bio Pharma Dive

With Zola Therapeutics, Krieg plans to design and sell a series of cancer immunotherapies without the help of outside investors, he told BioPharma Dive.

Drugs 177
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Antidote anecdotes: A conversation with an MS care partner

Antidote

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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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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EMA CHMP recommends Novo Nordisk’s weekly insulin for diabetes

Pharmaceutical Technology

The EMA CHMP has recommended marketing authorisation for Novo Nordisk's Awiqli for treating diabetes in adult patients.

Insulin 246
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Building the patient experience into observational studies produces stronger real-world evidence

pharmaphorum

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.

Research 104
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BioNTech Hit with NIH Notice of Default over COVID-19 Vaccine Royalties

BioSpace

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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Boundless Bio breaks IPO lull with $100M fundraise

Bio Pharma Dive

The startup’s performance will test investors’ appetite for early-stage drugmakers, as Boundless has only advanced as far as Phase 1 clinical trials.

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Accelerating Clinical Supply Through Integrated Drug Development

As the development pipeline for new drugs continues to grow, biopharmaceutical companies are re-evaluating how to best manage and balance resources across an increasing number of development projects and complex clinical trials. There are two approaches that can be used to speed a drug from development to clinic faster: timeline compression and parallel processing, but only one that considers the benefits of integrating clinical supply into the overall drug development process.