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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.

Trials 207
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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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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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Bionomics to advance non-SSRI PTSD candidate to Phase III

Pharmaceutical Technology

Bionomics plans to meet with the FDA following positive topline data from the Phase IIb ATTUNE trial of the post-traumatic stress disorder (PTSD) drug BNC210.

Trials 262
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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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Scientists Identify Speech Trait That Foreshadows Cognitive Decline

AuroBlog - Aurous Healthcare Clinical Trials blog

Can you pass me the whatchamacallit? It’s right over there next to the thingamajig. Many of us will experience “lethologica”, or difficulty finding words, in everyday life. And it usually becomes more prominent with age.

Scientist 187
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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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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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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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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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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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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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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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March 21, 2024: NINR Announces Funding Opportunity to Improve Health and Advance Equity in Rural Populations

Rethinking Clinical Trials

The National Institute of Nursing Research (NINR) published a funding opportunity for research to improve health outcomes and advance health equity in rural populations. Rural populations experience high rates of many causes of morbidity and disability, and high and increasing rates of premature death. Meaningful and sustained improvements in the health of rural populations require effective solutions to address the underlying causes.

Nurses 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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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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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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NextCure to lay off 37% of staff, dial back research plans

Bio Pharma Dive

The job cuts at the cancer drug developer will primarily impact manufacturing roles, but will touch on several other parts of the organization, the company said.

Research 278
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Novo Nordisk agrees $1.1bn takeover of RNA biotech Cardior

pharmaphorum

Novo Nordisk has agreed to buy Cardior Pharmaceuticals for $1.1 billion, adding expertise in RNA therapeutics and a heart failure therapy in mid-stage trials.

RNA 121
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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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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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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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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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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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Reuters Pharma USA 2024 - Day 2

pharmaphorum

Get live coverage of the latest updates and developments from Day 2 of Reuters Pharma USA 2024. Stay informed with real-time news and insights from the event.

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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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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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New wave of potential therapies to bring ‘paradigm shift’ in COPD treatment

BioPharma Reporter

The recent submission of clinical trial data for Sanofi/Regeneronâs Dupixent and Veronaâs Ensifentrine to the U.S. FDA indicates the entry of new therapies for chronic obstructive pulmonary disease (COPD) in 2024.

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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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Reuters Pharma USA 2024 - Day 1

pharmaphorum

Get live coverage of the latest updates and developments from Day 1 of Reuters Pharma USA 2024. Stay informed with real-time news and insights from the event.

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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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Merck to invest €300m in South Korean bioprocessing centre

Pharmaceutical Technology

Merck KGaA has announced an investment of over €300m ($326.1m) to establish a new bioprocessing production centre in Daejeon, South Korea.

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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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Caring Cross, Brazil's Fiocruz team up to produce cell and gene therapies at a fraction of their cost in the US

Fierce Pharma

Maryland non-profit Caring Cross has unveiled a partnership with the Brazilian government that's designed to provide access to advanced cell and gene therapies for diseases like leukemia, lymphoma | Maryland nonprofit Caring Cross has unveiled a partnership with the Brazilian government which is designed to provide access to advanced CAR-T and gene therapies for diseases like leukemia, lymphoma and HIV infection—and in the process provide a manufacturing model that demonstrates how to reduc

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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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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.