Sat.Mar 23, 2024 - Fri.Mar 29, 2024

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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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How Latinas are Shaping Clinical Research

WCG Clinical

This content is password protected. To view it please enter your password below: Password: The post How Latinas are Shaping Clinical Research appeared first on WCG.

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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 215
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Exploring the Power of Scale in Patient Recruitment: A Recap of the Velocity and HealthMatch Presentation at SCOPE

Velocity Clinical Research

Last month, Nick Spittal , Velocity’s chief operating officer announced the company’s latest partnership with HealthMatch and results from an unprecedented patient recruitment pilot at the SCOPE conference in Orland, Florida. He was joined by HealthMatch CEO, Manuri Gunawardena, on stage for a joint presentation, as Clinical Trials Report journalist Michael Causey reports: Velocity announced its partnership with HealthMatch on an innovative patient-centric recruitment pilot during the session, “

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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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One2Treat launches original treatment-decision approach to clinical research

Outsourcing Pharma

Today (March 26) One2Treat, a new innovative start-up offering progressive digital health solutions, has launched a pioneering approach addressing two of the most strategic challenges in the biopharma industry today.

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Improving clinical trial design with real-world data

Bio Pharma Dive

Leveraging real-world data (RWD) transforms global clinical trials, enhancing patient engagement and improving regulatory decision-making.

More Trending

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Nanoscope Therapeutics exhibits positive top-line Phase IIb results for MCO-010

Pharmaceutical Technology

Nanoscope Therapeutics released promising top-line results for its RESTORE trial, which is studying the gene therapy MCO-010 in patients with retinitis pigmentosa (RP).

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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 161
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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 285
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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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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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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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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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FDA rejects Regeneron lymphoma drug, setting back company’s oncology push

Bio Pharma Dive

The agency wants Regeneron to make more progress with a confirmatory trial before clearing odronextamab, a “bispecific” antibody being developed for multiple blood cancers.

Antibody 286
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Pfizer Terminates Phase III Sickle Cell Study Due to Slow Patient Recruitment

BioSpace

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.

Antibody 135
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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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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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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.

Sales 142
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Bristol Myers says KRAS drug succeeds in key trial

Bio Pharma Dive

Confirmatory results for Krazati, which Bristol Myers acquired via its buyout of Mirati, could help the drug win full approval while Amgen has been set back.

Drugs 291
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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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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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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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Intelligence officials warned lawmakers WuXi AppTec furnished China with client's intellectual property: Reuters

Fierce Pharma

An alleged development in the national security crackdown against WuXi AppTec and a handful of other Chinese companies in the U.S. | An alleged development in the national security crackdown against WuXi AppTec and a handful of other Chinese companies in the U.S. suggests intelligence officials and lawmakers may have good reason to be concerned about the CDMO’s potential political ties to its home country.

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FDA approves Merck lung disease drug acquired in $11B deal

Bio Pharma Dive

Merck is couting on Winrevair, which it acquired by buying Acceleron Pharma, to help soften the blow when Keytruda loses patent protection later this decade.

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Merck, Others Look to Immunotherapy Combos as Next Frontier in Oncology

BioSpace

Drugmakers are testing a variety of biologics and small molecules in conjunction with therapies aimed at modulating the immune system to target and destroy cancer cells.

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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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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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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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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 292
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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.

Antibody 133
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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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Astellas secures approval for gastric cancer antibody in Japan

Pharmaceutical Technology

The approval from Japan’s Ministry of Health, Labour, and Welfare (MHLW) is based on positive results from two studies.

Antibody 246
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After Amgen's stumble, BMS touts KRAS confirmatory trial win for newly bought Krazati

Fierce Pharma

Bristol Myers Squibb looks on track to overtake Amgen as the KRAS leader in lung cancer after following up its rival’s FDA setback with a positive confirmatory trial readout. | Bristol Myers Squibb looks on track to overtake Amgen as the KRAS leader in lung cancer after following up its rival’s FDA setback with a positive confirmatory trial readout.

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FDA approves Akebia anemia pill, two years after rejection

Bio Pharma Dive

The agency gave Akebia’s drug an OK after receiving more safety data, but imposed a strict boxed warning for its use that may limit uptake.

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Wegovy Cardiovascular Approval Furthers March into New Indications

BioSpace

The recent FDA decision will likely mean more Medicare patients gain access to the blockbuster weight loss drug, experts say. Meanwhile, results continue to roll in for GLP-1 agonists for conditions beyond diabetes and obesity.

Drugs 126
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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.