Drug Discovery World

APRIL 26, 2024

News round-up for 22-26 April by DDW Digital Content Editor Diana Spencer. The leading news story this week has been the launch of a new clinical trial in the UK for a melanoma personalised mRNA cancer vaccine, but there have been a number of other interesting developments in cancer drug discovery. These include the detection of new targets for skin cancer treatment, the benefits of vitamin D for cancer prevention, an extended approval in the EU for a CAR-T myeloma therapy and the discovery of a

Clinical Trials 130

Clinical Trials Vaccine Drugs Trials 130

Drugs.com

APRIL 26, 2024

FRIDAY, April 26, 2024 -- Clostridioides difficile (C. difficile) is a leading cause of illness and death, especially for frail and hospitalized Americans. Now, a new study suggests that the leading antibiotic used to fight it, vancomycin, may be.

Hospitals 137

Hospitals 137

Drug Discovery World

APRIL 26, 2024

Organ-on-a-chip (OOC) company CN Bio has raised a $21 million investment in the first close of its Series B fundraising round. The funding has been secured from several new investors; including $10 million from Bayland Capital, and $5.5 million from founding shareholder, CN Innovations Holdings Ltd. The investment will be used to accelerate the company’s expanding product portfolio and to scale the business to support commercial expansion across key global markets.

FDA 130

FDA Production Drug Development Marketing 130

BioPharma Drive: Drug Pricing

APRIL 26, 2024

The Food and Drug Administration approval of Beqvez comes as other gene therapies for the bleeding condition that were approved earlier struggle to gain traction.

Therapies 122

Therapies Drugs 122

Advertisement

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

Drug Discovery World

APRIL 26, 2024

A clinical trial of a personalised mRNA cancer vaccine for melanoma patients has been launched in the UK. As reported by The Guardian , the global Phase III clinical trial is being led by University College London Hospitals NHS Foundation Trust (UCLH) and will include around 1,100 people, with the UK arm taking place across eight centres in the UK.

Clinical Trials 130

Clinical Trials Vaccine Trials Immune Response 130

Science Daily: Pharmacology News

APRIL 26, 2024

Are mice clever enough to be strategic? A neuroscientist who studies learning in humans and animals, and who has long worked with mice, wondered why rodents often performed poorly in tests when they knew how to perform well. With a simple experiment, and by acting as 'a little bit of a mouse psychologist,' he and his team figured it out.

115

115

Science Daily: Pharmacology News

APRIL 26, 2024

Regenerative heart therapies involve transplanting cardiac muscle cells into damaged areas of the heart to recover lost function. However, the risk of arrhythmias following this procedure is reportedly high. In a recent study, researchers tested a novel approach that involves injecting 'cardiac spheroids,' cultured from human stem cells, directly into damaged ventricles.

Therapies 115

Therapies Research 115

NIOSH Science Blog: Drugs

APRIL 26, 2024

Each year, on April 28, we pause to recognize Workers’ Memorial Day and honor those whose death or suffering resulted from exposure to hazards at work. Words are not enough when it comes to change. Research has shown that the health and safety of workers relies on active and intentional involvement in ways that take into consideration workplace hazards, work arrangements and environment, employer-worker relationships, the workers themselves, and their families.

Research 113

Research 113

LifeSciVC

APRIL 26, 2024

Venture creation in biotech is witnessing a sustained contraction. After the pandemic bubble’s over-indulgence, the venture ecosystem appears to have reset its pace of launching new startups. According to the latest Pitchbook data, venture creation in biotech hit its slowest quarterly pace in eight years during 1Q 2024. With just over 60 new biotechs raising their first round of financing, the sector’s company formation activity has slowed 50-60% from its historic peak in 2021.

DNA 112

DNA Science Marketing Clinical Trials 112

Drugs.com

APRIL 26, 2024

FRIDAY, April 25, 2024 -- Warning letters sent by Medicare officials can prompt a decline in antipsychotic prescriptions for seniors with dementia, a new study finds.Letters sent to heavy prescribers of quetiapine (Seroquel), the most popular.

Nurses 111

Nurses 111

Advertisement

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

Drug Channels

APRIL 26, 2024

Today’s guest post comes from Kevin Kettler, President of CoverMyMeds. Kevin asks: What if there were no barriers across the therapy access and reimbursement process? In his view, eliminating barriers requires a combination of expert insight, actionable data, and simplification of the providers' experiences. Click here to learn more about CoverMyMeds’ comprehensive technology solutions.

Therapies 96

Therapies Drugs 96

Drugs.com

APRIL 26, 2024

FRIDAY, April 26, 2024 (HealthDay) -- Between 2018 and the spring of 2023, a cluster of clients who had gotten 'vampire facial' microneedling skin treatments at a New Mexico spa were diagnosed with HIV, probably via poorly cleaned instruments, a new.

Treatment 111

Treatment 111

Science Daily: Pharmacology News

APRIL 26, 2024

Using environmental DNA analysis, an international team of researchers identified a collection of plants used in ceremonial rituals in the ancient Maya city of Yaxnohcah in Mexico. The plants, known for their religious associations and medicinal properties, were discovered beneath a plaza floor where a ballcourt was built.

DNA 95

DNA International Research 95

Drugs.com

APRIL 26, 2024

FRIDAY, April 26, 2024 -- Each year, thousands of Americans head home after a surgery clutching prescription opioids to help ease post-surgical pain.

Drugs 111

Drugs 111

Advertisement

Clinical development organizations face a wide array of challenges when it comes to data, many of which can impact the operational effectiveness of their clinical trials. In this whitepaper, experts from Revvity Signals explore how solutions like TIBCO® Spotfire® enable better, more streamlined studies. The whitepaper also features a success story from Ambrx, a leading biopharmaceutical company, detailing how it has leveraged Spotfire to tackle data quality and collaboration challenges in clinic

Clinical Trials

Science Daily: Pharmacology News

APRIL 26, 2024

Researchers have developed a new PCB that performs on par with traditional materials and can be recycled repeatedly with negligible material loss. Researchers used a solvent that transforms a type of vitrimer -- a cutting-edge class of polymer -- into a jelly-like substance without damage, allowing solid components to be plucked out for reuse or recycling.

Research 93

Research 93

Drugs.com

APRIL 26, 2024

FRIDAY, April 26, 2024 -- The emotional turmoil caused by a stolen dog is akin to that of a parent losing a child, a new study finds.The findings support the idea that pets truly become family members to their owners, researchers said. When faced.

Research 98

Research 98

Collaborative Drug

APRIL 26, 2024

New Interface for Protocol Readout Definitions We are excited to announce a new, modern GUI for creating Protocol readout definitions in CDD Vault. This update provides a more intuitive and flexible approach to managing your data, especially for handling dose-response calculations essential for the upcoming Curve Analytics module. Key Features: Modular Approach to Readout Definitions: Dose-Response:: Users must define their concentration and raw data values independently.

83

83

Drugs.com

APRIL 26, 2024

FRIDAY, April 26, 2024 -- Bits of bird flu virus have been discovered in roughly 20% of retail milk samples tested in a national survey, the U.S. Food and Drug Administration said Thursday.The finding suggests that bird flu has spread far more.

Virus 98

Virus Drugs 98

Cytel

APRIL 26, 2024

Written by Marie Diamond and Maria Rizzo Systematic literature reviews (SLR) are essential to informing healthcare decision-making and are pivotal for reimbursement submissions to health technology assessment (HTA) bodies. One limitation of SLRs, however, is that they quickly become outdated due to the continuous publication of new literature. The living systematic review (LSR) model can overcome this challenge by incorporating relevant new evidence as it is published.

Clinical Development 64

Clinical Development 64

Drugs.com

APRIL 26, 2024

FRIDAY, April 26, 2024 -- Most seniors probably view any emergency surgery with a certain level of anxiety. Now, a new study seeks to sort out who might be at highest risk for a complication from such surgeries -- and which surgeries are more.

98

98

BioPharma Drive: Drug Pricing

APRIL 26, 2024

Prescription volume erosion is tracking with company forecasts, executives claimed, even as more insurers could exclude the branded drug.

Biosimilars 73

Biosimilars Drugs 73

Drugs.com

APRIL 26, 2024

FRIDAY, April 26, 2024 -- The U.S. Department of Agriculture is clamping down on salmonella bacteria found in breaded, stuffed raw chicken products, with the agency issuing a final rule on the issue Friday.The agency's Food Safety and Inspection.

Production 98

Production 98

Science Daily: Pharmacology News

APRIL 26, 2024

Researchers co-led a study that will improve the detection of gravitational waves--ripples in space and time.

Research 81

Research 81

Drugs.com

APRIL 26, 2024

FRIDAY, April 26, 2024 -- Better heart health can lead to a sharper mind for middle-aged Black women, a new study says.

98

98

Drug Patent Watch

APRIL 26, 2024

Annual Drug Patent Expirations for DROSPIRENONE Drospirenone is a drug marketed by Exeltis Usa Inc, Barr, Glenmark Pharms Ltd, Hetero Labs, Hlthcare, Jubilant Cadista, Mylan Labs Ltd, Watson Labs, Apotex,… Source

Drugs 59

Drugs Marketing 59

Agency IQ

APRIL 26, 2024

BY WALKER LIVINGSTON, ESQ The EPA has finalized a rule to designate PFOA and PFOS – two prevalent PFAS chemicals – as hazardous substances under the federal Superfund law. The designation will kickstart a wide array of actions across the U.S., including cleanups, remediation and litigation. Although a companion enforcement policy intends to exempt certain entities as responsible parties, questions on liability remain.

59

59

Drug Patent Watch

APRIL 26, 2024

Annual Drug Patent Expirations for OXYCONTIN Oxycontin is a drug marketed by Purdue Pharma Lp and is included in one NDA. It is available from three suppliers.

Drugs 59

Drugs Marketing 59

Agency IQ

APRIL 26, 2024

BY LAURA DIANGELO, MPH A final rule requiring Laboratory Developed Tests (LDTs) to be regulated as medical devices has obtained clearance from the White House’s Office of Information and Regulatory Affairs today, allowing the FDA to publish the regulation as early as this week. Simultaneously, OIRA also cleared two additional guidance documents that seek to define how diagnostics are used in public health emergencies, which are likely intended to answer key questions raised by the LDT final rule

Laboratories 59

Laboratories Regulations FDA 59

Drug Patent Watch

APRIL 26, 2024

Annual Drug Patent Expirations for SLYND Slynd is a drug marketed by Exeltis Usa Inc and is included in one NDA. It is available from one supplier.

Drugs 59

Drugs Marketing 59

Agency IQ

APRIL 26, 2024

BY RAYAN BHARGAVA, MSC , KARI OAKES The European Food Safety Authority’s (EFSA’s) substantial lowering of the limit of bisphenol A considered safe in humans was recently lauded by a group of scientists and clinicians. In an article, the group applauds a regulatory toxicology approach that considers academic as well as guideline-directed studies, though EFSA’s findings have engendered some regulatory dissonance between the EU and various national agencies on appropriate limits for the endocrine-d

59

59

Broad Institute

APRIL 26, 2024

Celebrating Broad’s 20th Anniversary By Maria Nemchuk April 26, 2024 Celebrating Broad’s 20th Anniversary In 2004, the Broad Institute was founded with an ambitious goal: to leverage the newly sequenced human genome and fulfill the promise of genomic medicine. We celebrate 20 years of progress toward understanding the roots of disease and narrowing the gap between new biological insights and impact for human health.

International 52

International Research Disease 52

Agency IQ

APRIL 26, 2024

BY RACHEL COE, MSC The FDA issued a revised draft guidance on the development of promotional labeling for biosimilars, reference products, and—newly—interchangeable products. But the guidance offers little in the way of advice for sponsors of interchangeable products, except to say that companies shouldn’t imply that their products are better than the competition.

Biosimilars 59

Biosimilars FDA Production 59

Fierce BioTech

APRIL 26, 2024

Top 5 Reasons for Futureproofing Cell Therapy Development Transitioning to GMP critical reagents ensures cell therapy programs stay futureproof. From bench to bedside, early use of high-quality reagents streamlines development, avoiding supply disruptions and balancing costs effectively. Download now. sdees Fri, 04/26/2024 - 13:30 Transitioning to GMP critical reagents ensures cell therapy programs stay futureproof.

Therapies 52

Therapies 52

Agency IQ

APRIL 26, 2024

BY KIRSTEN MESSMER, PHD, RAC Today, the European Commission launched the Critical Medicines Alliance to address medicines shortages in the E.U. The alliance brings together policy makers, industry and patients to evaluate supply chain vulnerabilities and develop recommendations on mechanisms to prevent shortages. Separately this week, EMA’s group on medicines shortages released eight recommendations that could be employed to address shortages.

52

52