World of DTC Marketing

JUNE 6, 2021

SUMMARY: The media headlines promise weight loss for diabetes patients, but Norvo’s new drug is in the same class as other drugs and carries many warnings. Can diabetes patients really stay adherent to a drug for 63 weeks in which 85% of patients report GI side effects and will insurance cover the cost? The headlines read “FDA approves obesity drug that helped people cut weight 15%” But buyer beware.

Drugs 318

Drugs Cosmetics Production FDA Approval 318

Bio Pharma Dive

JUNE 6, 2021

The year's biggest meeting for cancer drug research is about to wrap up. Here are three key storylines to emerge.

Drugs 258

Drugs Research 258

Pharma Mirror

JUNE 6, 2021

Terrassa (Barcelona): Telstar will be exhibiting the latest developments in aseptic technology for pharmaceutical production and integrated turnkey engineering & construction services for process facilities at Achema Pulse 2021. The company will be present at the digital flagship event of the global process industries during the whole of June and will be live during 15-16th June.

Engineer 130

Engineer Manufacturing Production Development 130

BioSpace

JUNE 6, 2021

In the field of drug discovery, one must always begin with the target, right? Not if you ask Cellarity, a quickly emerging biotech company revolutionizing the drug development space.

Development 106

Development Drugs 106

Advertisement

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

Pharma Mirror

JUNE 6, 2021

Emergency medical response requires a coordinated effort. It’s a field that burdens people with the task of providing an organized and immediate medical response in an often chaotic and high-pressure environment. To be able to do this in a consistent and timely manner, many emergency medical services (EMS) providers rely on electronic patient care reports (ePCR) solutions. ePCR is critical to the operation of EMS organizations because it allows staff members and response coordinators to stay on

130

130

BioSpace

JUNE 6, 2021

Grail presents its first data from the interventional PATHFINDER trial of Galleri, its multi-cancer early detection blood test. Galleri is now available in the U.S. by prescription.

Trials 103

Trials 103

BioSpace

JUNE 6, 2021

United claims Liquidia and a former employee misappropriated its trade secrets such as regulatory submissions and detailed financial forecasts for its inhaled treprostinil.

98

98

Scienmag

JUNE 6, 2021

Fermented meat snack is helping researchers develop a safe, all-natural food preservative Credit: RMIT University A traditional Vietnamese meat snack could hold the key to developing a safe and natural food preservative, addressing the twin global problems of food waste and food-borne illnesses. Key Points Bacteria-killing compound discovered in Nem Chua, a fermented pork snack […].

Bacteria 94

Bacteria Development Research Medicine 94

BioSpace

JUNE 6, 2021

Shares of Fate climbed nearly 4% in premarket trading after it announced positive interim data from a Phase I study of FT516 for patients with relapsed / refractory B-cell lymphoma.

98

98

Scienmag

JUNE 6, 2021

Fralin Biomedical Research Institute invests in MRI-guided focused ultrasound facility with support from Edward N. & Della L. Thome Memorial Foundation Credit: Clayton Metz/Virginia Tech By 2034, nearly one-quarter of Americans will have reached retirement age, according to the United States Census Bureau. But as people age, the brain becomes more susceptible to developing disorders, […].

Research 86

Research Development Engineer Medicine 86

Advertisement

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

BioSpace

JUNE 6, 2021

The FDA lifted the clinical holds on bluebird bio’s sickle gene therapy and its betibeglogene autotemcel gene therapy for adults, adolescents and children with TDT.

Gene Therapy 101

Gene Therapy Gene 101

Scienmag

JUNE 6, 2021

New resource for neuroscience maps cell types, secreted proteins, spatial organization, and more Credit: Dani N, Herbst RH, et al. Cell April 30, 2021, DOI 10.1016/j.cell.2021.04.003. Once viewed merely as a producer of the cerebrospinal fluid (CSF) bathing the brain and spinal cord, the choroid plexus is now known to be a key player in […].

Protein 72

Protein Allergies Medicine 72

BioSpace

JUNE 6, 2021

After three years, 85.9% of patients treated post-surgically with Lynparza were free of invasive breast cancer and second cancers compared to 77.1% of the placebo group.

106

106

Scienmag

JUNE 6, 2021

Credit: © Jean-Gabriel VALAY/JARDIN DU LAUTARET/UGA/CNRS In a white ocean, well above sea level, the algae thrive. Normally invisible to the naked eye, they are often spotted by hikers trekking through the mountains in late spring as strikingly coloured stretches of snow, in shades of ochre, orange and red. Known as “glacier blood”, this colouring […].

69

69

Advertisement

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

BioSpace

JUNE 6, 2021

June is turning out to be a busy month for PDUFA dates for the U.S. Food and Drug Administration. Here’s a look at this week’s dates.

Drugs 98

Drugs 98

JAMA Internal Medicine

JUNE 6, 2021

This cross-sectional study examines the spread of misinformation regarding the Danish Study to Assess Face Masks for the Protection Against COVID-19 Infection on Facebook.

76

76

BioSpace

JUNE 6, 2021

An ugly symbol of racism appears to have reared its head at a Merck facility in North Carolina. The pharma giant is investigating reports of a noose found hanging at a construction project on the 262-acre facility.

98

98

Scienmag

JUNE 6, 2021

Such genes have potential to spread when travelers return home Carried like stowaways in the guts of international travelers, new and potentially deadly strains of antimicrobial resistant superbugs may be coming to a community near you, suggests new research from Washington University School of Medicine in St. Louis. “Even before the COVID-19 pandemic, we knew […].

Gene 71

Gene Medicine Research 71

Advertisement

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

JUNE 6, 2021

With the 2021 American Society of Clinical Oncology meeting held late last week, there is plenty of clinical trial news.

Clinical Trials 98

Clinical Trials Clinical Trials Trials 98

Scienmag

JUNE 6, 2021

Climate experts warn that, without urgent action, climate change will continue to cause an increase in the intensity of extreme rainfall that can lead to severe flooding Climate experts warn that, without urgent action, climate change will continue to cause an increase in the intensity of extreme rainfall that can lead to severe flooding. An […].

65

65

BioSpace

JUNE 6, 2021

Wegovy is the first and only once-weekly GLP-1 receptor agonist that’s been approved for weight control in people living with obesity. This is the same drug used to treat type 2 diabetes.

Drugs 76

Drugs 76

Clinical Trial Podcast

JUNE 6, 2021

Clinical trials are conducted in compliance with regulations. Simply stated, you need a clinical and regulatory strategy when it comes to conduct of clinical trials for medical devices. As a clinical researcher, there have been times I’ve felt lost because I did not understand the regulatory framework. To close this knowledge gap, I thought it would be great to invite Priya Jagasia, Divisional Vice President (DVP) of Regulatory Affairs at Abbott Vascular on the show.

Clinical Trials 59

Clinical Trials Clinical Trials Trials Regulation 59

Advertisement

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.

Clinical Supply

Scienmag

JUNE 6, 2021

Patients with blood cancers at greatest risk of COVID-19 death New research indicates that patients hospitalized with active cancer were more likely to die from COVID-19 than those with a history of cancer or those without any cancer diagnosis. The findings published by Wiley early online in CANCER, a peer-reviewed journal of the American Cancer […].

Research 63

Research Allergies Vaccination Vaccine 63

BioSpace

JUNE 6, 2021

The U.S. Food and Drug Administration granted approval of Biogen’s aducanumab for the treatment of Alzheimer’s disease.

Drugs 79

Drugs 79

JAMA Internal Medicine

JUNE 6, 2021

This randomized clinical trial examines the use of high-sensitivity cardiac troponin testing for patients with kidney impairment.

Clinical Trials 75

Clinical Trials Clinical Trials Trials 75

FDA Law Blog

JUNE 6, 2021

The RAPS Wisconsin Chapter is hosting a webcast on Wednesday, June 23, 2021, discussing device requirements for drug-led combination products. Hyman, Phelps & McNamara, P.C.’s Adrienne Lenz will be the speaker. This webcast will cover U.S. FDA requirements applicable to sponsors of drug-led drug/device combination products, including device requirements for the quality management system and good manufacturing practices (GMPs), device content to include in a new drug application (NDA), regi

Production 52

Production Drugs Compliance Manufacturing 52

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

pharmaphorum

JUNE 6, 2021

Novo Nordisk is celebrating the FDA approval of its GLP-1 agonist semaglutide as a treatment for obesity, which it believes has the potential to redefine the market for weight-loss medicines. . Already approved at a lower dose as Ozempic for treating diabetes, the new 2.4 mg once-weekly formulation – which will be sold as Wegovy – is the first new medicine to be approved in the US for obesity since 2014.

Drugs 52

Drugs Sales Marketing Trials 52

BioSpace

JUNE 6, 2021

Novartis flexed its clinical muscles over the weekend, announcing results from multiple studies including different types of cancer and kidney disease.

59

59

JAMA Internal Medicine

JUNE 6, 2021

This Viewpoint explores the ethics of a UK SARS-CoV-2 human challenge trial.

Trials 77

Trials 77

Scienmag

JUNE 6, 2021

The friendship paradox is the observation that the degrees of the neighbors of a node within any network will, on average, be greater than the degree of the node itself. In other words: your friends probably have more friends than you do. While the standard framing of the friendship paradox is essentially about averages, significant […].

45

45

Advertisement

The global landscape of clinical trials is rapidly changing as studies become more complex. An increasing number of sponsors are seeking enhanced flexibility in their supply chains to address a variety of clinical supply challenges, including patient demand and reducing delays. Demand-led supply and direct-to-patient distribution are next-generation solutions that are helping to meet these growing needs, allowing for more streamlined processes and patient-centric studies.

Clinical Trials