Pharmaceutical Technology

SEPTEMBER 20, 2022

The study of lifetime exposures, also known as the “exposome”, is providing a new perspective on how environmental and social factors affect disease pathways and general wellbeing, and could influence the way pharma researches drugs. The Centers for Disease Control and Prevention (CDC) define the exposome as “the measure of all the exposures of an individual in a lifetime and how those exposures relate to health”.

Drugs 355

Drugs Medicine Allergies In-Vitro 355

Bio Pharma Dive

SEPTEMBER 20, 2022

When the company debuted in March, it announced plans to hire 200 employees over two years. Now, it’s laid off nearly half its staff in a year when the biotech sector has experienced a sharp market downturn.

Marketing 284

Marketing 284

AuroBlog - Aurous Healthcare Clinical Trials blog

SEPTEMBER 20, 2022

BA.4.6, a subvariant of the Omicron COVID variant which has been quickly gaining traction in the US, is now confirmed to be spreading in the UK. The latest briefing document on COVID variants from the UK Health Security Agency (UKHSA) noted that during the week beginning August 14, BA.4.6 accounted for 3.3 percent of samples […].

Clinical Trials 178

Clinical Trials Clinical Trials Clinical Research Trials 178

Bio Pharma Dive

SEPTEMBER 20, 2022

The roughly 200,000-square-foot facility will house about 400 employees and more than double the size of the drugmaker’s presence in San Francisco.

Research 293

Research 293

Advertisement

There’s been a rapid shift towards decentralization in clinical trials & it’s clear why. The potential for reaching a larger pool of recruits is possible when sponsors can bring more trial activities to the patient. Tele visits, digital consent, new monitoring sensors, & direct-to-patient supply are virtual tools that existed before the pandemic, but now there’s swift adoption of these methods because they’ve been proven to help launch & complete trials more effectively.

Trials

Rethinking Clinical Trials

SEPTEMBER 20, 2022

The Johns Hopkins Berman Institute of Bioethics this week opened the application period for its 2023-2024 postdoctoral fellowships, including a Postdoctoral Fellowship in the Ethics and Regulatory Aspects of Pragmatic Clinical Trials. From the announcement: The Johns Hopkins Berman Institute of Bioethics invites applications for a Postdoctoral Fellowship in the Ethics and Regulatory Aspects of Pragmatic Clinical Trials.

Clinical Trials 246

Clinical Trials Clinical Trials Trials Research 246

Bio Pharma Dive

SEPTEMBER 20, 2022

Rocket is acquiring Renovacor at a roughly 75% discount to its public debut price last year, when it became one of dozens of biotechs to merge with a blank check company, or SPAC.

Gene Therapy 184

Gene Therapy Gene 184

Bio Pharma Dive

SEPTEMBER 20, 2022

Safety concerns had derailed a slate of studies involving the drug, called islatravir, last fall. A partial FDA hold remains on any study using a higher dose.

Drugs 144

Drugs 144

Pharmaceutical Technology

SEPTEMBER 20, 2022

Running a clinical trial is a complex process that typically involves multiple vendors to obtain everything required, which has been made far more challenging during the global pandemic these past few years. Hospitals and medical facilities have been inundated with Covid-19 patients, with demand for medical professionals and supplies at an all-time high.

Clinical Trials 130

Clinical Trials Clinical Trials Trials Pharma Companies 130

Medical Xpress

SEPTEMBER 20, 2022

A concerning report recently published in Nature Medicine suggests even a mild case of COVID can increase the long-term risks of serious cardiovascular diseases such as stroke, heart attack and heart failure. The study highlights our limited understanding of the full consequences of COVID infection and the long-term impact of the COVID pandemic.

Medicine 145

Medicine 145

Pharmaceutical Technology

SEPTEMBER 20, 2022

The European Commission (EC) has granted approval for Roche's Vabysmo (faricimab) to treat two retinal conditions, neovascular or ‘wet’ age-related macular degeneration (nAMD) and diabetic macular oedema (DME) associated visual impairment. . This latest approval is based on findings from four Phase III clinical trials in the two indications, which enrolled a total of 3,220 subjects.

Clinical Trials 130

Clinical Trials Clinical Trials Antibody Trials 130

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.

Clinical Research

NPR Health - Shots

SEPTEMBER 20, 2022

Critics say a legal maneuver by one of the world's wealthiest corporations could set a precedent, allowing non-bankrupt companies and rich individuals to avoid liability for wrongdoing.

145

145

Pharmaceutical Technology

SEPTEMBER 20, 2022

Research and innovation in healthtech in the pharmaceutical sector has declined in the last year. The most recent figures show that the number of healthtech related patent applications in the industry stood at 785 in the three months ending July - down from 1052 over the same period in 2021. Figures for patent grants related to healthtech followed a similar pattern to filings - shrinking from 531 in the three months ending July 2021 to 262 in the same period in 2022.

Research 130

Research 130

NPR Health - Shots

SEPTEMBER 20, 2022

Research finds five to 10 minutes daily of a type of strength training for muscles used in breathing can help anyone reduce or prevent high blood pressure. The training can also help elite athletes.

Medicine 141

Medicine Research 141

Pharmaceutical Technology

SEPTEMBER 20, 2022

Europe was the fastest growing region for digital media hiring among pharmaceutical industry companies in the three months ending July. The number of roles in Europe made up 18.2% of total digital media jobs - up from 16.5% in the same quarter last year. That was followed by North America, which saw a 0 year-on-year percentage point change in digital media roles.

Marketing 130

Marketing 130

Advertiser: FourKites

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.

Research

Medical Xpress

SEPTEMBER 20, 2022

Autistic children seem to be at heightened risk of being admitted to hospital if they are exposed to air pollution for relatively brief periods, with boys more at risk than girls, suggests research published in the open access journal BMJ Open.

Research 136

Research 136

Pharmaceutical Technology

SEPTEMBER 20, 2022

In recent weeks, several regulatory decisions on Covid-19 vaccines and boosters have come through that are expected to spur vaccine manufacturing in the near future. In this ongoing series , Pharmaceutical Technology uses data from GlobalData’s Pharmaceutical Intelligence Center Deals database and PharmSource reports, along with publicly available news on the pharmaceutical and biotech industry, to analyze which players may be impacted by critical decisions by regulatory agencies.

Manufacturing 130

Manufacturing Drugs Clinical Trials Clinical Trials 130

NPR Health - Shots

SEPTEMBER 20, 2022

Biden's comments — made as officials try to convince Americans to get a new booster shot and the White House seeks $22 billion in new COVID funding — were "unfortunate," several epidemiologists said.

128

128

Pharmaceutical Technology

SEPTEMBER 20, 2022

BeiGene has received the UK National Institute for Health and Care Excellence (NICE) recommendation for Brukinsa (zanubrutinib) to treat Waldenström’s Macroglobulinemia (WM). In a final appraisal document (FAD), the institute recommended the treatment for use in adult patients who have received a minimum of one therapy, only if bendamustine plus rituximab is also appropriate.

Medicine 130

Medicine Development Production 130

Speaker: Steve Goldstein, Sales Leader

Are you currently in sales, or involved in a business that depends on strong sales results? What about the extremely competitive world of medical device sales? What are some of the top challenges your customers face and how do you approach understanding what’s most important to them? Join Steve Goldstein, Sales Success Coach, Motivational Speaker and Medical Device Sales Leader from Gold Selling LLC., to discover critical strategies and approaches you can take to engage your customers, achieve g

Sales

STAT News

SEPTEMBER 20, 2022

You’re reading the web edition of STAT Health Tech, our guide to how tech is transforming the life sciences.  Sign up to get this newsletter  delivered in your inbox every Tuesday and Thursday.

Life Science 116

Life Science 116

Pharmaceutical Technology

SEPTEMBER 20, 2022

Clinical packaging and labelling follow stringently controlled procedures and high-standard quality control measures to assure the safety and functionality of investigational medicinal products, during their storage, distribution, and use. Unlike commercial pharmaceutical packaging, the primary consideration in clinical trial packaging is protecting the product quality and reliability for research.

Packaging 100

Packaging Packaging Clinical Trials Clinical Trials 100

NPR Health - Shots

SEPTEMBER 20, 2022

Can we end poverty, provide food for all and otherwise make Earth a better place by 2030? By all accounts, the answer is no. So then what's the point of the Sustainable Development Goals?

Development 115

Development 115

Pharmaceutical Technology

SEPTEMBER 20, 2022

The production of commercial dose non-sterile products such as tablets, capsules, ointments, creams, and powders is rising due to their growing global demand, attributed to increasing demand for anti-ageing products, hereditary factors, genetic mutations, exposure to harmful radiation, and rising geriatric population. Contract marketing companies support pharmaceutical companies in creating, improving, and maintaining their brand, as well as reducing risk, and ensuring better product placement i

Drug Delivery Systems 130

Drug Delivery Systems Marketing Drug Delivery Medicine 130

Advertiser: Aggregage

New vaccine mandates and testing policies will affect employers with more than 100 workers. Get Paycor’s free, customizable vaccination policy template to communicate critical details and new requirements to your employees. Get Paycor’s Template today!

Vaccination

NPR Health - Shots

SEPTEMBER 20, 2022

Children who are regularly exposed to gun violence can struggle with feelings of hopelessness and anxiety. There's a lot communities and after-school programs can do to help.

115

115

STAT News

SEPTEMBER 20, 2022

In the business of selling record-keeping software to hospitals, Epic Systems is breaking away from the pack. The Wisconsin-based company’s contracts now account for nearly half the nation’s hospital beds, and in recent months it has jumped out to a commanding lead over No. 2 Oracle Cerner, taking away dozens of customers. More than 253 million Americans, or 77% of the population, are estimated to now have data in the company’s software.

Compliance 111

Compliance 111

pharmaphorum

SEPTEMBER 20, 2022

Findings from the litifilimab trial, undertaken by Northwell Health’s Division of Rheumatology and The Feinstein Institutes for Medical Research, have been published in the New England Journal of Medicine and show promise for those who have been diagnosed with systemic lupus erythematosus (SLE). Sponsored by Biogen Inc., data from the phase 2 LILAC (Part A) clinical trial published this month shows that the experimental lupus therapy could reduce disease activity in the joints of patients, globa

Trials 111

Trials Clinical Trials Clinical Trials FDA Approval 111

STAT News

SEPTEMBER 20, 2022

One question has plagued the field of blood donation for as long as there have been transfusions: Are we harming blood donors by taking blood from them? Our iron stores are largely self-conserved: Our bodies recycle iron from old red blood cells to make new red blood cells. Iron that’s in use doesn’t tend to exit the body unless a person loses blood, whether through menstruation, bleeding from trauma, illness — or through donation.

Research 105

Research 105

ACRP blog

SEPTEMBER 20, 2022

Leveraged wisely by those who understand when and how to best use it, single institutional review board (IRB) review for multisite studies can be employed by clinical trial practitioners to garner faster approvals for clinical studies of vital drugs and other treatments, says Barbara E. Bierer, MD, director of the Regulatory Foundations, Ethics, and the Law Program for Harvard Catalyst, the Harvard Clinical and Translational Science Center.

Clinical Trials 105

Clinical Trials Clinical Trials Trials Medicine 105

Medical Xpress

SEPTEMBER 20, 2022

Honey has exceptional antimicrobial and tissue-regenerative properties which should be exploited to the full to help wounds heal, say scientists from The university of Manchester.

Scientist 98

Scientist Research 98

STAT News

SEPTEMBER 20, 2022

A new CRISPR startup — backed by some big names in venture capital — is planning to develop gene-editing treatments that can insert a genetic sequence of any length, at any location in the DNA strand, according to industry insiders and documents. The biotech is called Tome Biosciences, and it hopes to write the next chapter in genomic medicines.

DNA 98

DNA Gene Editing Genome Genomics 98

Medical Xpress

SEPTEMBER 20, 2022

Social avoidance is a common symptom of PTSD, and scientists working to better understand why have laboratory evidence that while stress hormone levels consistently increase in the immediate aftermath of a traumatic event, there can be polar opposite consequences in parts of the brain down the line.

Hormones 98

Hormones Scientist 98

STAT News

SEPTEMBER 20, 2022

WASHINGTON — Major food makers are ready to cash in on selling CBD-filled foods and drinks. But the Food and Drug Administration isn’t having it. Technically all products containing CBD, or cannabidiol, are illegal under FDA’s rules — regardless of whether they’re a dietary supplement sold at the Vitamin Shoppe or a CBD seltzer from Whole Foods.

Drugs 98

Drugs Containment Production 98

Medical Xpress

SEPTEMBER 20, 2022

Are you an early bird or a night owl? Our activity patterns and sleep cycles could influence our risk of diseases, such as type 2 diabetes and heart disease. New research published in Experimental Physiology has found that wake/sleep cycles cause metabolic differences and alter our body's preference for energy sources. The researchers found that those who stay up later have a reduced ability to use fat for energy, meaning fats may build up in the body and increase risk for type 2 diabetes and ca

Research 98

Research 98