April, 2022

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A promising cancer drug leads Regeneron to reconsider its aversion to M&A

Bio Pharma Dive

Regeneron has agreed to purchase Checkmate Pharmaceuticals for $250 million, the first acquisition of a publicly traded company in the biotech's nearly 35-year history.

Drugs 337
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Cardiologists say information on wearables isn’t always useful.

World of DTC Marketing

Gadget firms — starting with Apple and now Fitbit, which Google owns — are selling wearable devices that check heartbeat rhythms and alert users when something is out of sync, according to KHN.com. Although the gadgets are a technical achievement, some cardiologists say the information the devices produce isn’t always helpful. Notifications from the devices aren’t definitive diagnoses.

Doctors 231
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Valneva and Pfizer report positive Phase 2 data for Lyme disease vaccine in children

BioPharma Reporter

Valneva and Pfizer report positive Phase 2 pediatric data for their Lyme disease vaccine candidate, VLA15: and now plan to include this population in an upcoming Phase 3 trial.

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Smartphone-based skin cancer diagnostic certified for use in UK

pharmaphorum

An artificial intelligence-powered digital tool for diagnosing skin cancers developed by Skin Analytics has been cleared in the UK as a Class IIA medical device, setting up broader use of the technology in patient assessments. DERM is being deployed in pilot studies across five NHS Trusts, for example to see if it can support GPs in referring patients to the urgent two week skin cancer referral laid out in NICE guidelines.

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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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New long COVID study highlights key symptoms

Pharma Times

Women, those who are obese and those on mechanical ventilation are all more likely to suffer from the effects long-term COVID-19

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Xtalks Voices: NIH Experts Share Insights on Increasing Clinical Trial Diversity

XTalks

Increasing clinical trial diversity remains a topic of significant importance in the clinical trial space. In the US, up to 80 percent of participants in medical research studies are Caucasian. Black, Hispanic and Native American/Indigenous populations remain grossly underrepresented in clinical trials. This is a problem as responses to treatments can vary between different racial groups owing to differences in genetics, physiology and lifestyle factors.

More Trending

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DTC marketers addicted to TV

World of DTC Marketing

TV creates awareness quickly when you have a big audience, but TV is a waste of money when your audience is small. I can get better results using digital laser targeting and targeted print ads, but DTC marketers are like TV because it makes them feel important within their company. Tepezza has been running many ads on TV, but it’s a waste of money. The money could have been better spent to learn all they can about their audience and take the message to where they are, either in print or online.

Marketing 227
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Pfizer set to acquire COVID-19 smartphone detection app for $100m

BioPharma Reporter

Pfizer is set to acquire Australiaâs ResApp - a company developing a smartphone app to detect COVID-19 and other respiratory diseases based on the userâs cough - for $100m AUD ($74m USD).

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Digital interventions cut heart failure mortality, study shows

pharmaphorum

An analysis of 10 clinical trials of digital health interventions targeted at patients recently hospitalised for acute heart failure has found they improve outcomes compared to standard care. The meta-analysis by researchers in the US pooled the results of the studies to assess the impact of digital approaches like telemedicine, use of monitoring sensors, Internet-based interventions, smartphone apps, or text messaging/email interactions on all-cause mortality.

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The value of method of use patent claims in protecting your therapeutic assets

Drug Patent Watch

This is a guest post by Ray Miller and Megan E. Bowers, Ph.D. at DLA Piper. Ray may be contacted at raymond.miller@dlapiper.com. When it comes to protecting therapeutic assets, I…. The post The value of method of use patent claims in protecting your therapeutic assets appeared first on DrugPatentWatch - Make Better Decisions.

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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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Moving away from genetic continental ancestry categories in research and medicine

Scienmag

In a Policy Forum, Anna Lewis and colleagues argue that, for researchers and others who want to invoke genetic ancestry, there is a scientific and ethical imperative to move away from continental ancestry categories and to instead embrace a view of genetic ancestry that reflects continuous variation and historical depth. Such change is a “prerequisite […].

Genetics 123
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Regeneron, in search of an eye gene therapy, turns to a young biotech

Bio Pharma Dive

Facing mounting competition to its top-selling drug Eylea, Regeneron is teaming up with ViGeneron to develop a genetic medicine for an inherited retinal disease.

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Clinical trial evolution, innovation center of Oracle Health Sciences event

Outsourcing Pharma

The two-day Oracle Health Sciences Connect will gather an array of research experts to discuss how to make the most of emerging technologies and practices.

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DNA analysis uncovers new cancer treatment clues

Pharma Times

Researchers were able to detect specific combinations of genetic alterations which may hold key to the growth of cancers

DNA 130
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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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Why the drug pricing debate is focused on insulin

pharmaphorum

The treatment has been around for over a century but insulin has still become the centre of the ongoing discussion over pricing of pharmaceutical products. Ben Hargreaves looks at why insulin’s price is so controversial and whether this could be set to change. It has now been 100 years since the first patient with diabetes received an injection of insulin, when Leonard Thomas, a 14-year-old boy, was treated with the hormone.

Insulin 130
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Catalent buys UK vaccine manufacturing centre

BioPharma Reporter

US company Catalent is acquiring the UKâs Vaccine Manufacturing and Innovation Centre in Harwell: a facility which had been planned to support COVID-19 and wider vaccine production and which is still under construction.

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Breakthrough in how buildings can promote health and well-being

Scienmag

Having understood the ill-effects if sick building syndrome and the need to better conserve energy by incorporating green features, architects are also utilizing certain elements of an architectural design system shown to reduce stress, improve sleep, promote physical and mental health, thereby improving the quality of life for its inhabitants. Credit: Maharishi International University Having […].

Engineer 109
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Medicare finalizes policy limiting coverage of Biogen Alzheimer's drug

Bio Pharma Dive

Treatment with Aduhelm would only be covered for patients enrolled in a clinical trial under the policy, which largely follows a draft proposal released in January.

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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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How PurePlus Upcycles Fruit into Climate-Friendly Candies

XTalks

Los Angeles-based startup PurePlus launched its first consumer brand, Faves, in 2021 as a sustainable alternative to the popular candy brand Startburst. Today, each packet of chewy candy contains one serving of fruits and vegetables and the company works collaboratively with farmers to secure tons of viable produce from ending up in landfills. According to PurePlus, every Faves packet upcycles six carrots, three beets, one sweet potato, half a squash and a quarter of a pumpkin that would have ot

Branding 105
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NICE recommend exercise over painkillers for arthritis pain

Pharma Times

NICE urges older people to stop routine painkiller use – over 10 million in the UK suffer a form of arthritis or other joint conditions

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Upskilling in a digital health world

pharmaphorum

It’s no secret that digital technologies are playing a significant role when it comes to shaping the next era of healthcare. Necessity accelerated the adoption of new and sophisticated technologies and systems throughout the COVID-19 pandemic, but this seismic shift towards digital health has opened up a gap in education. To successfully navigate the potential of digital technologies in healthcare, attention must be focused on upskilling professionals in the field to equip them with the necessar

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Milestone approval for Kite CAR-T cell therapy

BioPharma Reporter

The US FDA has approved Yescarta, Kite's CAR-T cell therapy, for initial treatment in adults with large B-cell lymphoma (LBCL) that is refractory to one prior therapy or that relapses within 12 months of first-line chemoimmunotherapy.

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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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Living near fast food restaurants in South Asia may increase risk of Type 2 diabetes

Scienmag

Globally, the prevalence of type 2 diabetes mellitus (T2DM) is increasing. A study publishing April 26th in the open access journal PLOS Medicine by Marisa Miraldo at Imperial College Business School, London, United Kingdom, and colleagues suggests that living near fast food restaurants increases the risk of developing Type 2 diabetes. Credit: Yalinda De Almeida […].

Medicine 106
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Pfizer, BioNTech to seek FDA OK for booster dose in 5- to 11-year-olds

Bio Pharma Dive

A third shot sparked a strong immune response in clinical testing, positioning the companies to make boosters available to the roughly 28 million kids in the U.S. who became eligible for their first two doses late last year.

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RoboBurger: America’s First Burger Vending Machine

XTalks

Newark, New Jersey-based RoboBurger claims to have created America’s first burger vending machine and is now looking to expand. The startup aims to bring its burger vending machines to the Philadelphia area within the year after launching its first outpost at the Newport Centre Mall in North Jersey last month. So, how does the unusual vending machine work?

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New study reveals emotional and psychological impact of infertility

Pharma Times

Infertility is estimated to affect one in seven couples across the UK and can have a profound effect on mental health

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An Innovative & Creative Problem Solver Approach to Selling in the Medical Device Space

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

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US study finds high rates of unneeded antibiotic prescribing

pharmaphorum

A study has found that there is still a very high level of inappropriate antibiotic prescribing to patients in the US, particularly to older and Black patients. Sifting through data from around seven billion outpatient visits to doctor’s offices, hospital clinics and emergency departments over a seven-year period, the researchers found that almost three-quarters (74%) of antibiotics prescribed to patients aged 65 years or older, and two thirds (64%) to Black patients, were unnecessary.

Scientist 122
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Moderna’s bivalent COVID-19 booster offers improved protection against Omicron

BioPharma Reporter

Modernaâs bivalent COVID-19 booster vaccine candidate, mRNA-1273.211, demonstrated superior neutralizing titers compared to the original mRNA-1273 booster dose against all variants of concern, including Omicron, according to data released by the company this week.

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Solar beats nuclear at many potential settlement sites on Mars

Scienmag

The high efficiency, light weight and flexibility of the latest solar cell technology means photovoltaics could provide all the power needed for an extended mission to Mars, or even a permanent settlement there, according to a new analysis by scientists at the University of California, Berkeley. Most scientists and engineers who’ve thought about the logistics […].

Scientist 101
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FDA clears Pfizer to restart Duchenne gene therapy trial, with new safeguards

Bio Pharma Dive

The regulator has asked Pfizer to closely monitor patients in a hospital setting for a week as part of a deal to end a study suspension that's lasted more than four months.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time