Sat.Apr 23, 2022 - Fri.Apr 29, 2022

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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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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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How a surprise finding made an Alnylam study one of biotech's most 'polarizing' trials

Bio Pharma Dive

A study testing Alnylam's drug Onpattro in a deadly heart condition was once seen as a sure bet. Now the trial is the source of much debate, and its outcome could influence how future treatments for the disease are developed.

Trials 281
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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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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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FDA sets back Novartis' best chance at a COVID-19 drug

Bio Pharma Dive

The agency indicated another trial of the drug, developed by Molecular Partners, will be needed. But whether such a study is doable is yet to be determined, according to Novartis' CEO Vas Narasimhan.

Drugs 273
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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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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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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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Omnichannel Benchmarking: a new era of HCP engagement

pharmaphorum

As the landscape of healthcare changes, so too must the way that we interpret and measure performance and success. This is particularly evident in marketing. Before the COVID-19 pandemic, measuring engagement typically involved detailed follow-ups, contacting a pool of practitioners to gauge their awareness of a particular product and then extrapolating that information across the country.

Marketing 116
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Bristol Myers wins FDA approval for first drug to treat inherited heart condition

Bio Pharma Dive

Bristol Myers paid $13 billion to acquire the drug's maker, MyoKardia, and expects a top-selling medicine. But a tricky dosing regimen, as well as safety concerns, could challenge the pharmaceutical giant's lofty forecast.

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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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Healome Therapeutics to accelerate development for ocular disease

Pharma Times

Studies have demonstrated that Healome’s formulations have anti-fibrotic activity and are augmented when combined with other therapeutics

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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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AstraZeneca plans new US R&D hub as revenues rocket

pharmaphorum

AstraZeneca has revealed plans to set up a new strategic R&D hub in Cambridge, Massachusetts as it reported a massive increase in first-quarter revenues, driven by COVID-19 and oncology drugs and heart failure therapy Farxiga. The new site will be at Kendall Square and will serve as the new corporate headquarters for Alexion – which is currently based across the Charles River in Boston’s Seaport District – as well as housing around 1,500 R&D staff from AZ and Alexion in a new purpo

Sales 106
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AbbVie's first shot at Vertex misses, but it's not abandoning cystic fibrosis

Bio Pharma Dive

Executives on Friday said that the company's three-drug therapy, a possible threat to Vertex's top-selling medicine Trikafta, didn't meet expectations in a key study. A new combination could start testing next year, however.

Medicine 265
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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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ViGeneron and Daiichi Sankyo to develop therapy for eye diseases

Pharma Times

Follow-on collaboration between ViGeneron and Daiichi Sankyo allows the companies to create and validate vgAAV-based therapeutic 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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Merck makes $3.2bn from COVID-19 drug Lagevrio in Q1

pharmaphorum

Orders for Merck & Co’s oral antiviral for COVID-19 helped to swell the drugmaker’s first quarter revenues by a massive 50%, although underlying growth was also strong. Lagevrio (molnupiravir) added $3.2 billion to Merck’s top line of $15.9 billion, but even without the drug sales would have risen 19% thanks to a strong performance from cancer immunotherapy Keytruda (pembrolizumab) and the Gardasil human papillomavirus (HPV) vaccine range.

Drugs 102
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Two biotechs set out to end sector's IPO drought

Bio Pharma Dive

HilleVax and Belite Bio could soon become the first biotechs to go public in almost two months, representing a key test of investors’ willingness to support emerging life sciences companies.

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The first scientific expedition to Panama’s unexplored Cordillera de Coiba sets sail

Scienmag

Last year, Panama expanded the Cordillera de Coiba marine protected area from 17,223 to 67,908 square kilometers (6,650 to 26,219 square miles). On April 27th, an international scientific expedition made up of researchers and students from the Smithsonian Tropical Research Institute (STRI), MigraMar, the International Maritime University of Panama (UMIP), the University of Costa Rica and […].

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The Steve Morgan Foundation donates £50m to diabetes research

Pharma Times

The Foundation also launched a new collaboration with Diabetes UK and the Juvenile Diabetes Research Foundation UK

Research 118
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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Understanding the microbiome as an ‘overlooked critical organ’

pharmaphorum

Compared to a ‘critical organ’ that had been largely ignored, companies working to develop microbiome-based therapies believe there is untapped potential in the area. Ben Hargreaves speaks to companies that are developing therapies not just in gastrointestinal conditions but also in broader areas, such an immuno-oncology. The interest in how the human microbiome influences health has grown substantially in the last decade.

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Nkarta gives first look at two 'natural killer' cell therapies for blood cancer

Bio Pharma Dive

The results build on early evidence that NK cell treatments may become viable medicines for leukemia and lymphoma, while it's still unclear whether they're as effective, or last as long, as T cell therapies.

Medicine 265
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Drug Channels News Roundup, April 2022: 340Boom, 340B Profits for Pharmacies & PBMs, Fixing Insulin, Walgreens’ Robots, and Doctors’ Day

Drug Channels

Baseball season is in full swing! Oil up your glove, lace up your cleats, and let's run the bases around this month's news stories. Remember: Sometimes you win, sometimes you lose, and sometimes it rains. In this issue: Green Monster : The 340B market hits new highs in 2021 Not-Free Agents : Big 340B profits for CVS, Walgreens, Express Scripts, et al Batter Up : Fixing the insulin market Pinch Hitters : Walgreens bets on robots Plus, Dr.

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Intouch Wins “Best Rare Disease” Manny Award

Intouch Solutions

Intouch was awarded the “Best Rare Disease Campaign” at the 33rd annual Med Ad News Manny Awards on April 22, a recognition for the “Kind to Each Other – Fierce Against MD” campaign for Kindness Over Muscular Dystrophy. The goal of the campaign was to increase awareness about Duchenne muscular dystrophy (DMD). DMD is an incurable and fatal genetic disorder that gradually weakens the body’s muscles, and affects one in 5,000 newborn babies, primarily boys.

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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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Novo Nordisk once-weekly insulin clears first phase 3 test

pharmaphorum

For many patients with type 2 diabetes, having to inject basal insulin every day is a burdensome fact of life, but Novo Nordisk is trying to change that. The Danish drugmaker has reported the first phase 3 results with its new basal insulin product – insulin icodec – which backs up earlier data suggesting it could provide effective blood glucose control when injected just once a week.

Insulin 98
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After setbacks, a gene therapy company mulls a sale

Bio Pharma Dive

Sio Gene Therapies, formerly known as Axovant, said it's focused on conserving cash, and has decided to significantly reduce its workforce and terminate licensing agreements on its last two pipeline programs.

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New patent for Janssen Pharms drug INVEGA TRINZA

Drug Patent Watch

Annual Drug Patent Expirations for INVEGA+TRINZA Invega Trinza is a drug marketed by Janssen Pharms and is included in one NDA. It is available from one supplier. There is one…. The post New patent for Janssen Pharms drug INVEGA TRINZA appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 98
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A Game-Changing Shift: Why Pharma Commercial Teams Are Turning to HEOR

Drug Channels

Today’s guest post comes from Chris Harvey, Director of Solutions Engineering at Panalgo, and Carolyn Zele, Senior Manager of Solution Enablement at MMIT. Chris and Carolyn discuss the insights that health economics and outcomes research (HEOR) professionals bring to commercial teams. They explain how that pairing benefits both manufacturers and patients.

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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.