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.

Doctor 231
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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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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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From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience

Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.

The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven

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Solid Bio joins slate of biotech layoffs, shedding 35% of its workforce

Bio Pharma Dive

The company is the latest in a growing list of gene therapy developers to restructure and cut jobs during an industry-wide downturn.

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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.

Vaccine 140

More Trending

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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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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 299
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Scientists to trial world-first long-acting injection for high blood pressure

Pharma Times

Long-acting hypertension treatment could provide patients with an injection of medication every six months

Scientist 125
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Shionogi and NEC Enter into Strategic Research Collaboration for Novel Hepatitis B Therapeutic Vaccine

Pharma Mirror

OSAKA, Japan and TOKYO, Japan. Shionogi & Co., Ltd. and NEC Corporation, today announced the execution of a strategic research collaboration agreement for the development of a novel hepatitis B therapeutic vaccine. NEC OncoImmunity, an NEC subsidiary that specializes in artificial intelligence-driven biotechnology, is also participating in this research collaboration.

Vaccine 130
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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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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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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 289
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Insulin glargine meets primary endpoint in Sanofi’s type 1 diabetes study

Pharma Times

InRange is the first worldwide multicentre RCT to compare second generation basal insulins

Insulin 124
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Leading inhalation APIs expert Inke to triple production capacity

Pharma Mirror

Barcelona, Spain, April 20, 2022 – Inke, a leading global manufacturer of inhalation APIs wholly owned by Neuraxpharm Group, announces it is investing €9 million to increase production capacity for inhalation APIs. The investment will allow Inke to triple the production capacity of chemical synthesis and the micronisation of inhalation APIs at its manufacturing plant in Castellbisbal, Barcelona, by 2024.

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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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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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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 279
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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 122
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NorthX Biologics signs GMP manufacturing collaboration agreement with Abera Bioscience

Pharma Mirror

Sweden-based NorthX Biologics (“NorthX”), which focuses on process development and large-scale production of advanced biological drugs, has signed a collaboration agreement with Abera Bioscience (“Abera”) for upscaling and GMP manufacturing of its vaccine candidate against pneumococcus, Ab-01.12. NorthX has recently established an innovation hub to offer support to partners in achieving their long-term drug development goals.

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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 111
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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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May Measurement Month aims to save more lives than ever

Pharma Times

MMM is a global campaign which raises awareness of high blood pressure and its long-term implications

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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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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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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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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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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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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 105
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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 279
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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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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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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.