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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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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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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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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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 286
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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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More Trending

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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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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 278
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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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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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Roles and Responsibilities of Specialized Clinical Supply Experts

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.

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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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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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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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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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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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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 269
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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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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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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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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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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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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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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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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 126
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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 269
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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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Partnering to advance digital therapeutics offerings

pharmaphorum

Aaron Gani, founder and CEO of BehaVR, and Krys Zaluski, director of business development, digital health at Sumitomo Dainippon Pharma, discuss their groundbreaking partnership to develop and commercialise digital therapeutics (DTx) products. . BehaVR and Sumitomo signed a potential $140 million deal to create virtual reality (VR) therapies to treat social anxiety disorder, generalised anxiety disorder, and major depressive disorder.

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Accelerating Clinical Supply Through Integrated Drug Development

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.

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Meat consumption must fall by at least 75 percent

Scienmag

Every EU citizen consumes around 80 kilograms of meat per year. But every juicy steak, every delicious sausage has a price that we do not pay at the counter, because livestock farming damages the climate and the environment. Ruminants for instance produce methane, which accelerates global warming. Animals also convert only a portion of the […].

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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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How Jelly Drops Help Boost Hydration Among People with Dementia and Cognitive Challenges

XTalks

Jelly Drops, a UK-based brand designed to boost hydration among those who struggle to consume enough water, announced it will be launching in the US. Made with 95 percent water, a grip-friendly shape and a variety of flavors, Jelly Drops have become popular among people with Alzheimer’s, seniors and others who struggle to stay hydrated. “Since launch, we have made over 3 million drops, empowering countless seniors, people with dementia and many more, to support their hydration in an easier and m

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Google, Sanofi back UK biotech OMass’ $100m second round

pharmaphorum

OMass Therapeutics has raised an impressive $100 million in a Series B financing that is said to be the largest ever for a UK biotech focusing on small-molecule drug development. The Oxford-based company said the financing, led by venture capital arms of Google and Sanofi as well as Northpond Ventures, will be used to bring its portfolio of drug candidates for immunological and rare disease into clinical trials.

Protein 105
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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.