Sat.Feb 12, 2022 - Fri.Feb 18, 2022

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BioMarin says gene therapy hold will endure as FDA questions cancer risk

Bio Pharma Dive

According to BioMarin, the regulator has requested additional data to assess the "theoretical" cancer risk to the treatment, information that will take "several quarters" to collect.

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Lung cancer deaths decline but.

World of DTC Marketing

The mortality rate from lung cancer has dropped in recent decades—by 56% in men from 1990 to 2019 and by 32% in women from 2002 to 2019. In recent years, early detection and treatment improvements have helped boost the 3-year survival rate for lung cancer from 21% in 2004 to 31% in 2015 through 2017. The 5-year survival rate has increased by 6% for distant-stage lung cancer, 33% for a regional-stage disease, and 60% for localized disease.

Medicine 271
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Collaborative approach to closing the digital health gap is needed

pharmaphorum

The pandemic-induced transition to digital health is, according to the Nuffield Trust, contributing to an “inverse care law” that’s compounding existing health inequalities. But, as demonstrated by initiatives like the Telehealth Equity Coalition (TEC), the sector is taking a united stand against inequitable access. Technological solutions, from online clinics to app-based long-term condition management, have long been hailed as a solution to problems such as limited capacity and low patient aut

Doctors 110
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Expect growth, innovation in digital health landscape: BCG Digital Ventures

Outsourcing Pharma

In its forward-looking report on digital health, the consulting outfit offers predictions on what changes are ahead and how they might impact the field.

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Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research

Planning on running clinical trials in Japan? How can you reliably supply these studies? Discover Catalent’s clinical supply packaging facility in Shiga, Japan. Strategically located between Tokyo and Osaka, and one of largest in Japan, this 6,000 square meter facility offers comprehensive services including primary and secondary clinical packaging and labelling, comparator sourcing, cold chain storage, local and global distribution, local language support and white glove service to support stud

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Yumanity cutting 60% of employees as it mulls possible sale

Bio Pharma Dive

The layoffs — which, according to Yumanity, should be completed by April — are part of a larger restructuring effort meant to reduce costs after a recent setback to the company's most advanced drug program.

Sales 325
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When it comes to telehealth it’s not numbers

World of DTC Marketing

Business Insider formed a relationship with eMarketer for so-called “intelligence.” Their report on telehealth has numbers, but that’s not what’s important. We need to understand “why” people are using telehealth and for what purposes versus an in-office visit. In-office visits also have more benefits. Here is a quote from the report that is debatable at best “over the next few years, telehealth will remain the domain of the younger digital natives.

Doctors 247

More Trending

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Scientists discover immune cell surveillance mechanism

Pharma Times

Francis Crick Institute and King’s College London collaborate to identify specialist cells which protect DNA

Scientist 129
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Sage claims new data show depression drug works, but doubts remain

Bio Pharma Dive

Study results indicate the company's fast-acting medicine may help patients already on existing drugs. But its limited effects may curb its potential, Wall Street analysts said.

Drugs 294
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For biotechs to attract investors think like marketers

World of DTC Marketing

Biotech startups are hurting for money as investments in biotech startups start to decline. Biotechs need to think like marketers to cut through the noise and attract investors. It begins with a CEO who not only has a stellar medical background but understands how to get the company on the radar. There are so many biotech startups right now that there isn’t enough money for them all to continue the development of new drugs.

Marketing 224
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NHS said to be central to Moderna interest in UK facility

pharmaphorum

Moderna is reportedly in late-stage negotiations with the UK government that could result in a new research and manufacturing facility being set up in the biotech ‘golden triangle’ between London, Oxford and Cambridge. The development has been prompted by a desire on the behalf of the US biotech to collaborate with the NHS, according to a report in the Financial Times, which cites people familiar with the matter.

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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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Data day: Trial results deliver hope for prostate cancer patients

Pharma Times

New combination treatment can significantly reduce the risk of death among prostate cancer patients

Trials 134
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How the biotech downturn is already affecting drug startups

Bio Pharma Dive

At an industry conference Monday, a group of venture investors noted changes in how long biotechs are taking to raise money, and a shifting outlook among investors who specialize in shepherding young companies to an IPO.

Drugs 294
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Pharma’s corporate social responsibility?

World of DTC Marketing

COVID may be winding down, but the damage is done in deaths and long COVID. We don’t understand much, but we do know that there is a correlation between COVID severity and obesity/diabetes. The question thus becomes, “will the medical community finally address the obesity epidemic, or will we continue to do nothing essentially?” Obesity turned out to be a significant risk factor for covid hospitalization and death, especially non-elderly.

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Pharma pollution ‘threatens world environment, health’; study

pharmaphorum

One in four of the world’s rivers are polluted with potentially toxic levels of pharma compounds, according to a new study. The findings point to a “threat to environmental and global health,” say the scientists, who found that paracetamol, antibiotics epilepsy drug carbamazepine, metformin for diabetes and other compounds like caffeine and nicotine were found in samples from around the world – including in Antarctica.

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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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Efficacy of Ivermectin on Disease Progression in Patients With COVID-19

JAMA Internal Medicine

This randomized clinical trial assesses the efficacy of ivermectin treatment in preventing progression to severe disease among high-risk patients with COVID-19 in Malaysia.

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Amgen sees potential for KRAS drug in treating pancreatic cancer

Bio Pharma Dive

Early study results suggest some efficacy for Amgen's KRAS-targeting drug in the tough-to-treat cancer type. The biotech plans to expand testing as a result.

Drugs 300
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Dig Restaurant Group is Introducing the Four-Day Workweek to the QSR Industry

XTalks

Dig Restaurant Group, a chain of locally farm sourced restaurants, is taking a page from the corporate world and introducing four-day workweeks to the quick service restaurant (QSR) industry. While salaried office workers tend to be the most popular cohort trialing the four-day workweek, hourly workers at some of Dig’s locations will be getting the same perk.

Trials 98
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Dupixent falls short in phase 3 chronic spontaneous urticaria trial

pharmaphorum

Sanofi and Regeneron have reported disappointing results in a trial of Dupixent in people with chronic spontaneous urticaria (CSU) who don’t respond to the only approved biologic treatment, Novartis/Roche’s Xolair. . CSU is a severe form of hives that affects around 1% of the global population, causing severe itching and swelling that can last for weeks at a time and resist even very high doses of antihistamines, the standard, first-line therapy for the condition.

Trials 101
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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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Pharma Franchise Business Is Beneficial For the Indian Pharmaceutical Market

Fossil Remedies

PCD Pharma Franchise Business. Why are more aspirants willing to make a career in the field of pharmaceuticals? It is because the business is not only promising, but it is going to remain profitable for many years. People have become health conscious and they want to maintain fitness. Also, the recent Covid-19 outbreak has also changed the scenario.

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Third Harmonic, led by former Audentes CEO, launches with $155M in funding

Bio Pharma Dive

Natalie Holles was named as head of the Atlas-backed startup last year after leaving gene therapy developer Audentes following its acquisition by Astellas.

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LNPs as drug delivery platforms: Overcoming bioanalytical hurdles

BioPharma Reporter

Lipid nanoparticle systems (LNPs) as a delivery mechanism for novel drug modalities are proving effective, but there are bioanalytical challenges associated with encapsulation, says an expert.

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Intouch Creatives on Super Bowl LVI Ads: Toyota Nailed It; T-Mobile Dropped the Ball

Intouch Solutions

Each year, we ask Intouch creatives to share their thoughts on the latest Super Bowl ads. This year, for Super Bowl LVI, we’re back with more creatives and more reactions. But wait: When you get a bunch of creatives (and one strategic planner) “in a room together,” can you get quick consensus? Turns out yes. Pretty much everyone agreed that the audience in mind was Gen X; that celebrities were more rampant than ever; and Eugene Levy driving fast with Fabio hair is AWESOME.

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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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Merck will assess Quris’ AI ‘patient-on-a-chip’ drug safety

pharmaphorum

German drugmaker Merck KGaA has reached an agreement to pilot an artificial intelligence platform developed by Quris that aims to identify potential safety problems with new therapeutic candidates as early as possible in the drug discovery process. Quris’ BioAI safety prediction platform – which is based on human tissue samples on chips, nanosensors and machine learning – will be compared to traditional in vitro and in vivo laboratory techniques for spotting toxicity.

Drugs 98
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EMA follows FDA in scrutinizing safety of certain immune drugs

Bio Pharma Dive

The European regulator began a safety review of so-called Janus kinase inhibitors from Pfizer, AbbVie, Eli Lilly and Galapagos, citing worrisome data from a study of Pfizer's drug Xeljanz.

Drugs 246
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Valentine’s Day Food Offers from Popeyes, Cinnabon and More

XTalks

Valentine’s Day is a celebration of love, and to many, that entails food. From heart-shaped treats to to buy one, get one free (BOGO) deals to share with loved ones, restaurants nationwide are celebrating the holiday in a delicious way. Here are some of this year’s Valentine’s Day food offers from choice-favorite restaurants and fast-food chains, starting with the savory, then the sweet. .

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Lichens are in danger of losing the evolutionary race with climate change

Scienmag

Algae are more than just the green scum that shows up on aquarium walls. The tiny plants, when teamed up with a fungus, can form a composite structure called lichen. Lichens grow everywhere, from tundras in the Arctic to the bark of the tree in your yard, and they do everything from creating oxygen to […].

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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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Bayer triples sales forecast for prostate cancer drug Nubeqa

pharmaphorum

Bayer now says it expects to make €3 billion in sales for its prostate cancer treatment Nubeqa, up from an earlier estimate of €1 billion, after reviewing new data for the drug in metastatic hormone-sensitive tumours. The optimistic assessment of the revenue potential for androgen receptor inhibitor Nubeqa (darolutamide) follows the publication of the results of the phase 3 ARASENS trial in the New England Journal of Medicine.

Sales 98
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Intellia follows CRISPR peers with deal to explore 'natural killer' cell therapy

Bio Pharma Dive

By partnering with ONK Therapeutics, Intellia joins CRISPR Therapeutics and Editas Medicine in striking deals that marry gene editing with a fast-emerging form of cancer immunotherapy.

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Clinical research trends include increased emphasis on study design: Advarra

Outsourcing Pharma

An expert from the institutional review board services company advises what trends to look for in the clinical trial industry over the course of coming months.

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What is Food Fraud and How Can the Food Retail Industry Prevent It?

XTalks

The globalization of the food chain has resulted in increased complexity and digital activity, meaning more opportunities for food fraud to occur. Since the COVID-19 pandemic forced many grocery stores, quick-service restaurants (QSRs) and other food industry players to pivot to digital technologies including mobile apps and contactless payment methods, food fraud has been prevalent in recent years.

Sales 97
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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.