Sat.Jan 29, 2022 - Fri.Feb 04, 2022

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Sarepta reveals gene editing alliance with biotech exploring alternative delivery methods

Bio Pharma Dive

The collaboration with GenEdit, a South San Francisco startup developing new ways of delivering gene editing tools into the body, dates back to December 2020, but has recently begun to advance.

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How agencies can help pharma DTC

World of DTC Marketing

The way people make treatment decisions is changing because of COVID. Agencies are responsible for working with clients to implement changes that support brand objectives. It won’t be easy and means changing the mindset from a vendor to a strategic partner. If you work in an agency, your job is not to develop a website or TV spot. You need to work with pharma clients to educate them on the complicated path from awareness to requesting an Rx.

Marketing 247
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Emmes Supports New Collaboration to Accelerate COVID-19 Research for Children

Pharma Mirror

Rockville, Emmes, a global, full-service Clinical Research Organization dedicated to supporting the advancement of public health and biopharmaceutical innovation, today announced its role as a Data Coordinating Center on a team whose work has accelerated pediatric COVID-19 research through the Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children per Standard of Care (POP02).

Research 130
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NJIT reaffirmed as an elite research university, retains R1 classification

Scienmag

New Jersey Institute of Technology (NJIT) has reaffirmed its status among the nation’s most elite and productive research institutions by once again achieving an R1 status — the highest designation — by the Carnegie Classification. Credit: NJIT New Jersey Institute of Technology (NJIT) has reaffirmed its status among the nation’s most elite and productive research […].

Research 129
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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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In England, Orchard secures rare agreement on gene therapy coverage

Bio Pharma Dive

Gene therapy developers have struggled to secure reimbursement in Europe, making Orchard's deal with the National Health Service in England and Wales a notable accomplishment.

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Is it too late for Biogen?

World of DTC Marketing

Biogen will partner with Roche on the development, and potential sale of a promising cancer drug the Swiss pharma is advancing for several types of lymphoma, announcing Tuesday it’s exercised an option to share rights to the treatment. But is it too late for Biogen to stage a comeback with their reputation damaged? Biogen executives vowed to fight hard to reverse Medicare’s preliminary decision to sharply limit coverage of the company’s Alzheimer’s drug while saying more

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Even the smallest pollution particles change the rainfall regime in the Amazon

Scienmag

Even the finest particles of pollution influence the process of cloud formation and the rainfall regime. A study conducted in Manaus, the capital of Amazonas state in Brazil’s North region, shows that oxidation leads small aerosols expelled by factories and car exhausts, for example, to grow very rapidly, reaching up to 400 times their original […].

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The pipeline of new antibiotics is drying up. A bill in Congress aims to change that.

Bio Pharma Dive

Despite the growing threat of drug-resistant bacteria, few new antibiotics are reaching the market because of hurdles that biotech executives and experts say stand in the way.

Bacteria 300
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A perfect storm for biotech stocks

World of DTC Marketing

According to STAT News “after a double-digit decline in 2021, the sector has fallen another 20% in the new year, erasing billions in value and leading even the most seasoned investors to question whether biotech has further to fall. Can small biotech companies survive? Many large pharmaceutical companies reported record performances in 2021, whether that’s a decade-high stock price or shares that outperformed the broader market as investors continued to pour money into companies maki

Drugs 234
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New diagnostic finds hidden lung damage in long COVID

pharmaphorum

People with long-lasting symptoms of breathlessness after COVID-19 infection may have damage to their lungs that does not show up using routine diagnostic scans, according to a small UK study. The researchers from Oxford, Sheffield, Cardiff and Manchester universities used a new form of diagnostic that involves patients breathing in the inert gas xenon whilst undergoing an MRI scan, which allows them to gauge how well gases like oxygen are being transferred from the lungs to blood vessels.

Research 111
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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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AI can be a powerful tool in drug development, discovery: Tellius

Outsourcing Pharma

A leader from the artificial intelligence insights specialist talks discusses how the effective use of advanced analytics can lead to a number of benefits.

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Roche wins FDA approval for rival to Regeneron's lucrative eye drug

Bio Pharma Dive

The drug, which will be sold as Vabysmo, is the first of several emerging competitive threats to Regeneron's top-selling Eylea, along with biosimilars and long-acting implants.

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How Cryptocurrency and the Metaverse Can Help the Food Industry

XTalks

Since cryptocurrencies and the Metaverse are based in the digital realm and food is firmly rooted in the physical, they might not seem like the most intuitive pairing. But back to the early days of crypto, the very first use case for Bitcoin was related to food. In the spring of 2010, two Papa John’s pizzas were purchased for 10,000 BTC, which would be worth about $389,500,000 today.

Engineer 105
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Biogen promises increased diversity in Phase 4 Aduhelm trial

BioPharma Reporter

Biogen releases further details on how its Phase 4 post-marketing confirmatory study for Alzheimerâs drug, Aduhelm, will run: including increased enrolment and enhanced efforts to encourage diversity.

Trials 105
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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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Coordinated conservation and restoration critical to save Asia’s threatened native trees

Scienmag

A new study has revealed that the rich native tree diversity in South and Southeast Asia is at risk of potential extinction. The region-wide and spatially explicit threat assessment focused on 63 socio-economically important native trees in Asia, showing that all species are highly vulnerable to at least one of the common threats in the […].

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More federal regulators investigating Biogen's Alzheimer's drug

Bio Pharma Dive

In a regulatory filing, Biogen said the FTC and the SEC are looking for information about Aduhelm's approval and marketing, meaning the drug is now the focus of four government probes.

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Global campaign aims to increase equity in cancer care

Outsourcing Pharma

On World Cancer Day, the Union for International Cancer Control is launching a three-year campaign with the goal to improve cancer care around the globe.

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BARDA scopes market as it looks to partner next-generation COVID-19 vaccine developers

BioPharma Reporter

US government agency, BARDA, is drawing on industry feedback to assist it in understanding the advanced developmental landscape of next-generation COVID-19 vaccines.

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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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Synthetic control arms in clinical trials: Making it happen

pharmaphorum

Across the industry, pharma companies are turning to AI and real-world data to address many of the challenges of running clinical trials. But what does it take to implement these innovations? Can the combined potential of new AI technologies and real-world patient data hold the key to overcoming the challenges in clinical trial design that have historically led to trial failure?

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Pfizer lures research chief from Roche, prompting high-level reshuffle

Bio Pharma Dive

William Pao led discovery and early development at the Swiss drugmaker, and will now head Pfizer's global efforts to launch new products.

Research 326
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Pennsylvania Doctor Accused of Prescribing Ivermectin for Covid Is Fired

NY Times

Tower Health Medical Group said in a statement that it learned of the allegations on Wednesday. After an investigation, the doctor’s employment was “terminated effective immediately.”.

Doctors 98
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Lürzer’s Archive Recognizes Intouch Group as a 2021 Top Five Creative Agency

Intouch Solutions

Accolades Confirm Intouch as Among the Fastest-Rising Creative Agencies in the World. New York, NY — (Feb. 3, 2022) – Intouch Group, an EVERSANA company and a full-service global agency network serving the pharmaceutical industry, was ranked by Lürzer’s Archive as among the top five creative advertising agencies in the United States and top fifteen in the world.

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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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Interpretation of At-Home COVID-19 Self-test Results

JAMA Internal Medicine

This randomized clinical trial assesses how the instructions and results of at-home COVID-19 self-tests are interpreted and whether users appropriately quarantine per federal recommendations.

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Lilly slows FDA submission of Alzheimer's drug after Medicare decision

Bio Pharma Dive

Executives for the pharma downplayed the impact of an accelerated approval for donanemab, pointing to Medicare's plans to restrict coverage of Alzheimer's drugs like it to only patients in clinical trials.

Drugs 286
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Plant-Based Lamb Producer Black Sheep Foods Raises $5.25 Million

XTalks

Black Sheep Foods, a plant-based food tech company focused on heritage breed meats and wild game, recently raised $5.25 million in seed funding led by Bessemer Venture Partners. This investment brings the company’s total seed funding to $5.5 million since its launch in 2019. So, how does Black Sheep Foods make its uncommon meat analogues and will it face competition in a heavily saturated market ?

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6 Digital Health Takeaways From CES 2022 That Will Change Healthcare as We Know It

Intouch Solutions

Digital health investments skyrocketed in 2021, increasing 79% from 2020, according to a year-end report by CB Insights , a marketing intelligence firm. This growing digital transformation within the healthcare industry was highlighted at CES 2022, with one of the main-stage keynote presentations by Robert Ford, President and CEO of Abbott. Ford discussed his vision and the promise of healthcare technology: to bring care that’s more personal and precise, proactively manage health, detect disease

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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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Omicron BA.2 variant more transmissible, say UK and Danish studies

pharmaphorum

The new BA.2 subvariant of Omicron is around 50% more transmissible than the original BA.1 strain, and there is somewhat conflicting evidence on its ability to evade the protection from vaccines, according to new studies. BA.2 is now the dominant strain of the COVID-19 virus in Denmark, and scientists from the country’s Statens Serum Institute (SSI) have compared the two subvariants in more than 8,500 households including almost 18,000 people.

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Pfizer stops development of once-promising heart drug, handing back rights to partner Ionis

Bio Pharma Dive

Pfizer concluded the data didn't support advancing the ANGPTL3-targeting drug — for which it paid $250 million two years ago to acquire the rights — despite positive study results.

Drugs 286
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Recipharm acquires Portuguese CDMO as it looks to grow its biologics business

BioPharma Reporter

Contract development and manufacturing organization (CDMO), Recipharm, has acquired GenIbet, a Portuguese CDMO, specializing in the manufacture of biological clinical trial material.

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Small group of genetic variants found in extremely ill patients with COVID may help explain big differences in how sick people get

Scienmag

AUGUSTA, Ga. (Jan. 31, 2022) – The search to better understand the tremendous range of responses to infection with the COVID-19 virus — from symptom free to critically ill — has uncovered in some of the sickest patients a handful of rare structural gene variants involved in body processes, like inflammation, which the virus needs to […].

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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.