Thu.Feb 03, 2022

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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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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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Biogen's Alzheimer's drug sales remain slow as company warns of further cost cuts

Bio Pharma Dive

Aduhelm sales totaled just $1 million in the fourth quarter as Biogen struggles to win over doctors and insurers. The company said it would reduce expenses by more than currently planned if Medicare limits coverage.

Sales 269
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Longterm Benefits of Wearing Scrubs to Work

Pharma Mirror

Everybody knows that life as a caretaker can get rough sometimes, but it also comes with its fair share of benefits. In this article, we aim to highlight some of the long-term benefits of wearing scrubs to work, day in and day out. Being youthful at heart and work Depending on the scrub policy you have at your place of work, charcoal grey scrubs can add a completely new layer to your professional attire.

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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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Intellia, expanding in gene editing, buys startup Rewrite for $45M

Bio Pharma Dive

Founded by University of California, Berkeley scientists, Rewrite is studying ways to expand the reach of gene editing beyond limitations of current technologies, including Intellia's.

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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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Dr Reddy’s jumps on medical cannabis train, buying Nimbus Health

pharmaphorum

India’s Dr Reddy’s Laboratories has joined the growing list of pharma companies that are looking to tap into the market for medical cannabis, buying German developer Nimbus Health for an undisclosed sum. While the regulatory framework for cannabinoid products remains fragmented and hard to navigate around the world, Germany has emerged as an early-mover.

Licensing 116
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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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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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No news anytime soon on Sandoz sale, says Novartis

pharmaphorum

Novartis chief executive Vas Narasimhan has downplayed any chances of swift decision on the future of its generics business Sandoz, saying that a decision on the possible sale of the unit may not come until the last quarter of the year. The comments came despite rumours of another private equity bid for Sandoz, with Bloomberg saying it had got wind of a $25 billion combined bid from investment groups Blackstone and Carlyle, with others including Advent International, Hellman & Friedman and K

Sales 95
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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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Puffy planets lose atmospheres, become super Earths

Scienmag

Exoplanets come in shapes and sizes that are not found in our solar system. These include small gaseous planets called mini-Neptunes and rocky planets several times Earth’s mass called super-Earths. Credit: Image Credit: Adam Makarenko (Keck Observatory) Release Credit: NASA, ESA, STScI, Caltech, Keck Observatory Exoplanets come in shapes and sizes that are not found in our […].

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Twelve simple ways to get ahead of acute stress

pharmaphorum

Oliver Stohlmann’s Corporate Survival Hacks series draws on his experiences of working in local, regional and global life science communications to offer some little tips for enjoying a big business career. This post looks at dealing with sudden stress and turning it into positive energy. We’ve all been there: stomach revolting, heart pounding, hands moist.

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Do bikeshare systems complement or replace public transit?

Scienmag

URBANA, Ill. – Bikeshare systems have come a long way since they were first introduced in the Netherlands in the 1960s. They are popular in cities around the world, but how do bike systems affect existing public transportation? That’s the topic of a new paper from the University of Illinois, published in Transportation Research Part […].

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Biogen’s former R&D chief Al Sandrock resurfaces at Voyager

pharmaphorum

Al Sandrock’s shock departure from Biogen in November sparked speculation about where he would show up next, and the answer came in today – gene therapy specialist Voyager Therapeutics. He has been appointed to Voyager Therapeutics’ board as well as a new executive committee alongside interim CEO Michael Higgins and interim chief scientific officer Glenn Pierce, another ex-Biogen executive.

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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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How to get chloride ions into the cell

Scienmag

Many bacteria and unicellular algae have light-driven pumps in their cell membranes: proteins that change shape when exposed to photons such that they can transport charged atoms in or out of the cell. Thanks to these pumps, their unicellular owners can adjust to the environment’s pH value or salinity. Credit: Guillaume Gotthard and Sandra Mous […].

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Timely intervention: First chronic kidney disease treatment in 20 years

Pharma Times

Significant landmark as NICE recommends AstraZeneca's chronic kidney disease treatment Forxiga

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Groundbreaking study in Science provides first statistical characterisation of methane ultra-emitters from oil and gas

Scienmag

Paris — Top-tier scientific journal Science today released a groundbreaking study of methane ultra-emitters linked to oil and gas activities that for the first time provides a statistical characterisation of these major drivers of climate change across various production activities. Credit: © Kayrros, Esri, HERE, Garmin, FAO, NOAA, USGS, OpenStreetMap contributors, and the GIS User […].

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Parkinson’s UK and Domainex join forces to develop neuroinflammation therapies

Pharma Times

Research collaboration between Parkinson’s UK and Domainex has potential to improve 140,000 lives

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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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Are scientists being fooled by bacteria?

Scienmag

For decades, a small group of cutting-edge medical researchers have been studying a biochemical, DNA tagging system, which switches genes on or off. Many have studied it in bacteria and now some have seen signs of it in, plants, flies, and even human brain tumors. However, according to a new study by researchers at the […].

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Memorial Sloan Kettering announces $100m gift for cancer research

Outsourcing Pharma

The oncology centerâs Marie-JosÃe and Henry R. Kravis Cancer Ecosystems Project is intended to elevate the next generation of preclinical cancer research.

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Cutting off liver cancer’s nutrient supply chain

Scienmag

The World Health Organization projects that starting in 2030, over a million people will die each year from liver cancer. Cold Spring Harbor Laboratory (CSHL) Professor Adrian Krainer, former postdoc Wai Kit Ma, and Dillon Voss, a Stony Brook University M.D.-Ph.D. student-in-residence in Krainer’s lab, have come up with a way to interfere with the energy pathway that […].

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CEPI looks to spur heat-stable vaccine innovation with $17.5m fund

BioPharma Reporter

The Coalition for Epidemic Preparedness Innovations (CEPI) has launched a Call for Proposals to improve the thermostability of vaccines: with a particular interest in temperature-stable vaccine nasal sprays, microarray patches, or orally administered vaccines.

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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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Maria Shriver and The Women’s Alzheimer’s Movement join Cleveland Clinic

Scienmag

Thursday, February 3, 2022, CLEVELAND: Cleveland Clinic and Maria Shriver, founder of The Women’s Alzheimer’s Movement (WAM), announced a ground-breaking partnership today aimed at further addressing and reducing women’s risk for Alzheimer’s disease: The Women’s Alzheimer’s Movement at Cleveland Clinic (WAM at Cleveland Clinic). Credit: Cleveland Clinic Thursday, February 3, 2022, CLEVELAND: Cleveland Clinic and […].

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US modular cleanroom systems supplier invests over $14m in new manufacturing hub

BioPharma Reporter

AES Clean Technology, a supplier of cleanroom facilities for the pharmaceutical and biopharmaceutical sectors, is ploughing $14.2m into a new US manufacturing facility.

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Pre-infection deficiency of vitamin D is associated with increased disease severity and mortality among hospitalized COVID-19 patients

Scienmag

Vitamin D is most often recognized for its role in bone health, but low levels of the supplement have been associated with a range of autoimmune, cardiovascular, and infectious diseases. Early on in the pandemic health officials began to encourage people to take vitamin D, as it plays a role in promoting immune response and […].

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Drugmakers fined for colluding on NHS price of nausea drug

pharmaphorum

The UK Competition and Markets Authority has ruled that several drugmakers worked together to raise the NHS price of widely-used nausea drug prochlorperazine, fining them £35 million ($47.5 million). Alliance Pharmaceuticals, Lexon, Medreich, and former and current owners of Focus – Advanz and private equity group Cinven – were involved in an agreement to fix the market for soluble prochlorperazine tablets, and raised the price they charged the NHS by 700%.

Drugs 59
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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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Scientists decode chemical defense against plant sap-sucking leafhoppers

Scienmag

Plants are at the bottom of the food chain and are continually threatened by pathogens and herbivorous insects. But the vast majority of attackers are unable to cause any damage due to a broadly based plant resistance, also known as non-host resistance. This resistance is permanent and effective. However, the mechanisms that lead to this […].

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New patent expiration for Boehringer Ingelheim drug SPIRIVA RESPIMAT

Drug Patent Watch

Annual Drug Patent Expirations for SPIRIVA+RESPIMAT Spiriva Respimat is a drug marketed by Boehringer Ingelheim and is included in one NDA. It is available from one supplier. There are seven…. The post New patent expiration for Boehringer Ingelheim drug SPIRIVA RESPIMAT appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 52
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Puffy planets lose atmospheres, become super-Earths

Scienmag

Maunakea, Hawai?i – Astronomers have identified two different cases of “mini-Neptune” planets that are losing their puffy atmospheres and likely transforming into super-Earths. Radiation from the planets’ stars is stripping away their atmospheres, driving hot gas to escape like steam from a pot of boiling water. Credit: W. M. Keck Observatory/Adam Makarenko Maunakea, Hawai?

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New patent for Allergan drug RESTASIS

Drug Patent Watch

Annual Drug Patent Expirations for RESTASIS Restasis is a drug marketed by Allergan and is included in one NDA. It is available from two suppliers. There are ten patents protecting…. The post New patent for Allergan drug RESTASIS appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 52
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The New Clinical Trial Supply Chain: Resilient, Flexible, and Patient-Centric

The global landscape of clinical trials is rapidly changing as studies become more complex. An increasing number of sponsors are seeking enhanced flexibility in their supply chains to address a variety of clinical supply challenges, including patient demand and reducing delays. Demand-led supply and direct-to-patient distribution are next-generation solutions that are helping to meet these growing needs, allowing for more streamlined processes and patient-centric studies.