Thu.May 05, 2022

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AstraZeneca and Daiichi set to broaden use of breast cancer drug, challenging Roche

Bio Pharma Dive

The FDA cleared Enhertu for second-line use in HER2-positive disease, the latest inroads the partners have made against Roche’s dominant portfolio of breast cancer medicines.

Medicine 263
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Oramed hits oral insulin clinical trial milestone

BioPharma Reporter

Oramed Pharmaceuticals announced this week that it has enrolled 100% of the patients in the worldâs first Phase 3 study of oral insulin under FDA approved protocols.

Insulin 128
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Intercept sells international rights to liver drug in $400M deal

Bio Pharma Dive

Advanz Pharma will obtain rights to Ocaliva outside the U.S., handing its maker an upfront payment nearly equivalent to its market value at the end of Wednesday trading.

Drugs 246
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The Paleo Diet Launches a Paleo Certification Program for Food Packaging

XTalks

The Paleo Diet LLC, the founding organization behind the corresponding lifestyle movement, has launched a new Paleo certification program. Based on the science from the researchers who established the framework of modern Paleolithic nutrition, the program aims to provide guidance for the food industry by codifying Paleo Diet standards and making them available to manufacturers, retailers and other partners.

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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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Argenx drug succeeds in trial, beats sales forecasts

Bio Pharma Dive

The biotech reported positive results from a study meant to expand Vyvgart's use to another immune disorder, while sales from the drug's first quarter on the market exceeded expectations.

Sales 130
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Qelbree: The First FDA-approved Nonstimulant ADHD Drug for Adults in 20 Years

XTalks

Supernus Pharmaceuticals’ Qelbree was approved by the FDA on Friday. Qelbree is the newest nonstimulant ADHD drug for adults after two decades. Attention deficit hyperactivity disorder (ADHD) is one of the most established psychiatric disorders found in children and can be diagnosed at 3 years of age. The common symptoms of ADHD include lack of attention, hyperactivity and increased impulsivity.

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Abortion Pills Will Be the Next Battleground in a Post-Roe America

NY Times

Medication abortion allows patients to terminate early pregnancies at home. Some states are moving to limit it, while others are working to expand access.

Drugs 98
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Cell division in moss and animals more similar than previously thought

Scienmag

For a new plant to grow from a seed, cells need to divide numerous times. Daughter cells can each take on different tasks and sometimes vary in size. How plants determine the plane of cell division in this process, known as mitosis, is being researched by Prof. Dr. Ralf Reski and Dr. Elena Kozgunova from […].

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ExcellGene and Cytena team up to optimize workflows for mAb and therapeutic protein manufacturing

BioPharma Reporter

ExcellGene SA, a Swiss biologics focused CDMO, has established a collaboration agreement with German biological cell instrument developer, Cytena.

Protein 98
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Why do some people get sicker than others from COVID?

Scienmag

COVID-19 vaccines have saved at least a million lives in the United States alone, but for many people, a lingering fear remains: if—or when—they get hit by the coronavirus, just how bad will it be? Will they breeze through with little more than a sore throat—or will it saddle them with long-term complications, perhaps even push them […].

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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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Farxiga demonstrates success in preserved ejection fraction trial

Pharma Times

DELIVER represents the largest ever trial to address heart failure with preserved ejection fraction

Trials 118
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BTI’s Greg Martin elected to National Academy of Sciences

Scienmag

Greg Martin, Boyce Schulze Downey Professor at the Boyce Thompson Institute and Professor in the School of Integrative Plant Science (SIPS) at Cornell University, has been elected to the National Academy of Sciences. Credit: Boyce Thompson Institute Greg Martin, Boyce Schulze Downey Professor at the Boyce Thompson Institute and Professor in the School of Integrative […].

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Survey: industry leaders looking to shore up pharma supply chain

Outsourcing Pharma

According to the 2022 EY CEO survey, life science executives are seeking to build resilience into their supply chains and dive into M&A opportunities.

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Land-building marsh plants are champions of carbon capture

Scienmag

DURHAM, N.C. – Human activities such as marsh draining for agriculture and logging are increasingly eating away at saltwater and freshwater wetlands that cover only 1% of Earth’s surface but store more than 20% of all the climate-warming carbon dioxide absorbed by ecosystems worldwide. Credit: Edwin Paree DURHAM, N.C. – Human activities such as marsh […].

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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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EC approval for post-steroid graft-versus-host treatment

Pharma Times

Jakavi treats a potentially life-threatening condition which often effects transplant patients

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Patient-derived micro-organospheres enable cutting-edge precision oncology

Scienmag

(LOS ANGELES) – A patient’s tumor cell response to therapy is affected by many factors, including genetic alterations, tumor microenvironment, and intratumoral heterogeneity. This can make it extremely difficult to determine optimum treatment regimens, amidst the ever-increasing number of drug candidates and cancer therapies that have recently been developed.

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AZ bites back at rivals with new Farxiga data in heart failure

pharmaphorum

AstraZeneca’s SGLT2 inhibitor Farxiga has hit the mark in a phase 3 heart failure trial that brings it back into contention with its main rival Jardiance from Boehringer Ingelheim and Eli Lilly. Top-line results from the DELIVER trial showed that Farxiga (dapagliflozin) was able to reduce the risk of cardiovascular deaths or worsening heart failure in patients who have heart failure with preserved ejection fraction (HFpEF), setting up filings for the new indication in the coming months.

Trials 59
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This kind of flirting works best

Scienmag

Some people are experts at flirting. Others of us never flirt or fail spectacularly. But what kind of flirting works best? One particular flirting technique almost always works for everyone and in every situation. More on that later, because not everything works every time. “What’s most effective depends on your gender and whether the purpose […].

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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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Next-generation data management calls for advanced tools: Saama

Outsourcing Pharma

A leader from the clinical technology company discusses some of the pain points in data collection and analysis, and tools that can help users level up.

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Stem cell therapy protects against the side effects of cancer drugs

Scienmag

Osaka, Japan – Immune checkpoint inhibitors are widely used to treat a variety of cancers; however, one serious side effect is the onset of type 1 diabetes. Now, researchers from Osaka University have discovered that stem cell therapy may protect against such side effects. Credit: Created with BioRender.com Osaka, Japan – Immune checkpoint inhibitors are […].

Drugs 84
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FDA Limits Use of Janssen COVID-19 Vaccine to Certain Individuals

The Pharma Data

Today, the U.S. Food and Drug Administration has limited the authorized use of the Janssen COVID-19 Vaccine to individuals 18 years of age and older for whom other authorized or approved COVID-19 vaccines are not accessible or clinically appropriate, and to individuals 18 years of age and older who elect to receive the Janssen COVID-19 Vaccine because they would otherwise not receive a COVID-19 vaccine.

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How AI spots legendary cricket batting backlift using video only

Scienmag

The greatest cricket batsman – Sir Donald Bradman – used a batting technique that fans loved, but some critics slammed. A critical component was his lateral batting backlift technique. Highly successful batters use it to this day. Credit: Video by Therese van Wyk, University of Johannesburg. The greatest cricket batsman – Sir Donald Bradman – […].

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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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MPAACT Consortium Unites Industry and Academia to Establish Measurable Residual Disease as a Surrogate Endpoint in Acute Myeloid Leukemia Drug Development

The Pharma Data

Validated Measurable Residual Disease Assays are Critical for the Rapid Development of Future Novel Therapeutics for Patients with Acute Myeloid Leukemia. The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the Measurable residual disease Partnership and Alliance in Acute myeloid leukemia Clinical Treatment (MPAACT), an industry-led research alliance founded in 2018 between Janssen Research & Development, LLC, Genentech (a member of the Roche Group), Novartis, and C

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Vaccines induce multiple immune system mechanisms to protect against severe COVID-19 illness

Scienmag

Globally, breakthrough COVID-19 infections among vaccinated people are increasing, raising concerns about the durability of protection against emerging, highly contagious variants of concern. A study publishing May 5th in the open access journal PLOS Biology, by Galit Alter at Harvard University, Cambridge, U.S. and colleagues, suggests that while vaccine-induced neutralizing antibody responses protect against infection, […].

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Investigational COVID mucosal vaccine protects against disease and transmission

The Pharma Data

In animal studies that mimic human exposures, an investigational COVID vaccine designed to be taken orally not only protects the host, but also decreases the airborne spread of the virus to other close contacts. The study, led by Duke researcher Stephanie N. Langel, Ph.D., demonstrated the potential of a COVID vaccine that works through the mucosal tissue to neutralize the SARS-CoV-2 virus, limiting infections and the spread of active virus in airborne particles.

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Understanding how sunscreens damage coral

Scienmag

You can love something to death. That is one way of thinking about a new Stanford University study that reveals how a common component of many sunscreens worn by coral reef-exploring tourists may hasten the demise of these endangered ecosystems. The surprising findings, published May 6 in Science, could help guide the development and marketing of […].

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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.

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New patent for Rvl Pharms drug UPNEEQ

Drug Patent Watch

Annual Drug Patent Expirations for UPNEEQ Upneeq is a drug marketed by Rvl Pharms and is included in one NDA. There are eight patents protecting this drug. This drug has…. The post New patent for Rvl Pharms drug UPNEEQ appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 52
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Land-building marsh plants are champions of CO2 capture

Scienmag

It is well known that CO2 emissions from burning fossil fuels underlie the havoc being wrought by climate change. Stemming further emissions through innovations in sustainable energy production is certainly part of the solutions. However, slowing global warming also hinges upon our ability to capture and retain CO2 from the atmosphere. In a study published today in […].

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Cognitive impairment from severe COVID-19 equivalent to 20 years of ageing, study finds

The Pharma Data

Cognitive impairment as a result of severe COVID-19 is similar to that sustained between 50 and 70 years of age and is the equivalent to losing 10 IQ points, say a team of scientists from the University of Cambridge and Imperial College London. The findings, published in the journal eClinicalMedicine, emerge from the NIHR COVID-19 BioResource. The results of the study suggest the effects are still detectable more than six months after the acute illness, and that any recovery is at best gradual.

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Critically endangered vaquita porpoise not doomed to extinction by inbreeding depression

Scienmag

Unchecked gillnetting has pushed the world’s smallest porpoise to the brink of extinction: there are roughly 10 vaquitas remaining in the Gulf of California in Mexico. However, they retain enough genetic resiliency for the species to recover if illegal gillnetting for a valuable fish in the same waters does not wipe them out first. Credit: […].

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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.