Bio Pharma Dive
APRIL 28, 2022
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.
Pharma Times
APRIL 28, 2022
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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Bio Pharma Dive
APRIL 28, 2022
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.
XTalks
APRIL 28, 2022
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
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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
Bio Pharma Dive
APRIL 28, 2022
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.
pharmaphorum
APRIL 28, 2022
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.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
pharmaphorum
APRIL 28, 2022
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.
Bio Pharma Dive
APRIL 28, 2022
The biotech's shot would become the first available to children under 6, the last remaining age group currently ineligible for vaccination.
pharmaphorum
APRIL 28, 2022
Pfizer’s $1.2 billion licensing deal with Biohaven for rights to oral migraine drug rimegepant is approaching a payoff after the European Commission approved the drug. The regulator cleared the oral CGRP inhibitor as Vydura for both treatment and prevention of episodic migraine attacks, becoming the first drug to be authorised for both uses in the EU, with a review also underway by the UK authorities.
Scienmag
APRIL 28, 2022
Maps have played an important role in scientific progress. Claudius Ptolemaeus transformed our understanding of the world with his map of Earth and Tycho Brahe our understanding of the Universe with his map of the stars. The maps of the human body from Claudius Galenus, Leonardo da Vinci, and Andreas Vesalius paved the path towards […].
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White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations
pharmaphorum
APRIL 28, 2022
Vifor Pharma and Cara Therapeutics’ Kapruvia has become the first drug to be approved in the EU to treat one of the most common and challenging side effects for people undergoing dialysis for chronic kidney disease (CKD) – chronic itching. The European Commission has cleared Kapruvia (difelikefalin) as an injectable treatment for chronic itching, also known as pruritus, in adult CKD patients on dialysis.
Scienmag
APRIL 28, 2022
Radiologists and artificial intelligence systems yield significant differences in breast-cancer screenings, a team of researchers has found. Its work, which appears in the journal Nature Scientific Reports, reveals the potential value of using both human and AI methods in making medical diagnoses. Credit: Image courtesy of Taro Makino, NYU’s Center for Data Science Radiologists and […].
Pharma Times
APRIL 28, 2022
Long-acting hypertension treatment could provide patients with an injection of medication every six months
Scienmag
APRIL 28, 2022
Artificial Intelligence (AI) is fast becoming ubiquitous in the modern society and will feature a broader implementation in the coming years. In applications involving sensors and internet-of-things devices, the norm is often edge AI, a technology in which the computing and analyses are performed close to the user (where the data is collected) and not […].
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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.
NY Times
APRIL 28, 2022
The data have not yet been peer reviewed or published. But experts said the drug may give people with obesity an alternative to bariatric surgery.
Scienmag
APRIL 28, 2022
WASHINGTON — As the earth’s climate continues to warm, researchers predict wild animals will be forced to relocate their habitats – likely to regions with large human populations – dramatically increasing the risk of a viral jump to humans that could lead to the next pandemic. Credit: Credit: Colin Carlson/Georgetown University WASHINGTON — As the […].
NY Times
APRIL 28, 2022
Both antiviral treatments and monoclonal antibodies that treat Covid-19 are available across the city, but some public health experts worry that too few people know how to get them.
Scienmag
APRIL 28, 2022
EL PASO, Texas (April 28, 2022) – A cutting-edge research facility being developed at The University of Texas at El Paso is the most recent addition to an ambitious expansion of biomedical research initiatives addressing Hispanic health disparities. Credit: UTEP Marketing and Communications EL PASO, Texas (April 28, 2022) – A cutting-edge research facility being […].
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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.
pharmaphorum
APRIL 28, 2022
Rare diseases aren’t as rare as the appellation suggests. For instance, according to the US Government Accountability Office , 30 million Americans have a rare disease, a little less than 10% of the population. But that total represents around 7,000 different diseases, with nothing in common other than their rarity. For pharmaceutical companies, rare diseases present many challenges.
Scienmag
APRIL 28, 2022
CHAMPAIGN, Ill. — Latinos view the support of friends, neighbors and other community members as so vital to their well-being in later life that they redefine these relationships as family, researchers say in a new study that explored older Latinos’ perspectives on positive aging. Credit: Photo by L. Brian Stauffer CHAMPAIGN, Ill. — Latinos view […].
JAMA Internal Medicine
APRIL 28, 2022
This cohort study examines changes in the diagnostic performance of home antigen tests during the course of SARS-CoV-2 infection.
Scienmag
APRIL 28, 2022
A new analysis of data from the Veterans Affairs Million Veteran Program has uncovered genetic links between COVID-19 severity and certain medical conditions that are known risk factors for severe COVID-19. Anurag Verma of the Corporal Michael Crescenz VA Medical Center in Philadelphia, Pennsylvania, US, and colleagues present these findings on April 28th in the […].
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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.
Intouch Solutions
APRIL 28, 2022
Amy Swissler Hutnik , General Manager, Agency, Advisory & Evidence Services, EVERSANA; and Paula Hackl , SVP, Managing Director, Transformation Officer, EVERSANA Intouch; have each been recognized by the Healthcare Businesswomen’s Association (HBA) as leading businesswomen in healthcare. Paula was named a Rising Star by the HBA, which signifies a woman who contributes significantly to her organization, exemplifying leadership and dedication.
Scienmag
APRIL 28, 2022
Capturing and storing carbon dioxide (CO2) deep underground can help combat climate change, but long-term monitoring of the stored CO2 within a geological storage site is difficult using current physics-based methods. Credit: Siddharth Misra/Texas A&M Engineering Capturing and storing carbon dioxide (CO2) deep underground can help combat climate change, but long-term monitoring of the stored […].
The Pharma Data
APRIL 28, 2022
The second report in a series detailing exploitative marketing practices employed by $55 billion baby formula industry, shows parents, particularly mothers, are being insidiously and persistently targeted online. Formula milk companies are paying social media platforms and influencers to gain direct access to pregnant women and mothers at some of the most vulnerable moments in their lives.
Scienmag
APRIL 28, 2022
Yale researchers have identified a particular immune response pathway that leads to severe illness and death in people infected by the SARS-CoV-2 virus. The study was published April 28 in the journal Nature. Researchers have known that once the COVID-19 virus infects the lungs it can trigger what has been called a “cytokine storm,” or […].
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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.
The Pharma Data
APRIL 28, 2022
Biogen is announcing plans to help patients in the U.S. currently on ADUHELM avoid any treatment interruptions following the final national coverage determination by Centers for Medicare & Medicaid Services (CMS) that could result in a loss of coverage for Medicare beneficiaries. All U.S. patients who began treatment on or before April 7, 2022 are now eligible to receive ADUHELM at no cost for the duration of their treatment or for the duration of the program.
Scienmag
APRIL 28, 2022
In the quest to build smart skin that mimics the sensing capabilities of natural skin, ionic skins have shown significant advantages. They’re made of flexible, biocompatible hydrogels that use ions to carry an electrical charge. In contrast to smart skins made of plastics and metals, the hydrogels have the softness of natural skin. This offers […].
The Pharma Data
APRIL 28, 2022
Novo Nordisk today announced headline results from the ONWARDS 2 trial, a phase 3a, 26-week efficacy and safety treat-to-target trial investigating once-weekly insulin icodec vs insulin degludec in 526 people with type 2 diabetes switching from daily insulin. The trial achieved its primary endpoint of demonstrating non-inferiority in reducing HbA 1c at week 26 with insulin icodec compared to insulin degludec.
Scienmag
APRIL 28, 2022
For the past thirty years, the star ? Pictoris has fascinated astronomers because it enables them to observe a planetary system in the process of formation. It is made up of at least two young planets, and also contains comets, which were detected as early as 1987. These were the first comets ever observed around […].
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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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