Bio Pharma Dive
MARCH 23, 2021
A disappointing recommendation from outside data reviewers raises doubts about the DNA-targeting drug's benefits and puts pressure on Roche's partner, Ionis Pharmaceuticals.
Pharma Mirror
MARCH 23, 2021
The Japanese pharmaceutical market is preparing for renewed international growth and partnering. In response, CPhI Japan has opened a two-month long virtual event to meet demand from international pharma. Informa introduced CPhI Japan Connect – a new virtual platform for global professionals looking to grow pharma business in Japan – specifically to help its international audiences continue conversations, identify leads, and build new partnerships while international travel remains restricted.
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Bio Pharma Dive
MARCH 23, 2021
Novo Nordisk said the FDA requested more data before starting review for a high dose of the Danish company's treatment semaglutide, extending a string of recent setbacks for drugmakers in the U.S.
pharmaphorum
MARCH 23, 2021
“Gamification” – adding game-like elements into non-game or real-world settings – has become a popular concept in the pharmaceutical, healthcare, and event industries, especially as virtual engagement becomes more common during COVID-19. However, it is proving more than a mere buzzword. With diverse applications and approaches, it is quickly becoming a promising tool for patient adherence, chronic disease management, preventive medicine, rehabilitation, and paediatric care, as well as for medica
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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
MARCH 23, 2021
The British drugmaker said it will release updated data from the large U.S. trial within 48 hours, but the puzzling episode is another communication misstep for the company.
NY Times
MARCH 23, 2021
According to federal officials, an independent panel of medical experts said the promising results announced by the company on Monday may have relied on “outdated information.”.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
BioSpace
MARCH 23, 2021
Moncef Slaoui was fired as chairman of the board of directors of Galvani Bioelectronics following the "substantiation" of allegations of sexual harassment and inappropriate conduct.
BioPharma Reporter
MARCH 23, 2021
The pharma company and the CDC are recommending that adults continue routine vaccination during the COVID-19 pandemic to reduce future vaccine-preventable disease (VPD) outbreaks and overall strain on the healthcare system.
BioSpace
MARCH 23, 2021
Study findings published in Alzheimer's & Dementia: Translational Research and Clinical Interventions suggest Leukine® leads to significant reversal of cognitive impairment and normalizes blood-based biomarkers of dementia in patients with mild-to-moderate Alzheimer’s disease.
BioPharma Reporter
MARCH 23, 2021
Preclinical data shows that CureVacâs COVID-19 vaccine protects against challenge infections with the B.1.351 âSouth Africaâ variant in a transgenic mouse model.
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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
BioSpace
MARCH 23, 2021
Boston Scientific’s settlement was not an admission of misconduct or liability. In a brief statement cited by Reuters, the company said the financial agreement was in its shareholder’s best interest.
pharmaphorum
MARCH 23, 2021
AstraZeneca has been rebuked by a US health authority after a trial monitoring board said data published from a large study of its COVID-19 vaccine may be out of date and may not give a representative view of its efficacy. The company’s share price ticked down after the statement on Monday from the US National Institute for Allergy and Infectious Diseases (NIAID).
BioSpace
MARCH 23, 2021
With the rise of mutant strains of SARS-CoV-2 and the unlikelihood of 100% compliance in getting vaccines out, investigators are focusing on developing even better vaccines and new drugs that might be able to knock back the disease. Here’s a look.
XTalks
MARCH 23, 2021
Food and beverage giant PepsiCo recently launched Hilo Life , a keto snack that looks like a Dorito but contains more protein and fewer carbohydrates. The tortilla-style chips are made from defatted almond flour, making them a good source of plant-based protein with nine grams per serving. Hilo Life also contains only three grams of net carbohydrates and zero grams of added sugar per one-ounce bag.
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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.
BioSpace
MARCH 23, 2021
Opportunities to optimize the revenue activities that maximize growth will continue to be abundant in 2021, as organizations deploy technology to gain granular insights. None-the-less, modernization is needed.
Scienmag
MARCH 23, 2021
Credit: Stephanie King/Michigan Medicine (the academic medical center of the University of Michigan) People who received a flu shot last flu season were significantly less likely to test positive for a COVID-19 infection when the pandemic hit, according to a new study. And those who did test positive for COVID-19 had fewer complications if they […].
BioSpace
MARCH 23, 2021
AbbVie has filed a legal complaint against Icelandic pharmaceutical company Alvotech for the latter’s alleged misappropriation of trade secrets involving the development of a generic version of AbbVie’s rheumatoid arthritis drug Humira.
Scienmag
MARCH 23, 2021
Evolution of auroral substorms revealed by physicists at University of Warwick using the same methods that link people through social media Credit: Background map credit: SuperMAG Evolution of auroral substorms revealed by physicists at University of Warwick using the same methods that link people through social media ‘If you like this magnetometer, you might like […].
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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.
BioSpace
MARCH 23, 2021
The study involved observations in neurologic function, cognition and biomarkers in three repeated administrations of Nurown®, which were given two months apart.
Druggist
MARCH 23, 2021
Ibuprofen is one of the most common drugs purchased over the counter in the UK. Ibuprofen prescribing decreased significantly in recent years due to the NHS strategy to minimise issuing of medicines that are available over the counter. In recent months, ibuprofen’s price went up significantly, with many shops and pharmacies being out of stock of ‘cheap’ ibuprofen.
BioSpace
MARCH 23, 2021
Merck Treasurer Caroline Litchfield will become the company’s new chief financial officer. She takes over the role for Robert M. Davis, who will become company president and chief executive officer upon the retirement of current CEO Kenneth C. Frazier.
pharmaphorum
MARCH 23, 2021
Roche has stopped dosing in a phase 3 trial of tominersen, a potential Huntington’s disease (HD) drug developed with Ionis, after a pre-planned review by independent experts. . The companies had been working on tominersen since December 2017, when Roche licensed it in from Ionis. There were high expectations for tominersen, which the companies hoped would be the first drug to treat the underlying cause of the disease, which leads to devastating neurological degeneration.
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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.
BioSpace
MARCH 23, 2021
People working in the biotech industry need to have a good, healthy balance of both hard and soft skills in order to succeed and achieve their career goals.
Scienmag
MARCH 23, 2021
Credit: Oliver Krone/Leibniz-IZW Over the past decades, the increased use of chemicals in many areas led to environmental pollution – of water, soil and also wildlife. In addition to plant protection substances and human and veterinary medical drugs, rodenticides have had toxic effects on wildlife. A new scientific investigation from scientists of the Leibniz Institute […].
BioSpace
MARCH 23, 2021
It’s March Madness in the life sciences industry, with money pouring in faster than LeBron James on a breakaway. Here’s where the big bucks went this week.
Outsourcing Pharma
MARCH 23, 2021
The companyâs Prime-Control Technology is designed to help study teams expand their subject enrollment beyond the reach of their clinical trial sites.
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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.
BioSpace
MARCH 23, 2021
Researchers at the University of Birmingham have identified 14 small non-coding RNAs in saliva that can diagnose a concussion with 96% accuracy, based on sample analysis from 1,028 professional rugby players.
Scienmag
MARCH 23, 2021
Credit: UNIST UNIST researchers who are in the early stages of their research careers will be given opportunities to advance their work, thanks to the Sejong Science Fellowship, recently promoted by the Ministry of Science and ICT (MSIT). Thirteen researchers, affiliated with UNIST have been chosen to receive the 2021 Sejong Science Fellowship Grants, which […].
BioSpace
MARCH 23, 2021
The first five on the list are emotional and attitudinal. The other five concern intellectual abilities and learned skills.
BioPharma Reporter
MARCH 23, 2021
Thermo Fisher Scientific has announced a new, first-of-its-kind human plasma-like cell culture medium that more closely resembles the natural cellular environment found in the human body to provide researchers with a realistic view of cell growth.
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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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