Bio Pharma Dive
JUNE 24, 2022
The decision brings what could be the first approved hemophilia gene therapy, Roctavian, closer to market, after a series of regulatory setbacks that have delayed its arrival.
Pharmaceutical Technology
JUNE 24, 2022
As regulatory agencies gear up for another round of Covid-19 vaccine deliberations centered on emerging variants, Moderna has released data on its booster’s efficacy against Omicron subvariants. In addition to providing protection against the Omicron BA.1 variant, on 22 June, Moderna said its booster also showed a “potent” antibody response against Omicron subvariants BA.4 and BA.5.
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Bio Pharma Dive
JUNE 24, 2022
A shot the partners have been developing reduced symptomatic infections associated with the variant by 72% compared to a placebo, positioning it as a potential option, if approved, to combat omicron.
Pharmaceutical Technology
JUNE 24, 2022
Novavax has obtained emergency use authorization (EUA) for its Covid-19 vaccine, Nuvaxovid (NVX-CoV2373), from the Taiwan Food and Drug Administration for use in people of the age 18 years and above. The protein-based vaccine is engineered from the genetic sequence of the SARS-CoV-2 virus’ initial strain. Developed utilising Novavax’s recombinant nanoparticle technology to generate antigen obtained from the coronavirus spike (S) protein, the vaccine is also formulated with the company’s saponin-
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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
Scienmag
JUNE 24, 2022
The Interactive Talk presentation, “Predicting Oral Cancer Risk using Machine Learning”, will take place on Saturday, June 25th, 2022 at 2 p.m. China Standard Time (UTC+08:00) during the “e-Oral Health Network I” session. The study, undertaken by John Adeoye of the University of Hong Kong, SAR China, aims to develop a machine learning-based platform to […].
Pharmaceutical Technology
JUNE 24, 2022
invoX Pharma has signed a definitive agreement for the acquisition of all issued and outstanding shares of clinical-stage biopharma firm F-star Therapeutics, in a deal valued at nearly $161m or $7.12 for each share in cash. invoX Pharma is a fully owned Sino Biopharmaceutical subsidiary. The latest deal will expedite the strategy of invoX to develop the International Biopharmaceutical R&D Platform of Sino Biopharm outside of China to transform the lives of patients globally.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharmaceutical Technology
JUNE 24, 2022
GlaxoSmithKline (GSK) has announced plans to invest $1.2bn (£1bn) over a decade to expedite research and development (R&D) for infectious diseases in lower-income countries. New vaccines and therapies for the prevention and treatment of malaria, tuberculosis, human immunodeficiency virus (HIV), neglected tropical diseases (NTDs) and anti-microbial resistance (AMR) will be the focus of this research.
Scienmag
JUNE 24, 2022
A robot operating with a popular internet-based artificial intelligence system consistently gravitates to men over women, white people over people of color, and jumps to conclusions about peoples’ jobs after a glance at their face. Credit: Georgia Tech/Getty A robot operating with a popular internet-based artificial intelligence system consistently gravitates to men over women, white […].
pharmaphorum
JUNE 24, 2022
Last year, AstraZeneca reported that a new drug to treat Wilson disease developed by its Alexion rare diseases unit had hit the mark in a phase 3 trial, setting it on course for regulatory filings. Now, the data has been revealed – and according to investigators could transform treatment. Wilson disease is a rare and progressive genetic condition in which the body’s process for removing excess copper is broken, allowing it to build to toxic levels and damage the liver, brain and other vita
Scienmag
JUNE 24, 2022
Tokyo, Japan – Scientists from Tokyo Metropolitan University have discovered the mechanism behind the rapid growth of ultra-thin nanowires or “whiskers” in organic compounds. Nanowires are both a desirable technological innovation and a hazard when they short electronics: understanding how they grow is crucial for applications. Curiously, filaments were found to grow from large crystalline […].
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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
Pharma Times
JUNE 24, 2022
MHRA extends UCB’s therapy for the treatment of partial-onset seizures
Scienmag
JUNE 24, 2022
People who received at least one influenza vaccine were 40% less likely than their non-vaccinated peers to develop Alzheimer’s disease over the course of four years, according to a new study from UTHealth Houston. Credit: UTHealth Houston People who received at least one influenza vaccine were 40% less likely than their non-vaccinated peers to develop Alzheimer’s […].
Drug Channels
JUNE 24, 2022
Today’s guest post comes from Logan Melchione, Senior Director of Account Management at Paysign. Logan describes how some patient affordability vendors capture funds that were intended for patients. She then provides manufacturers with ideas to better manage and oversee copay, bridge, and voucher programs. To learn more, register for Paysign’s July 13 webinar: Affording Patient Affordability Programs: The Truth About Voucher and Bridge Pricing.
Scienmag
JUNE 24, 2022
(Santa Barbara, Calif.) — For decades, field-effect transistors enabled by silicon-based semiconductors have powered the electronics revolution. But in recent years, manufacturers have come up against hard physical limits to further size reductions and efficiency gains of silicon chips. That has scientists and engineers looking for alternatives to conventional metal-oxide semiconductor (CMOS) transistors.
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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.
pharmaphorum
JUNE 24, 2022
Shares in Sarepta came under pressure after the biotech said it had temporarily halted a clinical trial of its new-generation Duchenne muscular dystrophy candidate, after a patient had a serious safety incident. The FDA has ordered a clinical hold on Sarepta’s SRP-5051 (vesleteplirsen) drug candidate after one patient in the study developed very low levels of magnesium, a condition known as hypomagnesaemia, that can lead to muscle weakness and tremors, seizures, and irregular heart rhythms
Scienmag
JUNE 24, 2022
When looking at the future of production of micro-scale organic electronics, Mohammad Reza Abidian – associate professor of Biomedical Engineering at the University of Houston Cullen College of Engineering – sees their potential for use in flexible electronics and bioelectronics, via multiphoton 3-D printers. Credit: University of Houston When looking at the future of production of micro-scale […].
Pharma Times
JUNE 24, 2022
COVID-19 Beta-containing vaccine provides 75.
Scienmag
JUNE 24, 2022
Kyoto, Japan — Humans have evolved as social animals. From childhood, we are taught the benefits of forging ties and being empathetic as a strategy for survival and mental well-being — or at least that is the ideal. Credit: KyotoU/Global Comms Kyoto, Japan — Humans have evolved as social animals. From childhood, we are taught […].
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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.
Sciensano
JUNE 24, 2022
On 27 June 27 2022, Belgium will host a launch event for PARC (European Partnership for the Assessment of Risks from Chemicals). In this large-scale European research project, nearly 200 institutions from 28 countries are working together with the European Commission to improve the assessment of chemical risks. Following the PARC kick-off in France at the beginning of May, Belgium is launching its participation in this project.
Scienmag
JUNE 24, 2022
Within and upon every human being reside countless microorganisms — the microbiota that help shape and direct the lives of their hosts. A similar phenomenon occurs between people, microbes and the homes they share. Credit: Prof. Eshel Ben-Jacob Within and upon every human being reside countless microorganisms — the microbiota that help shape and direct […].
Pharmaceutical Commerce
JUNE 24, 2022
The Health System Owned Specialty Pharmacy (HOSP) Alliance‘s Melissa Goff responds to the news of the FTC investigation into PBM practices news and outlines the alliance‘s vision for the integrated specialty pharmacy industry.
Scienmag
JUNE 24, 2022
(San Antonio, June 24, 2022) – Researchers at The University of Texas at San Antonio (UTSA) today released “Economic Contributions of Distilled Spirits in Texas 2020,” a new study highlighting the significant economic impact Texas distillers made to their local communities and the state in 2020, despite economic hardships of the pandemic and lingering Prohibition-era laws […].
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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.
Drug Patent Watch
JUNE 24, 2022
Annual Drug Patent Expirations for ELESTRIN Elestrin is a drug marketed by Mylan Speciality Lp and is included in one NDA. It is available from one supplier. There is one…. The post New patent expiration for Mylan Speciality drug ELESTRIN appeared first on DrugPatentWatch - Make Better Decisions.
Scienmag
JUNE 24, 2022
URBANA, Ill. – Intimate partner violence (IPV) can have significant implications for the wellbeing of mothers and children during separation and divorce. Yet IPV is often not included in custody cases or factored into court decisions, a new University of Illinois study shows. Credit: University of Illinois. URBANA, Ill. – Intimate partner violence (IPV) can […].
Drug Patent Watch
JUNE 24, 2022
Annual Drug Patent Expirations for GELNIQUE+3%25 Gelnique 3% is a drug marketed by Allergan and is included in one NDA. There is one patent protecting this drug. Drug patent litigation…. The post New patent expiration for Allergan drug GELNIQUE 3% appeared first on DrugPatentWatch - Make Better Decisions.
Scienmag
JUNE 24, 2022
As the climate crisis looms, scientists are racing to find solutions to common clean energy problems, including solar energy storage. Solar energy is one of the best renewable resources we have, but it has challenges that prevent it from being widely adopted and replacing conventional energy sources. Because solar energy is variable throughout the day […].
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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.
Drug Patent Watch
JUNE 24, 2022
Annual Drug Patent Expirations for PEPAXTO Pepaxto is a drug marketed by Oncopeptides Ab and is included in one NDA. There are five patents protecting this drug. This drug has…. The post New patent expiration for Oncopeptides Ab drug PEPAXTO appeared first on DrugPatentWatch - Make Better Decisions.
Scienmag
JUNE 24, 2022
Astronomers discovered a rocket body heading toward a lunar collision late last year. Impact occurred March 4, with NASA’s Lunar Reconnaissance Orbiter later spotting the resulting crater. Surprisingly the crater is actually two craters, an eastern crater (18-meter diameter, about 19.5 yards) superimposed on a western crater (16-meter diameter, about 17.5 yards).
Drug Patent Watch
JUNE 24, 2022
Annual Drug Patent Expirations for APTIOM Aptiom is a drug marketed by Sunovion Pharms Inc and is included in one NDA. It is available from one supplier. There are ten…. The post New patent for Sunovion Pharms drug APTIOM appeared first on DrugPatentWatch - Make Better Decisions.
Scienmag
JUNE 24, 2022
As people around the world are learning to live with a new phase of the COVID-19 pandemic, researchers from UConn’s College of Agriculture, Health and Natural Resources, in collaboration with Spanish institutions, have learned valuable lessons about the role social media played during pandemic lockdowns. In a recently published study in the International Journal of Environmental Research and […].
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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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