Scienmag
JANUARY 17, 2021
A five-year review of more than 800,000 vehicular stops, tickets, arrests, searches, and contraband in Vermont confirms widespread racial disparities and bias policing among the state’s authorities Credit: Ian Thomas Jansen-Lonnquist New research examining more than 800,000 traffic stops in Vermont over the course of five years substantiates the term “driving while Black and Brown.” […].
BioSpace
JANUARY 17, 2021
Daiichi Sankyo’s and AstraZeneca’s Enhertu (fam-trastuzumab deruxtecan-nxki) has become the first HER2-directed medication approved to treat gastric cancer in the U.S. in 10 years.
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Scienmag
JANUARY 17, 2021
Teens talking to teens: 1 in 3 parents strongly support schools having mental health programs like peer support leaders, new national poll suggests Credit: C.S. Mott Children’s Hospital National Poll on Children’s Health at Michigan Medicine ANN ARBOR, Mich. — An estimated one in five teenagers has symptoms of a mental health disorder such as […].
BioSpace
JANUARY 17, 2021
Will there be enough doses of the two authorized mRNA COVID-19 vaccines to meet the lofty goal of 100 million inoculations within 100 days of the start of Joe Biden's presidential administration?
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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
JANUARY 17, 2021
Findings among children in Amazonian Ecuador offer insights into relative importance of diet vs. energy expenditure for rise in obesity Credit: Samuel Urlacher Variation in consumption of market-acquired foods outside of the traditional diet — but not in total calories burned daily — is reliably related to indigenous Amazonian children’s body fat, according to a […].
BioSpace
JANUARY 17, 2021
After a start-of-the-year lull, activities at the U.S. Food and Drug Administration are starting to pick up. Here’s a look.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
BioSpace
JANUARY 17, 2021
Being studied for GAD, OCD, AD and spinocerebellar ataxia, Biohaven's troriluzole has now struck out in 3 late-stage studies.
Scienmag
JANUARY 17, 2021
Credit: N. Currier, New York Spiritualist mediums might be more prone to immersive mental activities and unusual auditory experiences early in life, according to new research. This might explain why some people and not others eventually adopt spiritualist beliefs and engage in the practice of ‘hearing the dead’, the study led by Durham University found. […].
BioSpace
JANUARY 17, 2021
LexaGene has begun a series of studies aimed to bring its MiQLab from research-only use to point-of-care use to detect the SARS-CoV-2 virus.
The Pharma Data
JANUARY 17, 2021
Alzheimer’s disease has found itself in the top three most expensive diseases. Billions of dollars are poured into research each year, yet the push for effective treatment and hope for a cure is dashed time and again. This week another biopharma announced the disappointing news that their trial too had failed to make an impact on the devastating progression of Alzheimer’s.
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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
JANUARY 17, 2021
n-Lorem Foundation has taken on a challenge that many nations consider too great: treating patients with ultra-rare diseases (which affect 30 or fewer people) for free, for life.
The Pharma Data
JANUARY 17, 2021
SEOUL, South Korea , Jan. 18 , 2021 /PRNewswire/ — Hanmi Pharmaceutical Co., Ltd. plans to create a global R&D achievement based on innovations of inflammation–fibrosis treatment, Triple-acting new drug for NASH (non-alcoholic steatohepatitis) treatment as well as various other innovations in metabolic disease, oncology and rare disease fields. What will be Hanmi’s 2021 R&D strategy on new drugs. In particular, two new dr
BioSpace
JANUARY 17, 2021
The year is starting to pick up in terms of clinical trial announcements. Here’s a look at last week’s news.
The Pharma Data
JANUARY 17, 2021
Alexi Rosenfeld/Getty Images. Sana Biotechnology recently filed with the U.S. Securities and Exchange Commission (SEC) to launch an initial public offering (IPO) worth $150 million. But that number doesn’t quite reflect the company’s likely market valuation , which is expected to be between $9 billion and $12 billion. Based in Seattle, Washington, Sana focuses on in vivo and ex vivo cell engineering platforms to develop therapies for cancer, diabetes, cardiovascular disease, CNS disorders, and g
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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.
Drug Patent Watch
JANUARY 17, 2021
Annual Drug Patent Expirations for CARNITOR Carnitor is a drug marketed by Leadiant Biosci Inc and is included in three NDAs. It is available from two suppliers. There are three…. The post New patent expiration for Leadiant Biosci drug CARNITOR appeared first on DrugPatentWatch - Make Better Decisions.
The Pharma Data
JANUARY 17, 2021
n-Lorem Foundation has taken on a challenge that many nations consider too great: treating patients with ultra-rare diseases (which affect 30 or fewer people) for free, for life. It received FDA guidance January 5 th and is in the midst of preparing the first package of investigational new drug (IND) applications – usually with an n-of-1, for individual patients.
Drug Patent Watch
JANUARY 17, 2021
Annual Drug Patent Expirations for CARNITOR Carnitor is a drug marketed by Leadiant Biosci Inc and is included in three NDAs. It is available from two suppliers. There are three…. The post New patent expiration for Leadiant Biosci drug CARNITOR appeared first on DrugPatentWatch - Make Better Decisions.
The Pharma Data
JANUARY 17, 2021
. Becomes the first botanically derived disinfectant approved for COVID-19 use. SHERBROOKE, QC , Jan. 18, 2021 /PRNewswire/ – Laboratoire M2, Inc. announces that the company’s THYMOX® brand spray disinfectant has become the first disinfectant with a botanically derived active ingredient to be approved by the U.S.
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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
JANUARY 17, 2021
The U.S. Food and Drug Administration approved Janssen Pharmaceuticals’ Darzalex Faspro for adults with newly diagnosed light chain amyloidosis.
The Pharma Data
JANUARY 17, 2021
NEW YORK , Jan. 18, 2021 /PRNewswire/ — Aruvant Sciences, a private company focused on developing gene therapies for rare diseases, and Lonza announced today their agreement in support of ARU-1801, Aruvant’s one-time investigational gene therapy for sickle cell disease (SCD). Aruvant has chosen Lonza to help develop and manufacture ARU-1801 for its upcoming pivotal trial. “We are partnering with Lonza, one of the world’s leading cell and gene therapy man
BioSpace
JANUARY 17, 2021
Despite its lofty valuation, the company does not yet have any drugs in the clinic, although it expects to submit Investigational New Drug applications in 2022 and 2023.
The Pharma Data
JANUARY 17, 2021
The treatment could be administered in primary care centers to people who test positive for COVID-19, avoiding hospitalization due to the progression of the disease and complementing the vaccine in the early phase after vaccination. The medicine, an anti-SARS-CoV-2 immunoglobulin, given subcutaneously, would provide immediate protection after exposure to the virus and could be used to protect the elderly and healthcare workers.
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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.
Scienmag
JANUARY 17, 2021
The spread of COVID-19 in Brazil overwhelmed the health systems in all the country’s regions, particularly in areas where they were already fragile, according to a collaborative effort involving the Barcelona Institute for Global Health (ISGlobal), an institution supported by the “la Caixa” Foundation, the University of Sao Paulo, the Catholic University of Rio de […].
The Pharma Data
JANUARY 17, 2021
Michael Vi/Shutterstock. The U.S. Food and Drug Administration (FDA) approved Janssen Pharmaceuticals ’ (a Johnson and Johnson company) Darzalex Faspro for adults with newly diagnosed light chain amyloidosis. Darzalex Faspro is a combination of daratumumab and hyaluronidase-fihj, a subcutaneous formulation of daratumumab. It was approved in combination with bortezomib, cyclophosphamide and dexamethasone (D-VCd).
Scienmag
JANUARY 17, 2021
New statistical model suggests an infected student returning home for Christmas would, on average, have infected just less than one other household member A student infected with COVID-19 returning home from university for Christmas would, on average, have infected just less than one other household member with the virus, according to a new model devised […].
The Pharma Data
JANUARY 17, 2021
The expressions of interest were confirmed after evaluation of Propanc’s scientific literature supporting the use of proenzymes in pancreatic and ovarian cancers. The Phase IIa POC studies will be conducted after a Phase Ib dose escalation study evaluating the tolerability and activity of proenzyme therapy in patients with advanced solid tumors is completed, planned for 2021, at the Peter Mac Cancer Center, Melbourne, Australia.
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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.
BioTech 365
JANUARY 17, 2021
ADDING MULTIMEDIA — ENHERTU® Approved in the U.S. for the Treatment of Patients with Previously Treated HER2 Positive Advanced Gastric Cancer ADDING MULTIMEDIA — ENHERTU® Approved in the U.S.
The Pharma Data
JANUARY 17, 2021
. CENTER VALLEY, Pa. , Jan. 18, 2021 /PRNewswire/ — Olympus announced that Highmark Blue Cross Blue Shield (BCBS) updated its coverage policy to include the Spiration ® Valve System for eligible patients suffering from severe emphysema, a form of Chronic Obstructive Pulmonary Disease (COPD). This coverage provides a minimally invasive treatment alternative for eligible patients. Highmark is a nationally recognized industry leader in developing up-
BioTech 365
JANUARY 17, 2021
Half-year report on the Sensorion liquidity contract with Kepler Cheuvreux Half-year report on the Sensorion liquidity contract with Kepler Cheuvreux MONTPELLIER, France–(BUSINESS WIRE)–Regulatory News: Sensorion (FR0012596468 – ALSEN) (Paris:ALSEN) a pioneering clinical-stage biotechnology company which specializes in the development of … Continue reading →
The Pharma Data
JANUARY 17, 2021
Jan. 18, 2021 09:00 UTC. CAMBRIDGE, England & LONDON–( BUSINESS WIRE )– Metrion Biosciences Limited (Metrion), the specialist ion channel CRO and drug discovery company, and LifeArc , a leading UK independent medical research charity, today announced a 12-month extension of their neuroscience drug discovery collaboration, as a result of the continued success of their ongoing agreement.
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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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