Bio Pharma Dive
MARCH 25, 2021
When given together with Opdivo, Bristol Myers' new drug kept skin cancers from progressing, a rare clinical victory for a combination of immunotherapies that puts the pharma a step ahead of several rivals.
Camargo
MARCH 25, 2021
The Camargo Blog is publishing a four-part blog series highlighting those designation programs available specifically for products with rare disease indications : Orphan Drug Designation (ODD), Rare Pediatric Disease Designation (RPDD), and Humanitarian Use Device (HUD) designation. Subscribe to our mailing list at the bottom of this page to be notified when future installments are published.
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Bio Pharma Dive
MARCH 25, 2021
Updated results show the vaccine is only slightly less effective than AstraZeneca originally reported. But an unusual break with a study committee may damage perception of the shot.
pharmaphorum
MARCH 25, 2021
In the year since the UK went into its first lockdown to limit the spread of COVID-19 the country’s health service has undergone an unprecedented digital transformation. . The NHS quickly scrambled to reduce face-to-face contact between patients and healthcare professionals, and manage demand for services that would soon be overstretched by dealing with the pandemic.
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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 25, 2021
Treatments from Lilly and Regeneron that combine two different antibodies should be used instead, according to health officials.
Outsourcing Pharma
MARCH 25, 2021
A survey by the Pistoia Alliance indicates most professionals believe the tech can accelerate R&D, but companies are stymied by a skills gap and data bias.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
pharmaphorum
MARCH 25, 2021
There is a pressing need for a joined-up cancer strategy to reverse the impact of the COVID-19 pandemic, according to a new report from the UK’s pharma industry. The Association of the British Pharmaceutical Industry ( ABPI) report said that the UK must be more ambitious with its cancer strategy if it is to compete with the leading nations across Europe.
BioSpace
MARCH 25, 2021
What has been learned about SARS-CoV-2, the virus that causes COVID-19, in only about 15 months, is truly a historical scientific achievement. And new information continues to come in.
pharmaphorum
MARCH 25, 2021
Boehringer Ingelheim invested €3.7 billion on R&D last year, the highest spend in its history, as it mobilised its scientists to seek out new therapies for COVID-19. . Not all those efforts have been successful. Boehringer abandoned BI 764198, an inhibitor of TRPC6 in phase 2 for acute respiratory distress syndrome (ARDS) in patients hospitalised for COVID-19 earlier this month.
BioSpace
MARCH 25, 2021
In his fifth year as CEO, his take-home was about $20.15 million – an almost $1.7 million base pay plus $13.5 million in stock awards, with another $5 million in incentive plan pay with “other” pay.
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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
Scienmag
MARCH 25, 2021
New George Mason University College of Health and Human Services study is one of first individual-level studies to track movements and symptoms during the COVID-19 pandemic Credit: George Mason University How can we better understand how people move during the pandemic and how they spread COVID-19? New George Mason University’s College of Health and Human […].
BioSpace
MARCH 25, 2021
In 2019, Novartis subsidiary AveXis announced it acquired a manufacturing facility in Colorado to provide additional production capacity for Zolgensma. Just 14 months later, the facility will be closed and 400 people will be without a job.
XTalks
MARCH 25, 2021
The Xtalks editorial team is pleased to announce the launch of the Xtalks Food Podcast. Each week, host Sydney Perelmutter will be joined by editorial team members, Mira Nabulsi, Ayesha Rashid and Sarah Hand to discuss trending food industry topics and share insights from industry experts. Sydney and Mira will lead the conversation by discussing some of their recent articles, sharing their perspectives and asking the team members for their thoughts.
Scienmag
MARCH 25, 2021
A project to assess the risks of well contamination in Madagascar receives major funding Credit: INSTN-Madagascar The project of Professor Geneviève Bordeleau, from the Institut national de la recherche scientifique (INRS), received financial support from the Quebec government under the International Climate Cooperation Program (ICCP), a program of the 2013-2020 Action Plan on Climate Change, […].
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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.
XTalks
MARCH 25, 2021
Following the success of Popeyes’ expansion to Spain and Switzerland, the cult-favorite chicken fast food chain announced plans to launch in the UK later this year, with the goal of opening hundreds of other locations as a part of an international expansion. The news comes about a year and a half after Popeyes’ chicken sandwich went viral, as it hopes to bring the craze across the globe.
Scienmag
MARCH 25, 2021
UIC researchers first to publish data on B-reader financial conflicts of interest Credit: UIC University of Illinois Chicago researchers are the first to report on the financial conflicts of interest that exist among doctors who review the chest X-rays of coal miners who file workers’ compensation claims of totally disabling disease with the U.S.
BioSpace
MARCH 25, 2021
The Orphan Drug Act passed in 1983 and granted tax credits, subsidies and fee waivers for rare disease drug development in areas of unmet need. It also guaranteed seven years of market exclusivity following approval, longer than the five years typical for most new chemical entities.
Scienmag
MARCH 25, 2021
Prototypes tested in India show promise as a low-cost, natural filtration option Credit: Courtesy: N.R. Fuller, Sayo Studio The interiors of nonflowering trees such as pine and ginkgo contain sapwood lined with straw-like conduits known as xylem, which draw water up through a tree’s trunk and branches. Xylem conduits are interconnected via thin membranes that […].
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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.
XTalks
MARCH 25, 2021
The US Food and Drug Administration (FDA) has granted approval to Merck’s Keytruda (pembrolizumab) for the treatment of metastatic or locally advanced esophageal or gastroesophageal (GEJ) adenocarcinoma in patients who aren’t eligible for surgical resection or definitive chemoradiation. The approval of Keytruda for esophageal cancer is indicated in combination with platinum- and fluoropyrimidine-based chemotherapy.
Scienmag
MARCH 25, 2021
This study will aid the understanding of, and future research on, inflammatory bowel disease, which afflicts about 1.6 million Americans Credit: UAB BIRMINGHAM, Ala. – Researchers have found an unexpected synergy between a T-cell stimulatory protein — the ICOS ligand — and interleukin-10, an immunoregulatory cytokine, to prevent inflammatory bowel disease in mice.
Pharma Times
MARCH 25, 2021
Study compared women who continued on relugolix combination therapy with women who discontinued treatment
Scienmag
MARCH 25, 2021
NIH-funded findings point to a role for saliva in SARS-CoV-2 transmission Credit: Paola Perez, PhD, Warner Lab, NIDCR An international team of scientists has found evidence that SARS-CoV-2, the virus that causes COVID-19, infects cells in the mouth. While it’s well known that the upper airways and lungs are primary sites of SARS-CoV-2 infection, there […].
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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.
Pharma Times
MARCH 25, 2021
Lead ‘Allosteric PLK1’ asset will initially target brain cancer
Scienmag
MARCH 25, 2021
New dimensions in organic chemistry through light-mediated synthesis; publication in ‘Science’ Credit: Peter Bellotti A major goal of organic and medicinal chemistry in recent decades has been the rapid synthesis of three-dimensional molecules for the development of new drugs. These drug candidates exhibit a variety of improved properties compared to predominantly flat molecular structures, which […].
BioSpace
MARCH 25, 2021
Every week there are numerous scientific studies published. Here’s a look at some of the more interesting ones.
pharmaphorum
MARCH 25, 2021
AstraZeneca has issued revised efficacy figures from the US trial of its COVID-19 vaccine following a complaint from independent monitors that figures from an interim analysis published earlier this week were out of date. The new figures from AZ, which developed the vaccine in partnership with Oxford University, give an efficacy at preventing symptomatic COVID-19 of 76%, down from 79%, while the efficacy against severed or critical disease and hospitalisation remains at 100%.
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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.
BioPharma Reporter
MARCH 25, 2021
A US courtâs recent decision to find in favor of Sanofi and invalidate Amgen's broad antibody patent claims has biotech manufacturers concerned about how to preserve their IP.
Scienmag
MARCH 25, 2021
AllianThera Biopharma lead by ex-pharma veterans, Dr. Yuan-Hua Ding and Dr. Javier Cote-Sierra partnered with an AI-driven drug discovery company, Insilico Medicine to tackle cancer and autoimmune diseases Credit: Insilico Medicine Thursday, 25th of March 2021 (5:00AM EST) — Today, AllianThera Biopharma (ATB), a Suzhou, China-based startup focusing on inventing and developing innovative medicines for […].
BioSpace
MARCH 25, 2021
This morning, Ikena Oncology, Design Therapeutics and Edgewise Therapeutics began trading on the exchange.
Scienmag
MARCH 25, 2021
Decade-long search uncovers genes responsible for lacunar strokes, a major cause of vascular dementia Scientists have identified new genetic clues in people who’ve had small and often apparently ‘silent’ strokes that are difficult to treat and a major cause of vascular dementia, according to research funded by the British Heart Foundation (BHF) and published in […].
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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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