BioSpace

SEPTEMBER 5, 2021

Sometimes the U.S. Food and Drug Administration (FDA) runs ahead of schedule. In the case of this week’s two PDUFA dates, that was completely true. Here’s a look.

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The Pharma Data

SEPTEMBER 5, 2021

Federal and Kaiser Permanente researchers combing the health records of 6.2 million patients found no serious health effects that could be linked to the 2 mRNA COVID-19 vaccines. The study published September 2 in JAMA reports the first comprehensive findings of the Vaccine Safety Datalink (VSD), which studies patient records for 12 million people in 5 Kaiser Permanente service regions along with HealthPartners in Minneapolis, the Marshfield Clinic in Wisconsin, and Denver Health.

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BioSpace

SEPTEMBER 5, 2021

There were a fair number of clinical trial announcements last week. Here’s a look.

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The Pharma Data

SEPTEMBER 5, 2021

Approval based on interim results from Phase III trial demonstrating complete terminal complement inhibition with reduced dosing frequency compared to Soliris. Ultomiris (ravulizumab) has been approved in the European Union for expanded use to include children (with a body weight of 10 kg or above) and adolescents with paroxysmal nocturnal haemoglobinuria (PNH), an ultra-rare and severe blood disorder characterised by the destruction of red blood cells that can cause thrombosis (blood clots) an

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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

Clinical Research

Scienmag

SEPTEMBER 5, 2021

East Hanover, NJ – September 3, 2021 – The August job numbers rose for people with disabilities in contrast to declines for people without disabilities, according to today’s National Trends in Disability Employment – Monthly Update (nTIDE), issued by Kessler Foundation and the University of New Hampshire’s Institute on Disability (UNH-IOD). This improvement may be […].

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The Pharma Data

SEPTEMBER 5, 2021

AstraZeneca and the European Commission have reached an agreement that ends legal proceedings over the execution of the Advance Purchase Agreement for the delivery of the COVID-19 vaccine Vaxzevria (ChAdOx1-S [Recombinant]). Under the agreement, AstraZeneca commits to deliver 60 million doses of the vaccine by the end of the third quarter 2021, 75 million by the end of the fourth quarter 2021 and 65 million by the end of the first quarter 2022.

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The Pharma Data

SEPTEMBER 5, 2021

Amgen will present at Citi’s 16th Annual BioPharma Conference at 1:25 p.m. ET on Wednesday, Sept. 8, 2021. Murdo Gordon, executive vice president of Global Commercial Operations at Amgen will present at the conference. Live audio of the conference call will be broadcast over the internet simultaneously and will be available to members of the news media, investors and the general public.

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Scienmag

SEPTEMBER 5, 2021

New archaeological research highlights major blind spots in Australia’s environmental management policies, placing submerged Indigenous heritage at risk. Credit: Credit: Dr John McCarthy in Australian Archaeology. Contains GEBCO 15 ArcSecond raster data (Public Domain) and Maritime Boundaries Geodatabase: Maritime Boundaries and Exclusive Economic Zones (200NM) (version: 11) (CCBY 4.0).

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Containment Research 52

Clinical Trial Gurus

SEPTEMBER 5, 2021

Continuosuly. expand your knowledge. Especially in a field like life sciences, understanding the changes occurring within the scientific communities can help you earn more over the course of your career.

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Clinical Research Life Science Research 52

Scienmag

SEPTEMBER 5, 2021

The COVID-19 pandemic has increased attention on links between public health and the planet’s health — areas traditionally addressed in separate science and policy circles. Now, an international research collaboration conducted the first comprehensive review of urban climate change responses and potential human health improvements. Credit: Hiroshima University The COVID-19 pandemic has increased attention on […].

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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

Clinical Trials

NY Times

SEPTEMBER 5, 2021

Clinical trials have repeatedly failed to show that the drug is effective against the virus. Still, U.S. demand is high.

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Scienmag

SEPTEMBER 5, 2021

Centrally located along trade routes and tightly nestled around the important waterways such as the Elbe River, Bohemia attracted many different archaeological cultures, rendering it a key region in understanding the prehistory of Europe. In addition to the expansions associated with the spread of agriculture and “steppe”-related ancestry previously discovered, this new study identifies at […].

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BioTech 365

SEPTEMBER 5, 2021

Newron Pharmaceuticals SpA / Key word(s): Study 06-Sep-2021 / 07:01 CET/CEST Release of an ad hoc announcement pursuant to Art. 53 LR The issuer is solely responsible for the content of this announcement. Ad hoc announcement pursuant to Art.

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Scienmag

SEPTEMBER 5, 2021

Warmer weather is linked to a worsening of chronic obstructive pulmonary disease (COPD) symptoms, according to research to be presented on Sunday at the ‘virtual’ European Respiratory Society International Congress [1]. Credit: Dr Supaksh Gupta Warmer weather is linked to a worsening of chronic obstructive pulmonary disease (COPD) symptoms, according to research to be presented […].

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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.

Clinical Supply

BioTech 365

SEPTEMBER 5, 2021

UK MHRA Grants GenSight Biologics’ LUMEVOQ® Ophthalmic Gene Therapy Promising Innovative Medicine Designation UK MHRA Grants GenSight Biologics’ LUMEVOQ® Ophthalmic Gene Therapy Promising Innovative Medicine Designation PARIS–(BUSINESS WIRE)–GenSight Biologics (Paris:SIGHT) (Euronext: SIGHT, ISIN: FR0013183985, PEA-PME eligible), a biopharma company focused … Continue reading →

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Scienmag

SEPTEMBER 5, 2021

Bird dispersal movements are thought to depend on complex demographic and genetic factors. Dr. Santiago Claramunt, Associate Curator of Birds at the Royal Ontario Museum (ROM) and Assistant Professor in the Department of Ecology and Evolutionary Biology of the University of Toronto, shows that there may be a simpler explanation: bird dispersal distances depend on […].

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Drug Patent Watch

SEPTEMBER 5, 2021

COMPLERA (emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate) Gilead sciences inc Patent: 6,703,396 Expiration: Sep 9, 2021 See More … For more information on how DrugPatentWatch can help with your pharmaceutical…. The post Drug Patent Expirations for the Week of September 5, 2021 appeared first on DrugPatentWatch - Make Better Decisions.

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Scienmag

SEPTEMBER 5, 2021

NEWPORT, Ore. – Core samples taken from a stand of old growth Douglas-fir trees in the South Beach area just south of Newport showed reduced growth following the 9.0 earthquake and subsequent tsunami that struck the Pacific Northwest in 1700. Credit: Bob Dziak. NEWPORT, Ore. – Core samples taken from a stand of old growth […].

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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.

Clinical Trials

BioTech 365

SEPTEMBER 5, 2021

EML-powered Vault Hopes Its Vaccine Rewards Cards Offer Hard-hit Australian Businesses A Lockdown Exit EML-powered Vault Hopes Its Vaccine Rewards Cards Offer Hard-hit Australian Businesses A Lockdown Exit EML’s partner, Vault, is helping businesses, suppliers and event organisers get their … Continue reading →

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Scienmag

SEPTEMBER 5, 2021

The first United Nations Food Systems Summit (UNFSS), scheduled for September, could be as historic to food system transformation as the Rio Earth Summit of 1992 was to climate change. Rio sparked the creation of the Intergovernmental Panel on Climate Change, or IPCC, which has brought scientists and governments around the world together and has […].

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BioTech 365

SEPTEMBER 5, 2021

Adaptimmune Updates Data from its Phase 1 Trial for Liver Cancer at ILCA Showing Clinical Benefit Adaptimmune Updates Data from its Phase 1 Trial for Liver Cancer at ILCA Showing Clinical Benefit – One complete response, and a disease control … Continue reading →

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Scienmag

SEPTEMBER 5, 2021

A project to unite seismic data analysis and modeling with supercomputing power may help answer some of the biggest questions about the Earth’s seismic activity. Credit: Daniel Walker, University of Alaska Fairbanks Geophysical Institute A project to unite seismic data analysis and modeling with supercomputing power may help answer some of the biggest questions about […].

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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.

Clinical Supply

BioTech 365

SEPTEMBER 5, 2021

Fresenius Kabi and AABB Celebrate 16th Annual Blood Collectors Week Fresenius Kabi and AABB Celebrate 16th Annual Blood Collectors Week Organizations join in honoring the inspiring contributions of blood collection professionals LAKE ZURICH, Ill. & BETHESDA, Md.

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Scienmag

SEPTEMBER 5, 2021

All of the data produced or used in 2020 was estimated to be about 59 zettabytes, each of which equals a billion terabytes. If each terabyte represents a mile, 59 zettabytes would allow for almost 10 full round trips from Earth to Pluto. Credit: James Provost and Rebecca Napolitano, Penn State All of the data […].

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BioTech 365

SEPTEMBER 5, 2021

DGAP-News: Newron Pharmaceuticals S.p.A. / Key word(s): Study 06.09.2021 / 07:00 The issuer is solely responsible for the content of this announcement.

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Scienmag

SEPTEMBER 5, 2021

People who have modestly but measurably worse lung function are more likely to suffer sudden cardiac death (SCD), according to research presented at the European Respiratory Society International Congress. [1] Credit: European Respiratory Society/Suneela Zaigham People who have modestly but measurably worse lung function are more likely to suffer sudden cardiac death (SCD), according to […].

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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.

Clinical Trials

Drug Patent Watch

SEPTEMBER 5, 2021

This chart shows the drugs with the most supplementary protection certificates (SPCs). SPCs are used in European Union and select others to encourage pharmaceutical innovation by compensating for the long…. The post Which drugs have the most supplementary protection certificates? appeared first on DrugPatentWatch - Make Better Decisions.

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Drugs 95

Scienmag

SEPTEMBER 5, 2021

University of Houston researchers are reporting a breakthrough in the field of materials science and engineering with the development of an electrochemical actuator that uses specialized organic semiconductor nanotubes (OSNTs). Credit: University of Houston University of Houston researchers are reporting a breakthrough in the field of materials science and engineering with the development of an […].

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The Pharma Data

SEPTEMBER 5, 2021

Improvements Also Demonstrated in Lung Function and Nasal Polyp Symptoms Exploratory Analysis From NAVIGATOR Phase 3 Trial Presented at European Respiratory Society (ERS) International Congress 2021 today announced new data from the pivotal NAVIGATOR Phase 3 trial demonstrating that tezepelumab reduced exacerbations and improved lung function and nasal symptoms in patients with severe, uncontrolled asthma and comorbid nasal polyps. 1 Tezepelumab is a potential first-in-class treatment that acts

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Scienmag

SEPTEMBER 5, 2021

ATLANTA—Dr. Michal Kuczma, a research assistant professor in the Institute for Biomedical Sciences at Georgia State University, has received a three-year, $270,000 Career Development Award from the Crohn’s and Colitis Foundation to study environmental influences on gut microbiota, immunity and inflammation. Credit: Georgia State University ATLANTA—Dr.

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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.

Clinical Trials