Pfizer, marking fast research pace, starts key trial of RSV vaccine
Bio Pharma Dive
SEPTEMBER 2, 2021
The pharma company is in a tight race with rivals, including GSK, to become the first with an approved shot for the infectious disease.
Thu.Sep 02, 2021
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DoKaSch Temperature Solutions opens new service station in India
Pharma Mirror
SEPTEMBER 2, 2021
Frankfurt/Hyderabad, DoKaSch Temperature Solutions has opened a new service station in India. It is located at GMR Hyderabad Air Cargo terminal. Strategically, the Hyderabad Airport location is a very important network station for the global supply of lifesaving medicines given Hyderabad’s status as a major pharma production and export hub. With the new location in India, DoKaSch strengthens its network in the region and globally.
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Italian ‘chatbot’ predicted COVID-19 spikes, says study
pharmaphorum
SEPTEMBER 2, 2021
An online tool used by people in Italy to manage their potential exposure to COVID-19 using a simple chat interface has shown that it can spot emerging trends days ahead of the national surveillance system. The decision support system (DSS) – developed by Italian digital health startup Paginemediche – provided a way for people to assess and interpret their symptoms and provide guidance on what to do next, such as self-isolate or seek out a test.
Plant-based biopharma firm iBio licenses novel antibody targeting regulatory T cells
BioPharma Reporter
SEPTEMBER 2, 2021
Anti-CD25 antibodies have emerged as one of the most promising next-generation cancer therapeutics, says US plant-based manufacturer of therapeutics and vaccines, iBio, as it enters the field.
Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research
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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
Automatic Student Loan Forgiveness for People with Disabilities
Triage Cancer
SEPTEMBER 2, 2021
Breaking News: Thanks to a new decision by the U.S. Department of Education , many people with disabilities will receive automatic student loan forgiveness through the Total and Permanent Disability (TPD) Discharge program! What is a Total and Permanent Disability (TPD) Discharge? If you have a disability and are unable to work because of your medical condition, you might not have to pay off your remaining student loan balance.
New Study Shows Diadem’s AlzoSure Alzheimer’s Blood Test Can Predict Disease Years Before Diagnosis
XTalks
SEPTEMBER 2, 2021
Results from a clinical validation study show that Diadem’s AlzoSure , a blood-based biomarker test, accurately predicts progression to Alzheimer’s disease (AD) up to six years prior to diagnosis. The data from the retrospective longitudinal study has been made available in a medRxiv preprint before its submission to the Journal of Neuroscience. The AlzoSure Predict prognostic biomarker Alzheimer’s blood test detects levels of an unfolded conformational variant of the p53 protein in the blood us
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Swedish Biotech Sobi Accepts Buyout Offer From Advent and GIC
BioSpace
SEPTEMBER 2, 2021
?Swedish Orphan Biovitrum AB (Sobi), the global biotechnology firm, has received an $8 billion (68 billion kronor) cash buyout offer from Advent International, valuing its shares at SEK 235 each.
Moderna asks FDA to consider booster vaccine: ECDC says ‘no urgent need’ for such shots right now
BioPharma Reporter
SEPTEMBER 2, 2021
Moderna has initiated its submission to the US Food and Drug Administration (FDA) to support the authorization of a booster dose of its mRNA COVID-19 vaccine at the 50-microgram (mcg) dose level.
Celsion DNA Vaccine Platform Produces Potent Response in Preclinical Study
BioSpace
SEPTEMBER 2, 2021
Celsion announced results from its PLACCINE DNA vaccine platform that showed it produced antibodies and cytotoxic T-cell response specific to the spike antigen of SARS-CoV-2.
Poppi: The Prebiotic Soda Taking the World by Storm
XTalks
SEPTEMBER 2, 2021
Russell Westbrook, Halsey and The Chainsmokers are among the many celebrities investing in Poppi, an emerging prebiotic soda brand, that garnered $13.5 million in a Series A2 funding round led by a slew of elite athletes, musicians and social media stars. So, what made this up-and-coming soda brand so attractive for celebrity investors and how does it differentiate itself from other better-for-you beverages?
The New Age of Decentralized Clinical Trials
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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
Disappointment for Forte Biosciences After Lead Assets Fails in Atopic Dermatitis
BioSpace
SEPTEMBER 2, 2021
Shares of Forte Biosciences plunged more than 80% in premarket trading after the company announced failure to demonstrate statistical significance of Phase II atopic dermatitis trial.
Curebase to partner on VR-based chronic pain clinical trials
Outsourcing Pharma
SEPTEMBER 2, 2021
The decentralized trial tech firm will work with Applied VR on five studies testing the viability of virtual-reality therapy in treating pain patients.
Novartis Scuttles Kidney Transplant Drug Study
BioSpace
SEPTEMBER 2, 2021
Novartis announced that it is discontinuing the trial in kidney transplant patients after conducting an interim analysis from its CIRRUS-1 trial of CFZ533 (iscalimab).
Abiomed’s Impella ECP; Helius’s PoNS Device; Smart Meter’s iGlucose BGM; XACT’s CT-Guided Percutaneous Procedures; BD’s Veritor At-Home COVID-19 Test; Delfi’s Liquid Biopsy
Delveinsight
SEPTEMBER 2, 2021
FDA awards Breakthrough Device Designation to Impella ECP. On August 18, 2021, Abiomed received breakthrough device designation from the United States Food and Drug Administration (FDA) for its Impella ECP expandable percutaneous heart pump , the world’s smallest heart pump and the first to be compatible with small-bore access and closure techniques.
Roles and Responsibilities of Specialized Clinical Supply Experts
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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.
Scopus Biopharma Flexes Immuno-Oncology Pipeline Following Its Acquisition of Olimmune
BioSpace
SEPTEMBER 2, 2021
?Scopus Biopharma recently launched Duet Therapeutics to integrate its immunotherapy assets' management and clinical development with Olimmune.
Heart failure med Jardiance scores MHRA approval
Pharma Times
SEPTEMBER 2, 2021
Marketing authorisation covers treatment of heart failure with reduced ejection fraction
Eli Lilly Accused of Keeping the Over 40 Crowd Out of Sales Rep Roles
BioSpace
SEPTEMBER 2, 2021
Lilly’s most recent legal woes come from a proposed class-action lawsuit filed on Wednesday, accusing the company of age bias.
IQVIA launches AI-powered medical information contact centre
Pharma Times
SEPTEMBER 2, 2021
AI tech designed to improve patient and HCP experience
The New Age of Decentralized Clinical Trials
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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.
U.S. Officials Rush to Reassure as Mu Variant Grabs International Headlines
BioSpace
SEPTEMBER 2, 2021
The Mu variation is the fifth strain to be designated as a "variant of interest" by the World Health Organization.
GSK’s shingles vaccine Shingrix gains UK license
Pharma Times
SEPTEMBER 2, 2021
Jab aimed at adults aged 50 years and older and those at increased risk
Research Roundup: COVID-19 Antibody Responses and More
BioSpace
SEPTEMBER 2, 2021
Every week there are numerous scientific studies published. Here’s a look at some of the more interesting ones.
Watch Your Heart! Simple Steps to Prevent Heart Disease
My Local Study
SEPTEMBER 2, 2021
Knowing how to prevent heart disease is a necessary skill. We all need to watch our hearts daily so that we can keep our hearts healthy! Heart disease comes in many forms and affects people at any age. So, here are some simple steps experts recommend taking to help prevent heart disease. What is Heart. Read more. The post Watch Your Heart! Simple Steps to Prevent Heart Disease appeared first on MyLocalStudy.com.
Accelerating Clinical Supply Through Integrated Drug Development
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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.
Tech Companies Are Breeding Grounds for Some Big Data Life Science Company Executives
BioSpace
SEPTEMBER 2, 2021
With the adaptation of new technologies, tech executives are finding new homes in biotech and the life sciences.
Blood vessels produce growth factor that promotes metastases
The Pharma Data
SEPTEMBER 2, 2021
Blood vessels supply tumors with nutrients and, on the other hand, enable cancer cells to spread throughout the body. The settlement of circulating tumor cells in a distant organ is promoted by factors whose production is induced by the primary tumor itself. Scientists from the German Cancer Research Center (DKFZ) and the Medical Faculty Mannheim, Heidelberg University, have now identified a new growth factor produced by blood vessels that enables tumor cells to metastatically colonize organs.
COVID-19: Supply Chain, Antibodies and Autoimmune Impacts
BioSpace
SEPTEMBER 2, 2021
?Heading into the Labor Day weekend in the U.S., there’s still plenty of COVID-19 news. Here’s a look.
New patent for Chiesi drug CLEVIPREX
Drug Patent Watch
SEPTEMBER 2, 2021
Annual Drug Patent Expirations for CLEVIPREX Cleviprex is a drug marketed by Chiesi and is included in one NDA. It is available from two suppliers. There are three patents protecting…. The post New patent for Chiesi drug CLEVIPREX appeared first on DrugPatentWatch - Make Better Decisions.
How Machine Learning Drives Clinical Trial Efficiency
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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 Movers & Shakers: Sept. 3
BioSpace
SEPTEMBER 2, 2021
Biopharma and life sciences companies strengthen their leadership teams and boards with these Movers & Shakers.
New patent for Trevena drug OLINVYK
Drug Patent Watch
SEPTEMBER 2, 2021
Annual Drug Patent Expirations for OLINVYK Olinvyk is a drug marketed by Trevena and is included in one NDA. There are three patents protecting this drug. This drug has thirty-five…. The post New patent for Trevena drug OLINVYK appeared first on DrugPatentWatch - Make Better Decisions.
On Speakers Programs and PhRMA’s Updated Ethics Code
Intouch Solutions
SEPTEMBER 2, 2021
Last month, the Pharmaceutical Research and Manufacturers of America (PhRMA) “updated and enhanced” its voluntary code of ethics regarding appropriate interactions between the drug industry and U.S. healthcare professionals (HCPs) while marketing pharma products, including speaker programs. Regarding these programs, the updated code states that their purpose should be to “present substantive educational information designed to help address a bona fide educational need among attendees, taking int
What Career Options Are There For An Assistant At A Clinical Trial Site or SMO ?
Clinical Trial Gurus
SEPTEMBER 2, 2021
Working at a clinical trial site offers so many future career opportunities for the employees. In this video I interview The CRC Academy instructor, Monica Cuitiva, and we discuss the career pathway that may become available to assistants at clinical research sites.
The New Clinical Trial Supply Chain: Resilient, Flexible, and Patient-Centric
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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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