BioSpace
APRIL 25, 2021
Leaked documents from provincial and municipal governments in China reveal a slew of previously unreported severe adverse events related to COVID-19 vaccines made and administered in China.
NY Times
APRIL 25, 2021
Nearly 8 percent of those who got initial Pfizer or Moderna shots missed their second doses. State officials want to prevent the numbers from rising.
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BioSpace
APRIL 25, 2021
AstraZeneca and Sanofi announced that their MELODY Phase III trial of nirsevimab hit the primary endpoint in medically attended lower respiratory tract infections (LRTI) caused by RSV in healthy late preterm and term infants.
Pharma in Brief
APRIL 25, 2021
On April 23, 2021, Proposed PM(NOC) Amendments [1] were published in the Canada Gazette, Part I. These amendments permit patents claiming different forms of a medicinal ingredient (e.g., salt forms) to be listed on the patent register and are intended to balance Proposed FDR Amendments [2] published on March 30, 2019 which allow generic manufacturers to file an ANDS for an alternative form of a medicinal ingredient in comparison to the CRP.
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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
APRIL 25, 2021
The ability to culture coral cells could usher in a new era in coral biology research. Credit: Reproduced from Researchers have successfully grown cells from the stony coral, Acropora tenuis, in petri dishes The cell lines were created by separating out cells from coral larvae, which then developed into eight distinct cell types Seven out […].
BioSpace
APRIL 25, 2021
There is hope for uniQure’s HOPE-B trial after all. Shares of uniQure NV are climbing this morning after the company announced the clinical hold on its hemophilia B gene therapy has been lifted by the U.S. Food and Drug Administration.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
BioSpace
APRIL 25, 2021
A new study published online has provided some hope for the citizens in India, with researchers suggesting that the Covaxin vaccine, developed by Bharat Biotech and Pennsylvania-based Ocugen, could neutralize the SARS-CoV-2 variant leading the second wave in the country.
Scienmag
APRIL 25, 2021
Credit: Credit: David Mencin via Imaggeo MUNICH — Rewilding–a hands-off approach to restoring and protecting biodiversity–is increasingly employed across the globe to combat the environmental footprint of rapid urbanization and intensive farming. The recent reintroduction of grey wolves in Yellowstone, America’s first national park, is regarded as one of the most successful rewilding efforts, having […].
BioSpace
APRIL 25, 2021
Five-year-old X-Biotix announced it is throwing in the towel on its antibacterial research efforts and changing gears for its corporate strategy.
Scienmag
APRIL 25, 2021
Capturing highly motile and invasive neuromast-associated ionocytes Credit: Piotrowski Lab KANSAS CITY, MO–One of the evolutionary disadvantages for mammals, relative to other vertebrates like fish and chickens, is the inability to regenerate sensory hair cells. The inner hair cells in our ears are responsible for transforming sound vibrations and gravitational forces into electrical signals, which […].
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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
APRIL 25, 2021
Sanofi will use its manufacturing capabilities to support the development of 200 million doses of the Moderna COVID-19 vaccine beginning in September.
Scienmag
APRIL 25, 2021
Credit: Phil Wilkes/Jana Skirnewskaja Researchers have developed the first LiDAR-based augmented reality head-up display for use in vehicles. Tests on a prototype version of the technology suggest that it could improve road safety by ‘seeing through’ objects to alert of potential hazards without distracting the driver. The technology, developed by researchers from the University of […].
BioSpace
APRIL 25, 2021
Special Purpose Acquisition Companies (SPACs) are here to stay, offering one more way for companies to access public markets. But doing so isn’t a quick snap of the fingers.
Scienmag
APRIL 25, 2021
Despite progress, group still faces barriers A majority of gay and bisexual Generation Z teenage boys report being out to their parents, part of an uptick in coming out among young people that researchers have noted in recent decades, according to research published by the American Psychological Association. However, stigma and religious beliefs still prevent […].
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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.
BioSpace
APRIL 25, 2021
It was a busy week for non-COVID-19-related clinical trial news, while fairly quiet on the COVID-19 arena. Here’s a look.
Scienmag
APRIL 25, 2021
Credit: Simone Marchi/SwRI MUNICH — The first emergence and persistence of continental crust on Earth during the Archaean (4 billion to 2.5 billion years ago) has important implications for plate tectonics, ocean chemistry, and biological evolution, and it happened about half a billion years earlier than previously thought, according to new research being presented at […].
BioSpace
APRIL 25, 2021
In keeping with Axsome’s mission of providing a solution for central nervous system (CNS) disorders that are difficult to treat, AXS-05 was developed to help patients exhibiting treatment-resistant depression (TRD) and major depressive disorder (MDD).
Scienmag
APRIL 25, 2021
Protecting long-term care residents from outbreaks requires different infrastructure, proper staffing conditions and a culture of quality assurance, researchers have found. The experts further determined that designing smaller, more homelike spaces would minimize the spread of viruses while promoting better health and quality of life for residents. “Community outbreaks and lack of personal protective equipment […].
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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.
Pharma Focus Asia
APRIL 25, 2021
The only way to accurately predict the future is to create it. If you predict the near future will feature everyone zipping about in flying cars, you need to make one and show that it is a viable product. That is exactly what many companies are doing right now. They are making the future happen […]. The post Signs That the Future Is a Lot Closer Than You Think first appeared on Pharma Focus Asia.
Outsourcing Pharma
APRIL 25, 2021
The 6th annual Clinical Research as a Care Option conference, taking place April 26-17, brings together experts seeking solutions to elevate the industry.
Scienmag
APRIL 25, 2021
A recent study provides insights on the COVID-19 pandemic’s effects on employment, anxiety, and financial distress among women who have gynecologic cancer and low income. The findings are published early online in CANCER, a peer-reviewed journal of the American Cancer Society. For the study, Y. Stefanie Chen, MD, of Weill Cornell Medicine in New York […].
BioTech 365
APRIL 25, 2021
InnoCare’s Orelabrutinib Recommended by China’s Clinical Diagnosis and Treatment Guidelines InnoCare’s Orelabrutinib Recommended by China’s Clinical Diagnosis and Treatment Guidelines BEIJING–(BUSINESS WIRE)–The 2021 edition of the Chinese Society of Clinical Oncology (CSCO) Lymphoma Diagnosis and Treatment Guidelines (hereinafter referred to … Continue reading →
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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
APRIL 25, 2021
This chart shows the pharmaceutical companies with the most supplementary protection certificates (SPCs) in Romania. SPCs are used in European Union and select others to encourage pharmaceutical innovation by compensating…. The post Which pharmaceutical companies have the most SPCs in Romania? appeared first on DrugPatentWatch - Make Better Decisions.
BioTech 365
APRIL 25, 2021
EMMAC Life Sciences Group: Cannabidiol Novel Foods Validation from the European Commission EMMAC Life Sciences Group: Cannabidiol Novel Foods Validation from the European Commission Pioneers new nature-identical, pure CBD alternative for wellness market LONDON–(BUSINESS WIRE)–EMMAC Life Sciences Group, Europe’s largest … Continue reading →
World of DTC Marketing
APRIL 25, 2021
QUICK READ:There are times when I really want to quit working in the industry and the latest news about pharma is aiming at U.S. lawmakers to stop the global push to lift intellectual property through a waiver for Covid vaccines is just the latest. Pfizer and Moderna are going to make billions of dollars from the development of their vaccines. Even if the vaccines cost a billion dollars to develop, the ROI here is staggering while countries like India see a huge wave of Covid deaths and patients
BioTech 365
APRIL 25, 2021
Philips delivers Q1 sales of EUR 3.8 billion, with 9% comparable sales growth; net income amounts to EUR 40 million and Adjusted EBITA margin improves 390 basis points to 9.5% Philips delivers Q1 sales of EUR 3.
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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.
The Pharma Data
APRIL 25, 2021
Nirsevimab demonstrate d protect ion against respiratory syncytial virus disease in healthy infants in Phase 3 trial. Respiratory Syncytial Virus (RSV) is the leading cause of hospitalization in all infants. 1 – 5. Nirsevimab is being investigated as a first-in-class single dose immunization to provide protection for all infants entering their first RSV season.
BioTech 365
APRIL 25, 2021
Addex Increases Issued Share Capital to Create Treasury Shares Addex Increases Issued Share Capital to Create Treasury Shares Geneva, Switzerland, April 26, 2021 – Addex Therapeutics Ltd (SIX: ADXN and Nasdaq: ADXN), a clinical-stage pharmaceutical company pioneering allosteric modulation-based drug discovery and … Continue reading →
BioTech 365
APRIL 25, 2021
Disclosure of received notification of Templeton Investment Counsel Disclosure of received notification of Templeton Investment Counsel Regulated informationNazareth (Belgium)/Rotterdam (The Netherlands), 26 April 2021 Disclosure of received notification of Templeton Investment Counsel Pursuant to the Belgian law of 2 May … Continue reading →
BioTech 365
APRIL 25, 2021
Disclosure of received notification of The Capital Group Companies Disclosure of received notification of The Capital Group Companies Regulated informationNazareth (Belgium)/Rotterdam (The Netherlands), 26 April 2021 Disclosure of received notification of The Capital Group Companies Pursuant to the Belgian law … Continue reading →
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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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