BioSpace
DECEMBER 13, 2020
Eureka Therapeutics' InvisiMask™ Human Antibody Nasal Spray can provide 10 hours of protection from SARS-CoV-2 virus in animal models, according to preclinical results released today. Now it’s heading to clinical trials.
pharmaphorum
DECEMBER 13, 2020
Alexion has routinely featured among lists of top biopharma takeover prospects in the last couple of years, and that was a good call – AstraZeneca has just swooped in with $39 billion cash-and-stock takeover offer. The deal – the largest in the pharma sector since the start of the pandemic – bolsters AZ’s immunology franchise with $4 billion blockbuster Soliris (eculizumab) and longer acting follow-up Ultomiris (ravulizumab), plus a pipeline of 11 drugs for rare and autoimmune diseases.
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BioSpace
DECEMBER 13, 2020
Germany’s CureVac announced it has enrolled the first volunteer in the pivotal Phase IIb/III trial of its own mRNA vaccine candidate, CVnCoV against COVID-19.
Scienmag
DECEMBER 13, 2020
Regenerative Medicine Foundation and Wake Forest Institute for Regenerative Medicine to present a co-located World Stem Cell Summit and Regenerative Medicine Essentials Course Credit: WFIRM WINSTON-SALEM, NC, Dec. 14, 2020 — The Wake Forest Institute for Regenerative Medicine (WFIRM) and the Regenerative Medicine Foundation (RMF) have announced that the 16th World Stem Cell Summit will […].
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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
BioSpace
DECEMBER 13, 2020
Relay Therapeutics announced today that it has entered a global license and collaboration agreement with Genentech for the commercialization and development of RLY-1971.
Scienmag
DECEMBER 13, 2020
Credit: Kim Ratliff, AU photographer Cancer immunotherapy using “designer” immune cells has revolutionized cancer treatment in recent years. In this type of therapy, T cells, a type of white blood cell, are collected from a patient’s blood and subjected to genetic engineering to produce T cells carrying a synthetic molecule termed chimeric antigen receptor (CAR) […].
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Scienmag
DECEMBER 13, 2020
Credit: Created by Antonio Ballell with BioRender.com, Thecodontosaurus silhouette from PhyloPic.org. A pioneering reconstruction of the brain belonging to one of the earliest dinosaurs to roam the Earth has shed new light on its possible diet and ability to move fast. Research, led by the University of Bristol, used advanced imaging and 3-D modelling techniques […].
BioSpace
DECEMBER 13, 2020
The deal has been approved by both companies’ boards and is expected to close in the third quarter of 2021.
Druggist
DECEMBER 13, 2020
Amitriptyline is one of the most popular antidepressants in the UK. Its use is not just restricted to the treatment of depression. Amitriptyline is one of the first options considered when a drug treatment is needed to help manage neuropathic pain. This post focuses on the use of amitriptyline for nerve pain. Summary of the post: What is amitriptyline?
BioSpace
DECEMBER 13, 2020
As the year wraps up, there are still some PDUFA dates on the agency’s calendar. Read on for this week’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
JAMA Internal Medicine
DECEMBER 13, 2020
This cross-sectional study estimates the association of political party affiliation with physical distancing behaviors among young adults during the coronavirus disease 2019 pandemic.
BioSpace
DECEMBER 13, 2020
145 hospitals and clinics received their first batch of Pfizer-BioNTech's coronavirus vaccine today.
Scienmag
DECEMBER 13, 2020
An international team of scientists, including doctors from the Champalimaud Clinical Centre, in Lisbon, has just published results in the prestigious journal The Lancet Oncology that suggest that the majority of rectal cancer patients may be able, in the not so distant future, to replace aggressive colorectal surgery with a course of radiochemotherapy and few […].
BioSpace
DECEMBER 13, 2020
It was an unusually busy week for clinical trial updates, largely because of the annual ASH meeting from Sunday December 5 through Wednesday December 9. There were also other meetings and the usual corporate updates.
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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.
Scienmag
DECEMBER 13, 2020
From safety and effectiveness to who should use sunscreen and how to apply it, Canadian dermatologists review the latest evidence and guidelines on use of sunscreen. The review, published in CMAJ (Canadian Medical Association Journal), recommends that everyone older than six months of age should use sunscreen to protect against skin cancer [link] Most skin […].
BioSpace
DECEMBER 13, 2020
Robert Coughlin announced in an open letter on Monday that he is leaving the Massachusetts Biotechnology Council (MassBio) following a 13-year tenure as the organization’s president and CEO.
Scienmag
DECEMBER 13, 2020
Peer reviewed; observational study & scientific commentary; people Neuroscientists at UCL have found no significant association between COVID-19 and the potentially paralysing and sometimes fatal neurological condition Guillain-Barré syndrome. Researchers say the findings, published in the journal Brain*, along with a linked scientific commentary** by UCL and other international experts, should provide the public with […].
BioSpace
DECEMBER 13, 2020
Incyte and Novartis announced a Phase III study of Jakafi (ruxolitinib), a first-in-class JAK1/JAK2 inhibitor, failed to hit endpoints as a treatment for patients 12 and up with COVID-19 associated cytokine storm.
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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.
JAMA Internal Medicine
DECEMBER 13, 2020
This cross-sectional study investigates the diversity of speakers who discussed COVID-19 and other content on cable news programs.
Scienmag
DECEMBER 13, 2020
NIH study shows how our brains may set expectations by comparing past and present experiences Credit: Courtesy of Zaghloul lab, NIH/NINDS. Imagine you are sitting on the couch in your living room reading. You do it almost every night. But then, suddenly, when you look up you notice this time something is different. Your favorite […].
The Pharma Data
DECEMBER 13, 2020
SILVER SPRING, Md. , Dec. 14, 2020 /PRNewswire/ — Today, the U.S. Food and Drug Administration (FDA) approved a first-of-its-kind intentional genomic alteration (IGA) in a line of domestic pigs, referred to as GalSafe pigs, which may be used for food or human therapeutics. This is the first IGA in an animal that the FDA has approved for both human food consumption and as a source for potential therapeutic uses.
Delveinsight
DECEMBER 13, 2020
Hepatitis is an infection that causes inflammation of the liver. The condition can be self-limiting or can progress to fibrosis (scarring), cirrhosis, or liver cancer. Hepatitis viruses are the most common cause of hepatitis; however, other infections such as toxic substances (e.g., alcohol, certain drugs) and autoimmune diseases can also cause hepatitis.
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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.
The Pharma Data
DECEMBER 13, 2020
BOSTON–( BUSINESS WIRE )– Gamida Cell Ltd. (Nasdaq: GMDA), an advanced cell therapy company committed to cures for blood cancers and serious hematologic diseases, today announced that the company conducted a Type B Meeting for omidubicel with the U.S. Food and Drug Administration (FDA) on Friday, December 11, 2020. During the meeting, the FDA provided encouraging feedback regarding the Phase 3 study of omidubicel pertaining to the pre-specified primary and secondary endpoints.
NY Times
DECEMBER 13, 2020
Baricitinib had previously attracted some scrutiny from experts, who were unsure when it would most help their patients.
The Pharma Data
DECEMBER 13, 2020
Although much of the U.S. Food and Drug Administration (FDA) ’s focus appears to be on Emergency Use Authorizations (EUAs) for the Pfizer-BioNTech and Moderna COVID-19 vaccines, as the year wraps up there are still some PDUFA dates on the agency’s calendar. Read on for this week’s. MacroGenics’ Margetuximab for Metastatic HER2+ Breast Cancer. MacroGenics , based in Rockville, Maryland, has a target action date of December 18 for its Biologics License Application (BLA) for margetuximab in combina
Scienmag
DECEMBER 13, 2020
PULLMAN, Wash. – The more people rely on social media as their main news source the more likely they are to believe misinformation about the pandemic, according to a recent survey analysis by Washington State University researcher Yan Su. The study, published in the journal Telematics and Informatics, also found that levels of worry about […].
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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
DECEMBER 13, 2020
NEW YORK, Dec. 13, 2020 (GLOBE NEWSWIRE) — SELLAS Life Sciences Group, Inc. (Nasdaq: SLS) (“SELLAS” or the “Company”), a late-stage clinical biopharmaceutical company focused on the development of novel cancer immunotherapies for a broad range of cancer indications, today announced that it has entered into a share purchase agreement with institutional investors to purchase approximately $16.2 million of its common stock in a registered direct offering at a purchase price of $7.00 per share
Drug Patent Watch
DECEMBER 13, 2020
DEXILANT (dexlansoprazole) Takeda pharms usa Patent: 6,462,058 Expiration: Dec 15, 2020 See More … For more information on how DrugPatentWatch can help with your pharmaceutical business intelligence needs, contact admin@DrugPatentWatch.com…. The post Drug Patent Expirations for the Week of December 13, 2020 appeared first on DrugPatentWatch - Make Better Decisions.
The Pharma Data
DECEMBER 13, 2020
DURHAM, N.C., Dec. 14, 2020 (GLOBE NEWSWIRE) — Precision BioSciences, Inc. (Nasdaq: DTIL) a clinical stage biotechnology company dedicated to improving life with its novel and proprietary ARCUS® genome editing platform, today announced that Abid Ansari, Chief Financial Officer, notified the Company that he will be leaving the organization after nearly five years to pursue a new career opportunity.
BioTech 365
DECEMBER 13, 2020
SELLAS Announces Pricing of $16.2 Million Registered Direct Offering SELLAS Announces Pricing of $16.2 Million Registered Direct Offering NEW YORK, Dec. 13, 2020 (GLOBE NEWSWIRE) — SELLAS Life Sciences Group, Inc.
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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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