BioSpace
JANUARY 24, 2021
The U.S. Food and Drug Administration gave the green light to Aurinia’s Lupkynis (voclosporin) in combination with a background immunosuppressive therapy regimen for LN.
Scienmag
JANUARY 24, 2021
Credit: Daniel Miller / UToledo Researchers at The University of Toledo have received a three-year funding award of $1.4 million from the U.S. Department of Defense for a pre-clinical study of promising new chemotherapy aimed at triple negative breast cancer. The treatment, which relies on a unique cell death pathway, could prove to be critical […].
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BioSpace
JANUARY 24, 2021
Roche announced topline data from two identical Phase III trials, TENAYA and LUCERNE, of faricimab in neovascular or “wet” age-related macular degeneration (nAMD).
Scienmag
JANUARY 24, 2021
Credit: Kim Ratliff, Augusta University photographer AUGUSTA, Ga. (January 25, 2021) – Immediately after a traumatic brain injury and as long as one year later, there are increased levels of immune cells called ILCs in the brain promoting inflammation, which can worsen brain damage, scientists report. They also report for the first time that the […].
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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
JANUARY 24, 2021
Part of the difficulty of treating breast cancer is the genomic variability of the patient population, as well as the different forms the cancer can take.
Scienmag
JANUARY 24, 2021
Findings demonstrate the interconnectedness of the Arctic and North Pacific on multimillennial timescales, consistent with future projections of less sea ice and more precipitation in Arctic Alaska Arctic sea ice is rapidly diminishing due to global warming, and scientists have found that sea ice dynamics have a big impact on circulation and precipitation patterns in […].
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Scienmag
JANUARY 24, 2021
A group of scientists is calling on governments to consider the continued use of strict control measures as the only way to reduce the evolution and spread of new COVID-19 variants. The experts in evolution, virology, infectious disease and genomics – at the University of East Anglia (UEA), Earlham Institute and University of Minnesota – […].
BioSpace
JANUARY 24, 2021
T cell company TScan Therapeutics announced it will push two cancer therapies into the clinic this year thanks to a $100 million Series C round.
JAMA Internal Medicine
JANUARY 24, 2021
This cohort study assesses the association of cumulative smoking exposure, as measured by pack-years, with outcomes of patients with coronavirus disease 2019.
BioSpace
JANUARY 24, 2021
With a presidential inauguration and a federal holiday, it wasn’t an enormously busy week for clinical trial news, but there was a fair amount, nonetheless. Read on to see.
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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
JANUARY 24, 2021
The latest study was ranked among the top five percent publications in the field, thus earning a VIP status, and a journal cover! Credit: Ru?er Boškovi? Institute These results were published in the prestigious journal ChemSusChem and thanks to the remarkable reviews, the paper was ranked among the top five percent publications in the field, […].
BioSpace
JANUARY 24, 2021
AstraZeneca spinout Albireo Pharma is moving closer to securing regulatory approval for its treatment of pruritus in patients with progressive familial intrahepatic cholestasis (PFIC).
The Pharma Data
JANUARY 24, 2021
. VANCOUVER, BC , Jan. 25, 2021 /PRNewswire/ — Notch Therapeutics Inc., a biotechnology company developing renewable stem cell-derived T cell therapies for cancer and other immune disorders, announced today the appointment of Chris Bond , Ph.D. as Senior Vice President, Preclinical and Translational Sciences. Dr. Bond joins Notch from Kite, where he most recently served as Vice President of Cellular Engineering. “We are excited to welcome Chris, a highl
BioSpace
JANUARY 24, 2021
Moderna announced it has started development on a booster to its COVID-19 vaccine, which the company hopes will work against the recently discovered (and more transmissible) SARS-CoV-2 variant from South Africa.
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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.
The Pharma Data
JANUARY 24, 2021
Toronto, Ontario–(Newsfile Corp. – January 25, 2021) – PharmaDrug Inc. (CSE: BUZZ) (OTC: LMLLF) (“ PharmaDrug ” or the “ Company “), a specialty pharmaceutical company focused on the development and commercialization of controlled-substances and natural medicines such as psychedelics, cannabis and naturally-derived approved drugs, today announced that it has entered into the definitive agreement in respect of the previously announced (see press release d
Drug Patent Watch
JANUARY 24, 2021
Annual Drug Patent Expirations for ORIAHNN+%28COPACKAGED%29 Oriahnn (copackaged) is a drug marketed by Abbvie Inc and is included in one NDA. It is available from one supplier. There are five…. The post New patent expiration for Abbvie Inc drug ORIAHNN (COPACKAGED) appeared first on DrugPatentWatch - Make Better Decisions.
The Pharma Data
JANUARY 24, 2021
Located in Korea’s ‘Bio Cluster’ of Songdo in the Incheon Free Economic Zone (IFEZ). The 52,000-square-foot campus to become the hub of Samsung Bioepis’ drive for accelerated development of next-generation biologic medicines. Includes ‘Welfare Center’ with cafeteria, in-house fitness center, and a daycare center. A photo accompanying this announcement is available at [link].
Drug Patent Watch
JANUARY 24, 2021
Annual Drug Patent Expirations for ORILISSA Orilissa is a drug marketed by Abbvie Inc and is included in one NDA. It is available from one supplier. There are eight patents…. The post New patent expiration for Abbvie Inc drug ORILISSA appeared first on DrugPatentWatch - Make Better Decisions.
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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.
The Pharma Data
JANUARY 24, 2021
Jan. 25, 2021 12:00 UTC. CAMBRIDGE, Mass.–( BUSINESS WIRE )– Faze Medicines , a biotechnology company pioneering therapeutics based on the groundbreaking new science of biomolecular condensates, today announced that it has appointed Philip Vickers, Ph.D., as its chief executive officer (CEO). Dr. Vickers previously served as president and CEO of Northern Biologics and has worked in a diverse array of senior leadership roles across biotech and leading pharma companies.
Pharma in Brief
JANUARY 24, 2021
In this article, the Pharma in Brief team has curated and provided updates on the most significant topics we covered in 2020. Introduction. The Canadian pharma and life sciences space saw many developments in 2020, despite and in some cases because of the COVID-19 pandemic. The industry was among the heroes of 2020, developing, commercializing and distributing drugs, vaccines, and personal protective equipment to deal with COVID-19 at remarkable speeds.
The Pharma Data
JANUARY 24, 2021
TORONTO, ON / ACCESSWIRE / January 25, 2021 / Theralase Technologies In c. (“ Theralase ” or the “ Company “) ( TSXV:TLT )( OTCQB:TLTFF ), a clinical stage pharmaceutical company focused on the research and development of light activated Photo Dynamic Compounds (“ PDC “) and their associated drug formulations used to safely and effectively destroy various cancers, bacteria and viruses announced today that MidLantic Urology (“M U “) has received sit
BioSpace
JANUARY 24, 2021
Ramaswamy told shareholders the move was to separate himself from Roivant’s day-to-day operations in part due to his “increasing public engagement.
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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
JANUARY 24, 2021
MONTREAL, Jan. 25, 2021 (GLOBE NEWSWIRE) — Canadian Blood Services and Canada’s COVID-19 Immunity Task Force (CITF) are releasing new results from their collaborative nine-province SARS-CoV-2 seroprevalence study. This analysis, based on 33,860 blood samples from blood donor centres across Canada (excluding Quebec and the Territories) collected in October and November 2020, suggests that 1.5 per cent of healthy Canadians had been exposed to SARS-CoV-2, the virus causing COVID-19.
BioSpace
JANUARY 24, 2021
Pfizer, Moderna, AstraZeneca, and Johnson & Johnson all have trials of their respective vaccines underway in various age-groups.
The Pharma Data
JANUARY 24, 2021
LOS ANGELES, Jan. 25, 2021 (GLOBE NEWSWIRE) — Calibre Scientific is pleased to announce the acquisition of AIT France (“AIT”), a manufacturer and distributor of innovative consumables for analytical chemistry and chromatography. With this acquisition, Calibre Scientific bolsters its strength in the chromatography market and continues to broaden its life sciences presence in Europe.
Scienmag
JANUARY 24, 2021
PULLMAN, Wash. – Man’s best friend might actually belong to a woman. In a cross-cultural analysis, Washington State University researchers found several factors may have played a role in building the mutually beneficial relationship between humans and dogs, including temperature, hunting and surprisingly – gender. “We found that dogs’ relationships with women might have had […].
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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
JANUARY 24, 2021
SUNDAY, Jan. 24, 2021 — The new year is the ideal time to focus on your health and one expert has some tips, especially for men, for doing that. According to Dr. Kevin McVary, director of Loyola Medicine Men’s Health Center, in Maywood, Ill., “Men don’t always focus on their health and, in fact, men are less likely to see a doctor or utilize health resources, and wait longer than women to seek care.
Scienmag
JANUARY 24, 2021
New estimates reveal extent of the health burden of armed conflict–affecting at least 630 million women and children worldwide in 2017, and contributing to more than 10 million deaths among children under 5 years of age over 20 years New estimates reveal extent of the health burden of armed conflict–affecting at least 630 million women […].
The Pharma Data
JANUARY 24, 2021
OCEANSIDE, Calif., Jan. 25, 2021 /PRNewswire/ — Therapeutic Solutions International, Inc., (OTC Markets: TSOI), announced today expansion of its preclinical dataset on StemVacs, an umbilical cord generated dendritic cell immunotherapy. In a series of laboratory experiments, StemVacs administration was demonstrated to induce regression of GL261 glioma, CT-26 colorectal cancer, and Lewis Lung Carcinoma tumors grown in mice. Last week the Company reported that StemVacs admi
Scienmag
JANUARY 24, 2021
Female childhood cancer survivors face a lower likelihood of becoming pregnant than women in the general population, but once pregnant, they are not more likely to undergo an abortion. The findings come from a new study published early online in CANCER, a peer-reviewed journal of the American Cancer Society. Cancer survivors might be reluctant to […].
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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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