Bio Pharma Dive
NOVEMBER 5, 2021
The drugmaker, which last week won FDA clearance of its vaccine in younger children, plans to quickly ask the agency for emergency authorization of the drug in high-risk patients.
World of DTC Marketing
NOVEMBER 5, 2021
SUMMARY: Wegovy is selling so well that it’s hard to get at pharmacies. It’s being positioned as an anti-obesity drug, but one study by Novo Nordisk has shown that people who stop taking Wegovy after a few months tend to regain much of their lost weight within a year. In addition, people who lost weight on Wegovy in clinical trials had nutritional counseling and had to stay on a strict diet.
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Pharma Times
NOVEMBER 5, 2021
The trial evaluated the investigational medicine in non-hospitalised adult patients with COVID-19 who are at high-risk of progressing to severe illness
pharmaphorum
NOVEMBER 5, 2021
An oral antiviral drug developed by Pfizer has been shown to dramatically cut the risk of hospitalisation or death from COVID-19 when given in the early stages of infection. The phase 3 trial found that Paxlovid – which combines new protease inhibitor PF-07321332 with already-approved HIV drug ritonavir – reduced the risk of hospitalisation or death by 89% when given to newly-diagnosed adults who were at risk of developing severe COVID-19 in the EPIC-HR trial.
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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
BioPharma Reporter
NOVEMBER 5, 2021
CEPI, the Coalition for Epidemic Preparedness Innovations, has announced the first funding awards under a $200m program to advance development of vaccines against SARS-CoV-2 variants and other betacoronaviruses.
pharmaphorum
NOVEMBER 5, 2021
Novartis has chalked up another successful trial for its targeted factor B inhibitor iptacopan, an orally-active drug trying to challenge antibody-based therapies for diseases associated with the complement pathway. A phase 2 trial of iptacopan in patients with the rare kidney disease C3 glomerulopathy (C3G) – which causes progressive kidney failure and has no approved treatments – showed reductions in kidney damage with the drug that Novartis said were “clinically important.” C3G of
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
pharmaphorum
NOVEMBER 5, 2021
In the latest episode of the podcast Dominic Tyer speaks with Pierre Bourdage, who’s global head of biopharmaceuticals at Sandoz about the big issues in biosimilars. They look at how biosimilars are changing healthcare and what the market looks like today, as well as Sandoz’s involvement in the area and the company’s future plans in biosimilars. It’s an episode that covers the regulatory position of biosimilars, uptake of these medicines by healthcare professionals and what biosimilars need next
BioPharma Reporter
NOVEMBER 5, 2021
bluebird bio has signed a long-term lease for a 61,000 square foot facility at Assembly Row, Greater Boston: saying the new headquarters has been designed to reflect modern ways of working and deliver significant cost savings.
XTalks
NOVEMBER 5, 2021
Maple Leaf Foods, one of Canada’s largest pork and poultry processors, announced yesterday it would be reevaluating its plant-based protein business. The company’s third-quarter financial results revealed that while its meat group performed well, there was a slowdown in its plant-based protein segment. Sales in the category fell 6.6 percent on the back of declining retail sales.
Scienmag
NOVEMBER 5, 2021
Frogs’ anatomy and organ function are strikingly similar to those of humans. An international team led by Soeren Lienkamp, professor at the Institute of Anatomy at UZH, has now exploited this similarity by using a tiny tropical frog called Xenopus tropicalis to model human genetic diseases. The researchers focused on polycystic kidney disease, a congenital […].
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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
pharmaphorum
NOVEMBER 5, 2021
Tens of thousands of people with chronic kidney disease in England could be eligible for treatment with AstraZeneca’s SGLT2 inhibitor Forxiga, after NICE backed NHS use of the drug in draft recommendations. AZ said that the decision is a “milestone” in the treatment of CKD, becoming the first new treatment option for patients in nearly 20 years, although it cautioned that the recommendations as they stand could apply a brake on broad access.
Scienmag
NOVEMBER 5, 2021
Alliance for Cancer Gene Therapy (ACGT) Scientific Advisory Council Chair Michael T. Lotze, MD, of the University of Pittsburgh, will be honored with the 2021 Society for Immunotherapy of Cancer (SITC) Lifetime Achievement Award at the SITC 36th Annual Meeting, Nov. 10-14, in Washington D.C. Credit: University of Pittsburgh Alliance for Cancer Gene Therapy (ACGT) […].
NY Times
NOVEMBER 5, 2021
Pfizer’s is the second pill to show effectiveness against Covid-19, and it is the first purpose-built to attack the virus that causes the disease.
Scienmag
NOVEMBER 5, 2021
Treating diseases such as Alzheimer’s or Parkinson’s is a challenge because drugs have to be able to cross the blood–brain barrier. As a result, the doses administered must be high and only a small fraction reaches the brain, which can lead to significant systemic side effects. To solve this issue, the postdoctoral researcher Jean-Michel Rabanel, […].
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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.
Pharma Times
NOVEMBER 5, 2021
Forxiga becomes the first new treatment option for CKD patients in nearly 20 years
Scienmag
NOVEMBER 5, 2021
Millions of people in Asia are dependent on rice as a food source. Believed to have been domesticated as early as 6000 BCE, rice is an important source of calories globally. In a new study, researchers compared domesticated rice to its wild counterparts to understand the differences in their photosynthetic capabilities. The results can help improve […].
Pharma Times
NOVEMBER 5, 2021
Investigational treatment is being evaluated in patients with C3 glomerulopathy
Scienmag
NOVEMBER 5, 2021
About 20 years ago, Michigan State University’s B. Alex Brown had an idea to reveal insights about a fundamental but enigmatic force at work in some of the most extreme environments in the universe. Credit: Credit: Facility for Rare Isotope Beams About 20 years ago, Michigan State University’s B. Alex Brown had an idea to […].
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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.
Drug Channels
NOVEMBER 5, 2021
Today’s guest post comes from Ashleigh Burdette, Senior Director of Clinical Innovation at Biologics by McKesson. Ashleigh explains how biopharma companies can help patients become more adherent and achieve better health outcomes by partnering with an experienced specialty pharmacy that offers risk-based care. . To learn more about the risk-based care approach, download the free whitepaper: Risk-Based Care Helps Cancer Treatment Adherence.
Scienmag
NOVEMBER 5, 2021
A temporal change in the titania surface chemical state during the UV light irradiation is not observable through conventional methods such as regular FTIR or Raman spectroscopy. Therefore, a team led by Professor Hiromasa Nishikiori of Shinshu University’s RISM observed this reaction through time-resolved fluorescence spectroscopy. The team noted the monoanion transformation to the dianion […].
The Pharma Data
NOVEMBER 5, 2021
Statistically significant and clinically important reductions in proteinuria were achieved for the primary endpoint for patients with C3G 1 Additionally, statistically significant reduction in C3 protein deposits were achieved in the same study in a cohort of patients whose C3G recurred following kidney transplantation 1 No current approved treatments exist for C3G – a rare and often progressive disease that often affects adolescents and young adults and frequently progresses to kidney failure 2
Scienmag
NOVEMBER 5, 2021
New Brunswick, N.J. (Nov, 5, 2021) – Rutgers researchers studying COVID-19 have created a new way to deliver DNA molecules into skin cells, using a suction technique similar to the ancient healing practice of cupping. Credit: Shutterstock New Brunswick, N.J. (Nov, 5, 2021) – Rutgers researchers studying COVID-19 have created a new way to deliver DNA […].
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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
NOVEMBER 5, 2021
U.K.’s Medicines and Healthcare Products Regulatory Agency Authorizes Molnupiravir for the Treatment of Mild-to-Moderate COVID-19 in Grown-ups With a Positive SARS-CoV-2 Diagnostic Test and Who Have at Least One Threat Factor for Developing Severe Illness. Operations Remain Under Review by Other Regulatory Authorities, IncludingU.S. Food and Drug Administration and the European Medicines Agency Merck (NYSE MRK), known as MSD outside the United States and Canada, and Ridgeback Biotherapeutics mom
Scienmag
NOVEMBER 5, 2021
New research, published in Scientific Reports by Smithsonian Tropical Research Institute (STRI) postdoctoral fellow Karina Chavarria and colleagues, shows that bacterial communities in streams adjacent to young secondary forests recover to resemble those of mature forest streams in as little as a decade after cattle has been removed from the land, and that these communities […].
The Pharma Data
NOVEMBER 5, 2021
– In a new sub-analysis of the landmark EMPEROR-Preserved® phase III trial, Jardiance reduced the combined relative risk of cardiovascular death and hospitalization for heart failure and slowed kidney function decline – Jardiance consistently improved outcomes across the full range of kidney function down to an eGFR of 20 mL/min/1.73 m2.
Scienmag
NOVEMBER 5, 2021
The international jury of the Stockholm Prize in Criminology has recognized the University of Cincinnati’s Distinguished Research Professor Emeritus Dr. Francis T. Cullen for his evidence-based research that demonstrates the value of rehabilitation services linked to criminal sentencing. Credit: University of Cincinnati The international jury of the Stockholm Prize in Criminology has recognized the University […].
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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
NOVEMBER 5, 2021
Producing Medicines for the United States, the Plant Features Innovative Technologies and Advancements in Sustainability. Amgen today announced the groundbreaking of its newest biomanufacturing plant, located in New Albany, Ohio. The final product assembly and packaging plant will support the growing demand for Amgen’s medicines in the United States and is expected to be operational by 2024. “Amgen’s choice to build a cutting-edge facility where approximately 400 Ohioans will a
Scienmag
NOVEMBER 5, 2021
As forests age, differences in species functional traits become more important and reliable in predicting forest productivity, according to an international study led by Prof. MA Keping at the Institute of Botany of the Chinese Academy of Sciences (IBCAS). Credit: Xiaojuan Liu As forests age, differences in species functional traits become more important and reliable […].
Drug Patent Watch
NOVEMBER 5, 2021
Annual Drug Patent Expirations for EPIDIOLEX Epidiolex is a drug marketed by Gw Res Ltd and is included in one NDA. It is available from one supplier. There are seventeen…. The post New patent for Gw Res drug EPIDIOLEX appeared first on DrugPatentWatch - Make Better Decisions.
Scienmag
NOVEMBER 5, 2021
The neurons, located in the brain are interconnected in a complex pattern and establish special communication points, the synapses. All neurons require a constant environment in order to function reliably. To ensure this, the brain is surrounded by the so-called blood-brain barrier. It ensures, for example, that the nutrient balance always remains the same and […].
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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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