Bio Pharma Dive
FEBRUARY 26, 2021
Friday's advisory committee meeting is one of the last steps in the FDA's review and could clear the way for an emergency authorization within days. Biopharma Dive will cover live here.
pharmaphorum
FEBRUARY 26, 2021
Healthcare organisations that have been traditionally slow to adopt new technology produced a response to the pandemic that was almost in line with less regulated industries, according to a new report. Findings of research from the cloud communications platform Twilio based on 2,500 enterprise decision makers, including 117 healthcare organisations, showed it took 36 days on average to accelerate a digital transformation strategy.
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Bio Pharma Dive
FEBRUARY 26, 2021
Executives shared an update on the biotech's investigation of the two cases at an investor conference, rather than via a statement or regulatory filing.
pharmaphorum
FEBRUARY 26, 2021
Rare diseases impact between 3.5%-5.9% of the world’s population. For Rare Disease Day, RBW Consulting’s Emma Thorp discusses why the consultancy is taking revenue earned from its rare disease clients and using it to fund research into the mental health impact of a rare disease diagnosis. Rare diseases are often chronic and life-threatening, and with a large percentage of cases presenting in young children, a diagnosis has a profound and unique impact on everyone affected.
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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
Bio Pharma Dive
FEBRUARY 26, 2021
In a unanimous vote, the panel of experts gave a green light to the FDA for clearing J&J's shot, judging the benefits of vaccination outweigh its risk.
pharmaphorum
FEBRUARY 26, 2021
UCB and Microsoft have announced a multi-year strategic collaboration to advance the digitalisation of the Belgian pharma company and accelerate its research efforts. The companies have already been working together on the COVID Moonshot Project, which aimed to create an orally available antiviral to combat the SARS-CoV-2 coronavirus. UCB completed six months’ worth of computational screening and compound design in three days using the technology.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
pharmaphorum
FEBRUARY 26, 2021
For episode 30 I spoke with Dr Ashton Harper, who’s head of medical affairs in the UK and Ireland at Roche Diagnostics, about the pressure COVID-19 has put on healthcare systems. A former NHS doctor, he noted how stressful and draining some days can be when working at healthcare’s frontline – even in normal times, and that the current fight against the pandemic brings little respite to staff.
Scienmag
FEBRUARY 26, 2021
Blast trauma and the human brain Credit: UT Arlington A University of Texas at Arlington researcher has received an Office of Naval Research (ONR) grant to examine the mechanics of how blast-like events cause damage to the brain. Ashfaq Adnan, professor of mechanical and aerospace engineering, has received a three-year, $944,845 grant to study the […].
pharmaphorum
FEBRUARY 26, 2021
Rare diseases affect a fraction of the population – 450 million + people globally. However, its effects can be equally severe and life-threatening as other prevalent diseases. For Rare Disease Day, Tarun Kumar Bansal discusses why we need to expedite innovation in the rare disease domain. Every time a patient with a rare condition walks into a hospital, doctors face the probable challenge of starting from scratch.
Scienmag
FEBRUARY 26, 2021
University of Missouri researcher says the exercise guides can also be used by low-income families to promote a healthy lifestyle Credit: University of Missouri College of Education COLUMBIA, Mo. – While physical activity is important for everyone, research has shown people with developmental disabilities do not exercise as often as their typically developed peers.
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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
FEBRUARY 26, 2021
AstraZeneca says full data from the NAVIGATOR trial of tezepelumab in severe asthma keep it on course to file for approval in the first half of this year, with a broader indication than rival biologic drugs. . Top-line data were reported last year, but a presentation at the American Academy of Asthma Allergy & Immunology (AAAAI) virtual congress today is the first opportunity for doctors to see the dataset in full.
XTalks
FEBRUARY 26, 2021
The plight of Black people in North America is defined by a long history involving battles for human rights, fighting against discrimination and incessant struggles for the assertion of Black people as equal members of society. Many of these battles unfortunately continue today, as historic prejudices and stereotypes have yet to be completely eradicated.
Scienmag
FEBRUARY 26, 2021
Rice University lab’s process simplifies fluoroketone synthesis Credit: Illustration by Renee Man/@chemkitty HOUSTON – (Feb. 26, 2021) – Save your silver! It’s better used for jewelry than as a catalyst for drugs. Rice University scientists have developed a greatly simplified method to make fluoroketones, precursors for drug design and manufacture that typically require a silver […].
pharmaphorum
FEBRUARY 26, 2021
Pharma’s historic R&D efforts have given us some light at the end of the COVID tunnel. Now it’s time for the industry to start doing what it was unable to do at the outset of COVID-19 – planning for the future to ensure the R&D landscape can remain as strong as it is now. As we find out in this issue, achieving this will require the industry to harness agile working, digitalisation and new, collaborative infrastructures.
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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
FEBRUARY 26, 2021
Credit: UM photo MISSOULA – University of Montana researchers and their partners have discovered a slimy strategy used by bacteria to defeat antibiotics and other drugs used to combat infections afflicting people with cystic fibrosis. The research was published Feb. 23 in the journal Cell Reports. Cystic fibrosis is a life-threatening disease that causes persistent […].
pharmaphorum
FEBRUARY 26, 2021
McCann Health has announced the promotion of medical director Dan Carucci to global chief medical officer. . An expert voice in the scientific and medical community, Dr Carucci will use vast knowledge and experience in innovative medicine, practice and delivery to contribute authoritative science to the agency’s clients and businesses. In this new role, Carucci will work closely with McCann Health clients’ medical teams to better understand how to address communications challenges an
Scienmag
FEBRUARY 26, 2021
Results have implications for life on Mars Credit: Photo courtesy Justine Sauvage NARRAGANSETT, R.I. – February 26, 2021 – A team of researchers from the University of Rhode Island’s Graduate School of Oceanography and their collaborators have revealed that the abundant microbes living in ancient sediment below the seafloor are sustained primarily by chemicals created […].
pharmaphorum
FEBRUARY 26, 2021
NICE has recommended moving Novartis’ Kisqali (ribociclib) from interim funding arrangements to regular NHS reimbursement for certain previously treated breast cancer patients. In the final draft guidance, NICE recommended Kiskali be taken out of the Cancer Drugs Fund, which has been providing interim reimbursement since 2019 until further trial data emerged addressing uncertainties about overall survival and cost-effectiveness.
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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.
Scienmag
FEBRUARY 26, 2021
Credit: Ida Christensen, University of Copenhagen Based on a manual recently discovered in a 3,500-year-old medical papyrus, University of Copenhagen Egyptologist Sofie Schiødt has been able to help reconstruct the embalming process used to prepare ancient Egyptians for the afterlife. It is the oldest surviving manual on mummification yet discovered.
NY Times
FEBRUARY 26, 2021
The government will pay $210 million for the doses, which Eli Lilly will ship by the end of March.
Scienmag
FEBRUARY 26, 2021
Computer scientists show benefits of bioinformatics with PlasmidHawk Credit: Tommy LaVergne/Rice University HOUSTON – (Feb. 26, 2021) – Tracking the origin of synthetic genetic code has never been simple, but it can be done through bioinformatic or, increasingly, deep learning computational approaches. Though the latter gets the lion’s share of attention, new research by computer […].
Olympian Clinical Research
FEBRUARY 26, 2021
Clinical trials are research studies designed to evaluate or test a medical, surgical, or behavioral intervention. Most studies center around a specific medical condition or mental disorder, such as Psoriasis , Atopic Dermatitis , Alzheimer’s, or Obsessive Compulsive Disorder. Most recently, clinical trials have gained recognition through the development and testing of Covid-19 vaccines.
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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.
Scienmag
FEBRUARY 26, 2021
Credit: A. Gillett The koala retrovirus (KoRV) is a virus which, like other retroviruses such as HIV, inserts itself into the DNA of an infected cell. At some point in the past 50,000 years, KoRV has infected the egg or sperm cells of koalas, leading to offspring that carry the retrovirus in every cell in […].
Drug Patent Watch
FEBRUARY 26, 2021
Annual Drug Patent Expirations for EXONDYS+51 Exondys 51 is a drug marketed by Sarepta Theraps Inc and is included in one NDA. It is available from one supplier. There are…. The post New patent for Sarepta Theraps drug EXONDYS 51 appeared first on DrugPatentWatch - Make Better Decisions.
Scienmag
FEBRUARY 26, 2021
Credit: KBRI Korea Brain Research Institute (KBRI, President Suh Pann-ghill) announced that the research team led by Dr. Jae-Yeol Joo discovered new cryptic splice variants and SNVs in PLCg1 gene of AD-specific models for the first time using Splice-AI. This research outcome was published in PNAS, a world-renowned academic journal. * (Title) Prediction of Alzheimer’s […].
Drug Patent Watch
FEBRUARY 26, 2021
Annual Drug Patent Expirations for IBRANCE Ibrance is a drug marketed by Pfizer and is included in two NDAs. It is available from three suppliers. There are five patents protecting…. The post New patent for Pfizer drug IBRANCE appeared first on DrugPatentWatch - Make Better Decisions.
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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.
Scienmag
FEBRUARY 26, 2021
Credit: Apiraksena K, Namchote S, Komsuwan J, and Krailas D. Parasitic flatworms known as agents of food-borne zoonoses were confirmed to use several species of thiarid snails, commonly found in freshwater and brackish environments in southeast Asia, as their first intermediate host. These parasites can cause severe ocular infections in humans who consume raw or […].
Drug Patent Watch
FEBRUARY 26, 2021
Annual Drug Patent Expirations for ZOKINVY Zokinvy is a drug marketed by Eiger Biopharms and is included in one NDA. The generic ingredient in ZOKINVY is lonafarnib. Additional details are…. The post New patent for Eiger Biopharms drug ZOKINVY appeared first on DrugPatentWatch - Make Better Decisions.
Scienmag
FEBRUARY 26, 2021
Credit: Cody Duty/UTHealth Dropping out of high school, having schizophrenia, or being diagnosed with a co-occurring personality disorder increases the likelihood of someone becoming a “high utilizer” of inpatient psychiatric hospital services, according to a new study by researchers at The University of Texas Health Science Center at Houston (UTHealth).
The Pharma Data
FEBRUARY 26, 2021
Novo Nordisk today announced plans to invest DKK 500 million in expanding facilities at its production site in Måløv, Denmark. The facility currently manufactures products for oral diabetes treatment and will be expanded to ensure capacity for future production of these products. The project is expected to be completed in 2022. “This investment in our production facilities in Måløv is an important step in building and ensuring future capacity for production of Rybelsus ® (oral semaglutide).
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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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