Bio Pharma Dive
JUNE 14, 2021
Highly anticipated results from a Phase 3 study testing the biotech company's shot showed it to be strongly protective and safe, a potential boon for the world's vaccination efforts.
Pharma Times
JUNE 14, 2021
CTX001 is being evaluated as a one-time treatment for transfusion dependent beta thalassemia and sickle cell disease
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Bio Pharma Dive
JUNE 14, 2021
The British drugmaker has become the latest large pharmaceutical company to make a sizable investment in a drug targeting TIGIT, following deals from Bristol Myers Squibb, Gilead and others.
pharmaphorum
JUNE 14, 2021
Accord Healthcare has introduced a new app in the UK designed to help people undergoing treatment for cancer maintain their physical and mental wellbeing. The Unify Health app helps patients understand their illness, track symptoms and treatment progress, receive tips on health habits and importantly can also be used to connect patients with local pharmacists who can provide additional advice and support.
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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
JUNE 14, 2021
We define the most influential clinicians as Clinical Leaders, those who measurably impact the clinical behavior of other clinicians in their "clinical networks.
BioSpace
JUNE 14, 2021
People working on business development are the ones responsible for dealing with the business side of the organization. Dealing with a lot of people, clients and a huge team is part of this job.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
pharmaphorum
JUNE 14, 2021
Rebecca Sanders from Lipodystrophy UK tells us how the patient voice helped convince NICE to approve a much-needed drug for this rare disease, and explores how regulators and pharma companies can help make patient involvement in HTA more impactful. This article appears in our free digital magazine Deep Dive: Market Access 2021. Read below for a preview!
Bio Pharma Dive
JUNE 14, 2021
To extend the shelf life and improve stability of biopharmaceuticals, a freeze-drying process—and a partner—can help.
Drug Patent Watch
JUNE 14, 2021
Annual Drug Patent Expirations for SOTALOL+HYDROCHLORIDE Sotalol Hydrochloride is a drug marketed by Altathera Pharms Llc, Apotex, Beximco Pharms Usa, Epic Pharma Inc, Impax Pharms, Mylan, Oxford Pharms, Sun Pharm…. The post New patent for Altathera Pharms drug SOTALOL HYDROCHLORIDE appeared first on DrugPatentWatch - Make Better Decisions.
Scienmag
JUNE 14, 2021
Credit: Srivastava Lab / Brown Univeristy PROVIDENCE, R.I. [Brown University] — By adding behavioral components to an infectious disease model, Brown University researchers have developed a new modeling approach that captures the peaks and valleys in new COVID-19 cases seen over the past 16 months. The approach, published in the journal Scientific Reports, could be […].
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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
Drug Patent Watch
JUNE 14, 2021
Annual Drug Patent Expirations for DUAKLIR+PRESSAIR Duaklir Pressair is a drug marketed by Astrazeneca and is included in one NDA. There are four patents protecting this drug. This drug has…. The post New patent for Astrazeneca drug DUAKLIR PRESSAIR appeared first on DrugPatentWatch - Make Better Decisions.
BioPharma Reporter
JUNE 14, 2021
Ocugen will pursue submission of a biologics license application (BLA) in the US for the COVID-19 vaccine candidate, COVAXIN, rather than a EUA application. The company believes that the differentiated vaccine has the potential to address variants, as well as planning to undertake paediatric and booster trials.
Drug Patent Watch
JUNE 14, 2021
Annual Drug Patent Expirations for VASCEPA Vascepa is a drug marketed by Amarin Pharms and is included in one NDA. It is available from two suppliers. There are sixty-two patents…. The post New patent for Amarin Pharms drug VASCEPA appeared first on DrugPatentWatch - Make Better Decisions.
Scienmag
JUNE 14, 2021
Credit: Kathryn Bailey, CERDEC CP&I Directorate ADELPHI, Md. — The Institute of Electrical and Electronics Engineers Communications Society recognized an Army researcher and collaborators their work on artificially intelligent techniques that will enhance Soldiers’ situational awareness in the multi-domain operating environment. Dr.
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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
JUNE 14, 2021
Eli Lilly and Company announced Tuesday the launch of a head-to-head study to compare once-monthly injectable Emgality® (galcanezumab-gnlm) with Nurtec® ODT (rimegepant) for the prevention of migraine.
Scienmag
JUNE 14, 2021
Researchers at the University of São Paulo discover that the fungus Fusarium verticillioides uses volatile compounds to manipulate insects and plants, promoting its own dissemination Credit: Heraldo Negri de Oliveira The fungus Fusarium verticillioides is one of the causes of red rot, the most serious sugarcane disease. Losses average around USD 1 billion per harvest […].
BioSpace
JUNE 14, 2021
A sense of urgency, powerful science, relentless ingenuity, hope and trust drove the development of Pfizer and BioNTech’s mRNA vaccine during the height of the COVID-19 pandemic. As the crisis appears to lessen, Pfizer is preparing for the next pandemic.
Scienmag
JUNE 14, 2021
Credit: Photo: Josefin Bergenholtz Nearly 12,000 people in Sweden received sickness benefit from the Swedish Social Insurance Agency for COVID-19 during the first wave of the pandemic. The median duration of sick leave in this group was 35 days, but for many it was considerably more long-drawn-out, according to a University of Gothenburg study. A […].
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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.
FDA Law Blog
JUNE 14, 2021
By Jeffrey K. Shapiro — In our last post on Laboratory Developed Tests (LDTs) , we suggested that Congress, not FDA, should lead in directing modernization of LDT regulation. Any change should be made by enacting new law, and not by Food and Drug Administration (FDA) administrative fiat. Coincidentally, on the same day the post went up, Senator Rand Paul introduced the “Verified Innovative Testing in American Laboratories Act of 2020” or the “VITAL Act of 2020,” a new bill clarifying that the C
Scienmag
JUNE 14, 2021
Credit: Advances in Atmospheric Sciences Earth’s atmosphere has a budget, and when expenses outpace savings, secondary aerosols form in areas of excessive pollution. Greenhouse gases enter the atmosphere, and free radicals bond to the molecules, rendering them inert. But when there are more pollution molecules than free radicals, they are left to recombine and form […].
BioPharma Reporter
JUNE 14, 2021
Thanks in part to swift COVID-19 response and relatively low infection rates, more sites and sponsors are looking at the region to locate their studies.
Scienmag
JUNE 14, 2021
Credit: UT Southwestern Medical Center DALLAS – June 14, 2021 – Overweight cancer patients receiving immunotherapy treatments live more than twice as long as lighter patients, but only when dosing is weight-based, according to a study by cancer researchers at UT Southwestern Medical Center. The findings, published in the Journal for ImmunoTherapy of Cancer, run […].
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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.
BioSpace
JUNE 14, 2021
A recent study conducted by Public Health England found that the available vaccines were “highly effective” at preventing hospitalization after two doses.
Scienmag
JUNE 14, 2021
Credit: by Gil Bashan, Hilel Hagai Diamandi, Yosef London, Kavita Sharma, Keren Shemer, Elad Zehavi and Avi Zadok The internet era that we live in depends completely on the transfer of vast information over optical fibers. Optical fibers are literally everywhere. In fact, the overall length of optical fibers installed on our planet is sufficient […].
BioSpace
JUNE 14, 2021
Besides providing a sense of hope for children with this devastating disease, this research could offer another clue toward unlocking the mystery behind other forms of ALS.
Scienmag
JUNE 14, 2021
UTA student teams take first place, honorable mention in EPA competition Credit: UT Arlington Student teams from The University of Texas at Arlington won first place and honorable mention in the Environmental Protection Agency’s ninth annual Campus RainWorks Challenge. They received the honors in the Master Plan category. The winning team redesigned the University’s master […].
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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.
XTalks
JUNE 14, 2021
Simulate, an American nutrition technology company known for its plant-based chicken product called NUGGS, raised $50 million in a Series B funding round led by Seven Seven Six in partnership with Chris & Crystal Sacca, NOMO Ventures, McCain Foods, Imaginary Ventures and Day One Ventures. To date, they have raised a total of $61 million. . In 2019, the company introduced NUGGS, a pea-protein-based nugget that removes the chicken from the nugget.
BioSpace
JUNE 14, 2021
Brooklyn ImmunoTherapeutics and Novellus have been doing quite a bit of business together lately, including a licensing agreement and co-locating at a research and development center. Now, a potential acquisition can be added to the growing list.
Drug Patent Watch
JUNE 14, 2021
Annual Drug Patent Expirations for PROAIR+DIGIHALER Proair Digihaler is a drug marketed by Teva Branded Pharm and is included in one NDA. It is available from two suppliers. There are…. The post New patent for Teva Branded drug PROAIR DIGIHALER appeared first on DrugPatentWatch - Make Better Decisions.
BioSpace
JUNE 14, 2021
Please check out the biopharma industry's COVID-19 stories that are trending for June 15, 2021.
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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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