Bio Pharma Dive
SEPTEMBER 1, 2022
A well-known physician-scientist who joined Novartis from Harvard, Jay Bradner spent over six years steering the company’s research hub. He will be replaced by Merck executive Fiona Marshall.
Pharmaceutical Technology
SEPTEMBER 1, 2022
Guardant Health has extended a partnership with Merck KGaA, Darmstadt, Germany, to aid in expediting precision oncology therapeutics development. Under the collaboration, the companies will use the GuardantINFORM real-world evidence (RWE) platform to boost works for developing Merck’s precision cancer pipeline. The development of therapies for key oncology indications with substantial unmet needs will be the expanded partnership’s focus.
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Bio Pharma Dive
SEPTEMBER 1, 2022
The target company, Forma Therapeutics, started as a developer of cancer drugs but has made the most progress in rare blood disorders, attracting Novo’s attention.
Pharmaceutical Technology
SEPTEMBER 1, 2022
Analysts at GlobalData predict that the market for point-of-care (POC) diagnostic devices will reach $297.6bn by 2023, a growth of almost $1bn from 2015. While a significant proportion of this increase is due to the volume of lateral flow tests (LFTs) manufactured to perform mass screening of populations for Covid-19 over the last two years, this trend towards POC diagnostics is positive news.
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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
SEPTEMBER 1, 2022
Approval of Xenpozyme, a treatment for a form of Niemann-Pick disease, comes with a valuable priority review voucher for Sanofi.
Pharmaceutical Technology
SEPTEMBER 1, 2022
Buildings vacated at the peak of Covid-19 are subject to greater risks of water stagnation due to a lack of flow and activity. Even if buildings have been reopened for some time, there may be unresolved risks within water systems. Returning occupants are at risk of exposure to harmful bacteria. From hospitals and hotels to offices and gyms, water stagnation must be mitigated wherever water may be directly consumed or used for washing.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
BioPharma Reporter
SEPTEMBER 1, 2022
Arcturus Therapeutics has obtained an award for up to $63.2m from the Biomedical Advanced Research and Development Authority (BARDA): allowing the company to expand its current influenza vaccine program to include development of a pandemic influenza vaccine based on its proprietary self-amplifying mRNA platform.
NPR Health - Shots
SEPTEMBER 1, 2022
One year after a restrictive abortion law took effect, a poll shows a majority of Texans surveyed say they support abortion access in most or all cases. Many say the issue will motivate them to vote.
STAT News
SEPTEMBER 1, 2022
As the country heads for its third autumn and winter with Covid-19, the forecasts are not auspicious. Given how transmissible the SARS-CoV-2 virus is, models anticipate more than 100,000 additional deaths by the time next summer rolls around. The toll will depend on whether new variants emerge and how humans behave. Will many Americans, for example, decide to get the new, Omicron-tailored booster that could be available as soon as this weekend?
pharmaphorum
SEPTEMBER 1, 2022
AstraZeneca has succeeded in a last-gasp effort to stop its former head of investor relations joining rival UK pharma group GSK, after winning an injunction in the High Court in London. Chris Sheldon ended an almost 19-year career at AZ in August, working his way up from a lab role and holding a series of senior positions at the company, most recently as head of investor relations.
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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
STAT News
SEPTEMBER 1, 2022
An expert committee that advises the Centers for Disease Control and Prevention on vaccine policy voted on Thursday to recommend use of updated Covid-19 vaccines. With the positive votes from the Advisory Committee on Immunization Practices, the issue now goes to CDC Director Rochelle Walensky. If she signs off on the recommendation — and she is expected to do so, possibly Thursday evening — the new boosters will be cleared for use.
pharmaphorum
SEPTEMBER 1, 2022
Cyrus Massoumi, founder of Dr. B, tells us about his online platform that makes physician assessment readily available to patients and provides access to COVID-19 therapeutics that may otherwise be difficult to obtain. COVID-19 antiviral medications Paxlovid (nirmatrelvir/ritonavir) and Lagevrio (molnupiravir) must be taken within five days of the onset of symptoms, but obtaining these medications within that window is difficult for some.
STAT News
SEPTEMBER 1, 2022
Much of the public’s perceptions around food as an intervention for health are dated. So are the U.S. government’s perceptions and its health care policies. Not by a matter of years, but by decades. The last time the nation focused on food — from the top — was the 1969 White House Conference on Food, Nutrition, and Health.
NPR Health - Shots
SEPTEMBER 1, 2022
The college's student health center became the center of a maelstrom this past week, after students learned the Catholic health agency hired to run it follows religious restrictions on contraception.
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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.
STAT News
SEPTEMBER 1, 2022
Maria Van Kerkhove gets it. Truly, she knows you’re over Covid. The World Health Organization’s technical lead for Covid-19, Van Kerkhove understands that the world is struggling with a lot right now. Devastating flooding in Pakistan, famine in the Horn of Africa, war in Ukraine, monkeypox around the globe — there are too many demands for our attention and concern, for philanthropic and government funding.
BioPharma Reporter
SEPTEMBER 1, 2022
The US regulator has granted emergency authorization for Pfizer-BioNTechâs and Modernaâs Covid booster shots that target the highly contagious BA.5 omicron subvariant.
STAT News
SEPTEMBER 1, 2022
Covid-19 pummeled public health agencies and organizations. Future crises, whether from infectious disease, extreme weather, or other sources, are likely to do the same unless they change their approach to public health reporting, data management, and information exchange. Managing public health is not easy, especially in the United States. Not only is this country home to diverse populations that have varying genetic predispositions and cultural patterns of medical significance, it is also geog
Pharma Times
SEPTEMBER 1, 2022
Fourth award from the Bill & Melinda Gates Foundation will support artemisinin research
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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.
STAT News
SEPTEMBER 1, 2022
What can worms teach us about immortality? How does one become the Godfather? And where does Biogen go from here? We cover all that and more this week on “The Readout LOUD,” STAT’s biotech podcast. Our colleague Megan Molteni joins us to explain the scientific discoveries, rampant hype, and Silicon Valley billions behind the burgeoning field of longevity research.
Pharma Times
SEPTEMBER 1, 2022
Pro-doxorubicin will advance to the fourth dose following a positive review of safety and tolerability
STAT News
SEPTEMBER 1, 2022
SAN DIEGO — Sequencing behemoth Illumina on Thursday won its case against the Federal Trade Commission in its bid to hold onto Grail, a Bay Area early cancer detection company that the genomics giant acquired for $8 billion last year. An administrative law judge rejected the FTC’s argument that the San Diego company’s acquisition of Grail would quash competition in the nascent market for multi-cancer early detection, a technology that picks up on a wide range of cancer types
pharmaphorum
SEPTEMBER 1, 2022
Jay Bradner, president of the Novartis Institutes for Biomedical Research (NIBR), is retiring from the position after seven years in the role, and will be replaced by Merck & Co R&D executive Fiona Marshall. Novartis said this morning that Bradner (pictured above left) – who is also stepping down from the executive committee – is leaving to “pursue a next chapter of scientific contribution and leadership” outside the company.
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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.
STAT News
SEPTEMBER 1, 2022
Good morning. This is Jonathan with you once more. We’re now close enough to the weekend that it’s time to start making plans (or looking forward to the ones you’ve made), but far enough that there’s still plenty of work to do. Oh, the agony. Hope these engaging news items help ease the pain. The Food and Drug Administration authorized new Covid booster shots that more closely match the strains of the coronavirus currently circulating in the U.S., STAT tells us.
Pharma in Brief
SEPTEMBER 1, 2022
In this post, we summarize the current status of reforms to the Patented Medicine Prices Review Board ( PMPRB ). These reforms commenced with August 2019 amendments to the Patented Medicines Regulations (the Amendments ) and accompanying changes to the Board’s Guidelines. Background of the proposed reforms. The Amendments were intended to lower the prices of patented medicines in Canada.
STAT News
SEPTEMBER 1, 2022
In 2021, Jennifer Huberty left her post in academia to become the first full-time head of science at Calm. She set about building a team to beef up the multibillion dollar meditation app’s bonafides, hiring researchers from Harvard, Brown, and other prestigious institutions. A year later, Huberty has departed the company to strike out on her own as a scientific consultant for digital health companies, and the future of her science team and the company’s broader research efforts is
Trialfacts
SEPTEMBER 1, 2022
Contents. About the Study. Why Participate? Your Rights. Who Can Participate? More Study Details. About the Research Center: Location. Research Center: University of Delaware. Location: Delaware, USA (in-person visits) or virtual visits via Zoom. Lead Researcher: Dr. Lauren Covington. IRB: This study has been reviewed and approved by the University of Delaware Institutional Review Board.
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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.
Intouch Solutions
SEPTEMBER 1, 2022
Authors: Paris Daniell, Jeff Greene, Andrew Grojean, Jeff MacFarland, Sarah Morgan, Rachel Stelmach, Carly Stillwell. The “nextmakers” of EVERSANA INTOUCH know the Medical Metaverse is changing everything, whether you’re a patient, a provider, a caregiver… or a brand marketer. So we scour the world for the latest on the metaverse in healthcare, and update you regularly on what you need to know.
pharmaphorum
SEPTEMBER 1, 2022
Mia Ekdahl, head of relations and communications at Health Works, an AstraZeneca division, joins pharmaphorum Editor-in-Chief Jonah Comstock to discuss the work her team is doing to approach healthcare problem-solving in a novel, patient-centric way. Too often digital health efforts find themselves in the unfortunate position of being solutions in search of a problem, with a company or health system so invested in a particular technology or modality it loses sight of the holistic, complex nature
Intouch Solutions
SEPTEMBER 1, 2022
Are you writing for Google instead of Gail or Greg? The new Google algorithm update may be bad news for you. Google updates its algorithm thousands of times a year, but they rarely announce them, let alone give advanced notice – so, when they do, webmasters need to pay attention. Google provided an early announcement of this “helpful content update” on August 18,offering guidance to prepare, and started its two-week rollout on August 25.
Drug Discovery World
SEPTEMBER 1, 2022
Scottish scientists are teaming up with researchers from Zambia to find new ways to diagnose and treat a condition which affects millions in Sub-Saharan Africa. . Ms Kanekwa Zyambo, from the University of Zambia, is spending two weeks at the Scottish Universities Environmental Research Centre in East Kilbride to master new technology to help understand environmental enteropathy (EE).
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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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