Bio Pharma Dive
JANUARY 11, 2021
Biogen faces a crucial FDA decision on its Alzheimer’s drug aducanumab, while Vertex gets used to investor pressure to do a deal. Sarepta, meanwhile, is picking up the pieces after a disappointing gene therapy readout.
World of DTC Marketing
JANUARY 11, 2021
KEY POINTS: The social media shutdown of far-right hate groups and speech is once again spotlighting freedom of speech issues. Whose responsibility is it to ensure that health information, for example, online is accurate and doesn’t lead to bad patient decisions? Pharma has an opportunity to help clarify misinformation via a content and personalization strategy.
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Bio Pharma Dive
JANUARY 11, 2021
Study results could come soon for several coronavirus vaccines, as well as experimental medicines from Amgen, Vertex and Sage Therapeutics.
Pharma Mirror
JANUARY 11, 2021
New program combines human hello to digital embrace for long-term medication support Boston, MA – Medisafe, a leading digital drug companion company, is teaming up with Pleio to launch a new integrated digital health model with a unique combination of human and digital resources. Known as the GoodStart program, Pleio’s concierge service uses mentors to acclimate patients on their prescription therapy via live phone calls and digital nudges, meeting patients’ need for human connection.
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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
JANUARY 11, 2021
Full one-year results from a Phase 3 study show the therapy, known as Roctavian, sharply reduced bleeds and use of blood-clotting treatments.
NY Times
JANUARY 11, 2021
Participants with the disease still declined, but much more slowly than those receiving a placebo, investigators say.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
BioSpace
JANUARY 11, 2021
Evidence continues to build for long-lasting immunity to COVID-19 following disease infection, with the publication of a new study showing a durable immune response as far as eight months after the initial onset of symptoms.
Bio Pharma Dive
JANUARY 11, 2021
PQE Group creates internal task force to fight the biggest side effect of the Covid-19 pandemic: the infodemic. A common vocabulary to reinforce knowledge, security and safety.
BioSpace
JANUARY 11, 2021
The lessons learned from the global pandemic are expected to translate to existing and emerging therapeutic areas - particularly oncology; more efficient regulatory-industry relationships; mRNA is a word we will continue to hear a lot about; and home health care is here to stay.
Bio Pharma Dive
JANUARY 11, 2021
Gain increased study efficiency and quality with risk-based quality management.
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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
BioPharma Reporter
JANUARY 11, 2021
Codagenixâs intranasal COVID-19 vaccine has entered Phase 1 clinical trials: with the first volunteers dosed in the UK.
Bio Pharma Dive
JANUARY 11, 2021
The high-profile biotech will separate into two independent, publicly traded companies in an attempt to revive its fortunes after several setbacks.
BioSpace
JANUARY 11, 2021
On Friday, the U.S. Food and Drug Administration (FDA) issued an official alert stating that it could trigger false negatives in COVID-19 tests.
Pharma Times
JANUARY 11, 2021
Partnership will aim to research and implement quantum computing in pharma R&D
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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
JANUARY 11, 2021
The advancing rollout of currently approved coronavirus disease 2019 (COVID-19) vaccines provides hope to many that existing lockdowns and social restrictions will soon be lifted, but experts suggest a “return to normal” likely won’t occur until herd immunity is achieved.
BioPharma Reporter
JANUARY 11, 2021
Moderna announced today that it is expanding its pipeline of innovative vaccines with three new development programs based on the 'clinical success' of its infectious disease vaccine portfolio to date.
BioSpace
JANUARY 11, 2021
On Monday, at the JP Morgan Healthcare Conference held virtually, Vertex Pharmaceuticals’ chief executive officer Reshma Kewalramani said the company is looking to buy “mid- and late-stage assets.
BioPharma Reporter
JANUARY 11, 2021
Sanofi will acquire Kymab, a clinical-stage biopharmaceutical company developing fully human monoclonal antibodies. The acquisition will give it global rights to KY1005, which has the potential to treat a range of immune-mediated diseases and inflammatory disorders.
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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.
BioSpace
JANUARY 11, 2021
Biotech CFOs, optimistic about economic recovery as COVID-19 vaccines role out, are busy digitally transforming their companies for a post-COVID way of working, according to the 2021 BDO Life Sciences CFO Outlook Survey, released January 11.
BioPharma Reporter
JANUARY 11, 2021
Indonesia's food and drug agency, BPOM, today granted emergency use authorization to Sinovacâs vaccine against COVID-19.
BioSpace
JANUARY 11, 2021
The deal adds Kymab’s lead asset KY1005 to its pipeline, a human monoclonal antibody targeting key immune system regulator OX40L.
pharmaphorum
JANUARY 11, 2021
2020 was the year that changed everything, and as the new year begins many are wondering what awaits the world in 2021. Impetus Digital co-founder and CEO Natalie Yeadon reflects on the last 12 months and shares her views on the healthcare, research and digital changes that could be here to stay. I think it is fair to say that 2020 will not be particularly missed by anyone.
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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
JANUARY 11, 2021
While Sutro’s technological platform opens multiple therapeutic doors, the company’s singular focus on homogeneous molecules is a key part of its competitive strategy.
Scienmag
JANUARY 11, 2021
Credit: IAS; Dana Berry It is well known that the expansion of the universe is accelerating due to a mysterious dark energy. Within galaxies, stars also experience an acceleration, though this is due to some combination of dark matter and the stellar density. In a new study to be published in Astrophysical Journal Letters researchers […].
Outsourcing Pharma
JANUARY 11, 2021
The drug delivery platform company is exploring the viability of remdesivir and other potential treatments for the virus using its DehydraTECH technology.
Scienmag
JANUARY 11, 2021
Rice engineers’ reactor converts gas directly into acetic acid Credit: Wang Group/Senftle Group/Rice University HOUSTON – (Jan. 11, 2021) – A sweet new process is making sour more practical. Rice University engineers are turning carbon monoxide directly into acetic acid — the widely used chemical agent that gives vinegar its tang — with a continuous […].
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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.
pharmaphorum
JANUARY 11, 2021
Sanofi is to acquire UK biotech Kymab in a deal worth up to $1.45 billion as the big French pharma seeks to add to its pipeline of drugs that treat inflammatory diseases and cancer. Cambridge-based Kymab is one of several rising stars on the UK biotech scene, with technology that uses transgenic mice to develop antibodies optimised for the human immune system.
Scienmag
JANUARY 11, 2021
Credit: Credit: Jalan Group, University of Minnesota A team led by University of Minnesota Twin Cities researchers has discovered a groundbreaking one-step process for creating materials with unique properties, called metamaterials. Their results show the realistic possibility of designing similar self-assembled structures with the potential of creating “built-to-order” nanostructures for wide application in electronics and […].
BioSpace
JANUARY 11, 2021
Novartis plunked down $650 million in upfront payment for BeiGene’s Tislelizumab, which is already approved for patients with classical Hodgkin’s lymphoma and metastatic urothelial carcinoma in China.
Scienmag
JANUARY 11, 2021
Proposed a principle of nanomagnetism, in which the spin direction changes on its own upon applying electric current without external spins. Expected to accelerate commercialization based on a paradigm shift from conventional spin memory devices Credit: Korea Institute of Science and Technology(KIST) The Korea Institute of Science and Technology (KIST) has announced that the research […].
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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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