Bio Pharma Dive
DECEMBER 6, 2021
The biotech's drug, called zavegepant, is delivered intranasally and could offer a similar convenience advantage as its first, the fast-selling Nurtec ODT.
pharmaphorum
DECEMBER 6, 2021
Pear Therapeutics has completed its merger with blank cheque company Thimble Point Acquisition Corp, claiming a Nasdaq listing and raising $175 million in gross proceeds for the digital health specialist. Pear will make its debut on the exchange today after combining with Thimble Point – a special purpose acquisition company (SPAC) – in a deal that sidestepped the conventional initial public offering (IPO) route and has propelled its valuation to around $1.6 billion.
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Bio Pharma Dive
DECEMBER 6, 2021
Like Pfizer's Xeljanz, the label for AbbVie's Rinvoq has been updated to warn about risks of death and major cardiovascular events like stroke.
pharmaphorum
DECEMBER 6, 2021
UK artificial intelligence specialist BenevolentAI has said it will float on the Amsterdam Euronext exchange in what is being touted as Europe’s largest ever special purpose acquisition company (SPAC) deal. BenevolentAI will merge with Odyssey Acquisition, a SPAC set up by investment bankers Michael and Yoel Zaoui that lists former Sanofi chief executive Olivier Brandicourt among its advisors – in a deal that will raise some €390 million in proceeds.
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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
DECEMBER 6, 2021
The emergency clearance from the FDA allows for treatment of mild and moderate disease as well as prevention in those exposed and at high risk.
BioSpace
DECEMBER 6, 2021
Recursion entered into a billion-dollar “transformational collaboration” with Roche to identify and develop up to 40 new medications for neuroscience and oncology.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
BioPharma Reporter
DECEMBER 6, 2021
The European Medicines Agency (EMA) has started a rolling review of VLA2001, Valnevaâs COVID-19 vaccine candidate, with the company set to supply up to 60 million doses to the European Union.
XTalks
DECEMBER 6, 2021
Flashfood, a Toronto, Canada-based startup, is making it easier for consumers to save on groceries while simultaneously preventing unbought food from ending up in landfills. With skyrocketing grocery prices brought on by pandemic-driven inflation , Flashfood is offering a solution that is lighter on the consumers’ wallets and better for the planet. So, how does Flashfood work?
Pharma Times
DECEMBER 6, 2021
GP practices can now postpone minor surgery and routine health checks for over-75s and new patients until 31 March 2022 to ensure booster jabs are rapidly and effectively delivered.
BioSpace
DECEMBER 6, 2021
Odyssey Therapeutics completed an oversubscribed $218 million Series A round. The funds will be used to advance multiple programs from its pipeline and its discovery platform.
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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
DECEMBER 6, 2021
Genezen, a cell and gene therapy focused CDMO, has just opened a new process development and analytical lab, a build that represents the first phase of a 75,000+ square foot cGMP-compliant lentiviral and retroviral vector production facility in Indianapolis.
BioSpace
DECEMBER 6, 2021
?Biopharmaceutical firm Alvotech Holdings announced merger plans with Oaktree Acquisition Corp. in a deal that will create a combined entity worth around $2.25 billion.
Pharma Times
DECEMBER 6, 2021
With the emergence of the new Omicron variant bringing into question the effectiveness of current vaccines, scientists caution that viruses will continue to evolve.
BioSpace
DECEMBER 6, 2021
Despite having 37 new mutations in the viral spike protein, there does not appear to be any deaths associated with Omicron, although it’s spreading rapidly in South Africa.
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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
DECEMBER 6, 2021
COLUMBUS, Ohio – Many people experience forgetfulness as they age, but it’s often difficult to tell if these memory issues are a normal part of aging or a sign of something more serious. A new study finds that a simple, self-administered test developed by researchers at The Ohio State University Wexner Medical Center, College of […].
BioSpace
DECEMBER 6, 2021
Richard Lerner, who played a significant role in shaping both Scripps Research and the San Diego life sciences ecosystem and developing AbbVie’s blockbuster drug Humira, died Dec. 2.
Scienmag
DECEMBER 6, 2021
In a discovery that could one day benefit people suffering from traumatic brain injury, Alzheimer’s disease, and schizophrenia, UT Southwestern researchers have identified the characteristics of more than 100 memory-sensitive neurons that play a central role in how memories are recalled in the brain. Credit: UT Southwestern Medical Center In a discovery that could one […].
BioSpace
DECEMBER 6, 2021
Ionis will manufacture and supply the drug for ongoing trials and process qualifications, while AstraZeneca will handle the commercial supply of eplontersen.
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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.
BioPharma Reporter
DECEMBER 6, 2021
Trince, a spin-off of Ghent University (UGent) that is focused on advancing cell-based science and therapeutics by facilitating the delivery of molecules into cells, both in vitro and ex vivo, has raised â4m from investors.
BioSpace
DECEMBER 6, 2021
?vTv Therapeutics said that the funds it saves through this process will allow it to focus on the Phase III development of TP399 and the company's future growth.
Scienmag
DECEMBER 6, 2021
Mutations in a crucial gene are the key reason that chemotherapy fails in some patients with blood cancer, a study by Nanyang Technological University, Singapore (NTU Singapore) and Singapore General Hospital (SGH) has found. Credit: NTU Singapore Mutations in a crucial gene are the key reason that chemotherapy fails in some patients with blood cancer, […].
BioSpace
DECEMBER 6, 2021
Surrozen's ethos is “CLIMB ON”. This catchy and focus-appropriate acronym stands for Collaborate, Lead, Innovate, Motivate and be Brave, Open and Nurturing.
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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
DECEMBER 6, 2021
PITTSBURGH, Dec. 6, 2021 – In a new analysis published today in the December issue of Health Affairs, University of Pittsburgh Graduate School of Public Health scientists propose four solutions states could implement to improve Medicaid eligibility for seniors, particularly for Medicare enrollees who are non-white or report being in poor health. Additional costs to […].
BioSpace
DECEMBER 6, 2021
The Cambridge, Massachusetts-based company has developed an artificial intelligence platform designed to optimize pharmaceutical formulation processes.
Scienmag
DECEMBER 6, 2021
CORVALLIS, Ore. – Research by the Oregon State University College of Engineering has led to a promising potential therapy for neonatal jaundice that’s more safe, simple and convenient than the blood transfusions currently given to babies suffering from the most dangerous forms of the condition. Credit: OSU College of Engineering CORVALLIS, Ore. – Research by […].
Outsourcing Pharma
DECEMBER 6, 2021
The organizations have issued an in-depth look on issues impacting inclusivity, why change is needed, and potential solutions for increasing trial diversity.
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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.
BioSpace
DECEMBER 6, 2021
The WHO's latest decision is based on advice from an independent panel of experts who evaluated data from 16 randomized controlled studies.
Scienmag
DECEMBER 6, 2021
Survival rates increased about 20% for children with high-risk neuroblastoma enrolled in a St. Jude Children’s Research Hospital clinical trial that included a novel monoclonal antibody produced onsite. The findings appeared today in the Journal of Clinical Oncology. Credit: Wayne Furman, M.D., of the St. Jude Department of Oncology Survival rates increased about 20% for children with high-risk […].
BioSpace
DECEMBER 6, 2021
The news comes just three weeks after Merck paused its Phase II IMAGINE-DR trial, which was studying a combination of islatravir with MK-8507.
Scienmag
DECEMBER 6, 2021
Credit: Los Alamos National Laboratory LOS ALAMOS N.M. December 2, 2021–The New Mexico Lab-Embedded Entrepreneur Program (New Mexico LEEP) announces the three fellows in the program’s first cohort, scheduled to launch in January 2022. The program, offered at Los Alamos National Laboratory, provides a two-year fellowship for entrepreneurs focusing on deep tech for national security. […].
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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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