Bio Pharma Dive
MAY 18, 2022
The addition, which will be located next to the company's newly dedicated cell and gene facility, could make Vertex the largest biotech by square footage in the city.
pharmaphorum
MAY 18, 2022
FDA veteran Bakul Patel has joined Google as its new senior director of global digital health strategy, ending a stint at the regulator that lasted more than 13 years. Bakul Patel. Patel – who is currently director for digital health at the FDA – said on social media that he is “looking forward to learning from the teams in health across Google and Alphabet and helping build a unified digital health and regulatory strategy.” He was also involved in the creation of the FDA’s Dig
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Outsourcing Pharma
MAY 18, 2022
An expert from the AI-focused technology company shares insights as to how it can be harnessed to better interpret, and even predict, patient behavior.
Drug Patent Watch
MAY 18, 2022
Annual Drug Patent Expirations for DUZALLO Duzallo is a drug marketed by Ironwood Pharms Inc and is included in one NDA. There are nine patents protecting this drug. DUZALLO drug…. The post New patent for Ironwood Pharms drug DUZALLO appeared first on DrugPatentWatch - Make Better Decisions.
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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
Outsourcing Pharma
MAY 18, 2022
A leader from the neurobiomarker platform provider tells how use of ML and other advanced analytical tools can help make better use of complex information.
pharmaphorum
MAY 18, 2022
SwanBio Therapeutics has raised $56 million in a second-round financing that will be used to advance its lead gene therapy candidate for adrenomyeloneuropathy (AMN) into clinical testing later this year. The Series B takes the total raised by the Philadelphia-based biotech to $133 million and is earmarked for a phase 1/2 trial of the gene therapy – codenamed SBT101 – in the second half of this year.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
pharmaphorum
MAY 18, 2022
Brand new UK startup RQ Biotechnology has been thrust into the spotlight after signing a $157 million licensing deal with AstraZeneca for monoclonal antibodies intended to protect vulnerable and immunosuppressed people from COVID-19. The deal covers a portfolio of early-stage antibodies targeting SARS-CoV-2, adding to the pipeline of COVID drugs following AZ’s already available Evusheld (tixagevimab/cilgavimab) therapy, which has been approved for pre-exposure prophylaxis of COVID-19.
Scienmag
MAY 18, 2022
LA JOLLA, CA—The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), is sponsoring a major new antiviral drug development center that will be led by Scripps Research. Credit: NIAID LA JOLLA, CA—The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health […].
pharmaphorum
MAY 18, 2022
Companies trying to bring digital therapeutic (DTx) products through development and onto the market have been navigating in uncharted waters for years. Now, trade organisation the Digital Therapeutics Alliance has provided a guide to help them during the journey. The DTx Value Assessment & Integration Guide lays out the DTA’s thinking on how developers can clinically evaluate DTx products, meet regulatory requirements to get the approved, and ensure their quality and security.
Scienmag
MAY 18, 2022
The American College of Lifestyle Medicine has released an expert consensus statement to assist clinicians in achieving remission of type 2 diabetes in adults using diet as a primary intervention. The expert consensus statement is endorsed by the American Association of Clinical Endocrinology (AACE), supported by the Academy of Nutrition and Dietetics (AND) and cosponsored […].
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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
Pharma Times
MAY 18, 2022
Device delivers currents to the brain to restore activity usually lowered in depression patients
Scienmag
MAY 18, 2022
This prospective, multicenter, randomized controlled trial published in the American Journal of Kidney Diseases (AJKD) demonstrated that, compared with a reactive strategy of potassium supplementation when serum potassium fell below 3.5 mEq/L, a protocol-based potassium supplementation strategy to maintain serum potassium in the target range of 4-5 mEq/L resulted in a longer time (90 days) to […].
Outsourcing Pharma
MAY 18, 2022
The pharmaceutical company is partnering with Yseop to install the software companyâs Augmented Analyst, designed to elevate and accelerate data analysis.
Scienmag
MAY 18, 2022
BUFFALO, NY- May 18, 2022 – Dr. Mikhail Blagosklonny published his new review paper in Aging (Aging-US) Volume 14, Issue 9, entitled, “Hallmarks of cancer and hallmarks of aging.” Credit: Aging-US.com BUFFALO, NY- May 18, 2022 – Dr. Mikhail Blagosklonny published his new review paper in Aging (Aging-US) Volume 14, Issue 9, entitled, “Hallmarks of […].
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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.
pharmaphorum
MAY 18, 2022
Considerable scientific progress across neurological diseases and disorders was reported at the recent 74th American Academy of Neurology (AAN) Annual Meeting. What may be important for healthcare professionals certainly makes encouraging news for patients waiting for effective solutions. One research-driven company with a strong patient focus in neurology is UCB.
Scienmag
MAY 18, 2022
Bronze Age funeral pyre in Northern Italy may have been used over generations, with cremated remains left in situ as part of complex funerary rituals Credit: Crivellaro et al., 2022, PLOS ONE, CC-BY 4.0 ([link] Bronze Age funeral pyre in Northern Italy may have been used over generations, with cremated remains left in situ as […].
Pharma Times
MAY 18, 2022
Orally available EP395 has met all endpoints in safety and is now undergoing phase 2 planning
Scienmag
MAY 18, 2022
An isotope of a chemical element contains the same number of protons in the center of its atom, but when compared to another atom, the number of neutrons is different. Regarding water, some hydrogen and oxygen atoms within water molecules contain different number of neutrons, resulting in water isotopes. Because of the wide range of […].
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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.
Outsourcing Pharma
MAY 18, 2022
The digital therapeutics specialist has announced the last patient has ended participation in a study investigating a precision solution for hypertension.
Scienmag
MAY 18, 2022
Top scientists and officials from government, academia, Alaskan Native communities, and industry are heading to the Dena’ina Center in Anchorage, Alaska, to focus on driving energy technologies for a more sustainable Arctic region. Credit: (Animation by Sara Levine | Pacific Northwest National Laboratory) Top scientists and officials from government, academia, Alaskan Native communities, and industry […].
pharmaphorum
MAY 18, 2022
Merck & Co has quietly added another drug to its immuno-oncology pipeline via an agreement with China’s Sichuan Kelun Pharmaceutical, and is keeping the details close to its chest. The US pharma group is paying $47 million in upfront payments to license rights to the undisclosed drug outside China, Hong Kong, Macao, and Taiwan, with another $1.36 billion in potential milestone payments plus royalties on sales.
Scienmag
MAY 18, 2022
A research team from Carnegie Mellon University and Columbia have combined two emerging imaging technologies to better view a wide range of biomolecules, including proteins, lipids and DNA, at the nanoscale. Their technique, which brings together expansion microscopy and stimulated Raman scattering microscopy, is detailed in Advanced Science. Credit: Carnegie Mellon University A research team […].
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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.
pharmaphorum
MAY 18, 2022
Women with breast cancer in England and Wales will soon be able to access a new diagnostic based on an injectable magnetic marker liquid called Magtrace that will identify if the disease has spread around the body. The diagnostic developed by UK firm Endomag can be used to detect ‘sentinel’ lymph nodes – the first lymph node to which cancer cells are most likely to spread from a primary tumour – showing if the cancer has progressed beyond the breast tissue.
Scienmag
MAY 18, 2022
Summertime is almost here, a time when many people try to beat the heat. But running air conditioners constantly can be expensive and wasteful. Now, researchers reporting in ACS’ Nano Letters have designed a lightweight foam made from wood-based cellulose nanocrystals that reflects sunlight, emits absorbed heat and is thermally insulating. They suggest that the […].
Sciensano
MAY 18, 2022
The “Joint-efforts for pathogen genomics in public health surveillance” symposium was successfully held on May 4, recording 160 registrations. This symposium was organized within the framework of the. BE READY project. The objective of this project was to implement a multidisciplinary approach and create a network of experts in order to improve the surveillance of infectious diseases with the help of cutting-edge technologies, such as high-throughput sequencing.
Scienmag
MAY 18, 2022
A new study has found contaminants that were banned decades ago are still imperiling critically endangered California condors. The condors may be at increased risk for reproductive impairment because they consume dead marine mammals along the California coast. Credit: Courtesy of San Diego Zoo Wildlife Alliance A new study has found contaminants that were banned […].
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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.
Drug Patent Watch
MAY 18, 2022
Annual Drug Patent Expirations for ODOMZO Odomzo is a drug marketed by Sun Pharm and is included in one NDA. It is available from one supplier. There are two patents…. The post New patent for Sun Pharm drug ODOMZO appeared first on DrugPatentWatch - Make Better Decisions.
Scienmag
MAY 18, 2022
Once humans discovered how to tame fire, they began using it for heat, cooking, to scare away animals and to alter their environs, especially burning areas to plant and to restore grazing land. In Madagascar, scientists and conservationists have long believed that fire is a leading cause of high landscape degradation, but an international team […].
Drug Patent Watch
MAY 18, 2022
Annual Drug Patent Expirations for ZONTIVITY Zontivity is a drug marketed by Xspire Pharma and is included in one NDA. It is available from one supplier. There are two patents…. The post New patent for Xspire Pharma drug ZONTIVITY appeared first on DrugPatentWatch - Make Better Decisions.
Scienmag
MAY 18, 2022
The 27th North American Meeting of the North American Catalysis Society (NAM27), the premier scientific event in the field of catalysis research and development in 2022, will be held May 22-27, 2022 (Hilton Midtown, Manhattan, NY, USA). Credit: Courtesy of the North American Catalysis Society The 27th North American Meeting of the North American Catalysis Society (NAM27), the premier […].
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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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