Bio Pharma Dive
NOVEMBER 6, 2020
In a tense meeting Friday, a group of independent experts found Biogen and the FDA's case for aducanumab unpersuasive, voting overwhelmingly against the drug.
pharmaphorum
NOVEMBER 6, 2020
Merck & Co has agreed to buy California biotech VelosBio and its experimental cancer drug for $2.75 billion in cash. Known as MSD outside North America, the big pharma already has a firm foothold in cancer thanks to its immunotherapy Keytruda (pembrolizumab), which has been on the market for several years and has proven to be effective across a wide range of oncology indications.
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Bio Pharma Dive
NOVEMBER 6, 2020
The Swiss drugmaker's COVID-19 research efforts now largely rest on the outcome of a recent alliance to develop oral medicines for the new coronavirus.
pharmaphorum
NOVEMBER 6, 2020
Ahead of Frontiers Health 2020, steering committee members Roberto Ascione and Paul Tunnah from Healthware give us their thoughts on the trends driving the bright future of digital health. It might be easy to think of pharma and healthcare as conservative industries, but the reality is that digital health is now far further along than we predicted it would have been 10 years ago – or even one year ago.
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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
NOVEMBER 6, 2020
Roctavian, the biotech's hemophilia gene therapy, was turned down by the FDA in August, while an important rare disease drug is now under review.
Scienmag
NOVEMBER 6, 2020
Credit: Karolinska Institutet A new study has found that a commonly prescribed anti-depressant may halt growth of a type of cancer known as childhood sarcoma, at least in mice and laboratory cell experiments. The findings, from researchers at Karolinska Institutet in Sweden and MD Anderson Cancer Centre in Texas, ignite hope of novel treatment strategies […].
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
BioTech 365
NOVEMBER 6, 2020
Ligand’s Partner Sedor Pharmaceuticals Receives FDA Approval for SESQUIENT™ for the Treatment of Status Epilepticus in Adult and Pediatric Patients Ligand’s Partner Sedor Pharmaceuticals Receives FDA Approval for SESQUIENT™ for the Treatment of Status Epilepticus in Adult and Pediatric Patients … Continue reading →
XTalks
NOVEMBER 6, 2020
Canadian clinical-stage biotech company Symvivo Corporation has developed an oral COVID-19 vaccine that entered clinical trials this week. The first healthy volunteer was dosed with the vaccine in Australia as part of the bacTRL-Spike COVID-19 Phase I clinical trial. In contrast to conventional vaccines that are administered via intramuscular injection, Symvivo’s bacTRL-Spike vaccine is taken orally, giving patients the potential to self-administer the vaccine as opposed to needing a healthcare
Scienmag
NOVEMBER 6, 2020
Credit: Eric Liffmann In late summer and autumn, millions of birds fly above our heads, often at night, winging their way toward their wintering grounds. Before the journey, many birds molt their bright feathers, replacing them with a more subdued palette. Watching this molt led scientists to wonder how feather color changes relate to the […].
Pharmacy Checkers
NOVEMBER 6, 2020
Importation of prescription drugs to help lower prices for Americans will remain a major issue no matter who is president next year. The more we know about where our meds are made (mostly not here) the less successful drug industry lobbying will be against lower-cost, imported medicines. In some cases, it’s as simple as a drug sold at a U.S. Walgreens is made in a manufacturing facility in one foreign country.
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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
Scienmag
NOVEMBER 6, 2020
Researchers from the Complutense University of Madrid (UCM) and the NOVA University of Lisbon (UNL) have used platinum (Pt) compounds of a liquid crystalline nature to design nanocrystal structures capable of effectively encapsulating and transporting water-insoluble drugs that are otherwise difficult to administer. The study, published in Nano Research, shows that besides their applications in […].
pharmaphorum
NOVEMBER 6, 2020
Accelerate the Bench to Bedside Development of Novel CAR Immunotherapies for Safe, Effective & Affordable Advanced Therapies. With CAR-TCR therapies on the cusp of achieving global approval, there are still many bottlenecks that are preventing this from becoming the ‘sell-out’ therapy that the field had hoped for. The CAR-TCR Summit Europe (16th-18th February 2021) will unravel the technical challenges across R&D, translation, scale and delivery to provide your team with the platform to
Scienmag
NOVEMBER 6, 2020
ATLANTA — New research presented at ACR Convergence, the American College Rheumatology’s annual meeting, reveals that romosozumab, an osteoporosis drug, produces substantial gains in bone mineral density in the hip and lumbar spine within one year, and that transitioning patients to a potent antiresorptive drug can lead to even more bone density gains (ABSTRACT #1973). […].
Drug Patent Watch
NOVEMBER 6, 2020
Annual Drug Patent Expirations for GALAFOLD Galafold is a drug marketed by Amicus Theraps Us and is included in one NDA. There are twelve patents protecting this drug. This drug…. The post New patent for Amicus Theraps drug GALAFOLD appeared first on DrugPatentWatch - Make Better Decisions.
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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
NOVEMBER 6, 2020
Bentham Science is pleased to announce an Institutional Member partnership with the Portugese university, Universidade Lusófona. The partnership gives researchers from the university an opportunity to publish their research under an Open Access license under economical terms. This agreement is a continuation of Bentham Science Publishers’ vision to make transformative agreements with renowned institutions around […].
pharmaphorum
NOVEMBER 6, 2020
Bristol-Myers Squibb posted a solid set of financial results for the third quarter, but shares slid on investor fears that a payout tied new product approvals was in jeopardy. BMS’ stock fell a little over 2%, but the big casualty was a contingent value right (CVR) due to former shareholders in Celgene, which BMS acquired for $74 billion a year ago.
Scienmag
NOVEMBER 6, 2020
What The Study Did: Clinicians in the U.S. were interviewed and described their experiences of planning and providing care for patients in settings of limited resources during the COVID-19 pandemic. Authors: Catherine R. Butler, M.D., M.A., of the University of Washington in Seattle, is the corresponding author. To access the embargoed study: Visit our For […].
Pharma Times
NOVEMBER 6, 2020
Around 400,000 people in the UK are living with rheumatoid arthritis
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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.
Scienmag
NOVEMBER 6, 2020
High deductible health plans (HDHPs) have become much more common among all racial/ethnic and income groups, but the health savings accounts (HSAs) that make these plans potentially workable are far less common among Black, Hispanic, and lower-income enrollees–and the gap is growing. That’s according to a new Boston University School of Public Health (BUSPH) study […].
NY Times
NOVEMBER 6, 2020
If ultimately approved, the drug, aducanumab, made by Biogen, would be the first new Alzheimer’s treatment in nearly two decades. Some evidence suggests it slows, but does not stop, cognitive decline.
Scienmag
NOVEMBER 6, 2020
Published in the prestigious Society of Vertebrate Paleontology Memoir Series, these landmark findings of over 350 fossils, will become a reference point for the origin of the horse, rhino, and tapir Credit: Elaine Kasmer New research published today in the Journal of Vertebrate Paleontology describes a fossil family that illuminates the origin of perissodactyls – […].
Pharma Times
NOVEMBER 6, 2020
PARP inhibitor approved for new ovarian and prostate cancer indications
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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
NOVEMBER 6, 2020
US-guided PCPNB is highly likely to be diagnostic for small pleural lesions with nodular morphology on CT or US, or with pleural thickness – 4.5 mm Credit: American Roentgen Ray Society (ARRS), American Journal of Roentgenology (AJR) Leesburg, VA, November 6, 2020–According to an open-access article in ARRS’ American Journal of Roentgenology (AJR), ultrasound (US)-guided […].
Pharma Times
NOVEMBER 6, 2020
Company subsidiary hVIVO will conduct study with a US biotech
Scienmag
NOVEMBER 6, 2020
UNC-Chapel Hill measures orbital flashes from Earth’s mass of satellites and space trash Quick flashes of light in the night sky have been linked to the growing mass of satellites and debris zipping around Earth’s orbit. The orbital flashes, often mistaken for stars, occur 1,000 times an hour, according to new research led by the […].
pharmaphorum
NOVEMBER 6, 2020
The UK’s drug cost-effectiveness body NICE has launched a public consultation, presenting the case for change about how it assesses medicines, medical devices and diagnostics. NICE has been assessing medicines for 21 years using the Quality Adjusted Life Year (QALY) – the cost to ‘buy’ a patient a year of quality life – as its main methodology. Big pharma was never going to be happy about the existence of a body like NICE, which is designed to drive down prices paid by the taxpayer-funded NHS, b
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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.
Scienmag
NOVEMBER 6, 2020
Scientists at Linköping University, Sweden, working with the perovskite family of materials have taken a step forwards and developed an optoelectronic magnetic double perovskite. The discovery opens the possibility to couple spintronics with optoelectronics for rapid and energy-efficient information storage. Perovskites form a family of materials with many interesting properties: they are cheap to manufacture, […].
The Pharma Data
NOVEMBER 6, 2020
NEW YORK , Nov. 7, 2020 /PRNewswire/ — Children with arthritis affecting five or more joints, called polyarticular juvenile idiopathic arthritis (polyarticular JIA), living in less affluent families were twice as likely to report more than an hour of morning joint stiffness, compared to their counterparts from more affluent families, according to a study by investigators at Hospital for Special Surgery (HSS).
Scienmag
NOVEMBER 6, 2020
ATLANTA — The American College of Rheumatology (ACR) will preview the 2021 Guideline for the Treatment of Juvenile Idiopathic Arthritis at ACR Convergence, the ACR’s annual meeting. The new recommendations address pharmacologic and non-pharmacologic treatments and are the culmination of a two-part update of the ACR’s JIA guidelines published in 2011 and 2013.
Drug Patent Watch
NOVEMBER 6, 2020
Annual Drug Patent Expirations for JANUVIA Januvia is a drug marketed by Merck Sharp Dohme and is included in one NDA. It is available from three suppliers. There are three…. The post New patent for Merck Sharp drug JANUVIA appeared first on DrugPatentWatch - Make Better Decisions.
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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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