Bio Pharma Dive
NOVEMBER 3, 2020
On Friday, a panel of experts and FDA staff will weigh in on a closely watched Alzheimer's drug from Biogen. Their feedback could affect how the disease is treated for years to come.
World of DTC Marketing
NOVEMBER 3, 2020
Cardiovascular disease deaths in the US have increased by nearly 17% since 2010, and are among the reasons that life expectancy in the U.S. is lower than in other high-income countries. The U.S. has also seen reversals in health improvements since 2010, partly due to increasing rates of obesity, high blood pressure, and high blood sugar. . We can’t ignore the poor shape of Americans.
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pharmaphorum
NOVEMBER 2, 2020
The UK drugs regulator has awarded a £1.5 million tender to a software company for an artificial intelligence tool that will be used to process “the expected high volume of COVID-19 vaccine adverse drug reactions (ADRs).”. The tender awarded to Maidenhead, Berkshire-based GenPact UK aims to “ensure that no details from the ADRs…are missed” as the UK prepares to start rolling out COVID-19 vaccines – assuming their safety and efficacy is supported in late-stage trials.
BioSpace
NOVEMBER 2, 2020
Three biopharma companies recently shuttered their clinical programs after either their compounds failed clinical trials or interim futility analysis suggested they were unlikely to meet their clinical endpoints. Here’s a look.
Bio Pharma Dive
NOVEMBER 4, 2020
Results the company will present at a medical meeting, while early, don't appear to meet the high bar set by rival CAR-T cell therapies from Bristol Myers Squibb and Johnson & Johnson.
World of DTC Marketing
NOVEMBER 1, 2020
THE SKINNY : President Trump’s repeated assertions the United States is “rounding the turn” on the novel coronavirus are proving to be untrue as new cases surge in Midwest states. “We’re in for a whole lot of hurt. It’s not a good situation,” Anthony S. Fauci, the country’s leading infectious-disease expert, said in a wide-ranging interview late Friday.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
BioSpace
NOVEMBER 2, 2020
Additional findings from Biogen’s Phase II LILAC study, announced today, show the company’s lupus drug candidate BIIB059 is superior to placebo for reducing joint disease activity in patients with systemic lupus erythematosus.
Bio Pharma Dive
NOVEMBER 3, 2020
While full data were not disclosed, the trial's outcome signals competition for Amgen's Otezla, which Celgene was forced to divest last year as a result of its acquisition by Bristol Myers.
World of DTC Marketing
NOVEMBER 4, 2020
THE SHORT : The confusion around the Presidential election, which is ongoing at the time of this post, has a lot of similarities with online health information. As social media becomes a bigger part of information gathering for health seekers they are often making bad treatment decisions based on what they read. According to Annual Review “in general, we do not have the cognitive capacity, motivation, or time to evaluate all the information that we encounter online.
Intouch Solutions
NOVEMBER 5, 2020
What’s the best approach for investments in AI-based implementations? At this year's Frontiers Health conference, Intouch experts will discuss the 'what' and 'how'; we'll also hear a case study on creating an augmented-reality tool to help oncology HCPs empathize with patients undergoing chemotherapy, developed together with Athenex Oncology. The post Intouch & Athenex Oncology Talk AI at Frontiers Health Global Hybrid Conference appeared first on Intouch Solutions.
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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
BioSpace
NOVEMBER 1, 2020
Santhera said the restructuring will allow the company to focus on the development of vamorolone, a first-in-class dissociative steroid with a novel mode of action that it gained the rights to from ReveraGen BioPharma.
Bio Pharma Dive
NOVEMBER 4, 2020
Documents made public ahead of a key advisory meeting Friday revealed an FDA more willing than expected to accept Biogen's controversial case for approval of aducanumab.
Pharma Times
NOVEMBER 2, 2020
Zejula is the first PARP inhibitor to be approved as monotherapy in the EU for patients with platinum-responsive advanced ovarian cancer, regardless of biomarker status
Scienmag
NOVEMBER 3, 2020
Credit: RUDN University A team of chemists from RUDN University synthesized new organosilicon compounds containing terbium and europium ions. These complexes have an unusual cage-like crystal structure that contains four metal ions. The team was the first to study the magnetic and photophysical properties of such compounds and to observe their magnetic phase transition and […].
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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
NOVEMBER 2, 2020
The life sciences industry is one of the fastest growing in the world. BioSpace provides a rundown of companies announcing facility and job expansions across the U.S. and beyond.
Bio Pharma Dive
NOVEMBER 5, 2020
Requests for more data on manufacturing, clinical holds and a surprise rejection have led to questions of a tougher standard at the agency. Officials, however, point to a large and fast-advancing pipeline.
Pharma Times
NOVEMBER 2, 2020
It is hoped that findings from the NIHR-funded trial will help better inform treatment decisions
Scienmag
NOVEMBER 2, 2020
Credit: Micah Freedman, UC Davis North America’s beloved Monarch butterflies are known for their annual, multi-generation migrations in which individual insects can fly for thousands of miles. But Monarchs have also settled in some locations where their favorite food plants grow year round, so they no longer need to migrate. Micah Freedman, a graduate student […].
Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist
What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.
BioSpace
NOVEMBER 2, 2020
GW Pharmaceuticals hopes to bring its cannabis-based treatment for multiple sclerosis spasticity to the United States.
Bio Pharma Dive
NOVEMBER 5, 2020
Sarepta and Pfizer are advancing their experimental treatments into late-stage trials, while others are accelerating research in what's become one of gene therapy's most active fields.
pharmaphorum
NOVEMBER 4, 2020
Professor Jean-Pierre Boissel outlines the urgent need for disruptive R&D approaches that can tackle the search for COVID-19 treatments more effectively. It may not be appropriate to use the word ‘failure’ when summarising the utility of clinical trials in the search for a curative or preventative treatment for disease. For the purposes of this text, let us assume that ‘success’ and ‘failure’ will be used in reference to the objective of clinical trial designers: to obtain sufficient evidenc
BioPharma Reporter
NOVEMBER 5, 2020
The Australian Government has inked an agreement with Novavax for 40 million COVID-19 vaccine doses; and with Pfizer/BioNTech for 10 million doses.
BioSpace
NOVEMBER 3, 2020
Biogen and Tokyo-based development partner Eisai are embroiled in controversy surrounding their investigational Alzheimer’s drug, aducanumab.
Bio Pharma Dive
NOVEMBER 5, 2020
Buying VelosBio is Merck's second investment in so-called antibody-drug conjugates since September, reflecting the drug class' fast turnaround.
pharmaphorum
NOVEMBER 3, 2020
Ring Chromosome 20 Syndrome, or (R)20, is an ultra-rare form of epilepsy with a devastating impact – yet despite huge leaps forward in gene sequencing in recent years, diagnoses are going down instead of up. We spoke to Allison Watson, co-founder of Ring 20 Research and Support, about raising awareness, building the evidence base, and the importance of helping people through a pandemic despite limited funding.
XTalks
NOVEMBER 4, 2020
It has long been known that mothers greatly influence the development of the growing fetus by not only providing nutrients through the placenta, but also a growing list of biological elements including beneficial antibodies, gut bacteria and now, allergies. New research from Duke University-NUS shows that allergen-primed antibodies may be passed to offspring in utero.
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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
NOVEMBER 4, 2020
Abbott is suing their former VP Jerome Clavel over allegations of trade secret theft with intent to share with his new employer, rival diagnostics company Bio-Rad.
Bio Pharma Dive
NOVEMBER 5, 2020
The drug, now being considered for emergency clearance by the FDA, seems to work best in patients whose immune systems haven't responded to infection. Fast antibody testing, however, is spotty.
Drug Patent Watch
NOVEMBER 3, 2020
Annual Drug Patent Expirations for RHOPRESSA Rhopressa is a drug marketed by Aerie Pharms Inc and is included in one NDA. It is available from one supplier. There are nine…. The post New patent for Aerie Pharms drug RHOPRESSA appeared first on DrugPatentWatch - Make Better Decisions.
Scienmag
NOVEMBER 3, 2020
Development of a next-generation mechano-sensitive material where parts requiring repair can be distinguished by color. 850% improved sensitivity compared to existing materials. Credit: Korea Institue of Science and Technology(KIST) Human skin bruises when the tissue and muscle in the area suffer trauma or become damaged due to an application of blunt force.
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