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.
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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 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.
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.
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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.
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.
Pharma Times
NOVEMBER 2, 2020
It is hoped that findings from the NIHR-funded trial will help better inform treatment decisions
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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.
pharmaphorum
NOVEMBER 5, 2020
After three brushes with cancer, Robert Weker understands the patient journey more than many – and he is determined to put that experience to good use. The avid blogger and passionate advocate retired from his R&D role four years ago to focus on his own health, and now works full time on making sure the patient voice is “in the room” when pharma companies make decisions.
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 […].
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
Aptevo is a clinical-stage biotech company developing novel therapeutics built on its proprietary platform ADAPTIR™technology which is modular and includes bispecific molecules that recognize and bind to two unique target antigens simultaneously.
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
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 […].
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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.
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.
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.
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
BioSpace
NOVEMBER 1, 2020
Kiadis has three compounds in the clinic: K-NK002 in Phase II for HSCT in blood cancer; K-NK003 for relapsed or refractory acute myeloid leukemia (AML); K-NK-ID101 for COVID-19.
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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.
JAMA Internal Medicine
NOVEMBER 1, 2020
This case series evaluates case investigation and contact tracing outcomes in San Francisco, California, during shelter-in-place restrictions during the COVID-19 pandemic.
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.
pharmaphorum
NOVEMBER 5, 2020
An experimental gene therapy developed by Texas biotech Genprex will be paired with AstraZeneca’s Tagrisso and Merck & Co’s Keytruda – both leading their respective drug classes in the treatment of non-small cell lung cancer (NSCLC). The two phase 1/2 trials are zeroing in on NSCLC patients with specific molecular biomarkers, to see if adding Genprex’ Reqorsa (quaratusugene ozeplasmid) – which delivers a gene that suppresses tumour growth – can enhance the activity of the AZ and Merck
BioSpace
NOVEMBER 2, 2020
GW Pharmaceuticals hopes to bring its cannabis-based treatment for multiple sclerosis spasticity to the United States.
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Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management. Learn how Revvity Signals helps drug developers deliver clinical trial data insights in real-time using a fast and flexible data and analytics platform to empower data-driven decision-making.
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