Bio Pharma Dive
JANUARY 21, 2021
Katherine High and Jude Samulski, two well-known gene therapy researchers, were longtime collaborators and competitors. Now they're colleagues at one of the world's largest drugmakers.
World of DTC Marketing
JANUARY 21, 2021
SUMMARY: Among US adults who looked for health information and used the internet for their most recent search, the percentage who reported accessing health information without frustration was stable during the study period (from 37.2% in 2008 to 38.5% in 2017). The percentage of online health information seekers reporting easily accessing health information did not meet the HP2020 objective.
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Camargo
JANUARY 19, 2021
Throughout our years of preparing and filing FDA submissions, Camargo has often encountered sponsors who cannot file an NDA or BLA within expected timeframes, most commonly due to a failure to start and complete prerequisite activities before the targeted filing date. In this post, we will highlight those requirements that seem to be the most misunderstood.
NY Times
JANUARY 22, 2021
After the surprise discovery of an extra dose in every vial, Pfizer executives successfully lobbied the F.D.A. to change the vaccine’s formal authorization language. The company charges by the dose.
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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
JANUARY 19, 2021
An alliance with Merus, a Dutch biotech, continues Lilly's push to revitalize its oncology research under the leadership of former Loxo Oncology executives.
World of DTC Marketing
JANUARY 19, 2021
OPENING : DTC marketers have relied too much on TV advertising. Despite data that shows that people are watching more TV than usual during the pandemic , there has been an overall and steady decline in traditional TV viewing in the past few years. Just 59% of US consumers watched traditional TV on a weekly basis in 2020, compared to 83% who did so in 2017.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
pharmaphorum
JANUARY 22, 2021
Gilead Sciences says its antiviral Veklury should be effective against the new, more contagious COVID-19 variants discovered in the UK and South Africa. According to the US biopharma company, genetic analyses of publicly available sequences for the new variants of SARS-CoV-2 suggest the mutations in the viral spike protein that have made them more transmissible shouldn’t affect the way Veklury (remdesivir) works.
Bio Pharma Dive
JANUARY 19, 2021
As worries about coronavirus mutations grow, Gritstone Oncology will work with the NIH to develop a shot capable of stimulating a broad immune response.
World of DTC Marketing
JANUARY 18, 2021
OPENING: Pharma companies are starting to embrace digital marketing forced, in large part, by changes brought on by the pandemic. There is, however, a difference between an evolutionary move to digital and a revolutionary move to digital. Digital marketing is becoming a valuable tool. But the reality is, health care relies on significant in-person engagements, and digital is only one part of the equation.
BioSpace
JANUARY 21, 2021
Despite the rising number of COVID-19 cases reported across the globe, rates of influenza have virtually flatlined across the Northern Hemisphere, leading many doctors and researchers to wonder how this could be replicated in non-pandemic times.
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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
pharmaphorum
JANUARY 18, 2021
Public health authorities in California are seeking a halt on dosing of one lot of Moderna’s COVID-19 vaccine after reports of allergic reactions at one immunisation clinic. According to state epidemiologist Dr Erica Pan, there were a higher-than-expected number of suspected allergic reactions at a community clinic being used to administer the shot, with some people needing medical attention in a 24-hour period.
Bio Pharma Dive
JANUARY 20, 2021
Results from a clinical trial in nursing home residents and staff offered the first evidence Lilly's bamlanivimab could protect against, as well as treat, COVID-19
BioPharma Reporter
JANUARY 22, 2021
The World Health Organizationâs Global Advisory Committee on Vaccine Safety says it has not seen any unexpected or untoward increase in fatalities in frail and elderly individuals who have received the Pfizer/BioNTech vaccine.
BioSpace
JANUARY 19, 2021
NEUVOGEN's official strategy revolves around covering the entire immune system so that the tumor cannot perform an “immune escape”. Past immune priming efforts have fallen short because they focus on only a handful of important targets that some tumor cells may not express, thereby allowing them.
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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.
pharmaphorum
JANUARY 19, 2021
A survey by rare disease patient network Raremark found that 86% of the community members asked were interested in taking part in clinical trials. CEO Jeremy Edwards looks at how decentralised trial models can solve some of the challenges for clinical trial recruitment in rare disease. With low and geographically dispersed patient populations in rare disease, deciding where best to place trial sites can be a headache for sponsors.
Bio Pharma Dive
JANUARY 20, 2021
BioNTech's CEO has also promised data will soon be available on the shot's protection against a South African variant that's worried public health experts.
BioPharma Reporter
JANUARY 20, 2021
We take a look at some of the COVID-19 vaccine candidates moving through Phase 1 and 2 clinical trials - and how they could offer a point of difference to authorized vaccines.
BioSpace
JANUARY 18, 2021
The U.S. FDA has granted rare pediatric disease and orphan drug designations for Taysha Gene Therapies’ AAV9-based gene treatment candidate currently in development for epilepsy caused by SLC13A5 deficiency.
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.
pharmaphorum
JANUARY 21, 2021
A partnership between University of Oxford, the Earlham Institute, and the global pharmaceutical companies Biogen Inc and Boehringer Ingelheim is announced today to investigate a new drug target for the treatment of schizophrenia. This is the first project to be funded by the international Psychiatry Consortium, a £4 million collaboration between seven global pharmaceutical companies, and two leading research charities, convened and managed by the Medicines Discovery Catapult, that supports high
Bio Pharma Dive
JANUARY 22, 2021
Rather than a once-a-day pill, Cabenuva comes as a once-a-month injection. That convenience could become a valuable tool for GSK as it tries to broaden adoption of two-drug treatments.
BioPharma Reporter
JANUARY 20, 2021
Pfizer and BioNTech have re-iterated that their COVID-19 vaccine appears to be effective against the UK strain, with the publication of new data today.
BioSpace
JANUARY 21, 2021
With the Pfizer-BioNTech and Moderna COVID-19 vaccines currently authorized in the U.S. and being distributed and dosed, some of the attention is shifting to Johnson & Johnson’s efforts for its one-shot vaccine.
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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
JANUARY 18, 2021
AstraZeneca and Daiichi Sankyo’s Enhertu cancer drug has picked up a second indication, in patients who have stomach cancer and haven’t responded to Roche’s Herceptin (trastuzumab). This latest indication adds to Enhertu first approval at the end of 2019 for advanced HER2-positive breast cancer after two or more HER2-targeted regimens. Around one in five gastric cancers are HER2-positive, opening up a new market niche for AstraZeneca and Daiichi Sankyo, who have been working on Enhertu (trastuzu
Bio Pharma Dive
JANUARY 19, 2021
With virtual interactions here to stay, it's important that pharma marketers continue to embrace the digital world. Learn how a personalized, insights-led approach to marketing drives results.
Scienmag
JANUARY 19, 2021
Credit: Mary Ann Liebert, Inc., publishers New Rochelle, NY, January 19, 2021–Gene editing therapies, including CRISPR-Cas systems, offer the potential to correct mutations causing inherited retinal degenerations, a leading cause of blindness. Technological advances in gene editing, continuing safety concerns, and strategies to overcome these challenges are highlighted in the peer-reviewed journal Human Gene Therapy. […].
BioSpace
JANUARY 21, 2021
Ten pharmaceutical companies have joined forces again to launch Accumulus Synergy Inc., a non-profit effort to pool data in the cloud and interact with regulators, in the hopes of speeding the drug approval process.
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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.
pharmaphorum
JANUARY 20, 2021
Ella Balasa says she owes her life to the experimental phage therapy she was able access in no small part thanks to her scientific background. Her mission, she told pharmaphorum, is to ensure everyone has the knowledge and power they need to navigate their own healthcare journey, no matter where they are from or what they do. Ella, 28, was diagnosed with cystic fibrosis – a rare genetic disease which causes a build-up of thick, sticky mucus in the lungs, digestive tract, and sinuses – at 18 mont
Bio Pharma Dive
JANUARY 20, 2021
Many officials in the administration will be focused on the U.S. response to the COVID-19 pandemic, which Biden has named as his top priority as cases and deaths remain near record highs.
BioPharma Reporter
JANUARY 21, 2021
The team behind the Oxford-AstraZeneca COVID-19 vaccine says it is carefully assessing the impact of new variants from the UK, South Africa and Brazil on vaccine immunity.
BioSpace
JANUARY 19, 2021
The U.S. Food and Drug Administration approved Merck and Bayer’s heart failure drug vericiguat, an orally administered soluble guanylate cyclase (sGC) stimulator, the pharma giants announced this morning.
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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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