Bio Pharma Dive
JULY 22, 2021
Three companies are testing their gene therapies in early clinical trials, with initial results due later this year. Others are in preclinical stages and aim to follow soon.
World of DTC Marketing
JULY 22, 2021
SUMMARY: Older, more experienced employees are being shoved aside in favor of more inexperienced ones. The culture within pharma is driving people away, including new hires. More and more meetings are based on ROI, not the voice of the patient. Don’t hire people who want big salaries; hire people who want to be part of an industry that helps patients.
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BioSpace
JULY 19, 2021
Preclinical data for its drug candidate, LP-184, reportedly showed over 90 percent efficacy in shrinking pancreatic cancer tumors in mouse models in vitro, in-vivo, and ex-vivo.
pharmaphorum
JULY 23, 2021
Could virtual reality tools be effective in helping patients ‘unlearn’ their chronic pain? p harmaphorum speaks to Professor Christopher Eccleston from the University of Bath’s Centre of Pain Research to find out how digital therapeutics are shaping the future of pain management. A digital software developed by Finnish drugmaker Orion is aiming to address chronic pain conditions using virtual reality (VR) devices that provide an immersive gamified therapeutic treatment program.
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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
JULY 23, 2021
The IPO is several times larger than what CRISPR Therapeutics, Intellia and Editas raised several years ago, and ranks well ahead of a more recent offering from gene editing startup Beam.
World of DTC Marketing
JULY 21, 2021
SUMMARY: DTC marketing is not the reason why prescription drugs cost so much. DTC ads raise awareness around health conditions. DTC ads do NOT lead to unnecessary Rxs. The FDA needs to study what people do when they see a DTC ad. The voices in Washington DC are once again calling for a moratorium on DTC marketing but lawmakers need to understand what DTC marketing actually does as upped to what people believe it does.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
pharmaphorum
JULY 22, 2021
Pfizer has pledged a whopping $1 billion upfront for rights to an Arvinas drug for breast cancer from its protein degrader platform, which harnesses cells’ natural protein-denaturing machinery to remove rogue proteins associated with disease. The deal focuses on ARV-471, currently in phase 2 testing for advanced breast cancer patients whose tumours expresses oestrogen receptors – so are hormone sensitive – but test negative for HER2 receptors that would make them candidates for treatment w
Bio Pharma Dive
JULY 23, 2021
Five trial participants with diabetic macular edema who received Adverum Biotechnologies' treatment experienced side effects never before reported for an eye gene therapy.
Pharma Times
JULY 22, 2021
Verquvo cleared for the treatment of symptomatic chronic heart failure in patients with reduced ejection fraction
XTalks
JULY 20, 2021
NuVasive , a medical device company focused on developing devices and procedures for minimally invasive spine surgery, has recommenced shipping of the newest version of its MAGEC line of spinal curve-correcting magnetic rod systems. The previous version of the MAGEC spinal implant was flagged by the US Food and Drug Administration (FDA) for potential mechanical risks.
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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
JULY 23, 2021
GlaxoSmithKline has said that Brian McNamara – currently head of its three-year-old consumer health joint venture with Pfizer – will retain the top job at the business after it is hived off into a separate company next year. The appointment, which had been expected, was confirmed in a statement by GSK’s board today. McNamara has been with GSK since 2015, when he joined the company as head of consumer health for Europe and the Americas, and previously worked for 10 years at Novartis, ultima
Bio Pharma Dive
JULY 21, 2021
The approval of Skysona for a genetic brain disease is a milestone for one of gene therapy's pioneering companies, but isn't expected to turn Bluebird's financial fortunes around.
BioPharma Reporter
JULY 19, 2021
Celltrion Group has reported that data from an in vivo efficacy study shows that its monoclonal antibody treatment for COVID-19, regdanvimab (CT-P59), has a strong neutralizing effect against the rapidly spreading Delta variant.
Pharma Times
JULY 23, 2021
Real-world data shows jab is effective after one dose against hospitalisation/death caused by Beta and Delta variants
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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.
XTalks
JULY 23, 2021
For years, consumers have been using olive oil on food and in cooking. Still, Strength Genesis believes it is time for a change and a move towards a more versatile cooking oil option — macadamia oil, otherwise known as “liquid gold” to some. Olive oil is known for its healthy omega-3 fats and is used to aid in body repair and improve health in general.
Bio Pharma Dive
JULY 21, 2021
The pharmaceutical company expects $2.5 billion in sales from its shot this year, despite concerns over protection against variants and significant manufacturing setbacks.
pharmaphorum
JULY 22, 2021
In just over a year, Celltrion Healthcare says it has identified and delivered a potential treatment for COVID-19. pharmaphorum spoke to Kwon Ki-sung, Head of Celltrion’s R&D unit, to learn more. Celltrion’s COVID-19 therapeutic, CT-P59, is a monoclonal antibody (mAb) with activity against COVID-19. It was identified as a potential treatment through the screening of antibody candidates from recovered patients and selecting those that showed the highest potency in neutralising the SARS-CoV-2
Pharma Times
JULY 20, 2021
A therapeutic dose of regdanvimab also reduced the viral load of the SARS-CoV-2 virus and inflammation in the lungs
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.
XTalks
JULY 20, 2021
Bougie Bakes, a Los Angeles-based healthy snack alternative company, has now released dog cookies under the “Bougie Barks” brand. The brand introduces Bougie Barks Peanut Butter Carob Dog Cookies, which are made of five main ingredients: almond flour, peanut butter, carob powder, collagen powder and ground flaxseed. The human version of this cookie was introduced in 2018 by Ryan and Meghan, who struggled to find better-for-you baked goods that satisfied their cravings.
Bio Pharma Dive
JULY 20, 2021
A $135 million investment will help the small biotech potentially prepare to launch the treatment in Canada and Europe as well as fund another trial requested by U.S. regulators.
pharmaphorum
JULY 21, 2021
Think of the R&D dollars that could be saved if artificial intelligence (AI) modelling could tell you at an early stage whether a drug was likely to succeed in clinical trials, and ultimately reach the market. In 2019, a team at Massachusetts Institute of Technology (MIT) in the US came up with just such a model, and found that it was able to perform “better than random” at predicting the outcome of a clinical trial or development programme.
Pharma Times
JULY 22, 2021
PFIC is a rare and progressive liver disease affecting young children which can lead to cirrhosis and liver failure
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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.
XTalks
JULY 19, 2021
Social media has been abuzz with posts about Kraft’s new vibrant orange macaroni-and-cheese-flavored ice cream —and for good reason. The maker of the famous boxed mac n’ cheese recently released a limited-edition ice cream in partnership with Brooklyn-based Van Leeuwen Ice Cream to merge together two iconic foods, whether consumers wanted it or not.
Bio Pharma Dive
JULY 20, 2021
The FDA cited problems with Ardelyx's case for its kidney disease drug just weeks before an approval deadline — feedback one analyst described as "troubling" evidence of FDA inconsistency.
pharmaphorum
JULY 20, 2021
EPG Health’s Allen Wellings assesses future symposia and congress models, outlining some learnings about content and reach. COVID-19 had a huge, and very obvious, initial impact on medical congresses and symposia when 2020’s lockdowns took effect, with many events struggling to move quickly enough to a purely digital format. While many did succeed in creating digital learning environments during those difficult early months of the pandemic, there are some clear learnings for pharma companies in
Pharma Times
JULY 23, 2021
NHS England has set out new plans to introduce five new waiting time guarantees for mental health services
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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
JULY 19, 2021
The Boston-based company merged with Capstar Special Purpose Acquisition Corp. and will begin trading on the New York Stock Exchange under the ticker symbol “GLS.
Bio Pharma Dive
JULY 19, 2021
The German biotech purchased Kite Pharma's Gaithersburg, Maryland-based site, along with related research on T cell receptor-based cancer treatments.
pharmaphorum
JULY 19, 2021
America’s biopharmaceutical industry says it is “ready to do its part” in building a stronger, more resilient, affordable, and equitable health care system for all. COVID-19 highlighted both the challenges of the US healthcare system and the huge change potential of the country’s pharmaceutical industry. Now, as vaccination continues at pace, the sector has pledged to help “build back better”, by lowering barriers between medical innovations and the patients who need them.
Pharma Times
JULY 23, 2021
Microbiome-based therapeutic failed to improve clinical remission rates among mild-to-moderate ulcerative colitis patients
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