Bio Pharma Dive
JUNE 26, 2021
Results published in The New England Journal of Medicine offer the first clinical evidence that CRISPR gene editing inside the body can be safe and effective, a culmination of years of scientific research.
World of DTC Marketing
JUNE 6, 2021
SUMMARY: The media headlines promise weight loss for diabetes patients, but Norvo’s new drug is in the same class as other drugs and carries many warnings. Can diabetes patients really stay adherent to a drug for 63 weeks in which 85% of patients report GI side effects and will insurance cover the cost? The headlines read “FDA approves obesity drug that helped people cut weight 15%” But buyer beware.
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pharmaphorum
JUNE 21, 2021
It would be easy to forget that back in 2019, BioNTech was an early-stage biotech firmly focused on cancer vaccines, before being catapulted onto the world-stage with its COVID-19 shot. Now, the German company has issued a reminder of its original R&D mission with the start of the first phase 2 trial of BNT111 – the first of several cancer vaccine candidates – in patients with skin cancer.
BioPharma Reporter
JUNE 28, 2021
Live biotherapeutic product (LBP) developer, 4D Pharma, says it is building a âstrong body of evidenceâ for its portfolio of bacterial strains in relation to cancer, asthma, and neurodegenerative diseases, while the company also calls its recent dual listing a âtransformational milestoneâ.
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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
BioSpace
JUNE 9, 2021
An immunocompromised patient in South Africa became a veritable COVID-19 variant laboratory as the virus mutated more than 30 times in 216 days of her infection, according to recent, not-yet-peer-reviewed research paper published in medRxiv.
Pharma Times
JUNE 22, 2021
An extra £40m will go toward enhancing mental health services for children and young people
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
XTalks
JUNE 8, 2021
Novartis’ Zolgensma (onasemnogene abeparvovec) gene therapy has been making significant strides as of late, including dosing of the first Spinal Muscular Atrophy (SMA) patient with the treatment in the UK last week. In addition, recent data from a Phase I trial has shown ‘remarkable’ long-term results of the gene therapy in children with the disease.
pharmaphorum
JUNE 16, 2021
Developers of mobile health apps are comprehensively failing to safeguard the privacy of users, according to a study by researchers in Australia. The team from Macquarie University compared 15,000 free mobile health (mHealth) apps available on the Google Play store and compared their privacy practices to those found in 8,000 non-health apps, finding “serious problems with privacy and inconsistent privacy practices.” The range of apps put under scrutiny included tools for managing hea
BioPharma Reporter
JUNE 7, 2021
The virtual clinical development firmâs analysis of patient profiles reflects obesity is the most significant indicator for severity in those under 40.
BioSpace
JUNE 29, 2021
Innate Pharma has an alternative to T cell-based immunotherapy that has the potential to quickly and safely eradicate solid and metastatic tumors in the body.
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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
Pharma Times
JUNE 2, 2021
Updated study results showed an overall response rate of 98% with a longer-term follow-up at a median of 18 months
Bio Pharma Dive
JUNE 3, 2021
Study results disclosed ahead of ASCO could make Lynparza a standard "adjuvant" treatment for people with an inherited form of breast cancer — as long as they know they have it.
JAMA Internal Medicine
JUNE 21, 2021
This cross-sectional study uses administrative health care data on 2.9 million households from the first 45 weeks of 2020 to assess the association between social gatherings and SARS-CoV-2 transmission by studying whether COVID-19 rates increase after birthdays in a household.
pharmaphorum
JUNE 7, 2021
Researchers in the US have developed a wearable fabric that can sense, store and analyse data that could be used to measure physiological functions or detect illness. The team from Massachusetts Institute of Technology (MIT) claim this is the first example of a fabric which can record data in a digital rather than in an analogue format, allowing it to be programmed like any other digital device.
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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.
BioPharma Reporter
JUNE 15, 2021
Ocugen has chosen Jubilant HollisterStier of Spokane, Washington as its manufacturing partner for COVID-19 vaccine candidate COVAXIN, ready for potential commercial manufacture for the US and Canadian markets.
BioSpace
JUNE 24, 2021
In what will be a big moment for CRISPR technology, Intellia and development partner, Regeneron Pharmaceuticals will share the world’s first data from a therapy that edits flawed genes inside the body.
Pharma Times
JUNE 15, 2021
New real world data from PHE shows vaccines can protect against hospitalisation caused by variant
Bio Pharma Dive
JUNE 7, 2021
With the decision, the agency cleared the way for what many predict will become a lucrative and highly sought-after option — though fierce debate continues over whether the medicine, Biogen's aducanumab, actually benefits patients' daily lives.
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
JUNE 21, 2021
In a new study, Amazon’s Halo app has been shown to predict body fat percentage with the same level of accuracy as standard lab testing. The app uses just four photos taken from a smartphone — of the front, back and each side of the body — to build a 3D model and produce body fat percentage results using the app’s built-in machine learning algorithms.
pharmaphorum
JUNE 1, 2021
Novo Nordisk is paying $55 million upfront to secure rights to a cell therapy for heart failure developed by Japanese startup Heartseed. The Danish drugmaker has acquired exclusive rights outside Japan to Heartseed’s HS-001 therapy based on heart muscle cells (cardiomyocytes) derived from human stem cells, and is due to start the phase 1/2 LAPiS trial in Japan later this year.
BioPharma Reporter
JUNE 1, 2021
The EMPHATHY clinical trial will enroll patients with COVID-19 to test the drugâs effectiveness in preventing worsening of symptoms and hospitalization.
BioSpace
JUNE 13, 2021
Retinal tissue has been regrown in three patients with age-related macular degeneration with geographic atrophy or dry (atrophic) AMD in a Phase I/IIa study conducted by Lineage Cell Therapeutics.
Advertiser: FourKites
A research study conducted by The Journal of Commerce and FourKites surveyed hundreds of international shippers, exploring how their usage of global supply chain visibility technology has evolved since the onset of global disruptions caused by COVID-19. For international shippers, ocean freight visibility has evolved from optional to essential and satisfaction with visibility varies greatly depending on how it is obtained and delivered.
Pharma Times
JUNE 29, 2021
Company initially withdrew a marketing authorisation application for the gene therapy last year
Bio Pharma Dive
JUNE 21, 2021
The next six months could feature clinical milestones for CRISPR gene editing, the treatment of COVID-19, microbiome drugs and gene-targeted cancer therapy.
Scienmag
JUNE 3, 2021
Credit: CABI Researchers have re-animated specimens of a fungus that causes coffee wilt to discover how the disease evolved and how its spread can be prevented. Coffee Wilt Disease is caused by a fungus that has led to devastating outbreaks since the 1920s in sub-Saharan Africa, and currently affects two of Africa’s most popular coffee […].
pharmaphorum
JUNE 15, 2021
NHS England will provide artificial pancreas devices to 1,000 type 1 diabetes patients as part of a pilot study of the technology, according to chief executive Sir Simon Stevens. The diabetics will be offered the closed-loop systems, which continually monitor glucose levels in the blood and uses the data to automatically adjust the dose of insulin delivered by an externally worn pump, at around 25 specialist centres across England.
Speaker: Steve Goldstein, Sales Leader
Are you currently in sales, or involved in a business that depends on strong sales results? What about the extremely competitive world of medical device sales? What are some of the top challenges your customers face and how do you approach understanding what’s most important to them? Join Steve Goldstein, Sales Success Coach, Motivational Speaker and Medical Device Sales Leader from Gold Selling LLC., to discover critical strategies and approaches you can take to engage your customers, achieve g
XTalks
JUNE 30, 2021
Blood health and research organization Versiti Inc. is offering a comprehensive diagnostic for COVID-19 vaccine-induced blood clot testing to help in the accurate and prompt diagnosis of the rare but serious blood clots being seen after some individuals are vaccinated with viral vector COVID-19 vaccines such as those from AstraZeneca and Johnson & Johnson.
BioSpace
JUNE 7, 2021
The first human case of a new strain of avian flu was diagnosed in China in late May. Chinese health authorities say there is a low risk of contagion. After China notoriously underreported COVID-19 mortality, can this new assurance be trusted?
Pharma Times
JUNE 3, 2021
Combination immunotherapy treatment approved in the EU for first-line treatment of adults with unresectable MPM
Bio Pharma Dive
JUNE 28, 2021
A study of Gilead's Yescarta found the cell therapy dramatically outperformed chemotherapy and stem cell transplant in treating lymphoma, a result that could support much broader use of the drug.
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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.
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