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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Camargo
JUNE 9, 2021
Camargo Research Group , Camargo’s managed nonclinical solution, has worked on more than 200 nonclinical programs since its inception in 2005, many of which include rare routes of administrations (ROAs) and use of uncommon animal species. We have collaborated with sponsors on many niche programs that have shone a light on both the creativity and the broad range of specialized capabilities needed for such complex development programs.
Pharma Times
JUNE 22, 2021
An extra £40m will go toward enhancing mental health services for children and young people
Speaker: Simran Kaur, Co-founder & CEO at Tattva Health Inc.
AI is transforming clinical trials—accelerating drug discovery, optimizing patient recruitment, and improving data analysis. But its impact goes far beyond research. As AI-driven innovation reshapes the clinical trial process, it’s also influencing broader healthcare trends, from personalized medicine to patient outcomes. Join this new webinar featuring Simran Kaur for an insightful discussion on what all of this means for the future of healthcare!
BioSpace
JUNE 21, 2021
Use of the anti-parasitic drug ivermectin could reduce COVID-19 related deaths, data from a peer-reviewed study shows.
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.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
World of DTC Marketing
JUNE 23, 2021
SKIMMERS SUMMARY: Jefferies analysts found doctors have shown strong interest in prescribing Aduhelm for about 35% of early-stage Alzheimer’s patients with mild cognitive impairment after surveying 50 U.S. neurologists or psychiatrists currently treating about 12,000 Alzheimer’s patients. Source: Fierce Pharma If that enthusiasm pans out in the long run, it could mean at least 300,000 patients taking the drug, or $10 billion to $15 billion in peak Aduhelm from U.S. sales alone, which is above co
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.
Pharma Times
JUNE 15, 2021
New real world data from PHE shows vaccines can protect against hospitalisation caused by variant
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.
Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.
The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven
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
Bio Pharma Dive
JUNE 15, 2021
Hahn's appointment as chief medical officer of Flagship Pioneering is another example of FDA officials joining industry after their government service. Hahn's predecessor, Scott Gottlieb, sits on Pfizer's board of directors.
World of DTC Marketing
JUNE 8, 2021
SUMMARY: The approval of Biogen’s Alzheimer’s drug, after its advisory panel turned it down, begs the Inspector General to open an investigation into the FDA. Biogen’s $56,000 drug is proof that it was never about the science; it’s about a lifesaver for a sinking company. In the meantime, caregivers are going to put their hope in a drug that doesn’t work and in garbage science with cherry-picked data.
Camargo
JUNE 23, 2021
While the COVID-19 pandemic has accelerated innovation in many areas, including clinical trial design, many recent advancements were already in motion before 2020 as sponsors and CROs sought to improve the patient journey and encourage trial participation. Traditional trials, especially those for pediatric populations, often place enormous burdens on patients and their families.
Pharma Times
JUNE 29, 2021
Company initially withdrew a marketing authorisation application for the gene therapy last year
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.
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.
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.
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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
World of DTC Marketing
JUNE 4, 2021
SUMMARY: The U.S. is one of the wealthiest countries in the world and accordingly has high obesity rates; one-third of the population has obesity plus another third is overweight. The cost of doing nothing is not an option. Yes, there are root causes for obesity that can’t be fixed quickly, but among the causes that we can try and change is our personal responsibility to live a healthier life.
Camargo
JUNE 15, 2021
Challenge. An international company developing an orphan drug product needed support navigating the US regulatory process from beginning formulation to NDA approval from a partner with experience in FDA interactions and a deep understanding of the Agency’s evolving thinking. Background. The sponsor’s product used a novel delivery platform technology designed to reduce the treatment burden for people with a rare chronic pituitary gland disorder.
Pharma Times
JUNE 18, 2021
POLQ inhibitors could be used to kill PARP inhibitor-resistant cancer cells
Pharma Mirror
JUNE 24, 2021
There are widespread misunderstandings about pharmacists’ job that make many prospective students give up on their dreams. But we are here to bring some light about what pharmacists do and don’t do. If you ask 10 different people “What do pharmacists do?”, they will all reply “They sell medications in drug stores”. But if you ask us, we have a far cry from that answer.
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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
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.
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.
World of DTC Marketing
JUNE 3, 2021
IN SHORT : Out-of-control health care spending exact an enormous and growing toll on Americans. The scale of the broken US health care system reveals itself in tragic ways. Fraud accounts for about $300 billion of annual US health care spending. Many employers no longer try to contain health care spending, but many more are fighting back. The Future of Health Care is Local, Open, and Independent.
Camargo
JUNE 4, 2021
Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. Approval of the Month: Non-Opioid for Post-Surgical Pain Gets FDA Nod. Heron Therapeutic received FDA approval for its bupivacaine/meloxicam extended-release solution product to treat post-operative pain after total knee replacement, bunionectomy, and groin hernia repair.
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.
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
Pharma Mirror
JUNE 24, 2021
By Dr Ash Ramzan, founder and principal consultant, Woodley BioReg During a pharmaceutical product’s lifetime, it’s widely known and accepted that manufacturing processes will drift within their specified ranges — typically due to equipment wear-and-tear and operator variance. To maintain the ‘validated state’, diligent producers spend a lot of time and effort in ensuring validation and periodic re-validation of processes to ensure that any process drift is accounted for and controlled.
pharmaphorum
JUNE 9, 2021
“Rarely does the answer come from the boardroom” – what can user experience teach us about building accessible digital health? No one should be left behind as the world embraces digital healthcare say leading user experience voices. The experts discussed the benefits and merits of co-creation during a session on bridging the digital divide, held during the recent Patient Experience Digital Summit.
Bio Pharma Dive
JUNE 18, 2021
The U.S. drugmaker is the latest to invest large sums of money in antibody-drug conjugates, following recent deals by Gilead, Merck and AstraZeneca.
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.
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