Bio Pharma Dive
OCTOBER 31, 2021
Through high-stakes litigation, aggressive patenting practices and a bit of luck, Amgen will likely stretch Enbrel's monopoly until 2029, more than 30 years after it was approved.
World of DTC Marketing
NOVEMBER 5, 2021
SUMMARY: Wegovy is selling so well that it’s hard to get at pharmacies. It’s being positioned as an anti-obesity drug, but one study by Novo Nordisk has shown that people who stop taking Wegovy after a few months tend to regain much of their lost weight within a year. In addition, people who lost weight on Wegovy in clinical trials had nutritional counseling and had to stay on a strict diet.
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Scienmag
NOVEMBER 4, 2021
Since the first reported pangolin seizure in Nigeria in 2010, the country has seen an explosion in the black market for the world’s most trafficked mammal – becoming Africa’s hub for the criminal export of pangolin products to East Asia. Credit: Charles Emogor Since the first reported pangolin seizure in Nigeria in 2010, the country […].
pharmaphorum
NOVEMBER 3, 2021
A real-world study of digital therapeutic (DTx) for opioid use disorder has found that patient show used it had 46% fewer hospital stays than a control group, saving more than $2,700 over a nine-month period. The study of Pear Therapeutics’ reSET-O found that the total cost of hospital and clinician costs were $11,141 among 64 patients who were prescribed the DTx but didn’t use it, but fell to $8,733 among active users of the 12-week course.
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
Bio Pharma Dive
NOVEMBER 5, 2021
The drugmaker, which last week won FDA clearance of its vaccine in younger children, plans to quickly ask the agency for emergency authorization of the drug in high-risk patients.
World of DTC Marketing
NOVEMBER 1, 2021
SUMMARY: According to eMarketer, “in 2020, spending on digital advertising in the healthcare and pharma industry will grow by 14.2% to reach $9.53 billion, making it the fastest-growing sector after computing products and consumer electronics (which will grow 18.0% this year). How reliable is this estimate? eMarketer has been wrong more times than I can count.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharma Times
NOVEMBER 2, 2021
93% of clinicians felt that remote medicine was worse than in-person consultations in terms of accuracy
Bio Pharma Dive
NOVEMBER 1, 2021
The FDA wants to better understand the risk of vaccine-associated myocarditis in 12- to 17-year-olds based on real-world use overseas, which will set back Moderna’s authorization plans in the U.S.
pharmaphorum
NOVEMBER 1, 2021
Daiichi Sankyo has launched its oncolytic virus therapy Delytact in Japan – its first world market – as a treatment for malignant glioma, an aggressive form of brain cancer. Delytact (teserpaturev) is a genetically engineered oncolytic herpes simplex virus type 1 (HSV-1) that was approved for marketing in Japan earlier this year, and received pricing approval in August at 1.43 million yen (around $12,500) per dose, according to a Pharma Japan report.
Deltaclinical
NOVEMBER 2, 2021
The sponsor of a study will assign one or multiple principle investigators (PI), usually a doctor. Along with a team of nurses and other stakeholders, the PI will conduct the trial at his/her study site. However, the sponsor will remain the monitor of the trial. The next figure shows the important stakeholders in a clinical trial. Traditionally, clinical trials have never been designed with patient-centricity in mind.
Pharma Times
NOVEMBER 5, 2021
The trial evaluated the investigational medicine in non-hospitalised adult patients with COVID-19 who are at high-risk of progressing to severe illness
Bio Pharma Dive
NOVEMBER 3, 2021
With an initial investment of $20 million, the collaboration will use technologies from various Flagship-backed companies to discover and develop new therapies for the disease.
pharmaphorum
NOVEMBER 5, 2021
An oral antiviral drug developed by Pfizer has been shown to dramatically cut the risk of hospitalisation or death from COVID-19 when given in the early stages of infection. The phase 3 trial found that Paxlovid – which combines new protease inhibitor PF-07321332 with already-approved HIV drug ritonavir – reduced the risk of hospitalisation or death by 89% when given to newly-diagnosed adults who were at risk of developing severe COVID-19 in the EPIC-HR trial.
Deltaclinical
NOVEMBER 2, 2021
The sponsor of a study will assign one or multiple principle investigators (PI), usually a doctor. Along with a team of nurses and other stakeholders, the PI will conduct the trial at his/her study site. However, the sponsor will remain the monitor of the trial. The next figure shows the important stakeholders in a clinical trial. Traditionally, clinical trials have never been designed with patient-centricity in mind.
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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
NOVEMBER 1, 2021
HRT treats menopause symptoms by replacing hormones that are at a lower level for those experiencing it
Bio Pharma Dive
NOVEMBER 3, 2021
Data readouts for Pfizer's hemophilia gene therapies are now expected later than previously forecast, while the company also works through modifying a trial of its Duchenne treatment.
pharmaphorum
NOVEMBER 1, 2021
Novartis has claimed FDA approval for one of its ‘wild card’ drugs – Scemblix – a first-in-class STAMP inhibitor for patients with previously-treated chronic myeloid leukaemia (CML). Scemblix (asciminib) was one of a clutch of high risk, high reward drug candidates for a range of diseases that Novartis chief executive Vas Narasimhan said last year were flying under-the-radar of industry watchers, but could potentially develop into blockbusters.
Deltaclinical
NOVEMBER 2, 2021
The sponsor of a study will assign one or multiple principle investigators (PI), usually a doctor. Along with a team of nurses and other stakeholders, the PI will conduct the trial at his/her study site. However, the sponsor will remain the monitor of the trial. The next figure shows the important stakeholders in a clinical trial. Traditionally, clinical trials have never been designed with patient-centricity in mind.
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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.
Pharma Times
NOVEMBER 1, 2021
Anyone who received their second dose at least six months ago can now receive their booster at one of these sites
Bio Pharma Dive
NOVEMBER 2, 2021
The three-month delay could give an advantage to Bristol Myers Squibb, which holds the first approval for a CAR-T therapy for the blood cancer.
Scienmag
NOVEMBER 2, 2021
Increased mortality risk among current alcohol abstainers might largely be explained by other factors, including previous alcohol or drug problems, daily smoking, and overall poor health, according to a new study publishing November 2nd in PLOS Medicine by Ulrich John of University Medicine Greifswald, Germany, and colleagues. Credit: Alexas_Fotos, CCO ([link] Increased mortality risk among […].
BioSpace
NOVEMBER 4, 2021
Pfizer plans to seek Emergency Use Authorization for an antiviral COVID-19 treatment following an interim analysis of Phase II/III data that show statistically and clinically meaningful results.
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
NOVEMBER 4, 2021
The antiviral medicine will be marketed with the trademark name Lagevrio in the UK
Bio Pharma Dive
NOVEMBER 2, 2021
The biotech has identified gene editing as a natural fit for the technology it uses to deliver its vaccines and drugs. A deal with Metagenomi, a startup backed by Bayer, will further those ambitions.
Scienmag
NOVEMBER 3, 2021
Clinicians and the wider research community involved in treating advanced breast cancer (ABC) need to do more to help and encourage patients to join clinical trials, according to a patient advocate who is leading a study that shows only 14% of ABC patients in the UK have been recruited to a trial. Credit: Lesley Stephen […].
BioSpace
OCTOBER 31, 2021
The decision made VUITY the very first and only eye drop to be approved for the condition.
Pharma Times
NOVEMBER 2, 2021
Indonesia becomes the first country to authorise the vaccine
Bio Pharma Dive
NOVEMBER 2, 2021
The biotech has officially filed for an accelerated review of its closely watched ALS drug, an outcome that seemed unlikely just a few months ago.
pharmaphorum
NOVEMBER 5, 2021
Novartis has chalked up another successful trial for its targeted factor B inhibitor iptacopan, an orally-active drug trying to challenge antibody-based therapies for diseases associated with the complement pathway. A phase 2 trial of iptacopan in patients with the rare kidney disease C3 glomerulopathy (C3G) – which causes progressive kidney failure and has no approved treatments – showed reductions in kidney damage with the drug that Novartis said were “clinically important.” C3G of
XTalks
NOVEMBER 1, 2021
Each year, World Vegan Day falls on November 1 as a way to celebrate veganism and appreciate its benefits to humans and the environment. While veganism is far from new, it has gained mass popularity over the last few decades with the advancement of plant-based food technology and a greater push for food sustainability. So, what is the history behind World Vegan Day and how is it being celebrated in 2021?
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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.
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