Bio Pharma Dive
NOVEMBER 26, 2021
Final trial data for molnupiravir were less convincing than what Merck previously reported and could alter how the FDA views the drug, which will be evaluated at a meeting Tuesday.
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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Pharma Times
NOVEMBER 25, 2021
A team of scientists and pharmaceutical collaborators have discovered a ‘bench to bedside’ drug design, which will hopefully improve the future treatment of Alzheimer’s disease.
JAMA Internal Medicine
NOVEMBER 7, 2021
This cross-sectional study of individuals from the French CONSTANCES cohort assesses whether the belief in having been infected with SARS-CoV-2, having serological test–confirmed COVID-19 infection, or both are associated with persistent physical symptoms often attributed to long COVID in the general adult population.
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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
pharmaphorum
NOVEMBER 16, 2021
An artificial intelligence algorithm developed by GE Healthcare that helps with the placement of endotracheal tubes (ETTs) has been approved by the FDA. The new tool – part of GE’s Critical Care Suite 2.0 – helps bedside staff and radiologists assess patients before intubation – for example prior to ventilation in patients with critical COVID-19 – and make sure their ETTs are positioned correctly.
BioPharma Reporter
NOVEMBER 18, 2021
Biogen says it is disappointed with feedback received from a European Medicines Agency committee on its aducanumab Marketing Authorization Application: but pledges to continue to engage with the regulator as it considers its next steps.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
World of DTC Marketing
NOVEMBER 24, 2021
SUMMARY: The U.S. needs to take substantial steps to address the high costs of cancer drugs. From 2009 to 2019, the median monthly treatment costs for new drugs at launch reached $11,755 in the U.S… Does the question become how much is a month(s) of other life worth? According to an analysis published by JAMA Oncology, prices for new drugs approved for use in the treatment of cancer in the United States more than doubled over the past decade.
Pharma Times
NOVEMBER 30, 2021
Following its recent approval of an injectable HIV-1 treatment from the National institute for Health and Care Excellence (NICE), GlaxoSmithKline (GSK) has high hopes in developing a cure for the virus in the future.
NY Times
NOVEMBER 27, 2021
A new treatment using stem cells that produce insulin has surprised experts and given them hope for the 1.5 million Americans living with the disease.
pharmaphorum
NOVEMBER 28, 2021
An investigator-led trial of Jazz Pharma’s cannabis extract-based drug Sativex in glioblastoma – an aggressive form of brain cancer – will get underway in the UK next year. The three-year phase 2 trial will be carried out by researchers at Leeds University led by professor of clinical oncology and neuro-oncology Susan Short, and see if adding Sativex (nabiximols) to standard chemotherapy for recurrent glioblastoma can extend survival.
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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
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 […].
Bio Pharma Dive
NOVEMBER 30, 2021
While agency advisers raised concerns over molnupiravir's modest benefits and potential risks, a majority felt the antiviral drug is a needed option for COVID-19 patients at high risk of severe disease.
World of DTC Marketing
NOVEMBER 16, 2021
SUMMARY: Omnichannel marketing employs the simultaneous implementation of channels across personal, non-personal, and media and addresses the integrated needs of multiple stakeholders – consumers/patients, healthcare professionals, and payers. Sounds good but is that the answer? There is no doubt that healthcare is the middle of an evolution not seen in over 30 years.
Pharma Times
NOVEMBER 11, 2021
ChAdOxl biEBOV is being tested for safety and immunogenicity, and may protect against multiple species of the virus
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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
NOVEMBER 18, 2021
The European Medicines Agency (EMA) could issue an opinion on Novavaxâ Conditional Marketing Authorization for its COVID-19 vaccine âwithin weeksâ.
pharmaphorum
NOVEMBER 12, 2021
Researchers in the US have developed an artificial intelligence-based tool that is able to predict COVID-19 symptoms and suggest which FDA-approved drugs might be used to treat patients. The MOATAI-VIR algorithm, developed by scientists at Emory University and Georgia Tech, was put through its paces in a study that showed it was able to predict 24 out of 26 clinical manifestations of COVID-19, including acute respiratory distress, blood clotting issues, cytokine storms, brain fog, and loss of sm
BioSpace
NOVEMBER 21, 2021
Even before the drug's approval on June 7, there were cases of amyloid-related imaging abnormalities (ARIA-E), or cerebral edema, observed in the trials.
Bio Pharma Dive
NOVEMBER 8, 2021
Study results for Mirati's drug combined with Keytruda have been much anticipated, as the San Diego biotech aims to challenge Amgen and its rival KRAS-blocking drug Lumakras.
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.
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 […].
Pharma Times
NOVEMBER 24, 2021
With the latest approval from the EC, patients in Europe suffering from metastatic triple-negative breast cancer can now receive Gilead Science’s Trodlevy as part of their treatment.
BioPharma Reporter
NOVEMBER 30, 2021
Australian biotech EnGeneIC, which is developing its nanocell tech for use in infectious diseases (including a COVID-19 vaccine) as well as a cancer treatment, has announced a deal with US biotech ImmunityBio to develop, manufacture and commercialize the tech.
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.
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.
BioSpace
NOVEMBER 9, 2021
A research team at the University of North Carolina – Chapel Hill (UNC) and Duke University, in Durham, NC identified an antibody that attacks SARS-CoV-2 and its variants and other types of coronaviruses.
Bio Pharma Dive
NOVEMBER 15, 2021
Luxturna, approved four years ago as the first gene therapy for an inherited disease in the U.S., is improving sight and quality of life for several of the patients who received it.
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 […].
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
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
BioPharma Reporter
NOVEMBER 15, 2021
Pfizer and BioNTech have completed long-range drone deliveries of their mRNA COVID-19 vaccine: with partner Zipline claiming to be the first to deliver vaccines in this way at a national scale.
pharmaphorum
NOVEMBER 16, 2021
Amazon’s push into the provision of remote healthcare services has been rewarded with a top-tier corporate client – the Hilton hotel chain. The deal – first reported by Reuters – involves the Amazon Care platform, which includes remote, online consultations with clinicians, as well as home visits in some areas. It provides primary and preventive care, ongoing support for chronic conditions, and referrals to secondary and tertiary care.
BioSpace
NOVEMBER 18, 2021
BioNTech is on the Fast Track. This morning, the company announced it received Fast Track Designation from the U.S. Food and Drug Administration for its cancer immunotherapy candidate.
Bio Pharma Dive
NOVEMBER 12, 2021
The industry giant and mainstay of corporate America will separate its consumer health business from its drug and medical device units, which will retain the J&J brand.
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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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