Bio Pharma Dive
JULY 9, 2021
After several setbacks, most notably the failure of a brain cancer vaccine, Celldex has a chance at reinvention should early drug results pan out for the 16-year-old biotech.
World of DTC Marketing
JULY 8, 2021
SUMMARY: TV continues to be the dominant channel for DTC advertising. Some of the TV spots for drugs are horrible, and some products should even be on TV because of terrible fair balance. TV ads only drive awareness as the first step for online health seekers. More conversations are happening on social media, and pharma seems to be immune to the conversations.
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Pharma Times
JULY 6, 2021
Vaccine will be evaluated in 13 HIV-negative adults aged 18-65 years old
pharmaphorum
JULY 8, 2021
Buoyed by the success of its COVID-19 vaccine, Moderna has started a phase 1/2 trials of its mRNA-based shot for seasonal influenza, targeting four different flu strains. . The first patents have now been enrolled into the study of the shot – codenamed mRNA-1010 – which is designed to generate antibodies against influenza A H1N1, H3N2 and influenza B Yamagata and Victoria – all of which are recommended by the World Health Organization (WHO).
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!
Bio Pharma Dive
JULY 7, 2021
Hoos, who led cancer R&D at GSK, will take over as head of Scorpion Therapeutics, a new biotech company that's raised $270 million in venture funding since launching last October.
World of DTC Marketing
JULY 9, 2021
SUMMARY: Pfizer asks for accelerated approval for a COVID booster shot even though the FDA says it’s unnecessary. From 2016 to 2020, the 14 leading drug companies spent $577 billion on stock buybacks and dividends—$56 billion more than they spent on R&D over the same period.” From 2016 to 2020, compensation for the 14 companies’ top executives totaled $3.2 billion.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
pharmaphorum
JULY 6, 2021
The UK’s biotechnology sector is going through a purple patch, attracting almost £1.6 billion ($2.2 billion) in financing in the three months to end-May – which is a record for the industry. The new figures – from the BioIndustry Association and Clarivate – were dominated by more than £1 billion in venture capital funding for UK biotech and life sciences companies, headlined by DNA sequencing company Oxford Nanopore’s £195 million raise in May that was just shy of the £205 million re
Bio Pharma Dive
JULY 8, 2021
Treatments from Bluebird bio and CRISPR Therapeutics have shown considerable promise and could soon be nearing regulatory review. A full pipeline is growing behind them.
Scienmag
JULY 8, 2021
New simulations suggest that waiting until a student tests positive is too late for prevention Credit: Paul Tupper (CC BY 4.0, [link] A new study examines factors that underlie COVID-19 outbreaks in schools and suggests that large outbreaks can only be prevented with regular monitoring of everyone in the school setting. Paul Tupper and Caroline […].
Pharma Times
JULY 8, 2021
Company is aiming to transform the discovery of therapeutics focused on enzyme inhibition
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
Camargo
JULY 8, 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. Old Antidepressants Being Repurposed to Treat Cancer . At Camargo, we have worked with hundreds of investigators who have found new targets for established drugs. It is exciting to find new uses of drugs with known safety because these drugs can reach new groups of patients in a relatively short timeframe.
Bio Pharma Dive
JULY 8, 2021
The approval of Aduhelm last month, already highly controversial, was made more so by the agency's decision to clear the drug for an exceptionally broad group of patients. New prescribing information more closely matches clinical testing.
Pharma Mirror
JULY 4, 2021
Testosterone is an essential hormone and steroid that affects many physiological functions. It is naturally more prevalent as an androgynous hormone in men, and it is therefore much more essential for them to have adequate amounts of it. However, with age, levels of this primary hormone can take a dive, usually for the worse. Symptoms of low testosterone may include weight gain, anxiety, low energy levels, low libido, insomnia, loss of concentration, and low mood.
Pharma Times
JULY 8, 2021
Priority review comes following positive results from the Phase III NAVIGATOR trial
NY Times
JULY 5, 2021
The World Bank said the financial crisis could rank among the world’s three worst since the mid-1800s. The currency has lost more than 90 percent of its value and unemployment has skyrocketed.
Bio Pharma Dive
JULY 6, 2021
The biotech's decision to pause testing of a cystic fibrosis drug is the latest reminder of the difficulty of delivering RNA medicines into the lungs.
pharmaphorum
JULY 6, 2021
A peptide vaccine developed by Australia’s Imugene has reduced tumour size in around half of patients with HER2-positive gastric or gastroesophageal junction (GEJ) cancer in a phase 2 trial. The interim readout from the 39-patient HERIZON trial found 50% of patients treated with the HER-Vaxx (IMU-131) vaccine on top of chemotherapy achieved a partial response or better, compared to 29% of patients given only chemo.
Pharma Times
JULY 8, 2021
Collaboration will focus on the development of smart neurostimulators for the treatment of severe chronic diseases
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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
Outsourcing Pharma
JULY 8, 2021
The immunotherapy firm is conducting a Phase III trial centered on an innovative approach to treating recurrent glioblastoma, an aggressive brain cancer.
Bio Pharma Dive
JULY 9, 2021
Janet Woodcock, the agency's acting head, asked the HHS inspector general to investigate contacts between Biogen executives and FDA staff as criticism mounts of the regulator's handling of the controversial approval.
pharmaphorum
JULY 6, 2021
Nina Garrett, R&D director at Abingdon Health discusses the key role antibody testing is playing in the pandemic and how an integrated approach with vaccines could help normal life resume. Millions of tests for COVID-19 are taken worldwide every day, as they become an increasingly important tool for our return to normality. Testing programmes have been rolled out by governments globally with the important purpose of tracking the spread of the SARS-CoV-2 virus and letting individuals know whe
Pharma Times
JULY 9, 2021
Currently, no preventative vaccines or effective treatments are available for the chikungunya 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.
BioSpace
JULY 7, 2021
Ivermectin has become a contentious issue as to whether it effectively prevents and treats COVID-19. Several studies suggest it is effective, while others have indicated it is not.
Bio Pharma Dive
JULY 6, 2021
The results are a potentially significant finding that could help change how heart failure patients with preserved ejection fraction are treated, and will support the companies' application for the drug's approval.
pharmaphorum
JULY 9, 2021
Orchard Therapeutics’ gene therapy for rare childhood disease metachromatic leukodystrophy (MLD) Libmeldy has been rejected for NHS use by NICE in draft guidance. The agency said that while there was evidence of a short-term benefit with Libmeldy (atidarsagene autotemcel or OTL-200 ), assumptions about its long-term effects are uncertain, making it unclear whether it will offer value for money to the NHS.
Pharma Times
JULY 6, 2021
Clearance in the UK is still pending and remains a requirement to complete the proposed deal
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.
BioPharma Reporter
JULY 7, 2021
WHO is recommending the use of interleukin-6 (IL)-6 receptor blockers in patients with severe and critical COVID-19, adding them to its list of treatments for the virus.
Bio Pharma Dive
JULY 7, 2021
Having proved mRNA's might in COVID-19, the biotech company aims to develop similar vaccines for other respiratory illnesses caused by influenza, RSV and metapneumovirus.
pharmaphorum
JULY 8, 2021
GlaxoSmithKline’s head of oncology Axel Hoos has resigned from the company, and will take up a new role as chief executive of US biotech Scorpion Therapeutics. . Hoos is leaving GSK after nine years, a period that saw a complete revamp of the unit including the wholesale divestment of cancer drugs to Novartis in a $16 billion deal announced in 2014 – which completed as he took over the division.
Pharma Times
JULY 8, 2021
COVID-19 infection rates were three times lower in fully vaccinated people compared to unvaccinated people
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