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The US Food and Drug Administration (FDA) released a statement this week about dosing schedules for COVID-19 vaccines, saying that any dose changes would be premature. In the statement , the FDA said that it wants to “remind the public about the importance of receiving COVID-19 vaccines according to how they’ve been authorized by the FDA in order to safely receive the level of protection observed in the large randomized trials supporting their effectiveness.”.
An in vitro study conducted by scientists from Northwestern University and Utah State University concluded that components found within the Xlear nasal spray, particularly grapefruit seed extract and xylitol, were successful in statistically reducing the amount of SARS-CoV-2 in a patient.
KEY TAKEAWAY: Consumer behavior has changed due to the pandemic, and DTC marketers should be aware of how consumers will evaluate and choose prescription drugs. Many organizations have postponed market research due to the pandemic but knowledgeable DTC marketers should be aware of the progressive trends in healthcare. Here’s my list: 1ne: DTC should focus more on providing health information about advertised medications and less on “selling.” The overwhelming majority of consum
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!
By Boris Goldstein, Co-Founder & Executive Chairman at Brain Scientific COVID-19 is known for its impacts on a patient’s respiratory system, but it has also been found to affect individuals in unique ways and with varying severity levels depending on their age, risk factors, and comorbidities. Several studies have recently shown that the development of neurological conditions and symptoms are prevalent in COVID patients.
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. FDA Issues Advice on Combination Products. In December, the FDA published “ Requesting FDA Feedback on Combination Products ” to (a) discuss how combination product sponsors can obtain FDA feedback on scientific and regulatory questions and (b) describe best practices for the FDA and sponsors when interacting on
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. FDA Issues Advice on Combination Products. In December, the FDA published “ Requesting FDA Feedback on Combination Products ” to (a) discuss how combination product sponsors can obtain FDA feedback on scientific and regulatory questions and (b) describe best practices for the FDA and sponsors when interacting on
With additional financing, Celularity will have $372 million to back development of experimental off-the-shelf treatments for cancer and autoimmune diseases.
While pharma has raced to develop COVID-19 vaccines, US-based company NeuroRx is taking a different approach to treating the virus. CEO Dr. Jonathan Javitt tells pharmaphorum about the science behind the company’s Zyesami, which targets the alveolar type II cells in the lung that are critical for transmission of oxygen. Zyesami was developed in conjunction with partner Relief Therapeutics, and NeuroRx is currently awaiting results from a Phase 2b/3 trial ( COVID-AIV ) evaluating the therapeutic
SUMMARY: Pfizer and Moderna will sell $28 billion of Covid-19 vaccines this year. Pharma companies will make an estimated $40 billion on the global COVID-19 vaccine market this year, which will be split between Johnson & Johnson, AstraZeneca, Novavax, and others. Wall Street has been speculating for a long time on which pharma company is going to make the most from the development of a Covid-19 vaccine.
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
The World Health Organizationâs vaccine advisory group recommends the two doses of the Pfizer/BioNTech vaccine should be delivered 21 to 28 days apart: although it adds that the maximum time period between doses could be up to six weeks in some situations.
Genome editing is an exciting but still nascent field, and companies in the area face as many obstacles as they do opportunities. Sangamo CEO Sandy Macrae told us how his company is being cautious about the hype and finding ways to be financially viable in an emerging space. ‘Cutting edge’ is, for once, a truly apt description when it comes to gene editing – both because the field is pushing medicine into areas we might never have dreamed possible, and because these technologies involve literall
MINUTE READ: Big pharma should take a good, hard look at small biotech companies and try to better understand how they succeed and are able to make strategic decisions faster without multi-levels of bureaucracy. This week a person with whom I have the highest level of respect because of her emotional and marketing intelligence landed a position with a small biotech company as Global Marketing Director.
After the surprise discovery of an extra dose in every vial, Pfizer executives successfully lobbied the F.D.A. to change the vaccine’s formal authorization language. The company charges by the dose.
By March, the FDA expects to conclude reviews of key drugs for heart failure, Duchenne's and multiple myeloma, as well as decide on whether to clear Biogen's controversial Alzheimer's treatment.
As the largest single-payer healthcare system in Europe, the UK’s National Health Service (NHS) has a uniquely beneficial health data and real-world evidence (RWE) environment. It’s one that has global potential to improve patient outcomes but efforts to harness the true potential of these information flows are only just beginning. The foundation for this is the NHS’ longstanding commitment to collecting healthcare data.
SUMMARY: Pharma has not embraced a content strategy when the number of online health seekers is climbing. A content management strategy can lead to a better brand-patient relationship and turn customers into brand ambassadors. I’m not a huge believer in content strategy for CPGs. I feel that there is so much content already out there that people don’t have the time to read it all.
Comparing Orphan Drug, Rare Pediatric Disease, and Humanitarian Use Device Designations. The US FDA offers sponsors a variety of special designation programs to incentivize them to develop and deliver therapies to treat unmet patient needs, such as Fast Track Designation (FTD), Breakthrough Therapy Designation , and Qualified Infectious Disease Product Designation.
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.
One approach that is being developed by researchers at Stanford University leveraged nanoparticles. Preclinical research was recently published on it in the journal ACS Central Science.
From telehealth to digital trials, customer engagement to healthcare data, Healthware Group outlines the key trends that are expected to shake up digital health this year. Well, it goes without saying, COVID-19 has resulted in a rapid adoption of digital technologies across all industries, most notably in healthcare. There are several important aspects to these shifts for pharma, biotech and medical device companies, so what can we expect to see over the next 12 months and beyond?
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.
SUMMARY: “How big pharma takeovers destroy innovation” a report from Congresswoman Porter does make some points. Still, she is missing a lot of facts at a time when hospital and health insurance costs are soaring. I always have pointed instances in which pharma puts Wall Street first and patients second. Ms. Porter points out that R&D seems to have been replaced with mergers and acquisitions, but she misses the big picture by focusing solely on drug costs.
Throughout our years of preparing and filing FDA submissions, Camargo has often encountered sponsors who cannot file an NDA or BLA within expected timeframes, most commonly due to a failure to start and complete prerequisite activities before the targeted filing date. In this post, we will highlight those requirements that seem to be the most misunderstood.
Despite the rising number of COVID-19 cases reported across the globe, rates of influenza have virtually flatlined across the Northern Hemisphere, leading many doctors and researchers to wonder how this could be replicated in non-pandemic times.
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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