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Sales of Nurtec ODT during the second quarter were double what Wall Street expected. CEO Vlad Coric explained to BioPharma Dive how the biotech did it, despite being far smaller than its chief rival.
SUMMARY: Pfizer says it has data on waning immunity from their COVID vaccine. The FDA and CDC say “not so fast.” Booster shots could bring billions in revenue to Pfizer and Moderna. The media is using scare headlines and is not always presenting accurate stories. Patients are left to wonder if they need a booster shot creating anxiety as a new strain emerges.
The company said it had determined that daily exposure to five Neutrogena and Aveeno sprays would not cause adverse health effects, but recalled the products out of an abundance of caution.
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!
Three months after a rare FDA rejection, Merck has data showing Keytruda can slow the return of triple-negative breast cancer but not, as of yet, proving whether the drug extends lives.
SUMMARY: There is a talent drain at the agency and DTC levels. More experienced DTC people are being forced to retire. TV still gets the biggest share of DTC budgets, but they don’t drive brand objectives. Talented marketers don’t want a career in pharma because of the culture. Many pharma agencies have allowed and sometimes forced experienced, talented people to leave while replacing them with inexpensive unproven people, and it shows.
Scientists in the US have developed an artificial intelligence-powered ‘clock’ that can estimate a person’s chance of developing an illness or dying based on the pattern of cytokines in their blood. The “inflammatory age” or iAge clock – described in the journal Nature Aging – uses a snapshot of the level of chronic inflammation in the body to predict the chances of developing cardiovascular or neurodegenerative diseases and to give an estimate of lifespan.
The agency said the benefits of vaccination with J&J's shot still "clearly outweigh" the risks, which now include very rare cases of a immune-driven condition known as Guillain-Barré
SUMMARY: The Committee on Oversight and Reform and the Committee on Energy and Commerce is investigating the approval process for Biogen’s new Alzheimer’s drug. Janet Woodcock acknowledged on Wednesday her agency may have misstepped in the handling of its polarizing approval of a new Alzheimer’s drug. Biogen undertook a secret campaign, termed Project Onyx, to persuade FDA to approve Aduhelm.
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 two companies will work together to come up with solutions that use machine learning and artificial intelligence to help accelerate innovation in R&D.
The Cleveland Clinic and Mount Sinai won't yet administer the controversial Alzheimer's drug, while UnitedHealth's CEO said the insurer would need more time to iron out coverage.
SUMMARY: The FDA has many puzzled as to why they approve some drugs with questionable data and ask for more data on other drugs. The FDA approves drugs on the potential to save a life, the cost of the drugs is never considered in the process. The FDA has been under criticism, but an internal investigation will focus on approval processes, not “why” a drug was approved.
Alcohol abuse is closely correlated with depression. This doesn’t necessarily mean one causes the other, but many people who suffer from depressive disorders turn to alcohol to escape. On the other side of that coin, those who abuse or overuse alcohol can develop symptoms of depression or exacerbate symptoms that are already present. So, how are these two issues related, and how can you help a loved one if you start to notice alcohol-induced depression or depression-induced alcohol abuse?
"Right now, and I think for a while, the access is going to be pretty limited," former CMS and FDA head Mark McClellan said at the meeting, which featured yet another rebuke by experts of Aduhelm.
Faced with a looming mental health crisis, the UK government has been urged to invest in the digitisation of service provision across the NHS in England in a new report from think tank Future Care Capital. The study’s author – FCC’s head of policy and research Dr Peter Bloomfield, argues that there has been a lack of support for mental health services for many years in the UK, and the pathways for accessing them are “convoluted, waiting lists are extensive, and outcomes are po
The research forecasts water supply and economic risks as tensions mount over Grand Ethiopian Renaissance Dam Credit: (Photo/NASA-JPL) Rapid filling of a giant dam at the headwaters of the Nile River — the world’s biggest waterway that supports millions of people — could reduce water supplies to downstream Egypt by more than one-third, new USC […].
Formed around research from the Broad Institute's David Liu and Andrew Anzalone, Prime has attracted significant funding from a wide range of high-profile biotech backers.
The UK’s competition authority has issued its largest ever fine of more than £260 million ($360 million) to several pharma companies accused of colluding to hike the price of medicines delivered to the NHS. The Competition and Markets Authority (CMA) took the action against Auden Mckenzie and Actavis UK – now known as Accord-UK – and other companies after an investigation into the price of hydrocortisone tablets, which rose by 10,000% over a 10-year period.
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.
Rival Novo Nordisk has jumped ahead in developing an injectable drug that responds to changes in blood sugar. An acquisition of Protomer Therapeutics could help Lilly close the gap.
After more than a year of COVID-19 dominating health conversations, HCPs have been engaging in dialogue about continually evident disparities that many are facing in healthcare. CREATION.co’s Mary Kangley explores what HCPs think about health equity in cancer care. The topic rose to significance in the American Society of Clinical Oncology (ASCO) whereby they updated their mission statement in 2020 to “Conquering cancer through research, education, and promotion of the highest quality, equ
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.
A deal with Innocare gives Biogen a second therapy for MS that targets a protein called BTK, an approach several other competing drugmakers are pursuing, too.
AstraZeneca and Johnson & Johnson are both exploring ways to modify their COVID-19 vaccines to minimise the risk of severe blood clotting reactions that are seen – albeit rarely – in some people receiving the jabs. At the same time, the UK’s National Institute for Health and Care excellence (NICE) is developing guidance to help doctors manage the cases of vaccine-induced immune thrombocytopenia and thrombosis (VITT) and low blood platelet counts that have been seen with the COVID-19 va
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