Bio Pharma Dive
OCTOBER 12, 2021
The gene editing company aims to expand its trial and add a second dose to improve effectiveness. However, safety worries have emerged since the FDA ordered CRISPR's rival Allogene to suspend clinical work.
Pharma Mirror
OCTOBER 13, 2021
Paris, Pharmapack Europe (#PharmapackEU) announce the winners of the 2021 Pharmapack Awards and, due to the exceptional quality of this year’s entries, seven winners have been chosen across both the ‘Exhibitor Innovation’ and ‘Health Product’ awards. The Exhibitor Innovation awards recognise four winners plus one highly commended product. EVEON was given the ‘routes of administration’ innovation award for their Intuity® Spray.
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World of DTC Marketing
OCTOBER 11, 2021
SUMMARY : DTC marketing is evolving as patients become more thoughtful about choosing treatment options. The model of “heavy TV followed by a website designed to sell people isn’t going to work anymore. I hear more and more from top pharma clients that “our DTC ROI is not where we want it to be.” In a detailed analysis across different health conditions, I’m finding two common causes.
Camargo
OCTOBER 14, 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. FDA Discusses Focus Areas for PDUFA VII During Public Meeting. Following the August publication of the proposed PDUFA VII commitment letter negotiated with industry, the FDA held its corresponding required public meeting on September 28.
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
OCTOBER 11, 2021
The biotech still believes a speedy approval filing for the closely watched treatment is possible, but expects to have to wait for the results of the recently launched Phase 3 trial, CEO Doug Ingram said on a conference call.
NY Times
OCTOBER 9, 2021
Some poorer countries are paying more and waiting longer for the company’s vaccine than the wealthy — if they have access at all.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
BioPharma Reporter
OCTOBER 11, 2021
Samsung Biologics and Enzolytics have entered into a strategic CDMO partnership agreement targeting monoclonal antibody production.
Bio Pharma Dive
OCTOBER 11, 2021
After lagging for months, M&A has accelerated over the past five weeks. But the average size of each transaction remains low compared to past years, as evidenced by the dual Monday buyouts of Adamas and Flexion.
Pharma Times
OCTOBER 13, 2021
Tolebrutinib reduced multiple sclerosis (MS) disease activity as measured by MRI
Pharma Mirror
OCTOBER 15, 2021
SYDNEY,Topelia Australia, a biotech company established to commercialise a novel ATT treatment for Australians in quarantine, has launched an investment program designed to keep the invention Australian owned – while rolling out treatment to the world. – Topelia announces US$25 mil Series A capital raise to fund manufacture and clinical trials of the COVID-19 Antiviral Triple Therapy (ATT).– Topelia has secured exclusive global patent rights to COVID-19 Antiviral Triple Therapy
pharmaphorum
OCTOBER 15, 2021
Digital Health veteran Eugene Borukhovich has joined Healthware Group as senior advisor to its Media and Community business unit, which aims to foster dialogue and connections among the digital health community. He is a serial intra- and entrepreneur, angel investor and venture builder and is currently scaling YourCoach Health as its co-founder and COO.
Bio Pharma Dive
OCTOBER 14, 2021
But the committee members remain opposed to broad use of boosters in healthy young adults, for whom the benefits of an additional shot are less clear.
Pharma Times
OCTOBER 14, 2021
The ATTC is coordinated as part of the Cell and Gene Therapy Catapult, and operates within the NHS framework
Pharma Mirror
OCTOBER 15, 2021
The right solution for every process step Karlsruhe/Germany, Romaco will take advantage of the upcoming CIPM 2021 (61st China International Pharmaceutical Machinery Exposition) to show its newest technologies for manufacturing and packing oral solids. From granulation, tableting and coating to packing into blisters and cartons, Romaco has the right solution for every process step.
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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
pharmaphorum
OCTOBER 12, 2021
Value-based, person-centred healthcare is the key to system resilience – and now is the time to make it happen. COVID-19 offers a “unique opportunity” to build healthcare systems that are both agile enough to deal with future crises and strong enough to overcome existing challenges. That’s according to a new policy paper from the European Alliance for Value in Health.
Bio Pharma Dive
OCTOBER 12, 2021
For an upfront payment of $45 million, Takeda gains access to as many as eight programs from Poseida Therapeutics and a potential method of delivering gene therapies without the help of viruses.
Pharma Times
OCTOBER 11, 2021
Pharmacies saw increased customer demand during the pandemic, says UHY Hacker Young
Pharma Mirror
OCTOBER 15, 2021
Milan, InSilicoTrials has been innovating the healthcare sector for some years now, helping pharmaceutical companies reduce the time and cost of drug development using modeling & simulation. The release of two new products for oncology that have no equals on the market – PCa GnRH Agonists Simulator and CTx NeutroSim – is going to accelerate the growth of this startup with offices in Italy, USA and the Netherlands.
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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.
pharmaphorum
OCTOBER 15, 2021
Headspace and Ginger have completed their $3 billion combination to create Headspace Health, a new frontrunner in the rapidly growing digital mental health and wellbeing sectors. The company will be led by Ginger’s former CEO Russell Glass, while Headspace’s co-founders Andy Puddicombe and Richard Pierson will sit alongside him on Headspace Health’s new board of directors.
Bio Pharma Dive
OCTOBER 15, 2021
Agency advisers unanimously supported offering a second dose of J&J's coronavirus vaccine to adults who previously received it, though guidance could change as regulators evaluate mixing boosters.
Pharma Times
OCTOBER 15, 2021
Patients in the trial were those with unresectable hepatocellular carcinoma (HCC) who had not received systemic therapy treatment previously, and were not eligible for localised treatment
Pharma Mirror
OCTOBER 15, 2021
The importance of teaching children and teens about healthy relationships is becoming more and more apparent. This education starts with teaching them the importance of their self-worth as well as that of others. Kids need to see healthy relationships modeled to understand what they should be striving for in their own life’s relationships. Role models are an essential part of this process.
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.
pharmaphorum
OCTOBER 12, 2021
A data-mining study conducted by researchers in the US has found that an already-approved diuretic drug could have potential as a treatment for some patients with Alzheimer’s disease. The research by a team of National Institutes of Health (NIH) scientists found that people who took bumetanide, a generic drug usually used to treat heart failure and oedema, had a significantly lower prevalence of Alzheimer’s compared to those not taking the drug.
Bio Pharma Dive
OCTOBER 14, 2021
The company's immunotherapy is the only drug of its type cleared for advanced cervical cancer. Others are being tested, however.
JAMA Internal Medicine
OCTOBER 11, 2021
This cohort study examines the spread of COVID-19 infection within family members living in the same residence with different levels of immunity.
BioSpace
OCTOBER 10, 2021
?The decision is based on promising results from the Marguerite RoAD and SCarlet RoAD open-label extension trials, showing a significant reduction in brain amyloid plaque in Alzheimer's patients.
pharmaphorum
OCTOBER 15, 2021
The World Health Organization has set up a new scientific group to study the origins of COVID-19 in the hope that it will help prevent future pandemics. The new Scientific Advisory Group for the Origins of Novel Pathogens (SAGO) will bring together experts from areas such as epidemiology, animal health, clinical medicine, virology and genomics. WHO chief Tedros Adhanom Ghebreyesus said: “SAGO will advise WHO on the development of a global framework to define and guide studies into the origins of
Bio Pharma Dive
OCTOBER 13, 2021
Results suggested Pfizer's and Moderna's vaccines may serve as a more potent booster for those who initially received Johnson & Johnson's shot, although data are limited and preliminary.
Pharma Times
OCTOBER 13, 2021
Conditional marketing authorisation granted for patients with advanced NSCLC with METex14 skipping alterations
XTalks
OCTOBER 15, 2021
The World Health Organization (WHO) honored the late Henrietta Lacks with a posthumous award to recognize her life, legacy and contribution to science as a Black woman whose cells became the first “immortal” cell line, leading them to become one of the most important and widely used in scientific research. The WHO’s Director-General Dr. Tedros Adhanom Ghebreyesus honored Henrietta Lacks with a WHO Director-General’s award, “recognizing the world-changing legacy of this Black American woman who d
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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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