Sat.Oct 09, 2021 - Fri.Oct 15, 2021

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CRISPR touts new results as fresh questions surround 'off-the-shelf' CAR-T

Bio Pharma Dive

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.

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Pharmapack Europe 2021 Award Winners Announced

Pharma Mirror

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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DTC is evolving: 10 things you must do

World of DTC Marketing

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.

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In the News: September 2021 Regulatory and Development Updates

Camargo

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.

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The New Age of Decentralized Clinical Trials

White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations

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Sarepta outlines final push for Duchenne gene therapy

Bio Pharma Dive

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.

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Topelia Australia launches US$25M Series A call for COVID-19 ATT Ziverdox

Pharma Mirror

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

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Healthware Group appoints Eugene Borukhovich as senior advisor

pharmaphorum

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.

Pharmacy 122
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Adamas, Flexion sell for $825M combined as biotech's dealmaking pace picks up

Bio Pharma Dive

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.

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Romaco at CIPM 2021 in Chengdu, China

Pharma Mirror

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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Moderna, Racing for Profits, Keeps Covid Vaccine Out of Reach of Poor

NY Times

Some poorer countries are paying more and waiting longer for the company’s vaccine than the wealthy — if they have access at all.

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Roles and Responsibilities of Specialized Clinical Supply Experts

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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No return to the status quo: Why now is the time for value-based change

pharmaphorum

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.

Medicine 116
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Takeda takes aim at a biotech's gene therapy work

Bio Pharma Dive

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.

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InSilicoTrials releases two new state-of-the-art simulation tools for oncology 

Pharma Mirror

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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Samsung Biologics to help Enzolytics advance clinical development of mAbs

BioPharma Reporter

Samsung Biologics and Enzolytics have entered into a strategic CDMO partnership agreement targeting monoclonal antibody production.

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How Machine Learning Drives Clinical Trial Efficiency

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.

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Phase III trial shows AZ’s liver cancer combination improves overall survival

Pharma Times

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

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FDA panel endorses second shot for adults who received J&J vaccine

Bio Pharma Dive

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.

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Why Kids Need Positive Role Models

Pharma Mirror

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.

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Data dive finds cheap diuretic could be Alzheimer’s drug

pharmaphorum

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.

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What the FDA's New Dosage Guidance Means for the Future of Clinical Research

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.

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Alzheimer’s Drug Granted FDA Breakthrough Designation as Space Heats Up

BioSpace

?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.

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FDA advisers unanimously back Moderna booster shot for many Americans

Bio Pharma Dive

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.

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How Researchers Stumbled Upon an Arthritis Vaccine Just in Time for World Arthritis Day

XTalks

Today is World Arthritis Day (WAD) and this year’s theme is “Don’t Delay, Connect Today,” initiated by the European Alliance of Associations for Rheumatology ( EULAR ), to help raise awareness about the early diagnosis of rheumatic and musculoskeletal diseases (RMD). Arthritis is a chronic disease that afflicts one in four Americans. But there could soon be a path to prevention of the disease.

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Actemra shortage spills over to include Sanofi’s rival Kevzara

pharmaphorum

Roche’s Actemra has been in high demand since its value in treating severe COVID-19 was established, leading to shortages. Now, Sanofi’s rival therapy Kevzara has also been hit by supply constraints. Sanofi said in a statement that supply of all four formats of Kevzara (sarilumab) – 150 mg or 200 mg pre-filled syringes or auto-injectors – will be short until early 2022 based on current demand.

Licensing 104
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The New Age of Decentralized Clinical Trials

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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Development of Generic Drug Products by Pharmaceutical Industries Considering Regulatory Aspects: A Review

Drug Patent Watch

This paper was originally published by Md. Imtiaz Hasan et al in Journal of Biosciences and Medicines under a Creative Commons Attribution 4.0 International License Abstract Development of generic drug product…. The post Development of Generic Drug Products by Pharmaceutical Industries Considering Regulatory Aspects: A Review appeared first on DrugPatentWatch - Make Better Decisions.

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NIH study finds mixing COVID-19 boosters increases immune response

Bio Pharma Dive

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.

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Hormel Foods Partners with Better Meat Co. To Bring Mycoprotein Products to Market

XTalks

Hormel Foods Corporation’s 199 Ventures which is the company’s venturing company, is entering the plant-based protein sphere by partnering with The Better Meat Co. Together, they will bring new mycoprotein and plant-based protein products to the market. In 2019 Hormel Foods wanted to bring forward a food incubator where the company invests in others that align with Hormel Foods’ growth strategies, which was when 199 Ventures was born.

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‘Build back better’ cannot mean longer waiting times for change

pharmaphorum

Global Blood Therapeutics (GBT) UK general manager Nigel Nicholls discusses the impact of COVID-19 for sickle cell patients in the UK. If the COVID-19 pandemic has shown us anything, it has highlighted the extent to which health inequity plagues our society. Although the Government, public and health care system have started to wake up to the insidious nature of systemic racism in the wake of the pandemic, many have been left facing tougher situations than pre-pandemic.

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Accelerating Clinical Supply Through Integrated Drug Development

As the development pipeline for new drugs continues to grow, biopharmaceutical companies are re-evaluating how to best manage and balance resources across an increasing number of development projects and complex clinical trials. There are two approaches that can be used to speed a drug from development to clinic faster: timeline compression and parallel processing, but only one that considers the benefits of integrating clinical supply into the overall drug development process.

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Are You a Woman in Healthcare? 6 Tips for Advancing Your Leadership Skills & Opportunities

Pharma Marketing Network

At the 7 th Advancing Women’s Leadership Skills & Opportunities in Pharma & Healthcare conference, top executives from across the pharmaceutical industry gathered to share their personal stories of success and perseverance to educate and inspire the next generation of female leaders. Despite a growing emphasis on diversity & inclusion and a more accepted understanding of the business impact that can be achieved through greater gender balance in organizational leadership, women still

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Intellia looks to eye diseases in latest deal

Bio Pharma Dive

The gene editing company will take a 10% stake in SparingVision, a young biotech that will use Intellia's CRISPR technology to develop treatments for up to three ocular targets.

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Popeyes Partners with Megan Thee Stallion for “Hottie Sauce” Collaboration

XTalks

Fast food chicken giant Popeyes announced a collaboration with chart-topping rapper Megan Thee Stallion for a new hot sauce. Starting October 19, Popeyes customers can spice up their chicken sandwich or chicken nuggets with Megan Thee Stallion Hottie Sauce, a sweet-and-spicy hybrid based on the rapper’s vibrant personality. “I’m appreciative of Popeyes’ commitment to empowering Black women and look forward to opening Popeyes Restaurants,” Megan Thee Stallion said in a press release.

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WHO plans pandemic prevention study of COVID’s origins

pharmaphorum

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

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Deliver Fast, Flexible Clinical Trial Insights with Spotfire

Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management. Learn how Revvity Signals helps drug developers deliver clinical trial data insights in real-time using a fast and flexible data and analytics platform to empower data-driven decision-making.