Sat.Apr 09, 2022 - Fri.Apr 15, 2022

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AbbVie, Genmab, with new data, prep FDA application for dual-acting cancer drug

Bio Pharma Dive

Fresh trial results intensify competition with Roche to deliver the first lymphoma drug that marries antibody technology with an immunotherapy pathway.

Drugs 361
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Covid comments hurt survivors

World of DTC Marketing

Over 70% of people have been exposed to medical or health-related misinformation. Of those exposed, almost half are not confident in their ability to discriminate between accurate health information and misinformation. Social media is cited as the most common source of misinformation. People on the right use social media to purposely hurt family members who lost loved ones to Covid.

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The 4 Essentials When It Comes To Starting A Medical Lab Business

Pharma Mirror

There are so many ways to get into the healthcare industry these days. There are a lot of changes happening in the industry which means that there are a lot of niche services that you can provide and make a lot of money while also serving your communities needs. For instance, telehealth is a burgeoning field these days and is a good place to start. Another area that has a lot of potentials is starting a medical lab facility.

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Pfizer set to acquire COVID-19 smartphone detection app for $100m

BioPharma Reporter

Pfizer is set to acquire Australiaâs ResApp - a company developing a smartphone app to detect COVID-19 and other respiratory diseases based on the userâs cough - for $100m AUD ($74m USD).

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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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Pfizer, BioNTech to seek FDA OK for booster dose in 5- to 11-year-olds

Bio Pharma Dive

A third shot sparked a strong immune response in clinical testing, positioning the companies to make boosters available to the roughly 28 million kids in the U.S. who became eligible for their first two doses late last year.

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Why the drug pricing debate is focused on insulin

pharmaphorum

The treatment has been around for over a century but insulin has still become the centre of the ongoing discussion over pricing of pharmaceutical products. Ben Hargreaves looks at why insulin’s price is so controversial and whether this could be set to change. It has now been 100 years since the first patient with diabetes received an injection of insulin, when Leonard Thomas, a 14-year-old boy, was treated with the hormone.

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How Much Do You Know About in silico Trials?

XTalks

Conventional in vitro and in vivo studies are used in the drug development pipeline. However, could there be another way for developing biomedical products using in silico technology? This involves the use of an individualized computer simulation for medical device or drug development. Therefore, companies can evaluate their drug candidates or medical device products in “virtual patients” before assessing them in humans.

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Pfizer, Moderna name new finance chiefs amid surging revenue

Bio Pharma Dive

Pfizer is bringing in former Lowe's and CVS Health executive David Denton, while Moderna hired Jorge Gomez, previously CFO at Cardinal Health. Both take the reins as their new companies face strategic questions.

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UK launches its ‘Netflix-style’ payment model for antibiotics

pharmaphorum

The UK is poised to become the first country in the world to launch a new payment model for antibiotics that could reverse decades of decline in the category. The Department of Health, NHS England and NICE have completed an evaluation of two new antibiotics – Pfizer’s Zavicefta (ceftazidime/avibactam) and Shionogi’s Fetcroja (cefiderocol) – that will be paid for using the new subscription-like model likened to a Netflix account.

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Why Understanding Ramadan Will Mean the World to Your Muslim Coworkers

Intouch Solutions

It’s officially Ramadan, the Islamic month where Muslims fast from sunrise to sunset. During this month, Muslims around the world will be taking time to reflect on their blessings, express gratitude, and give charity. With that said, Ramadan also poses some challenges for Muslims in the workplace. Here are some FYIs and tips on how to foster an inclusive environment for your Muslim employees or coworkers.

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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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Xtalks Voices with Laura Dunn Nelson, Alchemy’s Food Safety Expert

XTalks

In this video, Xtalks spoke with Intertek Alchemy’s Laura Dunn Nelson, Vice President of Food Safety and Global Alliances. Laura spoke about her role at Intertek Alchemy and shared the most rewarding aspects of her work. Xtalks also asked Laura to discuss the challenges that companies are having today with their food safety culture. Laura has more than 30 years of experience implementing food safety and quality control programs for packaging, processing, retail operations and food service.

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AACR 2022: NK cell promise, more TIGIT questions and extending CAR-T's reach

Bio Pharma Dive

This year's meeting on early cancer research featured promising study results from German biotechs BioNTech and Affimed as well as details from a "practice-changing" lung cancer trial.

Trials 316
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Innovation across the healthcare system is needed to realise the value of medicines

pharmaphorum

Janssen’s Catherine Taylor, vice-president, EMEA medical affairs, therapy area strategy, discusses the importance of systemic innovation across the healthcare system to realise the full value of medicines. Medicines and vaccines are among the most powerful interventions that can help improve quality of life for people across the world. As an oncology trained medical doctor who practiced in the UK NHS for 10 years, I have seen the benefits first-hand, as patients live longer lives, free from symp

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New patent for Alkermes Inc drug ARISTADA

Drug Patent Watch

Annual Drug Patent Expirations for ARISTADA Aristada is a drug marketed by Alkermes Inc and is included in two NDAs. It is available from one supplier. There are fifteen patents…. The post New patent for Alkermes Inc drug ARISTADA appeared first on DrugPatentWatch - Make Better Decisions.

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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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Ferrero Recalls Select Kinder Chocolates Before Easter

XTalks

Ferrero U.S.A., Inc., the owner of Kinder Chocolate, Nutella and Tic Tacs, among other brands, is voluntarily recalling its Kinder Happy Moments Chocolate Assortment and Kinder Mix Chocolate Treats basket, due to possible Salmonella contamination. “While there are no reports of illness in the United States to date, Ferrero is voluntarily recalling the products out of an abundance of caution due to reported cases of Salmonella in consumers that consumed products in Europe that were manufactured a

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GSK acquires Sierra Oncology, betting $2B on a bone cancer drug with a long history

Bio Pharma Dive

The British pharma is buying into the potential of a medicine meant to treat the anemia often associated with myelofibrosis, a complication that isn't adequately addressed by current therapies.

Medicine 316
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Digital investment promises to accelerate the use of wearable sensor data in clinical trials

pharmaphorum

In an interview with Dudley Tabakin (CEO, VivoSense), Chris Garabedian (CEO, Xontogeny) and Tanja Dowe (CEO, Debiopharm Innovation Fund), pharmaphorum discusses the recent announcement of the closing of a $25 million Series A financing round to scale up the innovative VivoSense® software, which uses wearable sensor data in clinical trials, and for the development of novel digital biomarkers.

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Lonza expands functionality of its automated cell therapy manufacturing platform

BioPharma Reporter

Lonza has added new integrated capabilities in cell binding, cell separation, and bead removal to its closed, automated, and scalable platform for personalized therapy manufacturing.

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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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Ultrasonic tech to develop safer railway track lubrication measurement system

Scienmag

THE University of Huddersfield has forged a partnership with an innovative technology business to work with Network Rail on developing a safer and more reliable track lubrication measurement system. Credit: University of Huddersfield THE University of Huddersfield has forged a partnership with an innovative technology business to work with Network Rail on developing a safer […].

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Biotech startups face 'trickle-down effects' as sector's IPO drought endures

Bio Pharma Dive

The slowdown has already forced many biotechs to wait longer to go public. There are early signs private financing deals may be flagging as well.

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GSK bolsters cancer pipeline with $1.9bn Sierra Oncology buy

pharmaphorum

GlaxoSmithKline has agreed a deal to buy Sierra Oncology and its lead drug momelotinib for anaemia associated with the blood cancer myelofibrosis, sending the US biotech’s shares skywards. GSK is paying $55 per share in cash for Sierra – a 39% premium to its closing share price yesterday – which values the company at around $1.9 billion. Shares in Sierra were up 38% in pre-market trading this morning.

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Novacyt PCR COVID-19 test approved under CTDA legislation

Pharma Times

Novacyt’s second direct-to-PCR test is the third product to be added to the Coronavirus Test Device Approvals (CTDA) register of approved products

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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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Unlocking the molecular mechanism of PTSD treatment

Scienmag

Post-traumatic stress disorder (PTSD) is a difficult-to-cure mental health condition that is caused by experiencing a traumatizing event, such as interpersonal violence or disaster. While sufferers of PTSD have existed across all of human history and the condition is even observed in animals, the diagnosis of this condition only appeared in the 1970s after the […].

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Versant-backed startup launches with plans to broaden cell therapy's reach

Bio Pharma Dive

Cimeio Therapeutics, which emerged Wednesday with $50 million in funding, will use "shielding" technology to try to bring stem cell transplants and adoptive cell therapy to more patients.

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Gaming health firm GripAble raises $11m for rehab platform

pharmaphorum

GripAble has raised $11 million in first-round financing that will be used to advance its digital health approach to rehabilitation for people with neurological and musculoskeletal conditions on the international stage. The London, UK-based company has developed a platform that combines a hand-held sensor, gamified mobile app software, and telehealth consultations with therapists, which is designed to entertain users while they train at home.

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Cannabis firm launches UK clinic following prescription license allocation

Pharma Times

Cantourage has appointed cannabis prescribers and is now officially operational via a new centre

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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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World’s first LED lights developed from rice husks

Scienmag

Milling rice to separate the grain from the husks produces about 100 million tons of rice husk waste globally each year. Scientists searching for a scalable method to fabricate quantum dots have developed a way to recycle rice husks to create the first silicon quantum dot (QD) LED light. Their new method transforms agricultural waste […].

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UK bid to battle antibiotic resistance yields first subscription-style plan

Bio Pharma Dive

Pfizer and Shionogi could receive 10 million pounds, or about $13 million, a year for new antibiotics. International participation might be needed further to spur development, however.

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Study finds unexpected prescription influencers in healthcare

pharmaphorum

Cate Evans, SVP group director, strategy at Havas Media Group, and Nick Lapolla, research director at MedSurvey tell us about a two-phase research study the companies recently performed to understand a patient’s prescription journey and who influences prescription-based decisions. The healthcare landscape has shifted dramatically due to the pandemic.

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FDA draft guidance outlines path to increased trial inclusivity

BioPharma Reporter

The US agencyâs latest draft document lays out guidelines to help increase involvement of underrepresented ethnic and racial populations in clinical research.

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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.