September, 2022

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Owkin’s AI solutions for breast and colorectal cancer receive European approval

MedCity News

The breast cancer solution will help determine which patients would benefit from targeted therapies and which patients could avoid chemotherapy. Meanwhile, the colorectal solution will be able to match patients with the most effective treatment sooner.

Patients 140
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Novo Nordisk partners with Microsoft for AI-driven drug discovery

Pharmaceutical Technology

Novo Nordisk has signed a new strategic partnership with Microsoft to expedite the discovery and development of drugs leveraging big data and artificial intelligence (AI). Under the deal, Microsoft's computational services, Cloud and artificial intelligence (AI) will be merged with the drug discovery, development and data science expertise of Novo Nordisk.

Training 139
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The discovery of a new and compounding cybersecurity threat to pharmacies

pharmaphorum

Sam Crowther, founder and CEO of cybersecurity company Kasada, tells us about a recent discovery his company made that revealed tens of thousands of accounts with prescription drug attachments in major online pharmacies had been compromised. While performing analysis for a client of online accounts for sale, Kasada uncovered a new and illegal way bots are being used – to steal pharmacy customers’ accounts and resell prescriptions on a secondary market for in-demand substances, such as Oxyc

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The Manufacturing Edge on Path to Market

PharmExec

FDA backs the benefits of adopting continuous manufacturing, a strategy which has accelerated approval and launch timelines, and its Emerging Technology Program could be a helpful tool.

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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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Quiet Quitting Isn’t the Problem. Your Managers Are.

Integrity Solutions

One of the first big workforce catchphrases to go viral after the onset of the pandemic was “The Great Resignation,” as employees began to reevaluate their careers and leave their jobs in record numbers. This max exodus of talent may be slowing down a bit, but it’s far from over. More than two years later, even with the threat of a recession looming in the background, companies continue to struggle with finding talent to fill open positions.

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Mass producing biodegradable stem cell therapy microrobots

European Pharmaceutical Review

Professor Hongsoo Choi’s team at The Department of Robotics and Mechatronics Engineering at the Daegu Gyeongbuk Institute of Science & Technology (DGIST), Korea, developed revolutionary technology that produces over 100 microrobots per minute. The collaboration with Professor Sung-Won Kim’s team at Seoul St. Mary’s Hospital, Catholic University of Korea and Professor Bradley J.

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Micro-robots, smart toilets, and 3D bioprinted organs: the future of healthcare

Pharmaceutical Technology

It is the year 2030. You have just received the results from your whole genome sequencing test, offered through your public health provider, and discovered that you have a 75% chance of developing a rare form of cancer. But you are not panicking; your genomic data was automatically uploaded, with your permission, to your electronic health record (EHR), which is fully secured with blockchain technology.

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FDA drops PreCert report, new digital health guidances

pharmaphorum

The US FDA’s Center for Devices and Radiological Health (CDRH) dropped a bevy of new digital health guidances and reports today and yesterday, providing some long-awaited clarity and peeks into the agency’s future plans. . The Pre-Cert pilot report. The push started yesterday with the 31-page key findings report from the FDA Pre-Certification Program pilot.

FDA 135
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Motion Sensors to Detect Age-Related Disease

Medgadget

Researchers at the University of Bern in Switzerland have developed a motion tracking system that is intended to assist in detecting age-related disease in elderly people. The system could be installed in someone’s home or in assisted-living facilities, and consists of a series of motion sensors that can monitor for signs of unusual movement. The system can inform caregivers if an emergency arises, such as a fall, which can be detected when someone does not return to their bed at night or is sta

Medicine 115
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The 2022 PharmaVoice 100

PharmaVoice

From standout executives to R&D pioneers — this year’s class of honorees is defining the next era of leadership.

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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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Citation Laureates 2022: Nobel class researchers who are changing the world

Clarivate

Clarivate draws on Web of Science publication and citation data to produce an annual list of Citation Laureates – researchers of Nobel class whose high-impact contributions have transformed their fields and changed our world for the better. Every October, the world watches as the Nobel Assembly votes to confer their prestigious prizes. While people around the globe can’t help but speculate about who will be chosen, Clarivate is the only organization to use quantitative data in addition to qualit

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3 care categories that matter in connected health care

MedCity News

Medical IoT is forecast to grow from $41 billion in 2020 to $188 billion by 2028. The growth is for a good reason: Connected medical devices, combined with the right software, can improve conditions and delivery, optimize care and devices, and save lives.

Medical 131
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bluebird bio wins back-to-back landmark FDA approvals for first-in-class gene therapies

Pharmaceutical Technology

After several setbacks, bluebird bio bounces back with two major FDA gene therapy approvals. Last month, Zynteglo (betibeglogene autotemcel), or beti-cel, was approved as a one-time potentially curative gene therapy for patients with beta-thalassaemia who require regular blood transfusions. Shortly after this, the FDA announced the accelerated approval of bluebird's Skysona (elivaldogene autotemcel), or eli-cel, on 19 September.

FDA 115
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The future of AI drug discovery & development in immunology and GPCR research

pharmaphorum

Alphabet subsidiary and precision health company Verily recently announced a breakthrough in its AI drug discovery GPCR research collaboration with Sosei Heptares. A mere six months ago Verily launched the study with Sosei Heptares – a global leader in GPCR structure-based drug design – with an aim to “prioritise protein targets for therapeutic targeting in immune-mediated disease”.

Leads 134
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How to Stay Competitive in the Evolving State of Martech

Marketing technology is essential for B2B marketers to stay competitive in a rapidly changing digital landscape — and with 53% of marketers experiencing legacy technology issues and limitations, they’re researching innovations to expand and refine their technology stacks. To help practitioners keep up with the rapidly evolving martech landscape, this special report will discuss: How practitioners are integrating technologies and systems to encourage information-sharing between departments and pr

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Surface Coating Rapidly Kills Pathogens, Lasts Months

Medgadget

A team at the University of Michigan has developed a coating for frequently touched surfaces that can rapidly kill a wide array of pathogens, including MRSA and SARS-CoV-2. The technology incorporates polyurethane that contains crosslinked compounds from essential oils with wide-spectrum anti-microbial action. The researchers fine-tuned the crosslinking process so that the oils were available to kill microbes but not sufficiently free to evaporate rapidly.

Food 112
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What Physicians Want from Pharma—And Where—During Diagnosis and Treatment

PM360

For life sciences commercial teams, effectively engaging physicians and supporting them with education on the evolving science around products and conditions requires a deep understanding of physician content needs and channel preferences. These are dynamic factors, playing out differently across specialty groups and stages of the patient journey, as well as the condition being treated.

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10 Ways to Attract New Patients from Key Local Employers

Healthcare Success

Help Providers Win New Patients from Large Local Businesses with These Tactics. Large or dominant employers in your local communities are excellent targets of opportunity for new patients and cases. Most healthcare providers have local businesses that are (or could be) a source of new business. Whether it’s a company that's conveniently located across the street, or a dominant employer in the community, your providers want their business—here’s how you can help them win it.

Patients 105
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Conversational AI helps alleviate impact of nurse shortages

MedCity News

One organization piloted a smart speaker system in its spinal injuries unit. Over the course of four weeks, patients interacted with the automated assistant more than 5,000 times. Sixty-three percent of nurses on the unit found the pilot improved their ability to deliver and prioritize patient care.

Patients 128
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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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AstraZeneca on the hunt for new acquisitions

Pharmaceutical Technology

Following AstraZeneca’s success in vaccine development during the Covid-19 pandemic , the pharmaceutical giant is now looking to expand its scope through acquisitions across a range of indications, says CEO Pascal Soriot. “We want to be a sustainably growing company. Until 2025, we have strong growth ahead of us, but we also believe we can continue to grow very strongly post-2025 and it’s all about innovation in the pipeline.”.

FDA 114
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Bridge Bio will use Brainomix AI in lung fibrosis trial

pharmaphorum

Brainomix has reeled in another pharma partner for its artificial intelligence-powered biomarker software, used to track the performance of therapeutic interventions in clinical trials. South Korea’s Bridge Biotherapeutics has signed up to use the UK medtech firm’s e-ILD software package in a phase 2 trial of BBT-877, its experimental therapy for serious lung disease idiopathic pulmonary fibrosis (IPF).

Patients 126
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Pneumatic Assistive Device for People with Disabilities

Medgadget

Researchers at Rice University have developed a pneumatic assistive device for people with disabilities. The technology includes an air pump that is mounted in the wearer’s shoe, providing pneumatic power with each step. This power is stored in a wearable belt that includes an “arm” that can reach out and grip items when activated. The device may be very practical for people with arm weakness who struggle to lift objects.

Medical 109
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CCC Launches OA Agreement Intelligence

Copyright Clearance Center

Sept. 13, 2022 – Danvers, Mass. – CCC , a leading provider of Open Access (OA) workflow solutions, has launched OA Agreement Intelligence , the only agreement modeling solution that enables publishers to prepare, build, and analyze their OA data so that they can create and communicate sustainable and transparent agreements with their partners. The solution combines sophisticated data preprocessing with easy-to-use analysis and export capabilities.

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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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Is TEE the key for novel antibiotics?

European Pharmaceutical Review

According to a new report , implementing a Transferable Exclusivity Extension (TEE) system could solve the “broken economic model” for researching and developing new antibiotics in Europe. As the threat of antimicrobial resistance (AMR), sometimes called the hidden or silent pandemic , grows, new and novel antibiotics are needed to combat infections becoming more resistant to current treatments.

Medicine 104
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The divorce of care from health in healthcare: Reuniting American healthcare

MedCity News

The drive to “fix healthcare” is ingrained in our society. Politicians speak about it regularly, consumers struggle to understand it, and yet the “how” of fixing it is delivered with ambiguity and jargon. With increased urgency to improve healthcare, everyone is now laser focused on this topic. But, over time, the term “healthcare” itself has lost the part about care.

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Pfizer to deliver up to six million courses of Paxlovid to Global Fund

Pharmaceutical Technology

Pfizer has entered an agreement with Global Fund to deliver up to six million courses of its oral therapy, Paxlovid (nirmatrelvir tablets and ritonavir tablets), under the Covid-19 Response Mechanism (C19RM). The C19RM has been the main channel to support low- and middle-income nations in procuring Covid-19 therapies, personal protective equipment, tests and vital elements to bolster health systems.

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NICE says no to Lynparza in prostate cancer, creating UK access divide

pharmaphorum

NICE has said it is unable to recommend NHS use of AstraZeneca’s Lynparza for some patients with prostate cancer, after failing to reach an agreement on price with the drugmaker. The health technology assessment (HTA) authority said that the PARP inhibitor “is not cost-effective at its current price” as a treatment for BRCA-positive prostate cancer that has spread to other parts of the body and relapsed after prior hormonal therapy.

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The New Clinical Trial Supply Chain: Resilient, Flexible, and Patient-Centric

The global landscape of clinical trials is rapidly changing as studies become more complex. An increasing number of sponsors are seeking enhanced flexibility in their supply chains to address a variety of clinical supply challenges, including patient demand and reducing delays. Demand-led supply and direct-to-patient distribution are next-generation solutions that are helping to meet these growing needs, allowing for more streamlined processes and patient-centric studies.

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Face Mask Detects Respiratory Viruses, Alerts User

Medgadget

Scientists at Shanghai Tongji University in China have created a face mask that can alert the wearer to the presence of respiratory viruses in the surrounding environment, including the viruses behind COVID-19 and influenza. The mask includes aptamers, which are short sequences of DNA or RNA that can bind to protein targets. When viral particles bind to the aptamers, ion-gated transistors boost the signal so that the mask can sensitively detect small amounts of virus.

Media 109
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How to Distribute Content to Doctors (Plus, 7 Tips on Email Marketing to Doctors)

Healthcare Success

Welcome to step four of our “Marketing to Doctors” blog series. This comprehensive playbook is designed to help people in virtually every sector (e.g., healthcare businesses, device and supply companies, SaaS, etc.) market their products and services directly to doctors, physicians, surgeons, and other healthcare professionals. If you haven’t read steps 1-3, I highly recommend doing so.

Doctors 103
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Novartis to invest $300mn in European biotherapeutics

European Pharmaceutical Review

Novartis has revealed plans to invest $300 million in next-generation biotherapeutics. The multi-year investment will be implemented across existing Novartis locations in Switzerland, Slovenia and Austria to create a fully integrated, “dedicated scientific environment will bolster its capacity and capabilities for early technical development of biologics”.

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FTC accuses data company of tracking visits to reproductive health clinics

MedCity News

Kochava allegedly sold geolocation data from hundreds of millions of cell phones that showed people’s visits to reproductive health clinics, places of worship, homeless and domestic violence shelters and addiction recovery facilities. .

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Clinical Supply Strategies for CROs

When a CRO is bidding on a project where clinical supplies will be one of the aspects to manage on behalf of the client via a partner, leveraging the expertise of a chosen clinical supply partner can be a valuable resource in demonstrating the CRO’s understanding of and ability to deliver upon critical drug-supply related aspects of the project, and ability to hit key milestones such as FPI for their client.