Bio Pharma Dive
JULY 25, 2022
The agency agreed to quickly assess the companies’ drug Enhertu for “HER2 low” metastatic breast cancer, an indication for which it could become the first targeted treatment option.
Pharmaceutical Technology
JULY 25, 2022
The COVID-19 pandemic triggered significant changes to the way healthcare operates. Digitalization is now in full swing as medical care integrates with ICT to take the patient experience to the next level. According to Tom Lenaerts, Head of Global Process Engineering at Datwyler, this transformation will reshape the entire healthcare ecosystem. “There are already opportunities for patients to track their health through smart medical devices sending reports directly to their healthcare provider.
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Bio Pharma Dive
JULY 25, 2022
Biogen will try to enforce patents protecting Tysabri, but an executive last week acknowledged that copycat drugs could launch when approved in the U.S.
Pharmaceutical Technology
JULY 25, 2022
The proportion of pharmaceutical companies hiring for machine learning related positions rose in June 2022 compared with the equivalent month last year, with 26.4% of the companies included in our analysis recruiting for at least one such position. This latest figure was higher than the 24.1% of companies who were hiring for machine learning related jobs a year ago and an increase compared to the figure of 26.3% in May 2022.
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Planning on running clinical trials in Japan? How can you reliably supply these studies? Discover Catalent’s clinical supply packaging facility in Shiga, Japan. Strategically located between Tokyo and Osaka, and one of largest in Japan, this 6,000 square meter facility offers comprehensive services including primary and secondary clinical packaging and labelling, comparator sourcing, cold chain storage, local and global distribution, local language support and white glove service to support stud
Bio Pharma Dive
JULY 25, 2022
The Lilly-backed Rona Therapeutics gains rights to a platform for small interfering RNA, along with a slate of preclinical candidates aimed at targets in the liver and other tissues.
Pharmaceutical Technology
JULY 25, 2022
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended an update to the conditional marketing authorization (CMA) to include Moderna ’s 50µg booster dose of Covid-19 vaccine, Spikevax, for usage in adolescents aged 12 to 17 years. As per the recommendation, the booster shot is indicated for use in people of this age group a minimum of three months after they receive the initial vaccine regimen.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharmaceutical Technology
JULY 25, 2022
Concept: Austin-based robotics startup Apptronik has unveiled a humanoid robot named Astro. It is a general-purpose robot that can work alongside humans. Nature of Disruption: Astro is a human-centered robotic system that includes vision-based grasping. It leverages ML technology to find, grab and pick up objects. The robot has modern actuation packed into a small form factor.
Bio Pharma Dive
JULY 25, 2022
Discover examples of how Droplet Digital™ PCR (ddPCR™) is enabling cell and gene therapies to reach further than ever before.
Pharmaceutical Technology
JULY 25, 2022
AstraZeneca and Daiichi Sankyo have received Priority Review for their supplemental Biologics License Application (sBLA) from the US Food and Drug Administration (FDA) of antibody-drug conjugate (ADC), Enhertu (trastuzumab deruxtecan), to treat unresectable or metastatic HER2-low breast cancer in adults. The treatment is intended for HER2-low immunohistochemistry [IHC] 1+ or IHC 2+/in-situ hybridisation [ISH]-negative breast cancer patients who have previously received treatment in the metastati
Bio Pharma Dive
JULY 25, 2022
The deal’s near-term effects might not be large, but Amazon’s acquisition still threaten’s One Medical’s primary care competitors and others seeking a greater slice of the market, experts said.
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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
Pharmaceutical Technology
JULY 25, 2022
The European Commission (EC) has extended Bavarian Nordic ’s smallpox vaccine Imvanex (MVA-BN or Modified Vaccinia Ankara-Bavarian Nordic) marketing authorisation to offer protection from monkeypox. A non-replicating smallpox vaccine, Imvanex was developed in partnership with the US Government. The move to expand the marketing authorization for Imvanex to include protection from monkeypox and disease caused by the vaccinia virus comes after the European Medicines Agency (EMA) Committee for Medic
NPR Health - Shots
JULY 25, 2022
Cases in the U.S. are 10 times higher than they were a month ago. Researchers advise that the coming days and weeks will be crucial as to whether the outbreak can be contained.
pharmaphorum
JULY 25, 2022
Sachin Grover, lead of solutions vertical at Philips India, tells me about the company’s innovations during India’s COVID outbreak and how they’ve led to increased healthcare access in the region. There is a vast difference in India’s healthcare system between rural and urban areas, but Philips’ team in the region is working hard to close that gap and improve access to healthcare. “It’s been 75 years since India’s independence.
NPR Health - Shots
JULY 25, 2022
A growing list of companies is offering to cover travel expenses for abortion care, if an employee lives in a state with restrictive laws. Yet corporate America still has its own issues to address.
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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.
STAT News
JULY 25, 2022
The term “brain-computer interface,” or BCI, has been buzzing around Silicon Valley and the mainstream media for years, thanks in part to Elon Musk’s secretive, yet flashy company Neuralink , which launched in 2017 with the promise of brain enhancement, telepathy, and similar sci-fi dreams of brain control. Neuralink, though, is one of the youngest players in the BCI field.
NPR Health - Shots
JULY 25, 2022
In the wake of the World Health Organization's declaration of a public health emergency, there are many pressing questions. Here's what we know — and don't yet know — about monkeypox.
Outsourcing Pharma
JULY 25, 2022
During the Decentralized Trial Technology event, experts from CVS Health, University of Chicago, and ACRP shared insight on what can increase DCT success.
NPR Health - Shots
JULY 25, 2022
When Randy Schiefer was hospitalized with COVID-19, he wasn't sure he would survive. Now, he looks back at that experience as the most important thing that has ever happened to him.
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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.
STAT News
JULY 25, 2022
There is a new theory about what may be causing puzzling cases of pediatric hepatitis of unknown origin — and it is complex. Two new and as-yet-unpublished studies from scientists in the United Kingdom theorize that children who have developed the hepatitis cases may have been co-infected with two different viruses and had a genetic predisposition to have an over-exuberant immune response when that happened.
NPR Health - Shots
JULY 25, 2022
An NPR investigation found stalled confirmatory trials and lax enforcement are plaguing the FDA's accelerated approval of drugs for urgent medical needs.
STAT News
JULY 25, 2022
ST. LOUIS — The calls for help poured in throughout the day: Overdose after overdose at the Parkview Apartments here, a double-winged complex with red brick capping the ends. Six people died that day this past February, five in this building and one at another apartment half a block away. Two others survived their overdoses, according to police.
BioPharma Reporter
JULY 25, 2022
The European Commission has extended the marketing authorization for Bavarian Nordicâs smallpox vaccine, Imvanex, to include protection from monkeypox and disease caused by vaccinia virus.
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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.
STAT News
JULY 25, 2022
Psychedelic medicine is having a moment of tremendous growth and innovation as researchers rediscover its potential mental health benefits. Although numerous biopharmaceutical companies are aiming to capitalize on these age-old therapies, many of them are leaving behind the Indigenous communities that pioneered the use of these medicines, have successfully used them for generations, and continue to have significant expertise in the area.
NPR Health - Shots
JULY 25, 2022
Independent funds that help people pay for abortions have been flooded with donations since Roe v. Wade was overturned, but demand and costs are also rising as more states enact restrictive bans. (Image credit: Armando L.
STAT News
JULY 25, 2022
In the 1990s, state Attorneys General learned how to leverage their resources when they retained private counsel to sue the tobacco industry. The private attorneys worked on contingency, meaning they did not get paid unless money was recovered from the tobacco industry. For their part, the states were able to take on novel litigation and draw from private investments in legal innovation without putting taxpayer dollars at risk.
pharmaphorum
JULY 25, 2022
Roche has been trumpeting the rapid uptake of its new eye disease drug Vabysmo as it takes on Regeneron and Bayer’s mighty Eylea in the US – and could soon start making inroads against its rival in Europe. Vabysmo (faricimab) has been recommended by the EMA’s human medicines committee as a treatment for neovascular or wet age-related macular degeneration (AMD) and diabetic macular oedema (DME), so could be fully approved and ready to roll out in the next few months, subject to pricin
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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.
STAT News
JULY 25, 2022
The rollout of Cerner’s electronic health record in Veterans Affairs hospitals has been a high-profile struggle: outages, training troubles, and now, an alarming report showing it directly harmed scores of patients. And while the system’s stumbles are noteworthy, they’re far from rare. Across the country, health systems large and small are engaged in the work of tweaking and transitioning between electronic health records.
Antidote
JULY 25, 2022
Atopic dermatitis is a type of eczema, a skin condition caused by an overactive immune system that can lead to redness, blotchiness, and itching, typically on the face, arms, and legs. Atopic dermatitis is the most common type of eczema , impacting more than 9.6 million children and 16.5 million adults worldwide.
STAT News
JULY 25, 2022
Tiffany Yarina didn’t max out her credit card from a home renovation or luxury purchase. It was from cancer. In 2005, Yarina started losing a lot of weight and watched her tonsils swell. Her doctors eventually diagnosed her with non-Hodgkin’s lymphoma. She needed chemotherapy and a tonsillectomy — but she had no health insurance.
NPR Health - Shots
JULY 25, 2022
The World Health Organization has declared monkeypox a public health emergency of global concern. Here's what that means and where the U.S. stands in terms of treatments and vaccines.
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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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