Bio Pharma Dive
JANUARY 25, 2023
The veteran investors see the marriage of tech and life sciences as the “largest opportunity in venture today,” said co-founder and former Lux Capital general partner Adam Goulburn.
AuroBlog - Aurous Healthcare Clinical Trials blog
JANUARY 25, 2023
Losing focus for a brief moment might actually help boost learning by giving our brains a quick reprieve from the task at hand. According to a new study, this could allow us to absorb information that might not be directly related to the task at hand, but could still be handy to know.
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Bio Pharma Dive
JANUARY 25, 2023
The former Biogen head is retiring after taking Vir from a small startup to a publicly traded developer of infectious disease drugs. Bayer executive Marianne De Backer will succeed him.
Pharmaceutical Technology
JANUARY 25, 2023
It was an exceptional year for Moderna’s vaccine Spikevax, with forecast sales of $19.5bn in 2022. Despite this, Spikevax’s average annual sales forecast has plummeted by 23% between H1 and H2 2022 according to GlobalData’s Coronavirus Disease 2019 (COVID-19) Sector Forecast reports, due to increasing competition from Pfizer’s Comirnaty, Novavax’s Nuvaxovid, and Covid-19 therapeutics.
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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
JANUARY 25, 2023
Carvykti, which was approved a year ago for hard-to-treat multiple myeloma, generated $55 million in fourth quarter sales, the same as it earned between July and September.
Pharmaceutical Technology
JANUARY 25, 2023
The Saudi Food & Drug Authority (SFDA) has approved the manufacturing and distribution of Alvotech and Bioventure’s AVT02 (adalimumab). The monoclonal antibody AVT02 is the approved biosimilar for AbbVie ’s Humira (adalimumab). Humira is commonly indicated to treat rheumatoid arthritis as well as many other inflammatory diseases. AVT02, which inhibits tumour necrosis factor, will be marketed as Simlandi in Saudi Arabia.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
AuroBlog - Aurous Healthcare Clinical Trials blog
JANUARY 25, 2023
Indian pharma is making a strategic shift towards botanicals or phytopharmaceutical formulations of medicinal plants and herbs. This is because of dwindling new chemical entity (NCE) pipeline. There is an increased interest to go back to nature.
Pharmaceutical Technology
JANUARY 25, 2023
French biopharmaceutical firm Poxel has received orphan drug designation (ODD) from the European Commission (EC) for its molecules PXL770 and PXL065 to treat adrenoleukodystrophy (ALD). The latest move follows a positive opinion issued by the European Medicines Agency’s (EMA) Committee for Orphan Medicinal Products (COMP). PXL770 is a new, first-in-class direct activator of adenosine monophosphate-activated protein kinase (AMPK).
Rethinking Clinical Trials
JANUARY 25, 2023
In this Friday’s PCT Grand Rounds, Dr. Derek Russell of the University of Alabama at Birmingham and Dr. Matthew Semler of Vanderbilt University will present “The PREPARE II Trial: Embedding a Pragmatic Trial Into Clinical Care During an Emergency Procedure.” The Grand Rounds session will be held on Friday, January 27, 2023, at 1:00 pm eastern.
Pharmaceutical Technology
JANUARY 25, 2023
Development of PROTACs (PROteolysis TArgeting Chimeras) has advanced fairly rapidly as excitement grows over their potential to selectively degrade proteins that are involved in various diseases, including cancer. PROTACs are a type of heterobifunctional degrader that offers multiple advantages over traditional small molecules. They provide a higher ability to regulate protein levels and can affect the non-enzymatic function of the protein while also providing an alternative to targeting drug-re
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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
Bio Pharma Dive
JANUARY 25, 2023
The drug, if approved, would be the first new treatment in more than a decade for two conditions that stem from Candida fungus.
NPR Health - Shots
JANUARY 25, 2023
The days might seem long, but the years go by quickly, friends warned when my son was born. I wanted to savor each precious memory, but how? Living on "toddler time," showed me the way.
Fierce Pharma
JANUARY 25, 2023
Merck's Keytruda dealt another blow in prostate cancer but readies new challenge to AZ's Imfinzi aliu Wed, 01/25/2023 - 10:17
STAT News
JANUARY 25, 2023
Three years ago, the World Health Organization declared that the mushrooming outbreak of a new coronavirus — later named SARS-CoV-2, the cause of Covid-19 — posed such a threat to global health that it merited designation as a public health emergency of international concern. On Friday, an emergency committee will meet again to deliberate whether the time has come to recommend to WHO Director-General Tedros Adhanom Ghebreyesus that he declare the global health emergency is over.
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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.
Medical Xpress
JANUARY 25, 2023
A multi-institutional team led by scientists from the Medical College of Wisconsin (MCW) Cancer Center has discovered PD-L2 as a therapy-relevant marker to identify patients with estrogen receptor-positive breast cancer who may benefit from new immunotherapies.
STAT News
JANUARY 25, 2023
Two new studies published Wednesday report good news about the updated Covid-19 vaccine, with one suggesting it is more effective than the previous monovalent vaccine and the other showing that even though it targeted an earlier strain of the SARS-CoV-2 virus, its protection is holding up against current variants. The findings suggest the updated vaccine, which targets both the original SARS-2 virus and the Omicron subvariants BA.4 and BA.5, is performing better than some critics of the decision
Medical Xpress
JANUARY 25, 2023
Cancer has many faces—no wonder, then, that the range of cancer-causing mutations is huge as well. The totality of such genomic alterations in an individual is what experts call a "mutational landscape." These landscapes differ from one another depending on the type of cancer. And even people suffering from the same cancer often have different mutation patterns.
NPR Health - Shots
JANUARY 25, 2023
We asked for a wish from expert wishers around the globe — from Nobel laureate Malala Yousafzai to MacArthur "genius" grantee Gregg Gonsalves to Melva Acostaa, who runs a soup kitchen in Peru.
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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.
Medical Xpress
JANUARY 25, 2023
Engineers and physicians have developed a wearable ultrasound device that can assess both the structure and function of the human heart. The portable device, which is roughly the size of a postage stamp, can be worn for up to 24 hours and works even during strenuous exercise.
STAT News
JANUARY 25, 2023
After a year defined by record inflation and double-digit health care premium increases, I hope that a few years down the road we can eventually look back at 2023 as the year that ignited change in U.S. health care and led to a new system that future generations are proud of. I’ll be doing everything I can to make that happen.
Medical Xpress
JANUARY 25, 2023
A healthy lifestyle, in particular a healthy diet, is associated with slower memory decline, finds a decade-long study of older adults in China, published today in The BMJ.
STAT News
JANUARY 25, 2023
The Food and Drug Administration aims to conduct priority reviews of at least two product applications for granting over-the-counter status to intranasal formulations of naloxone, an overdose-reversal drug. Naloxone prevents overdose deaths by binding to opioid receptors in the brain and blocking entry to competing opioids, or pushing them aside. The drug is sold in three versions: vials of injectable naloxone, auto-injectors (similar to EPIPENs) and as an intranasal spray.
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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.
Medical Xpress
JANUARY 25, 2023
Regularly eating a high-fat/calorie diet could reduce the brain's ability to regulate calorie intake. New research in rats published in The Journal of Physiology has found that after short periods of being fed a high-fat/high calorie diet, the brain adapts to react to what is being ingested and reduces the amount of food eaten to balance calorie intake.
STAT News
JANUARY 25, 2023
Vir Biotechnology CEO George Scangos said on Wednesday he will retire, ending an itinerant, nearly 40-year-career as one of biotech’s most recognizable executives. Scangos, 74, will be succeeded in April by Marianne De Backer , a longtime pharma executive who currently heads pharmaceutical strategy at Bayer. She will inherit a company that rose to prominence during the pandemic by developing the antibody drug sotrovimab and is trying to repeat the success with a series of candidates for C
Medical Xpress
JANUARY 25, 2023
FORTH-IMBB researchers have developed innovative computational tools to unravel the role of dendrites; complex neuronal brain structures with a key role in information processing. The new software allows the incorporation of important dendritic properties into neural network models. This work has important applications both in understanding brain function and in the field of artificial intelligence.
STAT News
JANUARY 25, 2023
In a rare move, the Better Business Bureau National Programs settled a dispute between two big drug companies over a prescription drug ad, suggesting the nonprofit may take a larger role in resolving complaints that might normally be handled by the U.S. Food and Drug Administration. The dispute began when Eli Lilly challenged some of the information in an ad that Novartis had run for its Kisqali breast cancer treatment.
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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.
Medical Xpress
JANUARY 25, 2023
Vaccine skeptics blocking transfusions for life-saving surgeries, Facebook groups inciting violence against doctors and a global search for unvaccinated donors—COVID-19 misinformation has bred a so-called "pure blood" movement.
STAT News
JANUARY 25, 2023
Almost a year ago, three top investors at Lux Capital and Obvious Ventures announced they were leaving the firms, teasing on Twitter that they were starting “something new.” That something is a new venture capital firm, which launched Wednesday with $350 million for its first fund.
Medical Xpress
JANUARY 25, 2023
The demand for donated organs has already exceeded supply, with patients waiting months and sometimes years for a donor. With so many people testing positive for SARS-CoV-2, the virus that causes COVID-19, a new study published in Transplant Infectious Disease could provide reassurance when it comes to using organs from SARS-CoV-2-positive donors.
STAT News
JANUARY 25, 2023
Belgian antitrust regulators fined Novartis nearly $2.8 million for making misleading statements about a treatment for a serious eye disease, the latest instance in which the company was cited by a government for anticompetitive practices in connection with the medication. The fine is only the latest act in a long-running drama over Lucentis, which is used to treat age-related macular degeneration, a common disease among older adults that can lead to blindness.
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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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