Bio Pharma Dive
NOVEMBER 8, 2022
Over the past several years, the investment firm has served as a financial adviser on biopharma acquisitions worth more than $200 billion in total, with the latest announced Monday.
Worldwide Clinical Trials
NOVEMBER 8, 2022
At Worldwide, we are committed to a cause that extends beyond ourselves. Our mission is to work with passion and purpose every day to improve lives. Our study teams are committed to working collaboratively with our sponsors, united in purpose. Worldwide aims to become an employer of choice?for veterans, military members, and?their families, by creating an?
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Bio Pharma Dive
NOVEMBER 8, 2022
A reformulated booster aimed at an earlier omicron subvariant outperformed Novavax’s current vaccine, but a bivalent version did not significantly raise antibody levels.
AuroBlog - Aurous Healthcare Clinical Trials blog
NOVEMBER 8, 2022
In his new autobiography, Matthew Perry reveals that his colon burst as a result of his addiction to opioid painkillers. The 53-year-old actor, who played Chandler Bing in Friends, was in a coma for two weeks following the incident and had to wear a colostomy bag for nine months. Many people take prescription opioids, such […].
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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
NOVEMBER 8, 2022
Newly released study results suggest treatment could lead to quicker weight loss, on less frequent dosing, than therapies from Eli Lilly and Novo Nordisk.
Pharmaceutical Technology
NOVEMBER 8, 2022
Viatris has signed definitive agreements to acquire Oyster Point Pharma and Famy Life Sciences in a deal totalling nearly $700m-$750m in cash to establish an ophthalmology franchise. According to the deal, all outstanding shares of Oyster Point will be acquired by Viatris for a price of $11 for each share in cash at closing, plus a non-tradeable contingent value right (CVR) for up to $2 for each share.
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
NOVEMBER 8, 2022
The National Institute of Mental Health and Neuro Sciences (NIMHANS) is concerned about the poor mental literacy levels and is working to reduce stigma around it. This could enable people to access care without any hesitation. The Institute sees stigma and discrimination as a major constraint to access mental healthcare. Worldwide it is reported that […].
Bio Pharma Dive
NOVEMBER 8, 2022
Shares have fallen more than 20% since Apellis chose to add new data to its U.S. submission, delaying the drug’s review in geographic atrophy. But on a conference call, executives argued the benefits are worth the cost.
Pharmaceutical Technology
NOVEMBER 8, 2022
The proportion of pharmaceutical companies hiring for internet of things related positions dropped in October 2022 compared with the equivalent month last year, with 14.3% of the companies included in our analysis recruiting for at least one such position. This latest figure was lower than the 17.3% of companies who were hiring for internet of things related jobs a year ago but an increase compared to the figure of 12.4% in September 2022.
NPR Health - Shots
NOVEMBER 8, 2022
For those at high risk, Pfizer's antiviral drug helps stave off severe COVID-19. Now research suggests it may also reduce their chances of long COVID.
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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
NOVEMBER 8, 2022
Fulgent Genetics has acquired clinical-stage therapeutics development firm Fulgent Pharma for a total deal price of nearly $100m. According to the deal, the purchase price, contingent on adjustments, has to be paid by Fulgent Genetics as a combination of cash on hand and its shares of common stock. With the takeover, Fulgent Genetics intends to transform into a completely integrated precision medicine firm focusing on oncology from a genomic diagnostic business.
STAT News
NOVEMBER 8, 2022
WASHINGTON – On Tuesday, Californians overwhelmingly voted to ban all flavored tobacco products in the state. The move makes California by far the largest state to ban such products, which are already illegal in a smattering of smaller states, including Rhode Island, New Jersey, and Massachusetts.
pharmaphorum
NOVEMBER 8, 2022
Due to the pandemic, decentralised trial solutions made the shift from an emerging trend to a crucial element of drug development. Ben Hargreaves examines the latest research suggesting that this transition looks set to become a permanent feature of trials in the years to come. The pharmaceutical industry’s role in developing effective vaccines against COVID-19 was a major benefit to the industry.
Medical Xpress
NOVEMBER 8, 2022
A year-long study of the dietary habits of 9,341 Australians has backed growing evidence that highly processed and refined foods are the leading contributor of rising obesity rates in the Western world.
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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.
Fierce Pharma
NOVEMBER 8, 2022
Moderna’s Spikevax carries higher risk of myocarditis than Pfizer's Comirnaty, study says. zbecker. Tue, 11/08/2022 - 11:03.
pharmaphorum
NOVEMBER 8, 2022
For the first time, patients in England with triple-negative breast cancer (TNBC) will be able to access immunotherapy at an earlier stage of their treatment journey, as Merck & Co/MSD’s KEYTRUDA is granted the go-ahead for use in patients with high-risk early-stage or locally advanced TBNC. The National Institute for Health and Care Excellence (NICE) has recommended the use of KEYTRUDA (pembrolizumab) as an option with chemotherapy for neoadjuvant, and alone as adjuvant treatment afte
STAT News
NOVEMBER 8, 2022
WASHINGTON — Vermont will make abortion a constitutional right after voters overwhelmingly approved a ballot measure in Tuesday’s election. Proposition 5, which would “ensure that every Vermonter is afforded personal reproductive liberty, is one of five abortion-related measures on the ballot in a midterm election where reproductive health care has taken center stage.
Medical Xpress
NOVEMBER 8, 2022
Sensory neurons of the peripheral nervous system, which sense touch, temperature, and pain, can be permanently lost during infections and trauma, in response to certain medications, and in diabetic patients with peripheral neuropathy. Current treatments reduce symptoms but cannot bring back lost sensory neurons, which are thought to have a very limited ability to regenerate after injury or disease.
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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
NOVEMBER 8, 2022
In 2003, Pancho’s life changed forever. That’s when a car crash sent the 20-year-old farm worker into emergency surgery to repair damage to his stomach. The operation went well, but the next day, a blood clot caused by the procedure cut off oxygen to his brain stem, leaving him paralyzed and unable to speak. In February 2019, another operation transformed his life again.
Medical Xpress
NOVEMBER 8, 2022
The social environments we grow up in are critical when determining our well-being and health later in life. Most Americans (67%) report experiencing at least one traumatic event in childhood, and a new study shows that these experiences have significant impacts on our health risks as adults. Physical illnesses such as obesity and chronic pain are affected, but mental disorders show the most significant association, including post-traumatic stress disorder (PTSD), bipolar disorder, substance abu
STAT News
NOVEMBER 8, 2022
As an American Indian pediatrician working in my own tribal community , I know how important it is to ensure that children have connections to their culture and community to support their well-being. That is why I think it is essential that the U.S. Supreme Court uphold the Indian Child Welfare Act when it hears a case on Nov. 9 that challenges the law.
Medical Xpress
NOVEMBER 8, 2022
Researchers at the University of Maryland School of Medicine's (UMSOM) Center for Precision Disease Modeling identified how a specific protein in SARS-CoV-2, the virus responsible for COVID-19, damages heart tissue. They then used a drug to reverse the toxic effects of that protein on the heart.
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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
NOVEMBER 8, 2022
SAN JOSE, Calif. (AP) — A federal judge rejected a bid for a new trial for disgraced Theranos CEO Elizabeth Holmes after concluding a key prosecution witness’s recent remorseful attempt to contact her wasn’t enough to award her another chance to avoid a potential prison sentence for defrauding investors at her blood-testing company.
Medical Xpress
NOVEMBER 8, 2022
The innate immune system fights infectious agents, and the alarm messenger interferon plays a central role in this. However, if interferon is produced in the absence of an infection, it can lead to autoimmune diseases. Researchers at the University Hospital Bonn (UKB) and the Technical University (TU) Dresden have investigated an underlying mechanism and deciphered the driving force of uncontrolled interferon production through studying the rare autoimmune disease Aicardi-Goutières syndrome.
STAT News
NOVEMBER 8, 2022
A biotech company that hoped to use cell biology to address neurological disorders is shutting down. Faze Medicines was built by VC Third Rock Ventures and launched in 2020 with $81 million from Third Rock, Casdin Capital, and venture funds run by drug giants Novartis, Eli Lilly, and AbbVie.
Medical Xpress
NOVEMBER 8, 2022
When evaluating vaccine efficacy, the conventional measures include a reduction of risk of hospitalization and death. The number of patients dying with or without vaccination is often in the public spotlight. However, when evaluating public health interventions or the burden of disease, it is more illustrative to use mortality metrics that also take into account the prematurity of the deaths, such as years of life lost (YLL) or years of life saved (YLS) due to the vaccination.
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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
NOVEMBER 8, 2022
In a surprising move, the Supreme Court rejected a bid by a Bristol Myers Squibb unit to reinstate a $1.2 billion award it won in a contentious patent fight with a Gilead Sciences subsidiary over the lucrative market for gene therapies. However, the decision came just days after the Supreme Court agreed to review a very similar case involving Amgen and two other drugmakers, which essentially involves the same issue, but comes at it from a different legal perspective.
Antidote
NOVEMBER 8, 2022
While there are many conditions that can cause memory loss , dementia and Alzheimer’s disease are probably two of the most well-known terms associated with cognitive decline. However, while these two terms are often used interchangeably, they actually refer to different kinds of memory loss diseases. In honor of November being National Alzheimer’s Disease Awareness Month , we wanted to take a few moments to address some important considerations when comparing Alzheimer’s and dementia.
STAT News
NOVEMBER 8, 2022
Weather-related disasters like the millions of Floridians left without power by Hurricane Ian or the record monsoon rains that have claimed 1,500 lives in Pakistan have increased five-fold in the past 50 years due to climate change. Researchers need to be ready to respond quickly to climate-related and human-made disasters. When investigating the health effects of a disaster like a hurricane or an oil spill on community members and cleanup workers, the most valuable information for researchers i
Medical Xpress
NOVEMBER 8, 2022
An interdisciplinary research team led by UCLA found that a drug already approved by the Food and Drug Administration for eye disease, verteporfin, stopped the replication of SARS-CoV-2, the virus that causes COVID-19. Their laboratory study identified the Hippo signaling pathway as a potential target for therapies against the coronavirus.
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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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