PharmaFocus Today – Page 279 – media

Syneos Health Appoints Colin Shannon as CEO

Exec joins the organization with decades of biopharma experience. Image Credit: Adobe Stock Images/Mongkol Syneos Health, a biopharma clinical and commercial solutions organization has appointed Colin Shannon as CEO, effective immediately. He succeeds Michelle Keefe, who will continue her tenure with Syneos Health as a member of the executive leadership team. Shannon and Keefe will remain on the board of directors. Shannon brings decades of leadership experience driving growth at global biopharmaceutical solutions organizations. During his 14 years at PRA Health Sciences, he served in executive roles, most recently as chairman and CEO. During his tenure, he led the company through a successful IPO and subsequent sale to ICON plc., where he also served on its board of directors. “It is an honor to be tasked with leading Syneos Health at such an exciting time in its evolution,” comments Shannon. “I look forward to working with Michelle and the rest ...
- Source: drugdu
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- October 6, 2023
Research could lead to the development of new weight-loss drug that mimics exercise

A brand-new kind of drug, tested in mice, shows promising new results that could lead to the development of a new weight-loss drug that mimics exercise. The new compound, developed and tested by a University of Florida professor of pharmacy and his colleagues, leads obese mice to lose weight by convincing the body’s muscles that they are exercising more than they really are, boosting the animals’ metabolism. It also increases endurance, helping mice run nearly 50% further than they could before. All without the mice lifting a paw. The drug belongs to a class known as “exercise mimetics,” which provide some of the benefits of exercise without increasing physical activity. The new treatment is in the early stages of development but could one day be tested in people to treat diseases like obesity, diabetes, and age-related muscle loss. The research comes as drugs like Ozempic have provided a breakthrough in ...
- Source: drugdu
- 247
- October 6, 2023
New Alzheimer’s disease medication approved in Japan

Eisai and BioArctic have received approval for the Alzheimer’s disease drug Leqembi (lecanemab-irmb) in Japan, making it the second country to gain access to the treatment. Leqembi is a monoclonal antibody that targets and reduces insoluble amyloid-beta (Aβ) forms in the brain. It is the first and only approved treatment that has demonstrated a reduction in the rate of disease progression in patients with Alzheimer’s. The Japanese approval unlocked a milestone-based payment of EUR 17m ($18m) to BioArctic. The approval is based on Phase III data from the Clarity AD trial (NCT03887455) led by Eisai that showed that treatment with Leqembi reduced clinical decline in patients by 27% at 18 months compared to the placebo. The prescribing information for Leqembi includes a warning for amyloid-related imaging abnormalities (ARIAs), a concern for Alzheimer’s patients taking certain medication. Last week, BrainScope announced an investment from the Alzheimer’s Drug Discovery Foundation (ADDF) to ...
- Source: drugdu
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- October 6, 2023
Novo Nordisk Foundation commits €127m for new cell therapy facility

The Novo Nordisk Foundation has announced that it has committed up to €127m in funding to develop and manufacture a new cell therapy facility, Cellerator, in Denmark, to help fight chronic diseases. The new Novo Nordisk Foundation, Cellerator, will be used for the final development steps of animal research and upscaling new cell therapies for testing in humans. This will help to accelerate treatments for people with diseases including chronic heart failure, Parkinson’s disease, kidney disease, type 1 diabetes and several forms of cancer. Cell therapies work by transplanting living cells into patients to treat diseases. It’s estimated that one in three adults suffers from multiple chronic conditions. In the US alone, it’s been calculated that out of 58 million deaths in 2005, chronic disease was responsible for 35 million. The funding follows a report prepared for the European Federation of Pharmaceutical Industries and Associations, which came to the conclusion ...
- Source: drugdu
- 117
- October 6, 2023
Pfizer restarts production at tornado-hit plant—but supply squeezes are expected to persist

In the aftermath of a devastating summer tornado at Pfizer’s Rocky Mount injectables plant in North Carolina, manufacturing has largely resumed. Still, the company expects supply shortfalls for some drugs produced at the plant to stretch into next year.The “majority” of the Rocky Mount facility’s manufacturing lines have restarted, Pfizer said in a Monday release. What’s more, Pfizer has launched an additional line in the site’s new sterile injectable manufacturing area, dubbed R3, the company added. The “expedited restart” comes ahead of Pfizer’s previously stated timeline. Late last month, Pfizer said it intended to restart manufacturing at the plant the fourth quarter of 2023. Pfizer is restarting production in phases, with full production across the site’s three manufacturing suites expected to come back online by the end of the year. The company has planned its production restarts based on patient need and inventory levels. There are roughly a dozen medicines ...
- Source: drugdu
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- October 6, 2023
Roche condemns ‘act of counterfeiting’ as authorities in Pakistan crack down on unapproved Avastin use

After several diabetic patients received a sham version of Roche’s Avastin and lost their sight, the Drug Regulatory Authority of Pakistan (DRAP) is halting the sale or distribution of the drug until it can verify quality, the agency said in a release Sunday.The affected patients received “altered/dispensed/diluted Avastin” to treat diabetic retinopathy, despite the drug only being approved in Pakistan to treat colorectal and other metastatic carcinomas, the regulator said. Roche itself isn’t being blamed for the issue. Rather, DRAP singled out Genius Advanced Pharmaceutical Services, which it accused of altering, dispensing, diluting and selling unlicensed Avastin made under unhygienic and non-sterile conditions. In response to Genius’ actions, Pakistan’s regulatory field force raided the company’s facility, according to the DRAP release. “The premises have been sealed and legal proceedings have been initiated against the personnel involved,” DRAP said. Roche “strongly condemns” the “criminal act of counterfeiting,” the company said in ...
- Source: drugdu
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- October 6, 2023
Novo Nordisk, Valo Health Partner to Develop Treatments for Cardiometabolic Diseases

Collaboration based on Valo’s large human dataset and computation powered by artificial intelligence. Image Credit: Adobe Stock Images/Shutter2U Novo Nordisk and Valo Health revealed that they have struck a deal to discover and develop novel treatments for cardiometabolic diseases based on Valo’s large human dataset and computation powered by artificial intelligence (AI). According to Novo Nordisk, this will include access to real-world patient data, AI-enabled small molecule discovery and Biowire human tissue modeling platform designed to speed up the discovery and development process. As per terms of the deal, Valo will receive an upfront payment and a potential near-term milestone payment of $60 million, with the potential to earn additional milestone payments up to $2.7 billion, plus R&D funding and potential royalty payments. “Artificial Intelligence and machine learning hold the promise to positively impact drug discovery and development, in particular enabling our vision of leveraging human datasets early in the ...
- Source: drugdu
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- October 6, 2023
MA Beneficiaries Have Lower Utilization Than Traditional Medicare

A new study found that MA beneficiaries have more than 50% fewer inpatient stays and 22% fewer emergency department visits than traditional Medicare enrollees. By MARISSA PLESCIA Medicare Advantage enrollees have significantly lower healthcare utilization and expenditures when compared to traditional fee-for-service Medicare enrollees, a new study shows. The study, published last week, was conducted by Harvard Medical School and Inovalon, a provider of cloud-based software solutions. It relied on Inovalon’s dataset, which tracks patients’ healthcare utilization under commercial insurance prior to turning 65 and their utilization after turning 65 under MA or traditional Medicare. The study period was from 2015 to 2019, and the researchers adjusted for differences between MA and traditional Medicare beneficiaries, such as demographic, clinical and socioeconomic factors. The researchers found that MA beneficiaries have more than 50% fewer inpatient stays and 22% fewer emergency department visits than traditional Medicare enrollees. In addition, there is comparable ...
- Source: drugdu
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- October 6, 2023
Can crafted meal plans in kindergarten lead to healthier kids?

In a recent study published in the journal Nutrients, researchers investigated whether a meticulously crafted meal plan for children in kindergarten aged five to six years could effectively increase their regular intake of vegetables, whole grains, and nuts. The preschool years are a time of rapid growth and development and a vital age for forming lifelong food habits. In pre-primary schools, students receive at least three meals (breakfast, lunch, and snack), which are frequently complemented by an additional snack. The relationships between foods, nutrients, and dietary patterns have significant health consequences, particularly for preventing and developing noncommunicable diseases (NCDs) such as diabetes, cardiovascular disease, and cancer. According to studies, preschoolers do not eat enough nutritional foods such as fruits, vegetables, nuts, and whole grains. About the study In the present cross-sectional study, researchers evaluated the impact of carefully designed kindergarten meals on the regular consumption of healthy foods among kindergarteners. ...
- Source: drugdu
- 141
- October 4, 2023
FDA Authorizes Novavax’s Covid-19 Vax, Set to Join Fall Rollout of Updated Shots

A Novavax Covid-19 vaccine developed for the fall vaccination season now has the FDA green light, bringing an alternative to the messenger RNA shots that are already rolling out to pharmacies, doctor’s offices, and other locations throughout the country. The FDA decision announced Tuesday afternoon is not an approval. Last year’s emergency authorization for the Novavax vaccine is now amended to include an updated formula, which reflects currently circulating variants. The initial Novavax vaccine was authorized for those 18 and older. For the updated shot, the FDA expanded the age range to 12 and older. The regulatory decision for the latest version of the Novavax vaccine means the company’s initial vaccine, developed for the original SARS-CoV-2 strain, is no longer authorized for use in the U.S. Gaithersburg, Maryland-based Novavax makes its protein-based vaccines with nanoparticle technology that engineers proteins that mimic antigens found on natural pathogens. For its Covid-19 vaccine, ...
- Source: drugdu
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- October 4, 2023

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