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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
- 129
- 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
- 122
- 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
- 217
- 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
- 132
- 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
- 130
- October 4, 2023
Pharmacists can play key role in boosting HPV vaccination rates

HPV, or human papillomavirus, is the most common sexually transmitted infection. It is also the leading cause of cervical cancer. Over 1,400 Canadian women are affected yearly, with almost 400 deaths, according to the Canadian Cancer Society. It is completely preventable with the HPV vaccine, and yet, unfortunately, many people are unvaccinated. University of Waterloo researchers have found a possible solution to this on-going issues. Using an electronic questionnaire at the time of appointment scheduling for seasonal influenza or COVID-19 vaccines, researchers have found, is a quick and efficient way to identify people in Ontario willing to receive additional life-saving vaccines. Dr. Wasem Alsabbagh, associate professor, University of Waterloo School of Pharmacy, said, “This is a massive opportunity for policymakers to focus on vaccine campaigns to reach more patients.” Questions were embedded into MedEssist, a platform many pharmacists use for scheduling vaccination appointments, to reveal if individuals booking for their ...
- Source: drugdu
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- October 4, 2023
FDA expands total product life cycle program to cover neurological devices

Dive Brief The Food and Drug Administration is expanding a program for accelerating device development to cover neurological and physical medicine technologies. Initially, the voluntary total product life cycle advisory program (TAP) pilot was limited to cardiovascular devices. This week, the FDA Office of Neurological and Physical Medicine Devices also began accepting enrollment requests. Expanding the program to cover cardiovascular, neurological and physical medicine devices is part of a scaling up of the pilot, which enrolled 12 products in its first year. The FDA could enroll up to 45 additional devices over the coming year. Dive Insight The FDA and industry agreed to the TAP pilot in MDUFA V. While the industry initially opposed the advisory program, the FDA secured a chance to show it can “spur more rapid development and more rapid and widespread patient access” by facilitating early engagement and coordination with external stakeholders. A year ago, the ...
- Source: drugdu
- 198
- October 4, 2023
908 Devices Launches Real-Time Monitoring Platform For Multiple Bioprocess Parameters

The device, Maverick, utilizes Raman spectroscopy for bioprocess control. 908 Devices Inc. launched Maverick, an optical in-line analyzer that provides real-time monitoring for multiple bioprocess controls. The device also provides control of glucose, lactate, and total biomass in mammalian cell cultures. According to a press release from 908 Devices, this is the first turn-key device that utilizes Raman spectroscopy for bioprocess control without also requiring modeling or development. Christopher D. Brown, chief product officer and co-founder of 908 Devices, said in a press release, “As the biopharmaceutical industry adopts Process Analytical Technologies to drive the advancement of Biopharma 4.0, scientists need an array of tools that enable them to monitor and control their process in real time.” He continued, “We are addressing this need with our full complement of devices. With MAVERICK, we are introducing a new platform that offers easy-to-integrate in-line analysis and control without the need for substantial ...
- Source: drugdu
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- October 4, 2023
Zocdoc Takes Aim At Phreesia, NexHealth With New Free Suite of Patient Engagement Tools

Zocdoc launched a new suite of tools to compete with the solutions sold by Phreesia, NexHealth and Solutionreach. The product suite, which is free for any provider to use, includes tools to streamline the patient intake process, facilitate online scheduling and enable video visits. By KATIE ADAMS Zocdoc launched a new suite of tools on Tuesday — one that takes aim at the solutions sold by Phreesia, NexHealth and Solutionreach. The product suite, called Zocdoc Practice Solutions, includes tools to streamline the patient intake process, facilitate online scheduling and enable video visits. The suite is available free of charge to any practice or provider, regardless of whether they are a Zocdoc marketplace customer. Providers can use these tools for all their patients — not just the ones who book appointments through Zocdoc. Zocdoc’s decision to launch its new product suite was based on conversations the company has had with its ...
- Source: drugdu
- 151
- October 4, 2023
FDA clears Krystal Biotech’s IND for Type 1 AATD treatment KB408

The US Food and Drug Administration has approved Krystal Biotech’s Investigational New Drug (IND) for a Phase I clinical trial of the investigational alpha-1 antitrypsin deficiency (AATD) treatment KB408. Earlier this month, the FDA granted orphan-drug status for KB408 in AATD. The first patient in the planned Phase I trial is expected to receive treatment in Q1 2024. The Phase I trial, involving adult patients with AATD and the PI*ZZ genotype, will assess the safety, tolerability, and efficacy at three planned dose levels. AATD is a rare genetic disorder that occurs when there is insufficient production or impaired functionality of the alpha-1 antitrypsin (AAT) protein. Low AAT levels result in damage to lung tissue, leading to chronic obstructive pulmonary disorder (COPD). KB408 is a gene therapy consisting of a modified herpes simplex virus 1 (HSV-1) derived vector, which delivers two full-length copies of the SERPINA1 gene to enable AAT expression. ...
- Source: drugdu
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- October 4, 2023

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