Gilead breaks through with first approval for new HIV drug
Bio Pharma Dive
AUGUST 22, 2022
European authorities cleared Gilead’s long-acting shot for patients whose HIV infection is resistant to other drugs. An FDA decision is expected by December.
Mon.Aug 22, 2022
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Half of cancer deaths are preventable
World of DTC Marketing
AUGUST 22, 2022
Globally, nearly half of deaths due to cancer can be attributable to preventable risk factors, including three leading risks of smoking, drinking too much alcohol, or having a high body mass index, a new paper suggests. According to the Lancet “, although some cancer cases are not preventable, governments can work on a population level to support an environment that minimises exposure to known cancer risk factors.
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Digital medicine company Akili gets cold market reception after blank-check merger
Bio Pharma Dive
AUGUST 22, 2022
After spiking on news of the merger’s close, shares in the ADHD treatment developer fell sharply in trading Monday and again on Tuesday.
Porton raises funds for gene and cell therapy CDMO platforms expansion
Pharmaceutical Technology
AUGUST 22, 2022
Porton Advanced Solutions has raised $80m in a Series B funding round to expand its end-to-end gene and cell therapy (GCT) contract development and manufacturing organisation (CDMO) platforms. Merchant Health, a healthcare private equity (PE) fund of China Merchants Groups, led the financing round together with its sister fund China Merchants Capital and China Merchants Securities Investments.
Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research
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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
Fauci plans to step down as NIAID chief in December
Bio Pharma Dive
AUGUST 22, 2022
Fauci will leave his post as the director of the National Institute of Allergy and Infectious Diseases and as the president’s chief medical advisor.
Compliance to convenience: understanding the latest innovations in capsule formulation
Pharmaceutical Technology
AUGUST 22, 2022
When it comes to pharmaceutical, nutritional or cosmeceutical dosing, some of the most crucial parameters are safety, product effectiveness and patient adherence. The right formulation can have a huge impact on whether the customer continues taking their capsules, as well as whether the ingredients act as intended. Today, innovations in the capsule formulation space are creating new possibilities for how capsules look, feel and act, with huge benefits for customers.
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Kid Cudi says he had a stroke at 32. Hailey Bieber was 25. How common are they?
NPR Health - Shots
AUGUST 22, 2022
Strokes in adults under 45 are on the rise. Now artist Kid Cudi — long considered an ambassador for mental health issues — and model Hailey Bieber have opened up about their experiences.
FDA authorizes Novavax’s COVID-19 vaccine for teens
Bio Pharma Dive
AUGUST 22, 2022
The decision will make a third vaccine available for children 12 to 17 years old in the U.S., giving them an option that doesn’t use the messenger RNA technology of shots by Pfizer and Moderna.
In early research, an AI model detects signs of Parkinson’s using breathing patterns
STAT News
AUGUST 22, 2022
James Parkinson first flagged a link between changes in breathing patterns and the debilitating disease that now bears his name. But since his work in the early 19th century, only minimal progress has been made in treating a condition that has become alarmingly prevalent. A study published Monday offers a glimmer of new hope.
Pharvaris studies of rare disease drug put on hold by FDA
Bio Pharma Dive
AUGUST 22, 2022
The agency suspended two trials of Pharvaris’ experimental treatment for hereditary angioedema after reviewing nonclinical data, the biotech said.
The New Age of Decentralized Clinical Trials
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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
Pfizer asks FDA to greenlight new omicron booster shots, which could arrive this fall
NPR Health - Shots
AUGUST 22, 2022
Pfizer has submitted data on its bivalent COVID-19 booster shot that specifically targets the latest omicron subvariants. If authorized, the company says the shots could be ready as soon as September. (Image credit: Nam Y.
August 22, 2022: IMPACt-LBP Awarded Continuation to Implementation Phase
Rethinking Clinical Trials
AUGUST 22, 2022
The NIH Pragmatic Trials Collaboratory is pleased to announce that the IMPACt-LBP Demonstration Project received approval this month to transition from the planning phase to the implementation phase. This pragmatic clinical trial embedded in healthcare systems is studying implementation of guideline-based care for low back pain, a leading cause of ambulatory care visits in the United States.
Fauci to step down in December after decades of public service
NPR Health - Shots
AUGUST 22, 2022
Dr. Anthony Fauci helped guide the U.S. through the COVID crisis, and earlier in his career played a key role in the response to AIDS. He has served under seven presidents.
Grand Rounds July 8, 2022: Results From the COVID-OUT Trial, A Phase-3 Trial of Outpatient Treatment for Covid-19 Using Metformin, Ivermectin, and Fluvoxamine (Carolyn Bramante, MD, MPH; Thomas Murray, PhD; Jared Huling, PhD)
Rethinking Clinical Trials
AUGUST 22, 2022
? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ?. Speakers. Carolyn Bramante, MD, MPH. Assistant Professor, General Internal Medicine and Pediatrics. Core Faculty, Center for Pediatric Obesity Medicine. Core Faculty, Program for Health Disparities Research. University of Minnesota Medical School. Thomas Murray, PhD.
Roles and Responsibilities of Specialized Clinical Supply Experts
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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.
New study use musical tests for early detection of cognitive decline
Pharma Times
AUGUST 22, 2022
Researchers at Tel Aviv University used a portable brain activity-measuring device to detect cognitive decline in older people
Pfizer seeks authorization for updated Covid vaccine, without fresh clinical trial data
STAT News
AUGUST 22, 2022
Pfizer and BioNTech said Monday that they have asked the Food and Drug Administration to authorize a new booster shot targeted at the Omicron BA.4/BA.5 strain of the coronavirus that causes Covid-19, the first step in a process that could lead to more effective booster shots. Notably, in the same press release, the companies said that a clinical study investigating the safety, tolerability, and immunogenicity of the vaccine, which also includes the original Covid strain, is expected to start thi
MolecuLight’s CEO Anil Amlani Discusses Next Steps for Their Wound Imaging Devices
XTalks
AUGUST 22, 2022
Medical imaging device company MolecuLight is a global leader in applying fluorescence imaging to detect and localize elevated bacterial burden in wounds. Their point-of-care devices allow clinicians to safely visualize the presence and location of high bacterial loads in real time so that clinicians can direct their wound care in the best possible way.
Jazz Pharmaceuticals’ epilepsy drug advances into phase 3 trial
Pharma Times
AUGUST 22, 2022
Epidiolex may ease symptoms associated with Doose syndrome, a rarer type of childhood-onset epilepsy
The New Age of Decentralized Clinical Trials
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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.
When spinal fluid from ALS patients was put into mice, the mice got weak. An unlikely protein could be the culprit
STAT News
AUGUST 22, 2022
It was a shot in the dark — or at best, a dimly lit room: injecting a mouse with a little bit of spinal cord fluid from someone with the most common form of amyotrophic lateral sclerosis, or ALS. Then, within a day, research scientist Jamie Wong observed her first rodent subject was acting differently. It was weak.
3 digital spaces for patients to find community and support
Antidote
AUGUST 22, 2022
Online communities have long provided people with the opportunity to connect with others across the globe, and as the internet has become more ubiquitous in our day-to-day lives, their popularity has only increased. Online groups often pop up surrounding a variety of focuses, from gardening to antiquing to listening to a particular podcast — but they have also become an important way for patients to connect with one another.
Zapping the brain with electricity shown to boost older people’s short- and long-term memory
STAT News
AUGUST 22, 2022
Sending weak electrical current into the brain for 20 minutes a day for four days in a row reversed declines in working and long-term memory that come with aging, scientists reported Monday in Nature Neuroscience. The researchers found that the effects lingered even after the electricity was turned off. When they tested subjects a month later, many of the improvements from the brief sessions of brain stimulation remained.
Blueprint Medicines Gets Positive Top-Line Data of Ayvakit (avapritinib) for Non-Advanced Systemic Mastocytosis
XTalks
AUGUST 22, 2022
Blueprint Medicines announced top-line results from their clinical trial of Ayvakit (avapritinib) in patients with non-advanced systemic mastocytosis (SM) that showed clinically meaningful and highly significant improvements. Blueprint plans to submit a Supplemental New Drug Application to the US Food and Drug Administration (FDA) in Q4 2022, as well as a type II variation marketing authorization application to the European Medicines Agency (EMA) in 2023.
Accelerating Clinical Supply Through Integrated Drug Development
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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+: Major Indian generic drugmaker closes a U.S. facility after years of manufacturing problems
STAT News
AUGUST 22, 2022
After a decade of manufacturing problems, a U.S. federal court ordered a unit of Wockhardt, one of the largest makers of generic drugs, to refrain from making allegedly adulterated medicines at a facility in Illinois. However, the U.S. subsidiary, Morton Grove Pharmaceuticals, recently decided to discontinue operations at the site, according to court documents.
Axsome’s Auvelity Wins FDA Approval as First Rapid-Acting Oral Treatment for Depression
XTalks
AUGUST 22, 2022
Axsome Therapeutics’ extended-release tablets of Auvelity (dextromethorphan HBr -bupropion HCl) has been approved by the US Food and Drug Administration (FDA) for the treatment of major depressive disorder (MDD). Auvelity offers many firsts, including being the first and only rapid-acting oral medication and first and only N-methyl D-aspartate (NMDA) receptor antagonist approved for the treatment of MDD.
‘People count on it’: In Boston, a mobile clinic meets health needs in the neighborhood
STAT News
AUGUST 22, 2022
BOSTON — By 9 a.m. on a recent Friday morning, the bright blue, colorfully branded van was already parked on a street in the Boston neighborhood of Dorchester. And while the street was still quiet, the community health workers were waiting inside for things to soon pick up. On that particular morning, about 10 people stopped inside the Family Van , a mobile clinic run by Harvard Medical School that provides free, basic care four days a week.
What happens to sweat in outer space (Hint: There's no gravity to help it drip away)
NPR Health - Shots
AUGUST 22, 2022
Humans' ability to sweat is useful on Earth — but when people go up into space, they find that perspiring in zero gravity presents some unique challenges.
How Machine Learning Drives Clinical Trial Efficiency
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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.
Opinion: The Biden-Harris administration needs to end fake abortion clinics
STAT News
AUGUST 22, 2022
In the aftermath of the Supreme Court’s decision to overturn Roe v. Wade , President Biden signed an executive order directing federal agencies to consider ways to protect abortion access. Three weeks later, at the first meeting of the new Interagency Task Force on Reproductive Healthcare Access, he announced another executive order aimed at assisting patients who travel out of state to obtain abortions.
Symposium "Health challenges of the 21st century"
Sciensano
AUGUST 22, 2022
Event type: symposium Audience: policy makers scientists university staff Description: Through this new Symposium “Health challenges of the 21st century”, Sciensano aims to highlight different areas of its research, and encourage you to interact with us. The themes selected for this first edition are: Crisis preparedness/Innovation. One Health. Food security and health.
STAT+: Hospitals wrangle billions in FEMA funding to offset Covid costs
STAT News
AUGUST 22, 2022
More hospitals are tapping into billions of dollars from the Federal Emergency Management Agency to offset costs for caring for Covid-19 patients. This spigot of taxpayer money can be directed toward things like workers’ overtime wages and contract labor — the specific costs hospitals have said have drained their budgets this year. As a result, the funds have helped hospitals that are struggling to get by, but also have padded the income of large and wealthy systems that have weath
American Kidney Fund launches resources to engage patients of color
Outsourcing Pharma
AUGUST 22, 2022
The group has introduced a downloadable guide, interactive quiz, and other tools to inform patients from underrepresented communities about trial participation.
The New Clinical Trial Supply Chain: Resilient, Flexible, and Patient-Centric
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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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