STAT
SEPTEMBER 11, 2024
CHICAGO — The last place you might have expected Kevin Hall to make a plea for help was at a conference of scientists who work for global food conglomerates. After all, the government researcher is the leading scientific voice in the United States warning that a steady diet of these engineered products might be a crucial driver of the nation’s epidemic of overeating.
PharmaVoice
SEPTEMBER 11, 2024
A handful of potential blockbusters are marching toward FDA review.
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STAT
SEPTEMBER 11, 2024
WASHINGTON — The largest health system in North Carolina simply wasn’t interested in canceling its patients’ medical debt. That is, until the state government dangled billions of dollars in incentive payments. Other health systems have gotten just cents on the dollar to cancel unpaid bills they probably couldn’t collect on anyhow — take Cook County, Ill., which aims to pay about a penny per dollar to cancel an estimated $1 billion of medical debt.
PharmaVoice
SEPTEMBER 11, 2024
A broader approach recognizes the challenges disproportionately impacting women and could lead to better outcomes, according to Organon.
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STAT
SEPTEMBER 11, 2024
WELLESLEY, Mass. — Amid heated discussions on how artificial intelligence should be regulated and who should be involved in health care AI governance, the U.S. Food and Drug Administration commissioner said that health systems need to take a leading role. “I think there’s a lot of good reason for health systems to be concerned that if they don’t step up, they’re going to end up holding the bag on liability when these algorithms go wrong,” said Robert Cal
pharmaphorum
SEPTEMBER 11, 2024
A machine-learning tool developed by AstraZeneca and trained on UK Biobank data, called MILTON, can predict over 1,000 diseases, before diagnosis
Pharmacist Digest brings together the best content for pharmacists from the widest variety of industry thought leaders.
FDA Law Blog: Biosimilars
SEPTEMBER 11, 2024
By John W.M. Claud — Last week, FDA revised one of its two guidances relating to nitrosamines, Control of Nitrosamine Impurities in Human Drugs. Nitrosamines are impurities that can form during drug manufacturing and are considered potentially potent carcinogens. One specific kind of nitrosamines called N-nitrosamine drug substance-related impurities, or NDSRIs, are especially vexing to FDA and to industry because they mimic the structure of the specific active pharmaceutical ingredients (API),
STAT
SEPTEMBER 11, 2024
When a patient is admitted to the hospital in the U.S., there’s a standard question physicians like me are supposed to ask: “If your heart stops beating, do you want us to do CPR?” On the surface, this may seem like a mechanic asking a customer, “If your car stalls, do you want us to jumpstart the engine?” Who would say no to this, especially in a hospital?
Drug Patent Watch
SEPTEMBER 11, 2024
The pharmaceutical industry has witnessed significant advancements in recent years, particularly in the realm of nanotechnology. This innovative field has revolutionized the way drugs are developed, manufactured, and delivered to patients.
STAT
SEPTEMBER 11, 2024
WASHINGTON — On Wednesday, two transplant doctors, one watchdog and a nephrologist-turned-advocate sat before members of Congress to talk about the nation’s troubled organ transplant system. For over two hours the House Subcommittee on Oversight and Investigations ran through allegations of inefficiency, inertia, negligence and corruption in the groups charged with coordinating transplants throughout the U.S.
Speaker: Joe Sharpe and James Carlson
In the world of small business management, the challenge of managing payroll & HR efficiently while scaling operations can be overwhelming. Yet, with the right strategies in place, these challenges can become opportunities for growth and innovation. In this session, Joe Sharpe, Senior Director of Managed Payroll Services at IRIS, will reveal practical methods and expert insights for outsourcing and streamlining payroll processes, resulting in substantial time and resource savings.
European Pharmaceutical Review
SEPTEMBER 11, 2024
Sanofi has inaugurated a new production unit in France which utilises a world-first modular concept. The site, Modulus, located in Neuville-sur-Saône (Rhône-Alpes), is supported by an investment of nearly €500 million and will produce Sanofi’s next vaccines and biologic drugs. Modulus can adapt to manufacture up to four vaccines simultaneously. Notably, reconfiguration of the technological platform (live attenuated viral vaccines, recombinant protein or messenger RNA vaccines, as well as treatme
STAT
SEPTEMBER 11, 2024
The U.S. Food and Drug Administration has scolded AbbVie for making false and misleading claims about a TV ad about a migraine pill that features Serena Williams, the third time this year the agency has taken a major pharmaceutical company to task for its marketing. The agency is upset with Abbvie for a couple of reasons. First, the TV spot suggests that the medication, which is called Ubrelvy, will “provide a greater treatment benefit to patients suffering from migraine headache th
Pharmaceutical Technology
SEPTEMBER 11, 2024
As the approval date for Bristol Myers Squibb’s schizophrenia drug KarXT looms, a prodrug approach emerges to potentially address dosing challenges.
STAT
SEPTEMBER 11, 2024
One of the most important measurements for cancer patients is the neutrophil count. Certain cancer therapies like chemotherapy can be harsh on these white blood cells, so cancer patients need their neutrophil count to be in a given range when undergoing those treatments or before enrolling in particular clinical trials. That can be a problem for people who have a natural blood variation called the Duffy-null phenotype.
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Express Pharma
SEPTEMBER 11, 2024
Optimal health and wellness for each citizen has been among the top objectives of successful countries. It is the backbone of economic and social growth. India too has realised the importance of a healthy nation. As we chase the goal of becoming Viksit Bharat by 2047, authorities have prioritised the concept of Swasth Bharat. But before we reach the summit, we must overcome some tall mountains.
STAT
SEPTEMBER 11, 2024
Surgeon General Vivek Murthy’s latest warning unearths concerning statistics about the mental health and well-being of American parents. These findings resonated with me deeply on two levels. First, I am a parent of three school-age children. Second, I am a trained therapist and head of behavioral health at a provider organization focused on caring for the most vulnerable members of our population — Medicaid members and those dually eligible for both Medicaid and Medicare.
pharmaphorum
SEPTEMBER 11, 2024
One in two UK doctors would not use GenAI to treat patients, but there was more willingness to use it for diagnostic purposes, survey finds
STAT
SEPTEMBER 11, 2024
Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. Amycretin has some intriguing results in obesity Amycretin, an experimental Novo Nordisk obesity pill that targets both amylin and GLP-1 receptors, spurred significant weight loss in a Phase 1 study, the company announced yesterday.
Speaker: Chris Antypas and Josh Halladay
Access to limited distribution drugs and payer contracts are key to pharmacy expansion. But how do you prepare your operations to take the next step? Meaningful data: Collect and share clinical data regarding outcomes, utilization, and more Reporting: Limited distribution models require efficient tracking and reporting systems Workflows: Align workflows with specific pharma and payer contractual requirements For in-depth, expert insights on pharmacy expansion, watch this webinar from Inovalon.
The Pharmacist
SEPTEMBER 11, 2024
Slow progress on the community pharmacy prescribing pathfinder project has sparked concerns that a viable commissioned community pharmacy prescribing service will not be ready by 2026, The Pharmacist has learned. Company Chemists' Association (CCA) chief executive Malcolm Harrison told The Pharmacist that while the new digital prescribing solution was ‘good news’, the CCA was still […] The post Concerns prescribing service will not be ready by 2026 appeared first on The Pharmacist.
STAT
SEPTEMBER 11, 2024
Fighting a massive snowstorm to get to the doctor in the Dakotas is an unpleasant business. So is driving hours to see one of the two or three obstetricians in northern Minnesota. But Dave Newman, chief medical officer of virtual care at Sanford Health, is counting on technology to change that. Last year, a STAT documentary highlighted how Sanford, a large rural health system serving North Dakota, South Dakota, and Minnesota, is using telehealth to reach more patients than ever before.
The Pharmacist
SEPTEMBER 11, 2024
An independent investigation into the NHS has praised the value of community pharmacies and preventative services, while highlighting that more investment is needed in primary care to improve the health and care of the nation as a whole. The Darzi review was commissioned by the health and social care secretary Wes Streeting to deliver 'a […] The post Darzi report: access to pharmacies 'a great strength' but 'at risk' appeared first on The Pharmacist.
STAT
SEPTEMBER 11, 2024
Hello, everyone, and how are you today? We are doing just fine, thank you, especially since the middle of the week is upon us. After all, we have made it this far, so we are determined to hang on for another couple of days. And why not? The alternatives — at least those we can identify — are not so appetizing. And what better way to make the time fly than to keep busy.
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Express Pharma
SEPTEMBER 11, 2024
Strides Pharma Science (Strides) has announced that its equity shareholders and secured creditors have overwhelmingly approved the company’s strategic initiative to create OneSource Specialty Pharma Limited, India’s first specialty pharma Contract Development and Manufacturing Organization (CDMO). The approval was also extended to OneSource and SteriScience Specialties Private Limited in meetings convened under the guidance of the Hon’ble National Company Law Tribunal (NCLT).
World Pharma News
SEPTEMBER 11, 2024
Pfizer Inc. (NYSE: PFE) continues to showcase potential practice-changing research and next-generation candidates across its robust Oncology portfolio at the European Society for Medical Oncology (ESMO) Congress 2024, being held September 13-17 in Barcelona. Data from more than 50 company-sponsored, investigator-sponsored and collaborative research abstracts, including more than 10 oral and mini-oral presentations, will be presented across the company's tumor areas and core scientific modalities
Pharmaceutical Commerce
SEPTEMBER 11, 2024
The parties’ want to provide customers with a “one-stop-shop,” with the hopes that their services will be easier to navigate.
Pharma Times
SEPTEMBER 11, 2024
New evidence highlights AI’s potential in early lung cancer detection
Express Pharma
SEPTEMBER 11, 2024
The U.S. Food and Drug Administration (FDA) has issued warning letters to two Chinese nonclinical testing laboratories, citing concerns about laboratory oversight and animal care violations. The labs, Mid-Link Testing Company in Tianjin and the Sanitation & Environmental Technology Institute of Soochow University in Suzhou, provide third-party testing and validation data services for device manufacturers’ premarket submissions to the FDA.
The Pharmacist
SEPTEMBER 11, 2024
A community pharmacy was forced to rely on donated personal protective equipment (PPE) from patients who were dentists during the pandemic, the UK Covid-19 Inquiry has heard. Lee John-Charles, a lawyer and a representative for the National Pharmacy Association (NPA), told the inquiry this week how 'many' pharmacies were required to source their own PPE […] The post Pharmacy forced to rely on donated PPE from dentist patients, Covid inquiry told appeared first on The Pharmacist.
Pharma Times
SEPTEMBER 11, 2024
Patients with relapsed multiple myeloma gain access to life-extending therapy
The Pharmacist
SEPTEMBER 11, 2024
The General Pharmaceutical Council (GPhC) has clarified what pharmacists need to do following a Medicines and Healthcare products Regulatory Agency (MHRA) warning to men taking valproate. Last week, the UK medicines regulator said men taking valproate and their partners should use effective contraception, because of a small increased risk of harm to children if the drug […] The post Advice on dispensing valproate to men shared by GPhC appeared first on The Pharmacist.
PharmaTech
SEPTEMBER 11, 2024
During a presentation at the PDA/FDA Joint Regulatory Conference, Nicholas Violand of Johnson & Johnson and Paul Palmer of Paul R. Palmer Limited discussed how aging facilities can impact the quality of pharmaceutical products.
pharmaphorum
SEPTEMBER 11, 2024
Viridian's thyroid eye disease drug veligrotug clears its first phase 3 trial, with data suggesting it could be competitive with Amgen's Tepezza
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