Fri.Sep 23, 2022

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FDA advisers back microbiota-based treatment for gut infection

Bio Pharma Dive

Committee members voted in support of Rebiotix’s treatment for recurrent C. diff infections of the intestines, a condition with no regulated options after antibiotics fail.

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Pfizer to deliver up to six million courses of Paxlovid to Global Fund

Pharmaceutical Technology

Pfizer has entered an agreement with Global Fund to deliver up to six million courses of its oral therapy, Paxlovid (nirmatrelvir tablets and ritonavir tablets), under the Covid-19 Response Mechanism (C19RM). The C19RM has been the main channel to support low- and middle-income nations in procuring Covid-19 therapies, personal protective equipment, tests and vital elements to bolster health systems.

Drugs 278
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AstraZeneca gives up on Ionis’ RNA drug for heart disease

Bio Pharma Dive

The British drugmaker decided the medicine, which works similarly to Novartis’s Leqvio, wasn’t potent enough to justify further testing.

RNA 311
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Rivus raises $132m to advance clinical development of obesity treatment

Pharmaceutical Technology

Rivus Pharmaceuticals has raised $132m in a Series B funding round to clinically advance its lead candidate, HU6, for the treatment of obesity and cardio-metabolic disorders. RA Capital Management led the financing round, which also saw participation from Bain Capital Life Sciences and BB Biotech. Existing investors of the company, including Longitude Capital, Medicxi and RxCapital, also took part in the round.

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Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research

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

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Pfizer, Sangamo set to resume gene therapy study after safety delay

Bio Pharma Dive

Concerns over blood clotting risk had derailed testing of the hemophilia treatment last year, leading the companies to adjust their trial protocol.

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Merck obtains favourable US court ruling on sitagliptin patent lawsuit

Pharmaceutical Technology

Merck (MSD outside of North America) has reported that it received a ruling in favour of the company from the US District Court for the Northern District of West Virginia in a patent infringement suit against Viatris linked to sitagliptin. Sitagliptin is an active ingredient in the Januvia, Janumet and Janumet XR therapies. The suit involved two Merck patents.

Marketing 173

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Drug developers look at innovative mechanisms to tackle dry eye syndrome

Pharmaceutical Technology

Dry eye syndrome (DES) is an indication whose mainstay treatment has been dominated by Allergan’s Restasis (cyclosporine ophthalmic emulsion 0.05%) ever since its launch in 2003 in the US. While a handful of therapies have launched since then, late-stage pipeline therapies that are currently in development reveal that drug developers are exploring a broad set of mechanisms of action (MOAs), many of which are innovative, to tackle DES.

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There’s One Simple Strategy to Reduce Alcohol Intake, Scientists Say, And It Works

AuroBlog - Aurous Healthcare Clinical Trials blog

Researchers have found an effective method of getting people to cut down on their drinking: Highlight the increased risk of cancer that comes with it, and pair that with counting each and every drink. Skip advert This particular combination of ‘why to reduce’ and ‘how to reduce’ messaging can be useful for promoting good health […].

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Fennec’s hearing loss drug for cancer patients wins breakthrough FDA nod

Pharmaceutical Technology

The recent FDA approval of Fennec Pharmaceuticals’ drug PEDMARK (sodium thiosulfate injection) marks a significant advance for cancer treatment-associated hearing loss therapies, amidst a bid to improve quality of life for cancer patients. Yesterday, the FDA approved Pedmark for reducing the risk of ototoxicity associated with cisplatin therapy in paediatric patients with localized nonmetastatic solid tumours.

Drugs 130
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TN IPGA to open Dharmapuri chapter on World Pharmacist Day

AuroBlog - Aurous Healthcare Clinical Trials blog

The pharmacist community in the districts of Dharmapuri, Krishnagiri and Tiruppattur in Tamil Nadu will join together on September 25 at the government medical college auditorium in Dharmapuri to celebrate the World Pharmacist Day (WPD) and to witness the opening of the new chapter of the Indian Pharmacy Graduates Association (IPGA) in the district.

Pharmacy 100
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The New Age of Decentralized Clinical Trials

White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations

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New Signify details, out-of-state telehealth use, and Fitbits to study brain exercise

STAT News

You’re reading the web edition of STAT Health Tech, our guide to how tech is transforming the life sciences.  Sign up to get this newsletter  delivered in your inbox every Tuesday and Thursday.

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Flu is expected to flare up in U.S. this winter, raising fears of a 'twindemic'

NPR Health - Shots

After virtually disappearing for the last two years, there are troubling clues that the flu could come roaring back this year, to cause trouble alongside COVID.

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Shakeup with Optum’s health data licensing sparks an outcry among scientists

STAT News

A move by Optum to change longstanding practices for licensing data to academic institutions has sparked an outcry among researchers, who argue the move will make accessing data so costly and difficult that universities will scale back their research programs. Optum notified users that they now must access insurance claims data through an enclave hosted by another unit of the company.

Licensing 111
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New report finds 'shocking' levels of lead in Chicago water

NPR Health - Shots

NPR's Ari Shapiro speaks with Taylor Moore and Erin McCormick, reporters for The Guardian, who analyzed thousands of Chicago water tests for lead, which yielded "shocking" results.

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Roles and Responsibilities of Specialized Clinical Supply Experts

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.

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Surgeons often take a fifth of the lungs to remove a small tumor. There may be a better way.

STAT News

Claudia Donohue was on the operating table first thing in the morning. It wasn’t where she wanted to end up when she first learned she had lung cancer. When she saw the constellation of white dots on her chest scan, she figured the last 59 years of smoking cigarettes had finally caught up to her. Plus, she’d already had cancer once before, in her bladder.

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Here's what the FDA says contributed to the baby formula shortage crisis

NPR Health - Shots

The Food and Drug Administration rattled off 15 reasons behind the national baby formula shortage, but couldn't identify a specific person or agency responsible.

Drugs 105
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STAT+: Inflation caused another big drop in net drug prices, analysis finds

STAT News

Amid ongoing debate over the cost of prescription medicines, a new analysis finds that brand-name drugmakers increased their wholesale prices by 4.9% in the second quarter this year, up slightly from 4.4% a year earlier. But when accounting for inflation, wholesale prices fell by 3.7%, and inflationary pressures are likely to push wholesale prices still higher.

Branding 105
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LumiraDx Partners with British In Vitro Diagnostics Association

Pharma Times

Link up will involve reporting on role of rapid diagnostics in taking on antimicrobial resistance

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The New Age of Decentralized Clinical Trials

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.

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STAT+: New details on Apple Watch study emphasize Medicaid enrollment

STAT News

Newly published details about a high-profile Apple Watch study call it “a priority” to recruit Medicaid patients — a population not usually considered the target for Apple’s pricey products. In September 2020, health insurer Anthem, which is now called Elevance, announced a large study investigating whether an Apple Watch-based system could be used to help manage asthma.

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EVERSANA INTOUCH Wins Agency of the Year

Intouch Solutions

Faruk Capan Named Advertising Agency CEO of the Year in PM360 Trailblazer Awards. KANSAS CITY – Sept. 23, 2022 – EVERSANA , a pioneer of next-generation commercial services to the global life sciences industry, today announced that EVERSANA INTOUCH was awarded the 2022 Advertising Agency of the Year, and Chief Executive Officer (CEO) Faruk Capan was named Advertising Agency CEO of the Year at the 2022 PM360 Trailblazer Awards.

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Opinion: Market share isn’t the only metric for biosimilars’ success

STAT News

Market share is often held up as the most relevant metric for the success of a biosimilar class. I believe there are other metrics, like cost savings or signs of greater patient access, that should also be used to define biosimilars’ successes or failures. In the U.S., the first biosimilar was launched in September 2015. As I write this, there are 38 FDA-approved biosimilars ; 22 of them are commercially available.

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FDA Warns Against Cooking Chicken in NyQuil

XTalks

The US Food and Drug Administration (FDA) issued a stern warning to address a disturbing trend among teens: cooking chicken in NyQuil. This TikTok dangerous “challenge” encourages participants to cook chicken in a mixture of acetaminophen, dextromethorphan and doxylamine. The trio of ingredients can be found in NyQuil and other over-the-counter (OTC) cold medicines.

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Accelerating Clinical Supply Through Integrated Drug Development

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.

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STAT+: Zuckerberg, Chan want new Harvard institute to answer questions about the brain and AI

STAT News

For the first time since gifting Harvard University  $500 million to launch a new research institute , Mark Zuckerberg and Priscilla Chan visited the school Thursday to talk about their ambitious goal to study the basis of intelligence. The couple, who originally met at Harvard, were in Boston to celebrate the launch of the  Kempner Institute for the Study of Natural and Artificial Intelligence , which will focus on the brain and AI systems — and what scientists don’t kno

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How much water do you actually need? Here's the science

NPR Health - Shots

Many feel tethered to a water bottle, having heard that hydration is key to being healthy. Here's what the science says about how much water to drink and when.

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STAT+: Up and down the ladder: The latest comings and goings

STAT News

Hired someone new and exciting? Promoted a rising star? Finally solved that hard-to-fill spot? Share the news with us, and we’ll share it with others. That’s right.   Send us your changes, and we’ll find a home for them.   Don’t be shy. Everyone wants to know who is coming and going. And here is our regular feature in which we highlight a different person each week.

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California plans to phase out new gas heaters by 2030

NPR Health - Shots

The California Air Resources Board approved a plan to phase out sales of new gas furnaces and water heaters in the state by 2030.

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How Machine Learning Drives Clinical Trial Efficiency

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.

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MSD’s pembrolizumab therapy gets NICE approval

Pharma Times

1,500 people set to receive new skin cancer treatment that reduces the risk of it returning

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Managing 340B, Medicaid Drug Discounts: Technology for Collaboration – Anywhere, Anytime

Drug Channels

Today’s guest post comes from Lindsey Alves, Vice President of Customer Success at Kalderos. Lindsey describes the challenges facing remote workers who manage government-managed drug discount programs. As she explains, all drug discount stakeholders require novel technology-enabled collaboration tools. To learn more, register for Kalderos’ panel discussion, The Dreaded Duplicate Discounts: Collaborating in the New Hybrid Working Landscape.

Drugs 72
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Curebase & Meru Health unite for app-based mental health trial

pharmaphorum

On Tuesday, Curebase announced a three-year clinical trial partnership with Meru Health, the study looking at the effectiveness of the latter’s 12-week treatment program, developed to reduce depression in primary care patients. According to the National Institute of Mental Health (NIMH), almost 1 in 5 adults in the US live with a mental health disorder and only half of those have access to treatment.

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Blazing Trails, EVERSANA INTOUCH Cleans Up at the PM360 Trailblazer Awards

Intouch Solutions

The 14th PM360 Trailblazer Awards were a thrilling night for EVERSANA INTOUCH! EVERSANA INTOUCH was named Advertising Agency of the Year for the sixth time. Our CEO Faruk Capan won the first-ever CEO of the Year award. Our Ticking Lyme Bomb Detector campaign with The Global Lyme Alliance won Gold in the AI/Data Analytics category. And Product Launch of the Year was awarded to GEMTESA® (Urovant Sciences, Inc., Area 23, An IPG Health Company, EVERSANA INTOUCH, Slate 360, and Carbon91).

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The New Clinical Trial Supply Chain: Resilient, Flexible, and Patient-Centric

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.