Regulatory experts LFH Regulatory have announced their attendance at MEDICA 2024 to provide insights and support to healthcare innovators facing the complexities of the UK and EU markets.

Surgical Holdings, a British manufacturer and repairer of medical devices, will return to MEDICA 2024 for the third consecutive year, focused on strengthening its partnerships across Europe and expanding its reach in key markets.

Is your kid in trouble? Blaming their friends is ill advised

As regular readers of Drug Channels know, U.S. distribution and dispensing channels for prescription drugs are undergoing significant evolution and consolidation as the changing economics of pharmaceuticals challenge conventional business models.

During this period of volatility, the core business model of the Big Three public pharmaceutical distribution companies—Cardinal Health, Cencora, and McKesson—remains intact. Put simply: Buy low, sell high, collect early, and pay late.

But as I explain below, wholesalers continue to position themselves as essential intermediaries by expanding their industry position and strengthening their economic fundamentals.

Read on for five key pricing, pharmacy, provider, and manufacturer trends that are driving the U.S. drug wholesaling industry.

For even more, check out DCI's new 2024-25 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors, the fifteenth edition of our deep dive into wholesale distribution channels.Click here to download a free report overview (including key industry trends, the table of contents, and a list of exhibits)
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The FDA doesn’t care about the First Amendment rights of the companies it regulates. It cares even less about the “free speech” rights of those companies’ sales and marketing representatives. And why should the agency care? One of FDA’s primary missions is to protect the public health and safety of the American people from illegal, adulterated and misbranded products. Doing so involves restraining food, drug, device and cosmetics companies from committing fraudulent and deceptive acts that are not protected by companies’ commercial free speech rights. Nonetheless, FDA Matters envisions opportunities for FDA and industry to broaden permissible product communications. The key is understanding history, not constitutional law.

<p>On 19&nbsp;September 2024, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP)&nbsp;adopted a positive opinion,&nbsp;recommending the granting of marketing authorization&nbsp;for&nbsp;two aflibercept biosimilars:&nbsp;&nbsp;Sandoz’s Afqlir and Samsung Bioepis’s Opuviz.&nbsp;These products are biosimilars of the reference product Eylea, developed by Regeneron and Bayer.</p>

For the first time, scientists have created a flexible programmable chip that is not made of silicon. The new ultralow-power 32-bit microprocessor from U.K.-based Pragmatic Semiconductor and its colleagues can operate while bent, and can run machine learning workloads. The microchip’s open-source RISC-V architecture suggests it might cost less than a dollar, putting it in a position to power wearable healthcare electronics, smart package labels, and other inexpensive items, its inventors add.

For example, “we can develop an ECG patch that has flexible electrodes attached to the chest and a flexible microprocessor connected to flexible electrodes to classify arrhythmia conditions by processing the ECG data from a patient,” says Emre Ozer, senior director of processor development at Pragmatic, a flexible chip manufacturer in Cambridge, England. Detecting normal heart rhythms versus an arrhythmia “is a machine learning task that can run in software in the flexible microprocessor,” he says.

Flexible electronics have the potential for any application requiring interactions with soft materials, such as devices worn on or implanted within the body. Those applications could include on-skin computers, soft robotics, and brain-machine interfaces. But, conventional electronics are made of rigid materials such as silicon.

Open-source, Flexible, and Fast Enough

Pragmatic sought to create a flexible microchip that cost significantly less to make than a silicon processor. The new device, named Flex-RV, is a 32-bit microprocessor based on the metal-oxide semiconductor indium gallium zinc oxide (IGZO).

Attempts to create flexible devices from silicon require special packaging for the brittle microchips to protect them from the mechanical stresses of bending and stretching. In contrast, pliable thin-film transistors made from IGZO can be made directly at low temperatures onto flexible plastics, leading to lower costs.

The new microchip is based on the RISC-V instruction set. (RISC stands for reduced instruction set computer.) First introduced in 2010, RISC-V aims to enable smaller, lower-power, better-performing processors by slimming down the core set of instructions they can execute.

“Our end goal is to democratize computing by developing a license-free microprocessor,” Ozer says.

RISC-V’s is both free and open-source, letting chip designer dodge the costly licensing fees associated with proprietary architectures such as x86 and Arm. In addition, proprietary architectures offer limited opportunities to customize them, as adding new instructions is generally restricted. In contrast, RISC-V encourages such changes.

A bent Flex-RV microprocessor runs a program to print ‘Hello World’. Pragmatic Semiconductor

“We chose the Serv designed by Olof Kindgren... as the open source 32-bit RISC-V CPU when we designed Flex-RV,” Ozer says. “Serv is the smallest RISC-V processor in the open-source community.”

Other processors have been built using flexible semiconductors, such as Pragmatic’s 32-bit PlasticARM and an ultracheap microcontroller designed by engineers in Illinois. Unlike these earlier devices, Flex-RV is programmable and can run compiled programs written in high-level languages such as C. In addition, the open-source nature of RISC-V also let the researchers equip Flex-RV with a programmable machine learning hardware accelerator, enabling artificial intelligence applications.

Each Flex-RV microprocessor has a 17.5 square millimeter core and roughly 12,600 logic gates. The research team found Flex-RV could run as fast as 60 kilohertz while consuming less than 6 milliwatts of power.

All previous flexible non-silicon microprocessors were tested solely on the wafers they were made on. In contrast, Flex-RV was tested on flexible printed circuit boards, which let the researchers see how well it operated when flexed. The Pragmatic team found that Flex-RV could still execute programs correctly when bent to a curve with a radius of 3 millimeters. Performance varied between a 4.3 percent slowdown to a 2.3 percent speedup depending on the way it was bent. “Further research is needed to understand how bending conditions such as direction, orientation and angle impact performance at macro and micro scales,” Ozer says.

Silicon microchips can run at gigahertz speeds, much faster than Flex-RV, but that shouldn’t be a problem, according to Ozer. “Many sensors—for example, temperature, pressure, odor, humidity, pH, and so on—in the flexible electronics world typically operate very slowly at hertz or kilohertz regimes,” he says. “These sensors are used in smart packaging, labels and wearable healthcare electronics, which are the emerging applications for which flexible microprocessors will be useful. Running the microprocessor at 60 kHz would be more than enough to meet the requirements of these applications.”

Ozer and his team suggest each Flex-RV might cost less than a dollar. Although Ozer did not want to say how much less than a dollar it might cost, he says they are confident such low costs are possible “thanks to low-cost flexible chip fabrication technology by Pragmatic and a license-free RISC-V technology.”

The scientists detailed their findings online 25 September in the journal Nature.

When it comes to the effects that the upcoming Trump presidency will have on healthcare, attendees’ attitudes ranged from cautiously optimistic to fairly anxious. Some of the issues they highlighted included mental health parity, telehealth prescribing flexibilities, and the role of Robert F. Kennedy Jr.

The post How Did Attendees at a Behavioral Health Conference React to Trump’s Victory? appeared first on MedCity News.

Among the topics INVEST will highlight are AI in life sciences, the investor perspective in healthcare and strategic priorities for hospitals.

The post A Sneak Peek of INVEST 2025 Agenda appeared first on MedCity News.

Faulty diagnostic tests can compromise both patient care and the nation’s response to infectious diseases—as made all too clear earlier this month when the Food and Drug Administration issued a safety alert about a COVID-19 test that carries a high risk of false negative results.

Between 1999 and 2014, opioid use disorder (OUD) among pregnant women more than quadrupled, risking the health of the women—before and after giving birth—and their infants. As states grapple with COVID-19’s exacerbation of the opioid crisis, several are taking innovative steps to address the needs of high-risk groups, including low-income, postpartum patients with OUD.

Modern innovation typically occurs one step-improvement at a time. Some clients initially question whether their new application of an existing technology is patentable. Usually, the answer is ‘yes.’ Under U.S. law (and most other jurisdictions), an innovation to an existing technology is patentable so long as at least one claim limitation is novel and non-obvious....… Continue Reading

This paper highlights the many enhancements to SAS/ETS software and demonstrates how these features can help your organization increase revenue and enhance productivity.

SINGAPORE - When an online retailer began selling his products on e-commerce platform Qoo10 in August 2023, he did not bat an eyelid when it took 30 to 45 days for the platform to disburse his first payout, compared with about three to seven days for other e-commerce sites he was using. But nearly a year later in July, payments owed to his business by Qoo10 had ballooned to about $1.6 million, as the platform’s payment delays exceeded two months and disbursements began trickling in, in smaller amounts. The Singaporean, who wanted to be known only as Mr T and did not wish to divulge what he sold, pulled the plug on his Qoo10 shop this year in the middle of July, and filed a civil claim with the courts. He obtained a default judgment in October for Qoo10 to pay him what he is owed, after the e-commerce site failed to serve a notice of intention to contest or not contest the claim. Mr T, who added that he had borrowed nearly $1 million from banks, friends and relatives to pay his suppliers, said: “I am not holding out hope that I will get much, or any, of my money back from Qoo10... By this point, I just want closure because it’s been so stressful.”

Feb 10, 2024

Assaf Zoran argues that it is crucial to hold Iran accountable and convey the cost associated with arming, training, financing, and promoting violence through proxies.

Because of production issues, missing the deadline could result in hundreds of millions of dollars in additional costs.

Proposed restrictions on transfer of sensitive nuclear items are a 'derogation', 'rollback' of U.S. commitments, Indian officials had warned

Jun 30, 2022

The Learning Agenda is an unprecedented effort by the Department to institutionalize evidence-based learning and implement the Foundations for Evidence-Based Policymaking Act of 2018 (“Evidence Act”). The Evidence Act requires federal agencies to develop a “learning agenda” – a systematic plan to answer a set of policy-relevant questions critical to achieving the agency’s strategic objectives. It will guide the Department’s efforts over the next four years across eight questions to increase the impact of U.S. foreign policy and bolster the Secretary of State’s modernization efforts.

This event featured a keynote address followed by a panel of foreign policy and evidence-building experts for a thoughtful discussion on addressing Learning Agenda Questions 1 and 2: How can the State Department improve the effectiveness of its diplomatic interventions to better advance foreign policy objectives? How can the Department improve the effectiveness and sustainability of its foreign assistance efforts?

Jun 1, 2024

How can scholars write effective policy recommendations? Despite the potential importance of academic work to the policy debate, many scholars receive little training on why and how to make policy recommendations. To remedy this problem, here are steps to guide scholars as they begin developing policy recommendations for their articles. 

Nov 6, 2023

The Harvard Project on Climate Agreements collaborated with the Salata Institute on Climate and Sustainability at Harvard University to provide financial and logistical support for students to attend the Twenty-Eighth Conference of the Parties (COP-28) to the United Nations Framework Convention on Climate Change (UNFCCC). COP-28 will be held in Dubai, Nov. 30 – Dec. 12, 2023.

Mar 12, 2024

What are the drivers of citizens’ support for electoral gender quotas in transitioning and authoritarian states? Despite extensive research examining public support for women in politics in democracies, we know little about how the public perceives them in less democratic settings. To address this shortcoming, we use original survey data from authoritarian Morocco and transitioning Tunisia – two Arab countries hailed for their progressive gender policies. We argue that in these countries where citizens lack political information, they instead rely on their assessment of the government’s performance to form attitudes toward gender quotas. Furthermore, electoral legitimacy plays an important role in shaping citizens’ support for quotas, which are closely linked to how elections and legislatures operate. The findings offer strong support for our theoretical expectations and uncover important gender differences.

May 23, 2024

MEI Fellow Yuree Noh assesses public opinion in Kuwait following the suspension of its parliament.

Mar 14, 2024

The non-Soviet members of the Warsaw Pact contributed to the end of the Cold War along with the superpowers. These Eastern European states recognized that their relationship with the Soviet Union would impede their success in the post–Cold War world, so they ended the Pact.

Jul 11, 2024

Stephen Walt writes that doubts about Biden’s ability to do the job over the next six months must be balanced against the qualities that Trump exhibited when he oversaw U.S. foreign policy. Insider accounts of Trump’s first term portray him as erratic, mercurial, uninterested in details, and incapable of giving most foreign-policy problems sustained attention.

Jan 29, 2024

Mohammad Tabaar argues that the attacks on Red Sea ships unintentionally advance the Houthis agenda by allowing it to claim that it is fighting imperialism, and the attacks help Iran by fortifying its political foothold in the Middle East. Washington should therefore cease the strikes. It should, instead, work to halt the war in Gaza. The United States should also try to strengthen the region's diplomatic agreements and shore up its security framework. Otherwise, the Houthi-Iranian partnership will only grow stronger, as will Tehran's leverage in the region.

Mar 14, 2024

David Kearn argues that the idea that the first use of nuclear weapons since 1945 would be by the United States in the defense of Taiwan against a conventional Chinese invasion would have significant, negative, and long-lasting, diplomatic ramifications. It is difficult to fathom the myriad potential consequences, but U.S. nuclear weapon use would almost certainly shatter the non-proliferation regime as a functioning entity, incentivize states (including China) to acquire or improve their existing nuclear arsenal, and damage America's standing globally.

Apr 23, 2024

Assaf Zoran examines the dynamics of Iran's shift from operating in the shadows or behind partners and proxies to directly attacking Israel and Pakistan.

 

May 21, 2024

Nicole Grajewski describes former Iranian President Raisi’s hardline stance and his willingness to deepen ties with Russia as assets. Collaboration with a like-minded authoritarian with a bent for confronting the West proved particularly valuable after Russia invaded Ukraine.

Jun 12, 2024

Joseph Nye argues that even as the hard power of weapons and armies resurges on the global stage, the cultivation and use of soft power will still hold currency in the twenty-first century.

Benchmarking the Accounting & Finance Function: 2014

SLS Las Vegas Grand Opening

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European Court of Auditors

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Kids on Spending and Saving

This #AutismAwarenessMonth we encourage families with special needs to take steps now to plan for their loved ones� futures. Our Director of Advanced Planning, Ruthann Driscoll, discusses the importance of planning to secure long-term security and quality of life for your family. Learn more: http://u.nm.com/1AQBAsN

Recommendations from Astana Economic Forum 2015

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Esurance Pass It On Sweepstakes goes into overtime with grand prize giveaway of $250,000.

AARP's Travel Ambassador Samantha Brown Unveils the 2016 Top Travel Trends for Baby Boomers

Santa Claus and Extended Stay America, �Santa�s Official Hotel,� Partner to ease holiday travel woes. In time for the holiday season, the ultimate holiday travel guru shares holiday travel tips.

Las Vegas Convention and Visitors Authority interviews Tina Sinatra

Bad traffic, tired drivers and cranky kids; life makes holiday travel anything but a holiday. Watch what happens when Ziploc� takes over a tollbooth and surprises real holiday travelers with gifts.

Emerging Chinese Smartphone maker Vargo Technology Showcased in Times Square

Stella Artois joins forces with Water.org and Co-Founders Matt Damon and Gary White to call on consumers to leave a mark and help end the global water crisis.