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SEC recommends marketing approval for Dr Reddy's SPMS drug Siponimod tablets

The Subject Expert Committee (SEC), which advises the national drug regulator on approval of new drugs and clinical trials, has recommended grant of market authorisation for Dr Reddy's Laboratories' Siponimod




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SEC recommends approval for MSN Laboratories' sleep disorder drug

The Subject Expert Committee (SEC), which advises the national drug regulator on matters related to approval of new drugs and medical devices and clinical trials, has recommended grant of market authorisation for




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In 2024’s Record-Hottest Year, U.S. Voters Will Decide Climate’s Path Forward

Global temperatures through September point to 2024 besting 2023 as the hottest year on record. How many future years set records depends in part on the outcome of the 2024 U.S. presidential election




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Why Election Polling Has Become Less Reliable

Election polls are increasingly vulnerable to huge mistakes




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New Prime Number, 41 Million Digits Long, Breaks Math Records

The discovery of a new prime number highlights the rising price of mathematical gold




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The Lucy Fossil’s Extraordinary Journey to Becoming an Icon of Human Evolution

The 3.2-million-year-old human ancestor known as Lucy rose to fame through an incredible combination of circumstances




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Available for Preorder: The 2024-25 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors

On October 8, 2024, Drug Channels Institute will release our 2024-25 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors. This report—our fifteenth edition—remains the most comprehensive, fact-based tool for understanding and analyzing the large and growing U.S. pharmaceutical distribution industry.

9 chapters, 350+ pages, 178 exhibits, 750+ endnotes: There is nothing else available that comes close to this valuable resource.

We are providing you with the opportunity to preorder this thoroughly updated, revised, and expanded 2024-25 edition at special discounted prices. This means that you can be among the first to access our new report. Those who preorder will receive a download link before October 8.
You can pay online with all major credit cards (Visa, MasterCard, American Express, and Discover) or via PayPal. Click here to contact us if you would like to pay by corporate check or ACH.

Special preorder and launch pricing discounts will be valid through October 23, 2024.

Read on for more details.
Read more »
       




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NOW AVAILABLE: 2024–25 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors

I am pleased to announce Drug Channels Institute's new 2024–25 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors, available for purchase and immediate download.
We’re offering special discounted pricing if you order before October 23, 2024.

2024–25 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors—our 15th edition--remains the most comprehensive, fact-based tool for understanding and analyzing the large and growing U.S. pharmaceutical distribution industry. This 2024-25 edition includes substantial new material—outlined on page vii of the report overview.

9 chapters, 380+ pages, 178 exhibits, more than 750 endnotes: There is nothing else available that comes close to this valuable resource.

You can pay online with all major credit cards (Visa, MasterCard, American Express, and Discover) or via PayPal. Click here to contact us if you would like to pay by corporate check or ACH.

Email Paula Fein (paula@drugchannels.net) if you’d like to bundle your report purchase with access to DCI’s video webinars.

If you preordered the report, you should have already received an email with download instructions last week. Please contact us if you did not receive your email.

Read on for some additional details.
Read more »
       




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What does the FDA do after drugs are approved? (15 seconds)

The U.S. Food and Drug Administration posted a video:

What happens after a drug is approved? And how and why do drug recalls happen? Learn more in this short video from FDA’s Center for Drug Evaluation and Research (CDER).




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What does the FDA do after drugs are approved? (30 seconds)

The U.S. Food and Drug Administration posted a video:

What happens after a drug is approved? And how and why do drug recalls happen? Learn more in this short video from FDA’s Center for Drug Evaluation and Research (CDER).




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What is FDA’s role in regulating drugs? (15 seconds)

The U.S. Food and Drug Administration posted a video:

The FDA oversees prescription, generic, biosimilars, and over-the-counter drugs. But what is the FDA’s role when it comes to drug regulation? Learn more in this short video from FDA’s Center for Drug Evaluation and Research (CDER).




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What is FDA’s role in regulating drugs? (30 seconds)

The U.S. Food and Drug Administration posted a video:

The FDA oversees prescription, generic, biosimilars, and over-the-counter drugs. But what is the FDA’s role when it comes to drug regulation? Learn more in this short video from FDA’s Center for Drug Evaluation and Research (CDER).




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How does the FDA approve new drugs? (15 seconds)

The U.S. Food and Drug Administration posted a video:

Prescription drugs go through many steps and phases before they’re approved by the FDA, from research to clinical trials. What does this process look like from beginning to end? Learn more in this short video from FDA’s Center for Drug Evaluation and Research (CDER).




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How does the FDA approve new drugs? (30 seconds)

The U.S. Food and Drug Administration posted a video:

Prescription drugs go through many steps and phases before they’re approved by the FDA, from research to clinical trials. What does this process look like from beginning to end? Learn more in this short video from FDA’s Center for Drug Evaluation and Research (CDER).




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Orphan Drugs at 30: Will Success Become Too Expensive?

The Orphan Drug Act (ODA) turned 30 this month, demonstrating that good laws really can have an enduring impact. Amidst the celebrations, a reporter asked me a provocative question: can we afford more orphan drugs costing hundreds of thousands of dollars per year? FDA Matters answered “yes.” However, I added a caveat that should worry everyone eager for orphan drugs to succeed. When genomics and personalized medicine become successful, this will multiply the number of rare diseases and the overall cost of orphan drugs, perhaps beyond what the system can bear.




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Minnesota Becomes 18th State to Adopt Consumer Data Privacy Law

On May 24, Governor Tim Walz signed into law Minnesota’s new comprehensive data privacy law, the Minnesota Consumer Data Privacy Act (HF 4757 referenced as the MCDPA). The MCDPA goes into effect on July 31, 2025, with some exceptions for colleges and universities (who have until 2029). The MCDPA is similar to other state privacy laws, […]




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EMA recommends approval of aflibercept biosimilars Afqlir and Opuviz

<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>




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Deconstructing the Diligence Process: An Approach to Vetting New Product Theses

By Aimee Raleigh, Principal at Atlas Venture, as part of the From The Trenches feature of LifeSciVC Ever wondered what goes into diligencing a new idea, program, company, or platform? While each diligence is unique and every investor will have

The post Deconstructing the Diligence Process: An Approach to Vetting New Product Theses appeared first on LifeSciVC.




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Superconducting Wire Sets New Current Capacity Record



UPDATE 31 OCTOBER 2024: No. 1 no longer. The would-have-been groundbreaking study published in Nature Communications by Amit Goyal et al. claiming the world’s highest-performing high-temperature superconducting wires yet has been retracted by the authors.

The journal’s editorial statement that now accompanies the paper says that after publication, an error in the calculation of the reported performance was identified. All of the study’s authors agreed with the retraction.

The researchers were first alerted to the issue by Evgeny Talantsev at the Mikheev Institute of Metal Physics in Ekaterinburg, Russia, and Jeffery Tallon at the Victoria University of Wellington in New Zealand. In a 2015 study, the two researchers had suggested upper limits for thin-film superconductors, and Tallon notes follow-up papers showed these limits held for more than 100 known superconductors. “The Goyal paper claimed current densities 2.5 times higher, so it was immediately obvious to us that there was a problem here,” he says.

Upon request, Goyal and his colleagues “very kindly agreed to release their raw data and did so quickly,” Tallon says. He and Talantsev discovered a mistake in the conversion of magnetization units.

“Most people who had been in the game for a long time would be fully conversant with the units conversion because the instruments all deliver magnetic data in [centimeter-gram-second] gaussian units, so they always have to be converted to [the International System of Units],” Tallon says. “It has always been a little tricky, but students are asked to take great care and check their numbers against other reports to see if they agree.”

In a statement, Goyal notes he and his colleagues “intend to continue to push the field forward” by continuing to explore ways to enhance wire performance using nanostructural modifications. —Charles Q. Choi

Original article from 17 August, 2024 follows:

Superconductors have for decades spurred dreams of extraordinary technological breakthroughs, but many practical applications for them have remained out of reach. Now a new study reveals what may be the world’s highest-performing high-temperature superconducting wires yet, ones that carry 50 percent as much current as the previous record-holder. Scientists add this advance was achieved without increased costs or complexity to how superconducting wires are currently made.

Superconductors conduct electricity with zero resistance. Classic superconductors work only at super-cold temperatures below 30 degrees Kelvin. In contrast, high-temperature superconductors can operate at temperatures above 77 K, which means they can be cooled to superconductivity using comparatively inexpensive and less burdensome cryogenics built around liquid nitrogen coolant.

Regular electrical conductors all resist electron flow to some degree, resulting in wasted energy. The fact that superconductors conduct electricity without dissipating energy has long lead to dreams of significantly more efficient power grids. In addition, the way in which rivers of electric currents course through them means superconductors can serve as powerful electromagnets, for applications such as maglev trains, better MRI scanners for medicine, doubling the amount of power generated from wind turbines, and nuclear fusion power plants.

“Today, companies around the world are fabricating kilometer-long, high-temperature superconductor wires,” says Amit Goyal, SUNY Distinguished Professor and SUNY Empire Innovation Professor at the University of Buffalo in New York.

However, many large-scale applications for superconductors may stay fantasies until researchers can find a way to fabricate high-temperature superconducting wires in a more cost-effective manner.

In the new research, scientists have created wires that have set new records for the amount of current they can carry at temperatures ranging from 5 K to 77 K. Moreover, fabrication of the new wires requires processes no more complex or costly than those currently used to make high-temperature superconducting wires.

“The performance we have reported in 0.2-micron-thick wires is similar to wires almost 10 times thicker,” Goyal says.

At 4.2 K, the new wires carried 190 million amps per square centimeter without any externally applied magnetic field. This is some 50 percent better than results reported in 2022 and a full 100 percent better than ones detailed in 2021, Goyal and his colleagues note. At 20 K and under an externally applied magnetic field of 20 tesla—the kind of conditions envisioned for fusion applications—the new wires may carry about 9.3 million amps per square centimeter, roughly 5 times greater than present-day commercial high-temperature superconductor wires, they add.

Another factor key to the success of commercial high-temperature superconductor wires is pinning force—the ability to keep magnetic vortices pinned in place within the superconductors that could otherwise interfere with electron flow. (So in that sense higher pinning force values are better here—more conducive to the range of applications expected for such high-capacity, high-temperature superconductors.) The new wires showed record-setting pinning forces of more than 6.4 trillion newtons at 4.3 K under a 7 tesla magnetic field. This is more than twice as much as results previously reported in 2022.

The new wires are based on rare-earth barium copper oxide (REBCO). The wires use nanometer-sized columns of insulating, non-superconducting barium zirconate at nanometer-scale spacings within the superconductor that can help pin down magnetic vortices, allowing for higher supercurrents.

The researchers made these gains after a few years spent optimizing deposition processes, Goyal says. “We feel that high-temperature superconductor wire performance can still be significantly improved,” he adds. “We have several paths to get to better performance and will continue to explore these routes.”

Based on these results, high-temperature superconductor wire manufacturers “will hopefully further optimize their deposition conditions to improve the performance of their wires,” Goyal says. “Some companies may be able to do this in a short time.”

The hope is that superconductor companies will be able to significantly improve performance without too many changes to present-day manufacturing processes. “If high-temperature superconductor wire manufacturers can even just double the performance of commercial high-temperature superconductor wires while keeping capital equipment costs the same, it could make a transformative impact to the large-scale applications of superconductors,” Goyal says.

The scientists detailed their findings on 7 August in the journal Nature Communications.

This story was updated on 19 August 2024 to correct Amit Goyal’s title and affiliation.




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The Startup Economy is Turbulent. Here’s How Founders Can Recognize and Avoid Common Pitfalls

While startups in highly regulated industries like healthcare and finance are almost certain to face heightened scrutiny, there are controllable factors that can offset these challenges.

The post The Startup Economy is Turbulent. Here’s How Founders Can Recognize and Avoid Common Pitfalls appeared first on MedCity News.




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FDA Takes Step Toward Removal of Ineffective Decongestants From the Market

The FDA has proposed removing oral phenylephrine from its guidelines for over-the-counter drugs due to inefficacy as a decongestant. Use of this ingredient in cold and allergy medicines grew after a federal law required that pseudoephedrine-containing products be kept behind pharmacy counters.

The post FDA Takes Step Toward Removal of Ineffective Decongestants From the Market appeared first on MedCity News.




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Standard Technology Presents Opportunities for Medical Record Data Extraction

Technology has revolutionized the way people live their lives. Individuals can use smartphones to access their bank account, shop from almost any store, and connect with friends and family around the globe. In fact, these personal devices have tethered communities together during the coronavirus pandemic, allowing many people to maintain much of their lives remotely.




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Global CO2 emissions to hit record high in 2024: Report

BAKU — Global carbon dioxide emissions, including those from burning fossil fuels, are set to hit a record high this year, pulling the world further off course from averting more destructive climate extremes, scientists said on Wednesday (Nov 13). The Global Carbon Budget report, published during the UN's COP29 climate summit in Azerbaijan, said global CO2 emissions are set to total 41.6 billion metric tons in 2024, up from 40.6 billion tons last year. The bulk of these emissions are from burning coal, oil and gas. Those emissions would total 37.4 billion tons in 2024, up by 0.8 per cent in 2023, the report said. The rest are from land use, a category that includes deforestation and forest fires. The report by more than 80 institutions was led by the University of Exeter in UK. "We don't see a sign of fossil fuel emissions peaking in 2024," said lead author Pierre Friedlingstein, a climate scientist at the University of Exeter. Without immediate and steep emissions cuts worldwide, "we will just go straight into the 1.5C target, we'll just pass it and continue," he said.




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233602: Finance minister Tarin on budgets, CSF dollar fund, and Pakistan's improving economic outlook

Tarin requested that an additional $500 million of U.S. assistance flow through the GOP - in addition to the $174 million already committed - to bolster GOP credibility and allow the GOP to more adequately support its priorities.




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77877: Embassy recommendation on engaging GOP on F-16 sale

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




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Data | Anonymous donations to parties in FY21: Congress tops list, BJP close second

In FY21, national parties and regional parties received ₹427 crore and ₹264 crore worth of funds, respectively, from unknown sources




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Cyrus Broacha on Indian wrestlers’ protest, IPL taking over sports and Ding Liren becoming the world chess champion

The columnist puts the spotlight on India’s star female wrestlers who have accused Wrestling Federation of India chief Brij Bhushan Sharan Singh of serial sexual harassment



  • Life &amp; Style

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Enabling an Economic Transformation of Ukraine: Recovery, Reconstruction, and Modernization

The aim of the report is to focus specifically on the critical role of private sector investment in Ukraine’s economic reconstruction, and how the private sector, both within Ukraine and internationally, can enable Ukraine to win the peace. It provides a short overview of the economic challenges facing Ukraine, including governance, the sectors that will be critical to Ukraine's reconstruction, the roles and responsibilities for the G7, EU, IFIs, and DFIs, and then recommendations for how Ukraine and its partners can best attract private sector investment.




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EVENT DEBRIEF: The Future of Ukraine: Reconstruction, Energy Security, and Innovation

The following is an event write-up about the recent Future of Diplomacy Project (FDP) seminar on “The Future of Ukraine: Reconstruction, Energy Security, and Innovation” moderated by Ambassador Paula J. Dobriansky, Senior Fellow with the Future of Diplomacy Project. 




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Writing Policy Recommendations for Academic Journals: A Guide for the Perplexed

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. 




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Education, Research, and Innovation in Africa: Forging Strategic Linkages for Economic Transformation

Africa is a youthful continent: nearly 41% of its population is under the age of 18. To address the unique challenges of this demographic structure, the African Union (AU) hopes to reposition the continent as a strategic player in the global economy through improved education and application of science and technology in development. The paper proposes the creation of “Innovation Universities” that combine research, teaching, community service and commercialization in their missions and operations. They would depart from the common practice where teaching is carried out in universities that do little research, and where research is done in national research institutes that do not undertake teaching. Under this model, there is little connection with productive sectors. The idea therefore is not just to create linkages between those activities but to pursue them in a coordinated way under the same university structure. Innovation universities can be created in diverse fields such as agriculture, health, industry, services, and environment to advance sustainable development and inclusive growth.




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Rebooting African Economies: The Place of Science and Technology in Society

"African countries are already at the forefront of harnessing these technologies. For example, Rwanda has set itself the ambitious goal of building the first drone airport in the world. An increasing number of African countries are leveraging drone technology to address a variety of resource mapping, delivery and agricultural services. It is through such efforts that salient basic research challenges are likely to emerge."




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If We Develop Africa's Bioeconomy It Will Be as Transformative for Us as Digital Has Been

"Unlike the digital revolution that relied on pre-existing technologies, the new bioeconomy will involve more local research, teaching and commercialization. This will require greater involvement of local universities, especially those with an entrepreneurial inclination."








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Polls Show Record Low Number of Russians Willing to Permanently Move Abroad

The share of Russians who would like to leave Russia for permanent residence in another country has reached a record low, according to the results of a national poll conducted by Russia’s Levada Center on March 21-27, 2024.  Of the countries Russians were eager to relocate to, the U.S. topped the list (11%), followed by Germany (8%) and Italy and Turkey (6% each). China ranked 10-11 along with Canada.That seven out of the top 11 countries Russians would like to relocate to are members of the collective West, with 46% interested in moving to these countries, also shows the limits of the Kremlin’s efforts to instill anti-Western sentiments in the Russian public.




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The Historical Puzzle of US Economic Performance under Democrats vs. Republicans

We have heard much about the puzzle that US economic performance under President Joe Biden has been much stronger than voters perceive it to be.  But the current episode is just one instance of a bigger historical puzzle:  the US economy has since World War II consistently done better under Democratic presidents than under Republican presidents.  This fact is even less widely known, including among Democratic voters, than the truth about Biden’s term.  Indeed, some poll results suggest that more Americans believe the reverse, that Republican presidents are better stewards of the economy than Democrats.




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Politics and Prosperity: Examining Economic Development in Africa

On April 9, the study group met for the third time to examine economic development in Africa. The group explored connections between politics and economic growth trajectories across the continent, and analyzed the role of political instability and policy decisions in fostering development. Discussions covered the impact of factors like commodity markets, foreign aid, trade deals, and regional integration initiatives on development indicators. The study group counted with the presence of external expert guest H.E. Patrick Achi, former Prime Minister of Côte d’Ivoire. Prime Minister Achi shared about his experience at the highest level of government and presented the story of Côte d’Ivoire’s post-independence development as a microcosm of the broader challenges and opportunities facing African nations.





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S&T Bank Unveils Updated Brand To Strengthen Customer-Centric Mission - S&T Bank Re-Brand TV Spot: 60 Second

Where lives and goals come together in one place � S&T Bank.





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San Diego Padres And Mercury Insurance Host Second Annual Event To Assemble 1,000 Care Packages For Marines And Sailors Overseas - Mercury Packing Party for Troops

Mercury Packing Party for Troops






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Las Vegas Redo: Irish 'GoPro Dad' Invited for Second Chance to Film Vegas Vacation - Irish GoPro Dad � Q&A

Global (INTERNET) sensation Joseph Griffin will make his triumphant return to Las Vegas on Thursday, Nov. 19, to properly capture the sights and sounds of the iconic Las Vegas Strip. This time, he�ll film a few familiar sites from his original �selfie� video paired with a selection of only-in-Vegas surprises for this Irish Dad.