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DGTR releases list of registered parties on anti─dumping investigation on sodium citrate imports from China

The Directorate General of Trade Remedies (DGTR), under the ministry of commerce and industry, has released a list of registered interested parties regarding the ongoing Second Sunset Review anti─dumping




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Bormioli Pharma partners with Chiesi to supplypackaging in Carbon Capture PET

Bormioli Pharma has announced a partnership with Chiesi, an international, research-focused biopharmaceutical company (Chiesi Group), to supply Carbon Capture PET bottles.




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Another IRA Surprise: Part B Coinsurance Inflation Adjustments Are Increasing Patient Costs (rerun)

This week, I’m rerunning some popular posts while we put the finishing touches on DCI’s new 2024-25 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors.

The article below highlights an underappreciated consequence of the Inflation Reduction Act’s inflation rebates for Medicare Part B drugs. Last night, I posted an updated analysis showing that the volatility in seniors' coinsurance rates continues. For the fourther quarter of 2024, coinsurance rates for 51 drugs increased, while rates for only 19 drugs decreased. What's more, rates for 17 drugs returned to their original 20% level. Click here to see our original post from May 2024.



Contrary to what you may have heard, the Inflation Reduction Act’s (IRA) inflation rebates for Medicare Part B drugs do not always save money for seniors.

As we document below, a growing share of Part B drugs have inflation-adjusted coinsurance rates that have been increasing, not declining. In many cases, the coinsurance rate declines only briefly before rebounding back to the standard 20% rate. What’s more, these fluctuations have triggered huge jumps in patients’ out-of-pocket obligations for some drugs—even when a drug’s costs were falling.

Chalk off these coinsurance surprises to yet another unintended consequence of the IRA. Seniors who are expecting to see costs drop may find they are instead being taken for a rollercoaster ride.
Read more »
       




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Bio-Thera and Gedeon Richter partner to commercialize Stelara biosimilar BAT2206

<p>In October 2024, China based Bio-Thera Solutions&nbsp;(Bio-Thera)&nbsp;and Hungary’s Gedeon Richter announced they have reached an exclusive commercialization and license agreement for BAT2206, a biosimilar candidate to&nbsp;Johnson &amp; Johnson’s Stelara (ustekinumab).</p>




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Pediatric Trial Enrollment (Shameless DIA Self-Promotion, Part 1)


[Fair Warning: I have generally tried to keep this blog separate from my corporate existence, but am making an exception for two quick posts about the upcoming DIA 2013 Annual Meeting.]

Improving Enrollment in Pediatric Clinical Trials


Logistically, ethically, and emotionally, involving children in medical research is greatly different from the same research in adults. Some of the toughest clinical trials I've worked on, across a number of therapeutic areas, have been pediatric ones. They challenge you to come up with different approaches to introducing and explaining clinical research – approaches that have to work for doctors, kids, and parents simultaneously.

On Thursday June 27, Don Sickler, one of my team members, will be chairing a session titled “Parents as Partners: Engaging Caregivers for Pediatric Trials”. It should be a good session.

Joining Don are 2 people I've had the pleasure of working with in the past. Both of them combine strong knowledge of clinical research with a massive amount of positive energy and enthusiasm (no doubt a big part of what makes them successful).

However, they also differ in one key aspect: what they work on. One of them – Tristen Moors from Hyperion Therapeutics - works on an ultra-rare condition, Urea Cycle Disorder, a disease affecting only a few hundred children every year. On the other hand, Dr. Ann Edmunds is an ENT working in a thriving private practice. I met her because she was consistently the top enroller in a number of trials relating to tympanostomy tube insertion. Surgery to place “t-tubes” is one of the most common and routine outpatients surgeries there is, with an estimated half million kids getting tubes each year.

Each presents a special challenge: for rare conditions, how do you even find enough patients? For routine procedures, how do you convince parents to complicate their (and their children’s) lives by signing up for a multi-visit, multi-procedure trial?

Ann and Tristen have spent a lot of time tackling these issues, and should have some great advice to give.

For more information on the session, here’s Don’s posting on our news blog.




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Preview of Enrollment Analytics: Moving Beyond the Funnel (Shameless DIA Self-Promotion, Part 2)


Are we looking at our enrollment data in the right way?


I will be chairing a session on Tuesday on this topic, joined by a couple of great presenters (Diana Chung from Gilead and Gretchen Goller from PRA).

Here's a short preview of the session:



Hope to see you there. It should be a great discussion.

Session Details:

June 25, 1:45PM - 3:15PM

  • Session Number: 241
  • Room Number: 205B


1. Enrollment Analytics: Moving Beyond the Funnel
Paul Ivsin
VP, Consulting Director
CAHG Clinical Trials

2. Use of Analytics for Operational Planning
Diana Chung, MSc
Associate Director, Clinical Operations
Gilead

3. Using Enrollment Data to Communicate Effectively with Sites
Gretchen Goller, MA
Senior Director, Patient Access and Retention Services
PRA





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Will Your Family Make You a Better Trial Participant?

It is becoming increasing accepted within the research community that patient engagement leads to a host of positive outcomes – most importantly (at least practically speaking) improved clinical trial recruitment and retention.

But while we can all agree that "patient engagement is good" in a highly general sense, we don't have much consensus on what the implications of that idea might be. There is precious little hard evidence about how to either attract engaged patients, or how we might effectively turn "regular patients" into "engaged patients".

That latter point - that we could improve trial enrollment and completion rates by converting the (very large) pool of less-engaged patient - is a central tenet of the mHealth movement in clinical trials. Since technology can now accompany us almost anywhere, it would seem that we have an unprecedented opportunity to reach out and connect with current and potential trial participants.

However, there are signs that this promised revolution in patient engagement hasn't come about. From the decline of new apps being downloaded to the startlingly high rate of people abandoning their wearable health devices, there's a growing body of evidence suggesting that we aren't in fact making very good progress towards increasing engagement. We appear to have underestimated the inertia of the disengaged patient.

So what can we do? We know people like their technology, but if they're not using it to engage with their healthcare decisions, we're no better off as a result.

Daniel Calvert, in a recent blog post at Parallel 6 offers an intriguing solution: he suggests we go beyond the patient and engage their wider group of loved ones. By engaging what Calvert calls the Support Circle - those people most likely to "encourage the health and well being of that patient as they undergo a difficult period of their life" - trial teams will find themselves with a more supported, and therefore more engaged, participant, with corresponding benefits to enrollment and retention. 

Calvert outlines a number of potential mechanisms to get spouses, children, and other loved ones involved in the trial process:
During the consent process the patient can invite their support team in with them. A mobile application can be put on their phones enabling encouraging messages, emails, and texts to be sent. Loved ones can see if their companion or family member did indeed take today’s medication or make last Monday’s appointment. Gamification offers badges or pop-ups: “Two months of consecutive appointments attended” or “perfect eDiary log!” Loved ones can see those notifications, like/comment, and constantly encourage the patients. 
Supporting materials can also be included in the Support Circle application. There are a host of unknown terms to patients and their team. Glossaries, videos, FAQs, contact now, and so much more can be made available at their fingertips.
I have to admit I'm fascinated by Calvert's idea. I want him to be right: the picture of supportive, encouraging, loving spouses and children standing by to help a patient get through a clinical trial is an attractive one. So is the idea that they're just waiting for us to include them - all we need to do is a bit of digital communication with them to get them fully on board as members of the study team.

The problem, however, remains: we have absolutely no evidence that this approach will work. There is no data showing that it is superior to other approaches to engage trial patients.

(In fact, we may even have some indirect evidence that it may hinder enrollment: in trials that require active caregiver participation, such as those in Alzheimer's Disease, caregivers are believed to often contribute to the barriers to patient enrollment).

Calvert's idea is a good one, and it's worthy of consideration. More importantly, it's worthy of being rigorously tested against other recruitment and retention approaches. We have a lot of cool new technologies, and even more great ideas - we're not lacking for those. What we're lacking is hard data showing us how these things perform. What we especially need is comparative data showing how new tactics work relative to other approaches.

Over 5 years ago, I wrote a blog post bemoaning the sloppy approaches we take in trial recruitment - a fact made all the more painfully ironic by the massive intellectual rigor of the trials themselves. I'm not at all sure that we've made any real progress in those 5 years.

In my next post, I'll outline what I believe are some of the critical steps we need to take to improve the current situation, and start bringing some solid evidence to the table along with our ideas.

[Photo credit: Flikr user Matthew G, "Love (of technology)"]







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CVS Health Exec: Payers Need to Stop Making Behavioral Health Providers Jump Through Hoops In Order to Participate in Value-Based Care

Value-based care contracting is especially difficult for behavioral health providers, Taft Parsons III, chief psychiatric officer at CVS Health/Aetna, pointed out during a conference this week.

The post CVS Health Exec: Payers Need to Stop Making Behavioral Health Providers Jump Through Hoops In Order to Participate in Value-Based Care appeared first on MedCity News.




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There’s an Opportunity for More Providers to Partner with the 988 Lifeline, Execs Say

Two executives at behavioral health care companies discussed why it’s important for provider organizations to partner with the 988 Suicide & Crisis Lifeline during a panel at the Behavioral Health Tech conference.

The post There’s an Opportunity for More Providers to Partner with the 988 Lifeline, Execs Say appeared first on MedCity News.




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How 4 Health Systems Are Partnering with Microsoft

Here’s how four different health systems are partnering with Microsoft to save time for clinicians.

The post How 4 Health Systems Are Partnering with Microsoft appeared first on MedCity News.




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Extended Medicaid Coverage Would Help Postpartum Patients With Treatment for Opioid Use Disorder

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.




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Pew Applauds Michigan for Enacting Bipartisan Legislation to Safely Reduce Jail Populations

The Pew Charitable Trusts today commended Michigan Governor Gretchen Whitmer (D), state Senate Majority Leader Mike Shirkey (R), and Lee Chatfield (R)—whose term as state House Speaker ended last month—for passing and signing a bipartisan package of bills aimed at protecting public safety while reducing the number of people in county jails.




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Trump names Musk to co-lead newly formed Department of Government Efficiency

WASHINGTON — US President-elect Donald Trump said on Nov 12 that Elon Musk and former Republican presidential hopeful Vivek Ramaswamy will lead the newly created Department of Government Efficiency. Musk and Ramaswamy "will pave the way for my Administration to dismantle Government Bureaucracy, slash excess regulations, cut wasteful expenditures, and restructure Federal Agencies", Trump said in a statement. Trump said their work would conclude by July 4, 2026, adding that a smaller and more efficient government would be a "gift" to the country on the 250th anniversary of the signing of the Declaration of Independence. Businessman and former Republican presidential candidate Vivek Ramaswamy attends Donald Trump's campaign event sponsored by conservative group Turning Point Action, in Las Vegas, Nevada, US, Oct 24, 2024. PHOTO: Reuters file The appointments reward two Trump supporters from the private sector.




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Noel Kempff Mercado Climate Action Project: The Promise and Peril of High-Potential Environmental Partnerships

In the first comprehensive post-mortem analysis of the Noel Kempff Mercado Climate Action Project (NKMCAP), Reine Rambert and Amanda Sardonis examine how NKMCAP failed to live up to its potential, by focusing on three different dimensions of partnership effectiveness: 1) the sustainability of the partnership, 2) the effectiveness of the collaboration process itself, and 3) the achievement of the planned objectives. Rambert and Sardonis extract several transferable lessons from the challenges faced by NKMCAP that are highly consequential to partnership effectiveness.




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State Department cable cited ISI links with militants




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Data | How regional parties in India are funded?

Total income for the selected regional parties in FY20 amounted to ₹803.24 crore, of which 55% was from unknown sources




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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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Odisha political parties urge ECI to ensure neutrality of government machineries during elections

As many as 3.32 crore voters will cast their votes in 37,809 polling stations across State




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State Department’s Learning Agenda Launch

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?




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Two peoples. Two states. Why U.S. diplomacy in Israel and Palestine needs vision, partners, and a backbone

Former U.S. Ambassador to Israel Ed Djerejian says Israeli Prime Minister Yitzak Rabin once told him, “There is no military solution to this conflict, only a political one.” Rabin was assassinated a few years later, and today bullets are flying, bombs are falling, and 1,200 Israelis are dead after the Hamas terrorist attacks of October 7 and nearly 30,000 Gazans have been killed in the Israeli response. Yet Djerejain still believes that a breakthrough is possible even in the current moment, as horrible as it is. Djerejian, a senior fellow at Harvard Kennedy School’s Belfer Center for Science and International Relations, says the crisis has shaken the regional status quo to the point where—if the United States pursues diplomacy that includes principled pragmatism, coalition-building, and good old-fashioned backbone—a breakthrough may finally be possible. But in a recent paper he argues that any breakthrough will have to be built around a two-state solution, which he says is the only path to peace and stability not only in Israel and Palestine, but the wider Middle East. Djerejian’s career as a diplomat spanned eight U.S. presidential administrations beginning with John F. Kennedy’s, and he also served as U.S. Ambassador to Syria and Assistant Secretary of State for Near Eastern Affairs.  




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Germany's government coalition breaks apart




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Database on U.S. Department of Energy Budgets for Energy Research, Development, and Demonstration (1978–2025R)

The July 2024 update to our database on the U.S. government investments in energy research, development, demonstration, and deployment (ERD3) through the U.S. Department of Energy.




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Reflecting on the U.S. Strategy Towards Africa: Embracing Partnership & Pragmatism

The Africa in Focus series is a forum for the intellectual and critical analysis of processes and policies from the continent and its engagement with the international community. Through thoughtful and dynamic programming, Africa in Focus brings greater African perspectives into broader policy conversations at HKS.




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Blu� Homes Partners with Real Simple and This Old House to Launch the �Design Smart, Live Beautifully� Home Tour and Announce the Selection of Blu�s L.A. Breezehouse as the First-Ever 

The �Design Smart, Live Beautifully� Home Tour coincides with the launch of the 2014 model of Blu�s award-winning�Breezehouse, which is�packed with luxurious features and an even more spacious floor plan





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U.S. Department of the Treasury, U.S. Department of Housing & Urban Development, and the Ad Council Launch New Public Service Ads to Reach Struggling Homeowners - Get mortgage help. This is why. MakingHomeAffordable.gov :60

Get mortgage help. This is why. MakingHomeAffordable.gov :60






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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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BGC Partners And Cantor Fitzgerald Raise Approximately $12 Million On BGC's Eleventh Annual Charity Day - BGC Charity Day 2015

Dozens of nonprofits, celebrities and BGC partners unite for Charity Day 2015.




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Cantor Fitzgerald and BGC Partners Raise Approximately $12 Million on Cantor Fitzgerald's Annual Charity Day - Cantor Fitzgerald Charity Day 2015

Dozens of charities and celebrity ambassadors join Cantor Fitzgerald on their 5th annual Charity Day in New York




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Conjoncture logement au 1er semestre 2015 : un march� soutenu par l'investissement locatif des particuliers, un march� qui repart ? - Les tendances du march� neuf

Les tendances du march� neuf







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Extended Stay America Partners With The Noerr Programs To Create The "Official Hotel of Santa Claus" - Santa Claus� Travel Secrets

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.





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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 - Stella Artois partners with Water.org

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.




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Nuelle Partners with Indiegogo Fundraising Platform to Launch Fiera� Arouser for Her - About Fiera� Arouser for Her� Overview

Nuelle� Chief Commercial Officer Lesa Musatto briefly shares why Fiera� was created, its benefits and how it works.




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Barometer Promise - BNP Exane "Exclusivity & Desirability" 2015: The Wealthiest Chinese Women Rank Luxury Brands - Philippe Jourdan: Partner - Promise Consulting

Philippe Jourdan: Partner - Promise Consulting




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The Holiday Inn� Brand Partners With Small Business Owners In Next Evolution Of Its Journey To Extraordinary Campaign - Sword & Plough Commercial

When traveling, the hotel becomes Sword & Plough�s mobile office, and Holiday Inn� hotels have become an integral extension of their team while on the road.




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El Departamento del Tesoro y el Departamento de Vivienda y Desarrollo Urbano de los Estados Unidos lanzan con el Ad Council nuevos anuncios de servicio público para ayudar a los propietarios de viviendas en dificultades - Esto es el por que :60

Esto es el por que :60




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El Departamento de Transporte de EE.UU. pone a disposición herramientas-y campaña para mejorar la seguridad de los niños a bordo de vehículos - Chairs :60

Chairs :60




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El Departamento de Transporte de los Estados Unidos, el Ad Council y el Television Bureau of Advertising se asocian para evitar las muertes causadas por conductores ebrios durante las fiestas de fin de año - Anuncio de servicio público para TV :

Anuncio de servicio público para TV :30




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Changing the Research Paradigm with a Patient-Powered Network - CCFA Partners: A patient-powered research network

CCFA Partners is an innovative network where patients and researchers work together. Become a part of groundbreaking research: www.ccfapartners.org.





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Strategic Partners, Inc. Launches New Medical Apparel Line with CERTAINTY� Antimicrobial Technology - CERTAINTY� Video

Strategic Partners, Inc. has created the next generation of medical apparel using the leading antimicrobial technology of CERTAINTY�.





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Danica Patrick All Smiles as Aspen Dental Management, Inc. Extends Partnership, Doubles Commitment - Danica�s Racecar Honors Veterans

Aspen Dental & Danica Patrick unveil a salute to more than 2,200 veterans at Chicagoland Speedway to honor their service and raise awareness about the need for oral health care.