From Stat

With Strong Data on Two Covid-19 Vaccines, We Have More Answers About the Road Ahead — and Questions Too

November 17, 2020

The success of a second vaccine against Covid-19 means the world is a big step closer to curbing the coronavirus pandemic.

Moderna, joined by U.S. government scientists, announced Monday that their mRNA vaccine candidate was 94.5% effective in preventing Covid-19, the disease caused by the novel coronavirus, according to an interim analysis of a 30,000-patient clinical trial. The news comes exactly one week after Pfizer and BioNTech said their respective Covid-19 vaccine candidate, also created using mRNA technology, was more than 90% effective in its own 60,000-patient clinical trial.

The success of a second vaccine against Covid-19 means the world is a big step closer to curbing the coronavirus pandemic.

Moderna, joined by U.S. government scientists, announced Monday that their mRNA vaccine candidate was 94.5% effective in preventing Covid-19, the disease caused by the novel coronavirus, according to an interim analysis of a 30,000-patient clinical trial. The news comes exactly one week after Pfizer and BioNTech said their respective Covid-19 vaccine candidate, also created using mRNA technology, was more than 90% effective in its own 60,000-patient clinical trial.

Here’s what we know — and still need to learn — about the two most advanced Covid-19 vaccines and how they might reshape the pandemic that has killed 1.3 million people worldwide and infected at least 54.5 million….

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Americans Are Spending More on Specialty Medicines, Despite Rebates Given to Payers

November 5, 2020

Between 2010 and 2017, Americans nearly doubled their spending on pricey specialty medicines that they purchased at pharmacies or by mail. And this was after accounting for rebates paid by drug makers to health plans, according to a new analysis in Health Affairs.

Specifically, specialty drugs accounted for 38% of retail and mail-order prescription spending in 2017, compared to 20% in 2010. Drilling down, spending tripled for Medicare Part D beneficiaries and more than doubled for people who are covered by private insurance, although Medicaid spending rose at a slower pace — again, after allowing for rebates. And this growth occurred even though specialty drugs comprised a very small portion of retail prescriptions that were filled during this period of time….

Between 2010 and 2017, Americans nearly doubled their spending on pricey specialty medicines that they purchased at pharmacies or by mail. And this was after accounting for rebates paid by drug makers to health plans, according to a new analysis in Health Affairs.

Specifically, specialty drugs accounted for 38% of retail and mail-order prescription spending in 2017, compared to 20% in 2010. Drilling down, spending tripled for Medicare Part D beneficiaries and more than doubled for people who are covered by private insurance, although Medicaid spending rose at a slower pace — again, after allowing for rebates. And this growth occurred even though specialty drugs comprised a very small portion of retail prescriptions that were filled during this period of time….

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Antibody Drugs Appear Effective. Now Can We Make Enough of Them?

October 29, 2020

The Covid-19 pandemic teaches one lesson, over and over: The virus is moving faster than we are.

That difficult message was driven home Wednesday evening with news that an antibody cocktail developed by the drug maker Regeneron — the same cocktail used to treat President Trump — reduced infected patients’ need to visit the doctor, virtually or in person, or go to the hospital by 57%.

The Covid-19 pandemic teaches one lesson, over and over: The virus is moving faster than we are.

That difficult message was driven home Wednesday evening with news that an antibody cocktail developed by the drug maker Regeneron — the same cocktail used to treat President Trump — reduced infected patients’ need to visit the doctor, virtually or in person, or go to the hospital by 57%.

Those are encouraging results — and, if authorized, the cocktail could be an important tool in beating back the virus. But right now, there are only 50,000 doses available, a pittance in comparison with the number of infections across the country….

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As Covid-19 Intensifies, Shortages of Staple Drugs May Grow Worse

October 21, 2020

You can add a new worry to the health concerns caused by Covid-19: a sustained shortage of medicines needed to combat the coronavirus and countless other illnesses.

Across the U.S. and Europe, 29 out of 40 drugs used to combat the coronavirus are currently in short supply. And those shortages are expected to grow even worse as the number of Covid-19 cases and hospitalizations surge in the coming winter months, according to a new report by the Center for Infectious Disease Research and Policy at the University of Minnesota.

You can add a new worry to the health concerns caused by Covid-19: a sustained shortage of medicines needed to combat the coronavirus and countless other illnesses.

Across the U.S. and Europe, 29 out of 40 drugs used to combat the coronavirus are currently in short supply. And those shortages are expected to grow even worse as the number of Covid-19 cases and hospitalizations surge in the coming winter months, according to a new report by the Center for Infectious Disease Research and Policy at the University of Minnesota.

Moreover, the problem is likely to be exacerbated by the vagaries of the global pharmaceutical supply chain, which is heavily dependent on China for active pharmaceutical ingredients and on manufacturers based in India. As of now, 43% — or 67 of 156 — of acute care medicines used to treat various illnesses are running low. This group includes such staples as antibiotics, blood thinners, and sedatives….

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Navigating the New ‘Buy American’ Drug Landscape: Opportunities for Some, Pitfalls for Others

October 15, 2020

President Trump’s executive order on essential medicines aims to encourage pharmaceutical companies to bring their manufacturing back to the U.S. But it may also have unintended consequences for both domestic and foreign companies.

Legitimate concerns exist about U.S. dependency on drugs, medical devices, and supplies manufactured abroad, and the Covid-19 pandemic has brought them into sharp focus. The executive order aims to address these concerns by extending advantages in U.S. government purchasing to essential drugs, critical countermeasures (such as certain devices and personal protective equipment), and critical inputs (such as raw materials and components) that are made in the U.S.

President Trump’s executive order on essential medicines aims to encourage pharmaceutical companies to bring their manufacturing back to the U.S. But it may also have unintended consequences for both domestic and foreign companies.

Legitimate concerns exist about U.S. dependency on drugs, medical devices, and supplies manufactured abroad, and the Covid-19 pandemic has brought them into sharp focus. The executive order aims to address these concerns by extending advantages in U.S. government purchasing to essential drugs, critical countermeasures (such as certain devices and personal protective equipment), and critical inputs (such as raw materials and components) that are made in the U.S.

The order directs government agencies, when possible, to procure domestically manufactured active pharmaceutical ingredients, finished drugs, and medical devices. Recognizing the practical reality that a substantial portion of drugs and devices are currently manufactured overseas, the executive order also recognizes that some — if not most — procurements will need to be open to non-U.S. products. This would cause what are often referred to as preferences, which favor U.S. products vis-à-vis competing nondomestic products, to be applied….

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