From Stat

Biosimilars Could Disappear If the Supreme Court Overturns the ACA

April 1, 2020

With the sense of urgency rightly focused on slowing or stopping the spread of Covid-19, it seems like everything else in the news, and in health care, has come to a grinding halt. Yet important decision-making continues in the background, including some that could have long-lasting effects on health care today and in the future.

One of these is the decision by the U.S. Supreme Court to hear California v. Texas, a case that will decide whether most or all of the Affordable Care Act should be overturned.

With the sense of urgency rightly focused on slowing or stopping the spread of Covid-19, it seems like everything else in the news, and in health care, has come to a grinding halt. Yet important decision-making continues in the background, including some that could have long-lasting effects on health care today and in the future.

One of these is the decision by the U.S. Supreme Court to hear California v. Texas, a case that will decide whether most or all of the Affordable Care Act should be overturned.

The story of how the case got back to the Supreme Court is a long one, but there is an underdiscussed component of the ACA that the court’s decision could affect: the fate of the U.S. biosimilars market, which is key to lowering health care costs. The outcome of the cases could affect biosimilars because embedded within the ACA is the Biologics Price Competition and Innovation Act (BPCIA). This act created a regulatory pathway for biosimilar medicines and marked the beginning of a new era for biologic treatments in the United States….

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What We’ve Learned About the Coronavirus — and What We Still Need to Know

March 26, 2020

As we approach the three-month mark since we all learned about a new virus triggering serious respiratory infections in China, the amount of information that’s been gained about the new coronavirus is staggering.

In 2003, when SARS first emerged in China, it took weeks for laboratories to figure out what was causing new and sometimes deadly cases of pneumonia there and elsewhere.

As we approach the three-month mark since we all learned about a new virus triggering serious respiratory infections in China, the amount of information that’s been gained about the new coronavirus is staggering.

In 2003, when SARS first emerged in China, it took weeks for laboratories to figure out what was causing new and sometimes deadly cases of pneumonia there and elsewhere.

This time, rumors of a possible new coronavirus were reported in China at the end of December, roughly the same time the country alerted the World Health Organization that it had a dangerous outbreak on its hands. By Jan. 10, the full genetic sequence of the virus had been shared with scientists around the globe….

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WHO to Launch Multinational Trial to Jumpstart Search for Coronavirus Drugs

March 18, 2020

The World Health Organization said Wednesday that it would launch a multiarm, multicountry clinical trial for potential coronavirus therapies, part of an aggressive effort to jumpstart the global search for drugs to treat Covid-19.

Four drugs or drug combinations already licensed and used for other illnesses will be tested, said WHO Director-General Tedros Adhanom Ghebreyesus. Ten countries have already indicated they will take part in the trial.

The World Health Organization said Wednesday that it would launch a multiarm, multicountry clinical trial for potential coronavirus therapies, part of an aggressive effort to jumpstart the global search for drugs to treat Covid-19.

Four drugs or drug combinations already licensed and used for other illnesses will be tested, said WHO Director-General Tedros Adhanom Ghebreyesus. Ten countries have already indicated they will take part in the trial.

The mere fact the WHO is sponsoring the trial suggests that efforts in China to test these drugs may not have come up with enough data to indicate whether any were of use to prevent patients from developing severe disease or save those with severe disease from death….

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A Detailed Guide to the Coronavirus Drugs and Vaccines in Development

March 2, 2020

In the months since the novel coronavirus rose from a regional crisis to a global threat, drug makers large and small have scrambled to advance their best ideas for thwarting a pandemic.

Some are repurposing old antivirals. Some are mobilizing tried-and-true technologies, and others are pressing forward with futuristic approaches to human medicine.

In the months since the novel coronavirus rose from a regional crisis to a global threat, drug makers large and small have scrambled to advance their best ideas for thwarting a pandemic.

Some are repurposing old antivirals. Some are mobilizing tried-and-true technologies, and others are pressing forward with futuristic approaches to human medicine.

Here’s a guide to some of the most talked-about efforts to treat or prevent coronavirus infection, with details on the science, history, and timeline for each endeavor….

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In Their Words: Warren, Buttigieg, Klobuchar, and Other Democrats Explain Exactly How They’d Lower Drug Prices

February 10, 2020

Every single Democratic presidential candidate agrees that the federal government should take a far more aggressive approach to lowering drug prices — including letting Medicare negotiate drug prices.

Every single Democratic presidential candidate agrees that the federal government should take a far more aggressive approach to lowering drug prices — including letting Medicare negotiate drug prices.

But beyond that plank, there are quite a few differences between the candidates when it comes to taking on the pharmaceutical industry. To suss out exactly where they diverge, STAT questioned seven candidates during their interviews with the editorial board of the Boston Globe, STAT’s sister publication. (STAT was not involved at all with the board’s discussions about a forthcoming endorsement.)

Most of the candidates have already rolled out drug-pricing plans, and they were well-prepared to discuss an issue they said voters regularly brought up. Both Sens. Elizabeth Warren and Amy Klobuchar seemed to light up at the question, eager to engage on the topic. Former South Bend, Ind., Mayor Pete Buttigieg seemed a ready candidate, mixing politics with personal stories from the campaign trail. And Andrew Yang, who comes from the entrepreneurial world, was quick to cite a financial analyst friend in his response.

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