From Stat

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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Here Come the Tortoises: In the Race for a Covid-19 Vaccine, Slow Starters Could Still Win Out

September 24, 2020

The race is not always to the swift, as the cocky hare learned in Aesop’s classic fable, “The Hare and the Tortoise.” Those handicapping the so-called competition to develop Covid-19 vaccines would do well to keep an eye on the slower runners in this pursuit.

Corporate giants Sanofi and Merck, which got a relatively late start in developing Covid-19 vaccines, may seem far behind the frontrunners. But experts say they also have such deep experience developing and testing vaccine candidates, and producing vaccine at commercial scale, that both could well close the gap considerably in the months ahead.

The race is not always to the swift, as the cocky hare learned in Aesop’s classic fable, “The Hare and the Tortoise.” Those handicapping the so-called competition to develop Covid-19 vaccines would do well to keep an eye on the slower runners in this pursuit.

Corporate giants Sanofi and Merck, which got a relatively late start in developing Covid-19 vaccines, may seem far behind the frontrunners. But experts say they also have such deep experience developing and testing vaccine candidates, and producing vaccine at commercial scale, that both could well close the gap considerably in the months ahead.

Each is developing two vaccines, in partnership with others….

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Lilly’s Covid-19 Antibody Helps Some Patients Rid Their Systems of Virus Sooner in Early Analysis

September 16, 2020

Adrug being developed by Eli Lilly helped sick patients rid their systems of the virus that causes Covid-19 sooner and may have prevented them from landing in the hospital, according to newly released data.

The drug is what is known as a monoclonal antibody, which experts view as being among the most likely technologies to help treat Covid-19. It’s a manufactured version of the antibodies that the body uses as part of its response to a virus.

Adrug being developed by Eli Lilly helped sick patients rid their systems of the virus that causes Covid-19 sooner and may have prevented them from landing in the hospital, according to newly released data.

The drug is what is known as a monoclonal antibody, which experts view as being among the most likely technologies to help treat Covid-19. It’s a manufactured version of the antibodies that the body uses as part of its response to a virus.

“This is a good start,” said Eric Topol, the director and founder of the Scripps Research Translational Institute. “A lot is pinned not only on Lilly but on the whole family of these [monoclonal antibodies], because even though they’re expensive and they’re not going to make a gajillion doses, they could make a big difference in the whole landscape of the pandemic….”

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