From Stat

New Covid-19 Testing Guidelines, Crafted at the White House, Alarm Public Health Experts

August 27, 2020

Public health experts reacted with alarm Wednesday to new Covid-19 testing guidelines issued by the Centers for Disease Control and Prevention, guidance that they said will make it harder to find and isolate people spreading the SARS-2 virus early and will undermine efforts to control transmission.

The guidance recommends against testing people who have been in contact with confirmed Covid-19 cases but who don’t yet have symptoms — even though such people can be infectious. It was crafted not by the CDC but by the White House coronavirus task force, and the nation’s best-known infectious disease expert, Anthony Fauci, didn’t sign off on it….

Public health experts reacted with alarm Wednesday to new Covid-19 testing guidelines issued by the Centers for Disease Control and Prevention, guidance that they said will make it harder to find and isolate people spreading the SARS-2 virus early and will undermine efforts to control transmission.

The guidance recommends against testing people who have been in contact with confirmed Covid-19 cases but who don’t yet have symptoms — even though such people can be infectious. It was crafted not by the CDC but by the White House coronavirus task force, and the nation’s best-known infectious disease expert, Anthony Fauci, didn’t sign off on it….

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Stunning FDA Rejection Signals Potential New Hurdles for Gene Therapies

August 20, 2020

The Food and Drug Administration’s unexpected rejection of a gene therapy for the bleeding disorder hemophilia has reverberated through the biotech industry, potentially complicating the path to market for these one-time treatments.

In deciding not to approve Roctavian, a BioMarin Pharmaceutical gene therapy for hemophilia A, the FDA demanded two additional years of data to strengthen the case that its benefits are durable. That contrasts with the agency’s perceived leniency in approving previous one-time therapies for rare diseases, and it could affect the plans of other gene therapy companies hoping to win FDA approval based on early signs of promise….

The Food and Drug Administration’s unexpected rejection of a gene therapy for the bleeding disorder hemophilia has reverberated through the biotech industry, potentially complicating the path to market for these one-time treatments.

In deciding not to approve Roctavian, a BioMarin Pharmaceutical gene therapy for hemophilia A, the FDA demanded two additional years of data to strengthen the case that its benefits are durable. That contrasts with the agency’s perceived leniency in approving previous one-time therapies for rare diseases, and it could affect the plans of other gene therapy companies hoping to win FDA approval based on early signs of promise….

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Teladoc Health Reaches Agreement to Buy Livongo in a $18.5 Billion Deal

August 5, 2020

Telemedicine provider Teladoc Health has reached an agreement to buy the diabetes coaching company Livongo in an $18.5 billion deal that will create the first true health tech giant — in an era in which demand for virtual care is surging.

The merger agreement, announced on Wednesday morning, is expected to create a combined company on track to bring in $1.3 billion in revenue this year, up 85% over last year. Jason Gorevic, Teladoc’s current CEO, will be the CEO of the newly combined company, which will be called Teladoc and will be based in New York. The transaction is expected to close by the end of this year, pending approval of regulators and shareholders.

Telemedicine provider Teladoc Health has reached an agreement to buy the diabetes coaching company Livongo in an $18.5 billion deal that will create the first true health tech giant — in an era in which demand for virtual care is surging.

The merger agreement, announced on Wednesday morning, is expected to create a combined company on track to bring in $1.3 billion in revenue this year, up 85% over last year. Jason Gorevic, Teladoc’s current CEO, will be the CEO of the newly combined company, which will be called Teladoc and will be based in New York. The transaction is expected to close by the end of this year, pending approval of regulators and shareholders.

Both companies have seen their stock prices soar during the pandemic, reaching all time highs this week. Livongo’s share price is nearly six times higher than it was at the start of 2020, and Teladoc’s has tripled in that period….

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‘A Huge Experiment’: How the World Made So Much Progress on a Covid-19 Vaccine So Fast

July 30, 2020

Never before have prospective vaccines for a pathogen entered final-stage clinical trials as rapidly as candidates for Covid-19.

Just six months ago, when the death toll from the coronavirus stood at one and neither it nor the disease it caused had a name, a team of Chinese scientists uploaded its genetic sequence to a public site. That kicked off the record-breaking rush to develop vaccines — the salve that experts say could ultimately quell the pandemic.

Never before have prospective vaccines for a pathogen entered final-stage clinical trials as rapidly as candidates for Covid-19.

Just six months ago, when the death toll from the coronavirus stood at one and neither it nor the disease it caused had a name, a team of Chinese scientists uploaded its genetic sequence to a public site. That kicked off the record-breaking rush to develop vaccines — the salve that experts say could ultimately quell the pandemic.

The colossal impact of the coronavirus is motivating the speed, opening a spigot of funding and inspiring research teams around the world to join the hunt. But the astonishing pace of the progress is also a consequence of the virus itself: It is, scientifically speaking, an easier target for potential vaccines than other pathogens, and a prime candidate for cutting-edge vaccine platforms new to scientists’ toolkits….

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This Is Supposed to Be Telemedicine’s Time to Shine. Why Are Doctors Abandoning It?

June 25, 2020

Telemedicine — the delivery of care by a clinician in one location to a patient in another — is seen as a vital component of the nation’s response to the Covid-19 pandemic. The Centers for Disease Control and Prevention and the World Health Organization have urged physicians and other health care providers to use telemedicine, and both the federal government and private health plans have implemented numerous temporary regulatory and payment changes to facilitate its use.

Physicians initially responded to these changes. Based on a sample of more than 50,000 clinicians who are clients of Phreesia, a health care technology company where two of us (D.L. and H.H.) work, we saw a sudden and dramatic rise in telemedicine (see the chart below). From almost no telemedicine visits before the pandemic struck in the U.S., by early April almost 14% of the usual weekly number of pre-pandemic visits were being conducted via telemedicine.

Telemedicine — the delivery of care by a clinician in one location to a patient in another — is seen as a vital component of the nation’s response to the Covid-19 pandemic. The Centers for Disease Control and Prevention and the World Health Organization have urged physicians and other health care providers to use telemedicine, and both the federal government and private health plans have implemented numerous temporary regulatory and payment changes to facilitate its use.

Physicians initially responded to these changes. Based on a sample of more than 50,000 clinicians who are clients of Phreesia, a health care technology company where two of us (D.L. and H.H.) work, we saw a sudden and dramatic rise in telemedicine (see the chart below). From almost no telemedicine visits before the pandemic struck in the U.S., by early April almost 14% of the usual weekly number of pre-pandemic visits were being conducted via telemedicine. The assumption among many was that, after witnessing the benefits of telemedicine, physicians and patients would embrace it and growth would continue….

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