From Stat

Biden Officials Rebuff Appeals to Surge Covid-19 Vaccine to Michigan Amid Growing Crisis

April 8, 2021

Amid Michigan’s worst-in-the-nation coronavirus surge, scientists and public health officials are urging the Biden administration to flood the state with additional vaccine doses.

So far, though, their plea has fallen on deaf ears. Instead, the federal government is sticking to a vaccine-allocation strategy that largely awards doses to states and territories based on their population. As a result, most jurisdictions are still receiving similar per-capita vaccine supplies, regardless of how many people there are getting sick — or how many excess vaccine doses they have.

Amid Michigan’s worst-in-the-nation coronavirus surge, scientists and public health officials are urging the Biden administration to flood the state with additional vaccine doses.

So far, though, their plea has fallen on deaf ears. Instead, the federal government is sticking to a vaccine-allocation strategy that largely awards doses to states and territories based on their population. As a result, most jurisdictions are still receiving similar per-capita vaccine supplies, regardless of how many people there are getting sick — or how many excess vaccine doses they have.

Experts have cast a surge in Michigan’s vaccine supply as a critical tool in combating the state’s most recent Covid-19 crisis. The state is currently recording nearly 7,000 new cases per day, just shy of its all-time peak in December. Hospitalizations and deaths, which tend to lag a few weeks behind increasing case counts, are also on the rise. …

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Behind the Scenes, Companies Helping Big Covid-19 Vaccine Makers Are Getting Rich

March 25, 2021

Pfizer and Moderna aren’t the only vaccine money-makers. Much of the revenue and profits from Covid-19 vaccines are flowing behind the scenes, going to the contract manufacturers and clinical-trial organizers that turn the shots from lab-bench theory to mass-produced reality.

Both AstraZeneca and Johnson & Johnson publicly committed to not profiting off their products during the pandemic — though AstraZeneca has reserved the right to declare the pandemic over on July 1, even if the World Health Organization has not. Pfizer and Moderna made no such pledge, with Pfizer expected to make $15 billion in vaccine-related revenue this year, while Moderna is forecasting $18.4 billion in vaccine sales.

Pfizer and Moderna aren’t the only vaccine money-makers. Much of the revenue and profits from Covid-19 vaccines are flowing behind the scenes, going to the contract manufacturers and clinical-trial organizers that turn the shots from lab-bench theory to mass-produced reality.

Both AstraZeneca and Johnson & Johnson publicly committed to not profiting off their products during the pandemic — though AstraZeneca has reserved the right to declare the pandemic over on July 1, even if the World Health Organization has not. Pfizer and Moderna made no such pledge, with Pfizer expected to make $15 billion in vaccine-related revenue this year, while Moderna is forecasting $18.4 billion in vaccine sales.

Contractors hired to test and manufacture these vaccines have enjoyed a share of the profits without the same level of public scrutiny….

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The Short-Term, Middle-Term, and Long-Term Future of the Coronavirus

March 4, 2021

When experts envision the future of the coronavirus, many predict that it will become a seasonal pathogen that won’t be much more than a nuisance for most of us who have been vaccinated or previously exposed to it.

But how long that process takes — and how much damage the virus inflicts in the interim — is still anyone’s guess.

“The most predictable thing about this coronavirus is its unpredictability,” said Howard Markel, a historian of medicine at the University of Michigan, who has studied other pandemics.

When experts envision the future of the coronavirus, many predict that it will become a seasonal pathogen that won’t be much more than a nuisance for most of us who have been vaccinated or previously exposed to it.

But how long that process takes — and how much damage the virus inflicts in the interim — is still anyone’s guess.

“The most predictable thing about this coronavirus is its unpredictability,” said Howard Markel, a historian of medicine at the University of Michigan, who has studied other pandemics.

However long it takes, the transition to a mild endemic virus is unlikely to be a straight line. Some infectious disease researchers envision a healthier summer — with low circulation of the virus and more people vaccinated — but a more tenuous fall. Other factors, like how long protection provided by vaccines will last, what percentage of people gets them, and whether variants of the virus sap the strength of vaccines, will determine the outcome….

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Pharma’s Ambitious New Antibiotic Venture Hires a CEO to Fix a ‘Broken’ Pipeline

February 18, 2021

Several months after a splashy announcement, an ambitious pharmaceutical industry venture to tackle antibiotic resistance has hired its first chief executive officer and received $140 million in additional funding commitments.

The AMR Action Fund, which was organized with $1 billion in pledged funds from nearly two dozen drug makers, tapped Henry Skinner, a venture capitalist and the former head of Novartis (NVS) Venture Funds, to pilot the project. The goal is to acquire or invest in small companies that can develop two to four novel antibiotics by 2030 and replenish the global supply chain with needed treatments.

Several months after a splashy announcement, an ambitious pharmaceutical industry venture to tackle antibiotic resistance has hired its first chief executive officer and received $140 million in additional funding commitments.

The AMR Action Fund, which was organized with $1 billion in pledged funds from nearly two dozen drug makers, tapped Henry Skinner, a venture capitalist and the former head of Novartis (NVS) Venture Funds, to pilot the project. The goal is to acquire or invest in small companies that can develop two to four novel antibiotics by 2030 and replenish the global supply chain with needed treatments.

“The value proposition is broken. The pipeline is not as robust as it should be and the access to capital to is extremely constrained, which is our job to fix,” said Skinner, a trained microbiologist who until recently, was a senior vice president for venture investments at Tekla Capital Management, which runs funds that invest in health care and life sciences….

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To the Delight of Generic Drug Makers, Federal Appeals Court Tosses Controversial ‘Skinny Labeling’ Decision

February 10, 2021

In a surprising move, a federal appeals court panel may revisit a controversial decision that has raised concerns about the ability of generic drug makers to supply Americans with lower-cost alternatives to pricey brand-name medicines.

At issue is an odd term with important implications: skinny labeling. The phrase refers to an effort by a generic company to seek regulatory approval to market its medicine for a specific use, but not other patented uses for which a brand-name drug is prescribed. For instance, a generic drug could be marketed to treat one type of heart problem, but not another. By doing so, the generic company seeks to avoid lawsuits claiming patent infringement….

In a surprising move, a federal appeals court panel may revisit a controversial decision that has raised concerns about the ability of generic drug makers to supply Americans with lower-cost alternatives to pricey brand-name medicines.

At issue is an odd term with important implications: skinny labeling. The phrase refers to an effort by a generic company to seek regulatory approval to market its medicine for a specific use, but not other patented uses for which a brand-name drug is prescribed. For instance, a generic drug could be marketed to treat one type of heart problem, but not another. By doing so, the generic company seeks to avoid lawsuits claiming patent infringement….

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